[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"systemic-lupus-erythematosus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:systemic-lupus-erythematosus":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,153,0,25,[9,42,71,93,117,144,171,198,226,245,277,303,333,362,390,417,439,458,479,502,522,543,572,594,623],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100632540","phase-2-a-study-of-e6742-in-participants-with-systemic-lupus-erythematosus-100632540",false,"NCT07515014","A Study of E6742 in Participants With Systemic Lupus Erythematosus","A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose Response Study to Evaluate the Efficacy and Safety of E6742 in Subjects With Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Male or female adult, age \\>=18 years (the minimum age may be different from 18 years in certain countries based on regional requirements) and \\\u003C=75 years at the time of informed consent\n2. Diagnosed with SLE at least 6 months before the informed consent AND fulfill the 2019 EULAR\u002FACR classification criteria at Screening based on medical history\n3. At least BILAG-2004 category A in \\>=1 organ system or BILAG-2004 category B in \\>=2 organ systems at screening\n4. SLEDAI-2K score \\>=6 points at Screening AND Clinical SLEDAI-2K score \\>=4 points at Baseline\n5. Receiving at least one of the following treatments for SLE (if more than 1 treatment is used, all medications must be within the dosage defined in the protocol):\n\n   1. OCS (\\\u003C=30 mg\u002Fday, prednisone or equivalent): The dosing regimen should be stable for at least 4 weeks before the first dose of study drug.\n   2. Oral hydroxychloroquine (\\\u003C=400 mg\u002Fday), quinacrine (\\\u003C=200 mg\u002Fday): These medications should have been initiated or discontinued at least 12 weeks before the first dose of study drug, and the dosing regimen should remain stable for at least 8 weeks before the first dose.\n   3. Immunosuppressants: The following medications should have been initiated or discontinued at least 12 weeks before the first dose of study drug, and the dosing regimen should remain stable for at least 8 weeks before the first dose\n\n      * Mycophenolate mofetil (\\\u003C=3 g\u002Fday)\n      * Mycophenolate sodium (\\\u003C=2160 mg\u002Fday)\n      * Azathioprine (\\\u003C=200 mg\u002Fday)\n      * 6-mercaptopurine (\\\u003C=100 mg\u002Fday)\n      * Methotrexate (oral\u002Fsubcutaneous\u002Fintramuscular) (\\\u003C=25 mg\u002Fweek)\n6. Willing and able to provide written informed consent and comply with all aspects of the protocol\n\nExclusion Criteria\n\n1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin \\[ß-hCG\\] or human chorionic gonadotropin \\[hCG\\] test). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.\n2. Females of childbearing potential who:\n\n   1. Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:\n\n      * Total abstinence (if it is their preferred and usual lifestyle)\n      * An intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)\n      * A contraceptive implant\n      * Combined estrogen and progestogen-containing hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception associated with inhibition of ovulation, such as desogestrel (oral, injectable). Participants using hormonal contraceptives must be on a stable dose of the same contraceptive product for at least 28 days before dosing, throughout the study, and for at least 28 days following study drug discontinuation.\n      * Have a vasectomized partner with confirmed azoospermia\n   2. Do not agree to use a highly effective method of contraception throughout the entire study period and for 28 days after study drug discontinuation.\n   3. Participants on an oral contraceptive must use an additional barrier method throughout the study and for 28 days after study drug discontinuation.\n3. Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners meet the exclusion criteria above (ie, the female partners are of childbearing potential and are not willing to use a highly effective contraceptive method throughout the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation). No sperm donation is allowed during the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation.\n4. Drug-induced lupus erythematosus\n5. Active or unstable neuropsychiatric lupus (including but not limited to any condition defined by BILAG category A in neuropsychiatric organ system)\n6. Systemic autoimmune diseases other than SLE (eg, rheumatoid arthritis, Crohn's disease, systemic sclerosis \\[SSc\\], multiple sclerosis, polymyositis\u002F dermatomyositis \\[PM\u002FDM\\]) that may affect the assessment of SLE pathology at Screening. The participants with the following diseases may be included in the study\n\n   * Sjögren's syndrome secondary to SLE\n   * Antiphospholipid antibody syndrome (APS) secondary to SLE\n   * Mixed Connective Tissue Disease (MCTD) not meeting diagnostic criteria for PM and SSc\n7. Any clinically significant symptom or organ impairment found by chest X-ray, ophthalmic examination, vital signs, or ECG finding at Screening or Baseline, laboratory test at Screening that in the opinion of the investigator could affect the participants safety or interfere with the study assessments.\n8. Laboratory test results meeting any of the following criteria at Screening:\n\n   * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3× upper limit of normal (ULN)\n   * Absolute neutrophil count (ANC) \\\u003C1,000 \u002FmcL\n   * Platelet count \\\u003C50,000 \u002FmcL\n   * Hemoglobin \\\u003C8.0 g\u002FdL\n9. Renal impairment falling under any of the following criteria at Screening:\n\n   * Urine protein\u002Fcreatinine ratio \\>2.0 g\u002FgCr\n   * Estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \\[MDRD\\]) \\\u003C40 mL\u002Fmin\u002F1.73 m\\^2\n10. Received vaccination within 2 weeks before the first dose of study drug (4 weeks before in case of live\u002F live attenuated vaccines)\n11. Currently or previously receiving gene therapy for SLE (eg, CAR-T cell therapy)\n12. Currently enrolled in another clinical study or used any investigational drug or device (including E6742) within 28 days (or 5× the half-life, whichever is longer) before obtaining informed consent\n13. Any history of the following clinically significant infections:\n\n    * Infections requiring hospitalization or intravenous antibiotics, or administration of antiviral drugs, within 4 weeks before the first dose of study drug\n    * Active tuberculosis\n14. Any findings indicating a history of tuberculosis on chest X-ray at Screening\n15. Positive or repeated hold (indeterminate or intermediate) in tuberculosis test (Interferon-γ release assays) at Screening\n16. A prolonged QTc interval calculated using Fridericia's formula (QTcF) greater than 450 millisecond (ms) according to central reading at Screening. If the QTcF machine read is greater than 440 ms on the first single 12-lead ECG, 2 additional 12-lead ECGs will be performed 1 minute apart and the mean of the 3 QTcF values will be used for evaluation.\n17. A prolonged QTcF interval (mean QTcF \\>450 ms) as demonstrated by triplicated ECGs at Baseline. Has any risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT Syndrome) or the use of concomitant medications that prolonged the QTcF interval (excluding hydroxychloroquine).\n18. Hypersensitivity to the study drug, drug product chemical derivate or any of the excipients at Screening\n19. Any history of or concomitant medical condition that in the opinion of the investigators would compromise the participants ability to safely complete the study\n20. Planned surgery that requires general, spinal, or epidural anesthesia that would take place during the study. Planned surgery which requires only local anesthesia and that can be undertaken as a day case without inpatient stay postoperatively need not result in exclusion if in the opinion of the investigator this operation does not interfere with study procedures and participant safety\n21. Positive on test at Screening for human immunodeficiency virus (HIV)\n22. Positive on test at Screening for hepatitis B virus (HBV) with a detectable (eg, hepatitis B virus surface \\[HBs\\] antigen reactive, HBs antibody, hepatitis B virus core \\[HBc\\] antibody, HBV deoxyribose nucleic acid (DNA)) or hepatitis C virus (HCV) with a detectable (eg, HCV ribonucleic acid (RNA) \\[qualitative\\], HCV antibody) viral load\n23. Psychotic disorders or unstable recurrent affective disorders evident by use of antipsychotics within 2 years before Screening\n24. History of drug or alcohol dependency or abuse within 2 years before Screening\n25. History or concurrent of malignancy, lymphoma, leukemia, or lymphoproliferative disease (except for basal cell skin cancer, squamous cell skin cancer, and cervical cancer that have been cured by surgical operation)\n26. Assessed to be inappropriate for clinical study by investigators","ALL","18 Years","75 Years",{"count":21,"type":22},256,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The main purpose of the study is to demonstrate the efficacy based on dose response of E6742 compared with placebo as defined by the proportion of participants achieving a response using the British Isles Lupus Assessment Group (BILAG) based Composite Lupus Assessment (BICLA) with a low dose of oral corticosteroids (OCS) (prednisone or equivalent) at Week 24 in participants with systemic lupus erythematosus (SLE).",[28],"Systemic Lupus Erythematosus","RECRUITING","2026-07-01",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2026-03-31",{"date":37,"type":22},"2029-03-01",{"name":39,"class":40},"Eisai Co., Ltd.","INDUSTRY",41,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100608438","phase-1-study-evaluating-safety-tolerability-pkpd-of-surovatamig-in-adult-ra-or-sle-participants-100608438","NCT07201558","Study Evaluating Safety, Tolerability, PK\u002FPD of Surovatamig in Adult RA or SLE Participants","An Open-label, Phase I Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Surovatamig Following Single-ascending Dose and Step-up Dose Administration to Adult Participants With Rheumatoid Arthritis or Systemic Lupus Erythematosus","ASSURO","Inclusion Criteria:\n\n1. Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 65 years of age, inclusive, at the time of signing the informed consent.\n2. For RA participants, only:\n\n\u003C!-- -->\n\n1. Diagnosis of RA as defined by the 2010 EULAR\u002FACR classification criteria\n2. Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory.\n\n   (a) RF (b) ACPA\n3. Moderate or severe disease activity defined as:\n\nDAS28-CRP \\> 3.2 AND\n\n* 4 tender joints and ≥ 4 swollen joints\n\n  (a) US-Specific Criterion: DAS28-CRP \\> 3.2 AND ≥ 6 tender joints and ≥ 6 swollen joints 4. Intolerance to or inadequate response following approximately 3 month's treatment or longer to ≥2 b\u002FtsDMARDs (with different mechanisms of action) after failing csDMARD therapy (unless csDMARD therapy is contraindicated). There is no minimum duration for taking a treatment in cases of intolerance.\n\n  5\\. Background standard of care is not a requirement for participation, however, the following therapies are permitted and may be continued during the study (alone or in combination). Any other systemic immunosuppressive treatment or immune modulating biologic drug must be discontinued in line with the washout periods listed in Inclusion Criterion 12:\n\n  (a) Oral prednisone (or equivalent). Dose must be stable and ≤ 10mg a day for ≥ 2 weeks prior to Day 1. (b) Oral anti-malarial (e.g. hydroxychloroquine ≤ 400 mg a day). Dose must be stable for ≥ 4 weeks prior to Day 1. (c) Treatment with one of the following csDMARDs for ≥ 3 months and at a stable dose for ≥ 4 weeks prior to Day 1. (i) Methotrexate ≤ 25 mg per week, without change of route of administration for 8 weeks prior to Day 1 (ii) Sulfasalazine ≤ 3g\u002Fday (iii) Leflunomide ≤ 20 mg\u002Fday 3. For SLE participants, only:\n  1. Diagnosis of SLE as defined by the 2019 EULAR\u002FACR classification criteria\n  2. Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory. If autoantibodies are negative on central laboratory test, documented history of test results may be used. (a) ANA immunofluorescent assay test (titer ≥ 1:80) (a) Anti-dsDNA (b) Anti-Sm.\n  3. Moderate or severe disease activity defined as clinical SLEDAI-2K \\> 4\n\n     (a) US-specific criterion: clinical SLEDAI-2K ≥ 6\n  4. Intolerance to or inadequate response following approximately 3 months treatment or longer ≥ 3 SoC (includes: corticosteroids, anti-malarial drugs, calcineurin inhibitor, methotrexate, azathioprine, leflunomide, mycophenolic acid or its derivatives, cyclophosphamide, belimumab, anifrolumab, telitacicept, or B-cell depleting monoclonal antibodies). There is no minimum duration for taking a treatment in cases of intolerance.\n  5. Background standard of care is not a requirement for participation, however, the following therapies are permitted and may be continued during the study (alone or in combination). Any other systemic immunosuppressive treatment or immune modulating biologic drug must be discontinued in line with the washout periods listed in Inclusion Criterion 12: (a) Oral prednisone (or equivalent. Dose must be stable and ≤ 20mg a day for ≥ 2 weeks prior to Day 1. (b) Oral anti-malarial (eg, hydroxychloroquine ≤ 400 mg a day). Dose must be stable for ≥ 4 weeks prior to Day 1. (c) Treatment with one of the following immunosuppressive treatments. for ≥ 3 months and at a stable dose for ≥ 4 weeks prior to Day 1. (i) Methotrexate ≤ 25 mg\u002Fweek, without change of route of administration for 8 weeks prior to Day 1 (ii) Mycophenolate mofetil or equivalent ≤ 2 g\u002Fday (dose must be ≤ 2 g\u002Fday for 3 months prior to Day 1) (iii) Azathioprine ≤ 200 mg\u002Fday (iv) Leflunomide ≤ 20 mg\u002Fday (v) Tacrolimus ≤ 0.1 mg\u002Fkg\u002Fday with maximum dose of 5 mg\u002Fday (vi) Cyclosporin ≤ 3 mg\u002Fkg\u002Fday with maximum dose of 200 mg\u002Fday\n\n  4\\. Blood B cells ≥ 50 cells\u002FμL at screening. 5. IgG levels ≥ 6 g\u002FL at screening. 6. Eligibility for re-treatment of previously treated participants only. The following criterion applies only to participants being considered for re-treatment and is not applicable to participants undergoing initial screening for study entry.\n\n  1\\. Participants treated in prior study cohorts who did not experience an IMP-related DLT or discontinue treatment and\u002For participation due to an IMP-related AE are eligible for re-treatment in Parts 2 and 3. Participants must otherwise meet all protocol-defined eligibility criteria, with the exception of Inclusion Criterion 17 (B cell count), and meet one of the 2 criteria below:\n  1. Completed the 6-month treatment period OR\n  2. Completed a minimum of 90 days in the treatment period and have peripheral B cell counts that are ≥ 90% of baseline or above lower limit of normal (LLN)\n\n     Exclusion Criteria:\n     1. Any complications of disease under study that are judged by the Investigator to be life or organ threatening or to require treatments which are not permitted in the protocol, including but not limited to: (a) Active severe SLE-driven renal disease. (b) Severe lung or cardiac involvement. (c) History of, or current diagnosis of, catastrophic or severe APS (eg, diagnosis of an arterial or central\u002Fpulmonary venous clot) within 1 year prior to signing the ICF. Participants with clinically evident APS which is adequately controlled by anticoagulants or aspirin for at least 12 weeks can be recruited into the study. (d) Rapidly progressive and\u002For severe ILD or ILD that requires oxygen supplementation\u002Ftherapy (of any type). (e) Felty's syndrome\n     2. History of HLH\u002FMAS.\n     3. For RA participants, only:\n\n     \u003C!-- -->\n\n     1. Juvenile idiopathic arthritis or idiopathic arthritis diagnosed before the age of 16.\n     2. Axial spondylarthritis or any other disease associated with inflammatory arthritis\n\n     4\\. For SLE participants, only:\n\n     1.History of active, severe or unstable neuropsychiatric SLE, except for headache and peripheral neuropathies. 5. Other active or prior documented severe, complex, autoimmune or inflammatory disorders. Exceptions to this exclusion criteria include: (a) Vitiligo or alopecia (b) Hypothyroidism stable on hormone replacement (c) Controlled type I diabetes mellitus on insulin (d) Any chronic skin condition that does not require systemic immunosuppressant or biologic therapy (e) Celiac disease, controlled by diet alone (f) Participants with secondary Sjögren's disease are eligible provided that immunosuppression is primarily prescribed for the disease under study (ie, SLE or RA) and not for secondary Sjögren's. 6. Significant CNS co-morbidity (eg, Parkinson's, stroke, CNS vasculitis, severe brain injury, dementia, neurodegenerative diseases, cerebellar disease, epilepsy\u002Fseizure disorders, PML, severe uncontrolled mental illness, psychosis, CNS involvement of autoimmune diseases).\n\n     7\\. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection.\n\n     8\\. Exclusion Criteria Related to Infection:\n\n     1\\. Any clinical suspicion or diagnosis of active infection at screening. 2. Opportunistic infection that meets criteria to be an SAE within 3 years. 3. Clinically significant chronic infection (for example osteomyelitis, bronchiectasis) with treatment completed less than 2 months prior to signing the ICF (except for chronic nail infections which are not exclusionary) 4. Any infection requiring hospitalisation or treatment with IV anti-infectives with treatment completed less than 4 weeks prior to signing the ICF.\n\n     5\\. Any infection requiring oral anti-infectives within 2 weeks prior to signing the ICF.\n\n     6\\. History of recurrent infection requiring hospitalisation or IV antibiotics (eg, 3 or more of the same type of infection, including systemic fungal infections, over the previous 52 weeks).\n\n     9\\. Participants who, as judged by the Investigator, have evidence of active TB, or latent TB or have a household contact with known diagnosis of current active TB.\n\n  \u003C!-- -->\n\n  1. TB evaluation will be performed according to the local SoC as determined by local guidelines and may include history and physical examinations, chest X-ray, or TB test (eg, purified protein derivative or QuantiFERON® test).\n  2. Participants with a prior diagnosis of active or latent TB who have documented evidence they have completed a full course of appropriate treatment are not excluded.\n\n     However, a previous history of multidrug-resistant or extensively drug-resistant TB is exclusionary regardless of treatment status. 10. Participant with human immunodeficiency virus infection (confirmed by central laboratory at screening) 11. Participant with active EBV or CMV, assessed clinically. 12. Participant with evidence of chronic or active hepatitis B defined as HBsAg positive or HBcAB positive (tested at screening visit).\n\n     13\\. Participant with evidence of chronic or active Hepatitis C, meeting any of the criteria below: (a) HCV RNA positive or detectible at screening (b) HCV antibody positive at screening (apart from those with negative HCV RNA \\>12 weeks after completion of curative antiviral treatment for HCV or those with sustained negative HCV RNA 12 weeks apart following resolution of HCV infection if not treated).\n\n     14\\. Participant positive with COVID-19 PCR at screening. If patients test positive at screening or Day 1 but meet other eligibility criteria, they may be re-tested after ≥ 2 weeks. If this falls within the screening window, then they do not require re-screening.\n\n     15\\. Receipt of any of the following treatments or interventions ever: (a) TCEs, with the exception of surovatamig under the conditions specified in Inclusion Criterion 19 (b) Bone marrow transplant (c) Stem cell transplant (d) Total lymphoid irradiation (e) CAR-T cell therapy (f) Alemtuzumab 16. For females only - currently pregnant (confirmed with positive pregnancy test), planning to become pregnant within the study period, or breast feeding.","65 Years",{"count":52,"type":22},48,[54],"PHASE1","This open-label, Phase I study will assess the safety and tolerability of surovatamig and characterise its PK and PD following subcutaneous administration to participants with RA or SLE.",[57,28],"Rheumatoid Arthritis",[59,60,61,62],"adult participants","rheumatoid arthritis","systemic lupus erythematosus","surovatamig",{"date":32,"type":33},{"date":65,"type":33},"2025-12-02",{"date":67,"type":22},"2028-06-27",{"name":69,"class":40},"AstraZeneca",33,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100641531","phase-1-a-study-to-assess-adverse-events-how-the-drug-moves-through-the-body-and-effectiveness-of-intravenous-infusions-and-subcutaneous-injections-of-abbv-519-in-adult-participants-with-systemic-lupus-erythematosus-sle-or-rheumatoid-arthritis-ra-100641531","NCT07607964","A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions and Subcutaneous Injections of ABBV-519 in Adult Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)","A Phase 1, First-in-Human, Single Ascending Dose, Open-label, Non-randomized Study Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of ABBV-519 in Subjects With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)","Inclusion Criteria:\n\nKey Inclusion Criteria:\n\n* Individuals between 18 and 75 years of age inclusive at the time of Screening.\n* Minimum baseline B-cell count of 50 cells\u002FmcL.\n\nInclusion Criteria for SLE Participants:\n\n* Clinical diagnosis of SLE and fulfilling the 2019 EULAR\u002FACR classification criteria.\n* Positive ANA ≥ 1:80 and the presence of at least one of the following autoantibodies above the upper limit of normal (ULN): anti-double-stranded DNA (dsDNA), anti-Smith (Sm), anti-ribonucleoprotein (RNP), or anti-Sjogren's syndrome antigen A (SSA).\n* Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score of ≥ 4 (excluding anti-dsDNA and C3\u002FC4). Lupus headache or organic brain syndrome do not count towards the hSLEDAI points required for eligibility.\n* Participants must have an inadequate response to ≥ 1 immunosuppressant therapies, used for at least 3 months.\n\nInclusion Criteria for RA Participants:\n\n* Clinical diagnosis of RA and fulfilling the 2010 ACR\u002FEULAR classification criteria for RA.\n* Presence of rheumatoid factor (RF) or anti-citrullinated peptide antibodies (ACPA) above the ULN.\n* Presence of at least 6 swollen and 6 tender joints\n* High-sensitivity C-reactive protein (hs-CRP) ≥ 3 mg\u002FL.\n* Failed at least 1 conventional synthetic disease-modifying antirheumatic drug (DMARD) and ≥ 1 biological or targeted DMARDs of different classes.\n\nExclusion Criteria:\n\nKey Exclusion Criteria:\n\n* Participants with a history of infection.\n* Participants with uncontrolled hypertension\n\nExclusion for SLE Participants:\n\n* Active neuropsychiatric SLE, or signs or symptoms of neuropsychiatric SLE within the 6 months prior to Screening (lupus headache permissible).\n\n  \\- Unstable or progressive glomerulonephritis (active class III or IV).\n* SLE overlap syndromes including, but not limited to RA, Sjogren's disease (SjD), SSc, polymyositis, dermatomyositis, or mixed connective tissue disease.\n\nExclusion for RA Participants:\n\n\\-- History of RA overlap syndromes, including but not limited to SLE, SjD, scleroderma, mixed connective tissue disorder or polymyositis.",{"count":79,"type":22},30,[54],"Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity.\n\nRheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety of ABBV-519 in adult participants with SLE or RA.\n\nThis is a single ascending dose study in an estimated 30 adult participants with moderate SLE or RA. The total duration of the study will be approximately 425 days (60-day Screening Period, 1-day Treatment Period, and a 52 week Follow-up Period) at approximately 15 to 20 sites globally.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[28,57],[28,57],"2026-06-29",{"date":30,"type":33},{"date":87,"type":33},"2026-05-28",{"date":89,"type":22},"2029-01",{"name":91,"class":40},"AbbVie",10,{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"100640944","phase-2-a-study-to-evaluate-mosunetuzumab-in-participants-with-systemic-lupus-erythematosus-with-or-without-active-lupus-nephritis-100640944","NCT07598396","A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis","A Phase II Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Mosunetuzumab in Patients With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis","SOLUNA","Inclusion Criteria:\n\n* Diagnosis of SLE for ≥ 6 months as assessed using the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) Classification Criteria at screening\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required\n* Treatment with investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment and during the study\n* Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening, or any planned surgery or procedure requiring hospitalization during the 12 weeks following study drug administration\n* Alcohol or substance abuse within the 12 months prior to screening\n* Active infection of any kind, excluding fungal infection of the nail beds\n* Any major episode of infection as defined by the protocol\n* History of serious recurrent or chronic infection\n* History of progressive multifocal leukoencephalopathy (PML)\n* Tuberculosis (TB) infection\n* History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the past 5 years\n* Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within the 12 months prior to screening or during screening\n* Catastrophic or severe antiphospholipid syndrome within the 12 months prior to screening or during screening. Antiphospholipid syndrome adequately controlled by anticoagulant therapy for at least 2 months prior to screening is acceptable\n* High risk for clinically significant bleeding or any condition requiring plasmapheresis, IV immunoglobulin, or acute blood product transfusions\n* Active severe or unstable lupus-associated neuropsychiatric disease or where, in the opinion of the investigator, it is likely to require treatment with protocol-disallowed therapies. Examples of neuropsychiatric SLE manifestations include, but are not limited to the following: meningitis, retinitis, cerebral vasculitis, myelopathy, demyelination syndromes, acute confusional state, psychosis, acute stroke or stroke syndrome, cranial neuropathy, status epilepticus or seizures, cerebellar ataxia, and mononeuritis multiplex\n* History of any non-SLE disease treated with oral, intravenous, or intramuscular corticosteroids for more than 14 days in total during the one year prior to Day 1\n* History of treatment with any T cell-engaging bispecific antibodies or CAR-T therapy within the past 2 years\n* Receipt of any live or attenuated vaccine in the 28 days prior to or during screening",{"count":79,"type":22},[25],"This study will assess how mosunetuzumab works in people who have systemic lupus erythematosus (SLE) who may or may not also have active lupus nephritis (LN).",[105,28,106],"Lupus","Lupus Nephritis","2026-06-26",{"date":109,"type":33},"2026-06-30",{"date":111,"type":33},"2026-05-25",{"date":113,"type":22},"2028-08-31",{"name":115,"class":40},"Hoffmann-La Roche",15,{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":124,"targetDuration":4,"studyType":23,"phases":125,"briefSummary":127,"conditions":128,"keywords":133,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":135,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":143},"100633412","early-phase-1-mts109-in-patients-with-refractory-autoimmune-diseases-100633412","NCT07526350","MTS109 in Patients With Refractory Autoimmune Diseases","A Study on the Safety, Tolerability and Efficacy of MTS109 Injection in the Treatment of Moderate to Severe Refractory Autoimmune Diseases, an Investigator-Initiated Trial","Inclusion Criteria:\n\n1\\) The subject or his\u002Fher legal representative has voluntarily signed a written informed consent form and is willing and able to comply with study procedures. 2) Aged 18 to 65 years (inclusive) at the time of signing the informed consent form, with no gender restriction.\n\n3\\) Subjects with SLE must meet the following criteria: a) Meet the 2019 EULAR\u002FACR classification criteria for systemic lupus erythematosus (SLE); b) SLEDAI-2K score ≥6, with at least 1 BILAG-2004 organ domain score of Grade A (severe manifestation) or 2 Grade B (moderate manifestation), or both; or SLEDAI-2000 score ≥8; c) Meet the definition of refractory and relapsing disease: inadequate response to conventional therapy for more than 6 months, or disease flare after remission. Conventional therapy is defined as: glucocorticoids plus at least 2 of the following immunomodulatory agents: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, and telitacicept.\n\n4\\) Subjects with idiopathic inflammatory myopathy (IIM) must meet the following criteria: a) Meet the 2017 EULAR\u002FACR classification criteria for idiopathic inflammatory myopathies (including dermatomyositis \\[DM\\], polymyositis \\[PM\\], anti-synthetase syndrome \\[ASS\\], and necrotizing myopathy \\[NM\\]); b) Positive for myositis-specific antibodies; c) Moderate-to-severe IIM during screening, defined as: MMT-8 ≥142 with active interstitial lung disease (ILD) (ground-glass opacity on HRCT); OR MMT-8 \\\u003C142 and at least 2 of the following: Physician's Global Assessment (PGA, VAS) ≥2 cm (10-cm VAS scale); Patient's Global Assessment (PtGA, VAS) ≥2 cm (10-cm VAS scale); Health Assessment Questionnaire Disability Index (HAQ-DI) \\>0.25; One or more muscle enzymes (CK, LDH, AST, ALT) ≥1.5 × upper limit of normal (ULN); d) Meet the definition of refractory, relapsing, or progressive disease: Refractory: inadequate response to conventional therapy for more than 6 months, or disease flare after remission; conventional therapy as defined for SLE; Progressive: worsening myositis or rapidly progressive interstitial lung disease.\n\n5\\) Subjects with systemic sclerosis (SSc) must meet the following criteria: a) Meet the 2013 ACR classification criteria for systemic sclerosis; b) Positive for SSc-related specific antibodies; c) Meet the definition of refractory or progressive disease: Refractory: inadequate response to conventional therapy for more than 6 months, or disease flare after remission; conventional therapy as defined for SLE; Progressive: rapid skin progression (increase in mRSS \\>25%); or progressive lung disease (decrease in FVC ≥10%, or decrease in FVC \\>5% with decrease in DLCO ≥15%).\n\n6\\) Subjects with ANCA-associated vasculitis (AAV) must meet the following criteria: a) Meet the 2022 ACR\u002FEULAR classification criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis; b) Positive for ANCA-associated antibodies (MPO-ANCA or PR3-ANCA); c) Birmingham Vasculitis Activity Score (BVAS) ≥15 (total score 63), indicating active vasculitis; d) Meet the definition of refractory: inadequate response to conventional therapy for more than 6 months, or disease flare after remission; conventional therapy as defined for SLE.\n\n7\\) Subjects with Sjögren's syndrome (SS) must meet the following criteria: a) Meet the 2002 AECG criteria for primary Sjögren's syndrome or the 2016 ACR\u002FEULAR classification criteria; b) Disease activity ESSDAI ≥6; c) Positive for anti-SSA\u002FRo antibody; d) Meet the definition of refractory: inadequate response to conventional therapy for more than 6 months, or disease flare after remission; conventional therapy as defined for SLE.\n\n8\\) Screening laboratory results meet the following criteria (excluding abnormalities related to the study disease): a) Neutrophil count ≥1.5 ×10⁹\u002FL; b) Hemoglobin ≥80 g\u002FL; platelet count ≥50 ×10⁹\u002FL; c) Alanine aminotransferase (ALT) ≤3 × ULN; aspartate aminotransferase (AST) ≤3 × ULN (unless elevation is judged by the investigator to be related to PM or DM); total bilirubin (TBIL) \\\u003C2 × ULN (for subjects with Gilbert syndrome, direct bilirubin \\[DBIL\\] ≤1.5 × ULN); d) Creatinine clearance ≥30 mL\u002Fmin; e) Activated partial thromboplastin time (APTT) ≤1.5 × ULN; prothrombin time (PT) ≤1.5 × ULN; f) Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%, with no clinically significant electrocardiogram (ECG) abnormalities; g) Baseline oxygen saturation \\>92% while breathing room air.\n\n9\\) Female subjects of childbearing potential: negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening.\n\n10\\) Male subjects with female partners and female subjects of childbearing potential agree to use effective contraceptive methods (e.g., oral contraceptives, intrauterine device, condom) from screening until at least 1 year after the last dose of MTS109.\n\nExclusion Criteria:\n\n1. SLE subjects: a) Drug-induced SLE; b) Subjects with lupus crisis, or who require medications prohibited by the protocol due to comorbidities, or who are considered ineligible by the investigator.\n2. IIM subjects: a) Subjects with documented inclusion body myositis (IBM), drug-induced PM or DM, malignancy-associated PM or DM, or non-inflammatory myopathy (e.g., muscular dystrophy); b) Uncontrolled extramuscular involvement related to PM or DM: ILD: FVC \\\u003C55% or requiring oxygen therapy (FVC ≥55% to be evaluated for eligibility by the lead investigator); Severe dysphagia that, in the investigator's judgment, would increase subject risk by participating in the clinical trial; Severe cardiac manifestations (e.g., congestive heart failure, arrhythmia, treatable conduction abnormality, or myocardial infarction) that, in the investigator's judgment, would increase subject risk by participating in the clinical trial.\n3. SSc subjects: a) Uncontrolled severe pulmonary arterial hypertension (PAH) related to SSc; b) Rapidly progressive lower gastrointestinal tract (small and large intestine) involvement related to SSc requiring parenteral nutrition; active gastric antral vascular ectasia; c) Uncontrolled or rapidly progressive ILD with oxygen saturation (SaO2) \\\u003C92% on room air; or requiring mechanical ventilatory support within 1 year prior to signing informed consent.\n4. AAV subjects: a) Crescentic glomerulonephritis, acute polyneuritis, or central nervous system (CNS) involvement other than AAV at screening; b) Life-threatening severe vasculitis (including diffuse alveolar hemorrhage, respiratory failure, intestinal perforation or massive bleeding, cerebral vasculitis, cardiac vasculitis, etc.); c) Secondary vasculitis (e.g., SLE, Henoch-Schönlein purpura, drug-induced, malignancy-associated, infection-induced, primary immunodeficiency, etc.).\n5. SS subjects: a) Poorly controlled severe systemic primary Sjögren's syndrome (pSS) manifestations at baseline that, in the investigator's assessment, may place the subject at excessive risk; b) Secondary Sjögren's syndrome with other confirmed autoimmune diseases (e.g., rheumatoid arthritis, SLE, scleroderma, inflammatory bowel disease); c) Subjects requiring regular use of medications known to cause dry mouth\u002Fdry eye as common major side effects; d) Subjects with other diseases that may interfere with efficacy assessment of primary Sjögren's syndrome, such as inflammatory bowel disease, gout, sarcoidosis, amyloidosis, IgG4-related disease, etc. All subjects:\n6. Subjects with a history of severe hypersensitivity or anaphylaxis;\n7. Subjects with contraindications or hypersensitivity to any component of the investigational product;\n8. Subjects with any of the following cardiac diseases: a) New York Heart Association (NYHA) Class III or IV congestive heart failure; b) Myocardial infarction or coronary artery bypass grafting within 6 months prior to screening; c) Clinically significant ventricular arrhythmia at screening, history of unexplained syncope not due to vasovagal reaction or dehydration, corrected QT interval (QTc) \\>480 ms, or history of severe non-ischemic cardiomyopathy;\n9. Subjects with any active malignancy or history of malignancy within 5 years prior to screening, excluding: early-stage tumors treated with curative intent (carcinoma in situ or Stage I tumor, non-ulcerated primary melanoma \\\u003C1 mm depth without lymph node involvement), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, or breast carcinoma in situ treated with potentially curative therapy;\n10. Subjects with any other known autoimmune disease other than the study disease;\n11. Subjects requiring long-term use of anticoagulants affecting coagulation function;\n12. Subjects with clinically significant bleeding symptoms or obvious bleeding tendency within 6 months prior to screening, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.; hereditary or acquired bleeding and thrombotic tendency (e.g., hemophilia, coagulopathy, hypersplenism, etc.); subjects with arterial or venous thrombotic events within 6 months prior to screening, such as cerebrovascular disease (including cerebral hemorrhage, cerebral infarction, etc.), deep vein thrombosis and\u002For pulmonary embolism;\n13. Subjects with any severe underlying disease at screening, e.g.: a) Evidence of uncontrolled infection or viral, bacterial, fungal, or other infection treated with systemic intravenous antibiotics; b) Evidence of clinically significant dementia or altered mental status; c) History of any other central nervous system disease or neurodegenerative disease, such as epilepsy, seizure, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, psychosis;\n14. Subjects with positive screening results for any of the following: a) Positive human immunodeficiency virus (HIV) antibody; b) Positive hepatitis B surface antigen (HBsAg); or positive hepatitis B core antibody (HBcAb) with HBV-DNA above the lower limit of detection of the assay; c) Positive hepatitis C virus (HCV) antibody with HCV RNA above the lower limit of detection of the assay; d) Active syphilis (excluding false-positive due to disease);\n15. Subjects with positive plasma cytomegalovirus (CMV) DNA or plasma Epstein-Barr virus (EBV) DNA (viral active);\n16. Subjects with active tuberculosis or untreated latent tuberculosis prior to screening;\n17. Subjects who received other investigational drugs within 4 weeks prior to signing informed consent form (ICF), or for whom the time from the last dose of a previous investigational drug to the date of signing ICF is less than 5 elimination half-lives of that drug (whichever is longer);\n18. Subjects who received plasmapheresis or immunoadsorption therapy within 4 weeks prior to dosing;\n19. Subjects who received B-cell targeted therapy within 6 months prior to dosing, including but not limited to belimumab, telitacicept, etc.;\n20. Subjects who received biologic therapy such as anti-TNF-α antibody within 12 weeks prior to dosing;\n21. Subjects who received tacrolimus, cyclosporine, azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate, etc., within 2 weeks prior to dosing;\n22. Subjects who received neonatal Fc receptor (FcRn) antagonist therapy (e.g., efgartigimod) within 3 weeks prior to dosing;\n23. Subjects who received complement inhibition therapy (e.g., eculizumab) within 3 weeks prior to dosing;\n24. Subjects who received live attenuated vaccine or mRNA vaccine within 8 weeks prior to enrollment, or inactivated vaccine within 2 weeks prior to enrollment;\n25. Subjects who underwent major surgery within 8 weeks prior to screening or plan to undergo surgery during the study;\n26. Subjects with a history of organ\u002Fbone marrow\u002Fperipheral blood\u002Fumbilical cord blood transplantation;\n27. Subjects who previously received CAR-T product therapy targeting any target;\n28. Subjects with any condition that, in the investigator's judgment, may prevent completion of the entire study, interfere with study results, or make participation in the study not in the subject's best interest.",{"count":116,"type":22},[126],"EARLY_PHASE1","This is the first-in-human trial of MTS109 (mRNA-LNP). The goal of this clinical trial is to evaluate the safety, tolerability of intravenous injection of MTS109 in moderate to severe autoimmune diseases.",[28,129,130,131,132],"Idiopathic Inflammatory Myopathies","Systemic Sclerosis (SSc)","ANCA-Associated Vasculitis (AAV)","Sjogren's Syndrome (SS)",[134],"MTS109",{"date":109,"type":33},{"date":137,"type":33},"2026-03-24",{"date":139,"type":22},"2029-04-01",{"name":141,"class":142},"Shanghai Changzheng Hospital","OTHER",1,{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":152,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":155,"phases":4,"briefSummary":156,"conditions":157,"keywords":160,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":143},"100632588","immun4cure-cohort-of-autoimmune-diseases-100632588","NCT07515638","Immun4Cure Cohort of Autoimmune Diseases","Prospective Cohort Study of Clinical and Biological Data in Patients With Autoimmune Diseases (Immun4Cure Cohort)","Immun4Cure","Inclusion Criteria Participants:\n\nGroup 1: RA\n\n* Adults ≥18 years\n* Patient followed as part of their MAI in one of the departments participating in the study at UHM\n* Confirmed diagnosis according to international criteria :ACR\u002FEULAR 2010\n\nGroup 2: LES\n\n* Adults ≥18 years\n* Patient followed as part of their MAI in one of the departments participating in the study at UHM\n* Confirmed diagnosis according to international criteria :ACR\u002FEULAR 2019\n\nGroup 3: SSc\n\n* Adults ≥18 years\n* Patient followed as part of their MAI in one of the departments participating in the study at UHM\n* Confirmed diagnosis according to international criteria :ACR\u002FEULAR 2013\n\nGroup 4: Healthy Controls\n\n* Adults ≥18 years\n* No symptoms of autoimmune disease\n* No first-degree family history of autoimmune disease\n\nExclusion Criteria (all groupes):\n\n* Patients who have refused or are unable to give informed consent\n* Inability to follow the subject during the study period\n* Participation in another interventional study that includes an exclusion period that is still ongoing\n* Pregnant women\n* Not affiliated with a social security scheme\n* Patients without a national insurance number\n* Persons under judicial protection, guardianship or trusteeship\n* Persons deprived of their liberty",true,{"count":154,"type":22},500,"OBSERVATIONAL","This prospective cohort study aims to constitute a 500-participant database and biobank including 450 adults with systemic autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis) and 50 healthy controls.",[57,28,158,159],"Systemic Sclerosis","Healthy Adult Volunteers",[161,162,163],"Autoimmune disease","multi-omic profiling","immunology",{"date":109,"type":33},{"date":166,"type":33},"2026-06-23",{"date":168,"type":22},"2034-06-23",{"name":170,"class":142},"University Hospital, Montpellier",{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":179,"enrollmentInfo":180,"targetDuration":4,"studyType":23,"phases":182,"briefSummary":184,"conditions":185,"keywords":186,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":191,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},"100626028","phase-3-a-study-to-evaluate-the-treatment-outcomes-of-subcutaneous-anifrolumab-in-immunosuppressant-nave-and-biologic-nave-systemic-lupus-erythematosus-100626028","NCT07430306","A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus","Multinational, Interventional, 52-week, Open-label, Single-arm Study to Evaluate the Treatment Outcomes of Anifrolumab 120 mg Subcutaneous Once Weekly in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus (SUNFLOWER)","SUNFLOWER","Inclusion Criteria:\n\n1. Males or females aged 18 to 70 years of age.\n2. Participants who have a diagnosis of SLE confirmed by a rheumatologist.\n3. ANA-positive per the Central Lab at screening:\n\n   (a) ANA (b) Anti-dsDNA (c) Anti-Smith (anti-Sm)\n4. Must be on the standard therapy regimen: antimalarials with or without OCSs\n5. Must have at screening and baseline:\n\n   1. Clinical SLEDAI-2K ≥ 4 points OR\n   2. Clinical SLEDAI-2K \\\u003C 4 with GC dose ≥ 7.5 mg\u002Fday (prednisone equivalent)\n6. Should have no evidence of current active infection, (e.g., pneumonia, tuberculosis \\[TB\\]) or previous TB\n7. Should have no evidence of malignancy; and clinically significant abnormalities (unless due to SLE).\n8. No medical history or signs or symptoms of active TB prior to or during Screening.\n9. Body weight ≥ 40.0 kg\n10. Negative pregnancy test for females during screening\n11. Normal HPV test result within 2 years prior to Week 0 (Day 1).\n12. Willing and able to participate in all required study evaluations and procedures including completion of PROs.\n13. Willing to not use any other forms of experimental treatment during the study.\n\nExclusion Criteria:\n\n1. Subjects with history of, or current diagnosis of, a clinically significant non-SLE related vasculitis syndrome.\n2. Subjects with antiphospholipid antibody syndrome on stable anticoagulant therapy at an effective dose (e.g., if on warfarin, an international normalized ratio \\[INR\\] target 2 to 3 or as appropriate for the clinical situation) are only allowed if this is not the sole or the predominant feature of their SLE.\n3. Subjects with a serious thrombotic event (e.g., pulmonary embolism stroke, deep vein thrombosis) or unexplained pregnancy loss within 1 year before the screening visit are excluded.\n4. Subjects with a history of catastrophic antiphospholipid syndrome or saddle embolism.\n5. Subjects with a history of 3 or more unexplained consecutive pregnancy losses.\n6. History or evidence of suicidal ideation within the past 6 months; or any suicidal behavior within the past 12 months or recurrent suicidal behavior in the lifetime of the participant based on an assessment with the Columbia Suicide Severity Rating Scale (C SSRS) at Screening.\n7. Active severe or unstable neuropsychiatric SLE including, but not limited to aseptic meningitis, cerebral vasculitis, myelopathy, demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy), acute confusional state, impaired level of consciousness, psychosis, acute stroke or stroke syndrome, cranial neuropathy, status epilepticus, cerebellar ataxia, lupus headache and mononeuritis multiplex, where, protocol-specified standard therapy is insufficient.\n8. Active severe SLE-driven renal disease where, protocol-specified standard therapy is insufficient.\n9. Current diagnosis of, catastrophic antiphospholipid syndrome (APS).\n10. History of recurrent infection requiring hospitalization and IV antibiotics (e.g., 3 or more of the same type of infection over the previous 52 weeks).\n11. Known History of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV at Screening.\n12. Confirmed positive test for hepatitis B.\n13. Any clinical cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection that has not completely resolved within 12 weeks prior to signing the ICF.\n14. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of Week 0 (Day 1).\n15. Clinically significant chronic infection (e.g., osteomyelitis, bronchiectasis, etc.) within 8 weeks prior to signing the ICF (chronic nail infections are allowed).\n16. Severe HZ or recurrent HZ.\n17. Malignancy. History of cancer, apart from:\n\n    (a) Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1).\n\n    (a) Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1).\n18. Received any SLE-related therapies other than antimalarials and GCs.\n19. History of allergy or reaction to any component of the study intervention formulation or history of anaphylaxis to any human gamma globulin therapy.\n20. History of an anaphylactic reaction to human proteins or mAbs.\n21. Received any live or attenuated vaccine within 8 weeks prior to signing the ICF.\n22. Blood transfusion or receipt of blood products except albumin.\n23. Received more than 2 investigational products for the SLE since time of diagnosis.\n24. Received any investigational product (small molecule or biologic agent) within 4 weeks or 5 half-lives prior to signing of the ICF, whichever is greater.\n25. Concurrent enrollment in another clinical study with a study intervention.\n26. Subjects with any abnormal lab result as specified in the protocol.\n27. Subjects with other autoimmune diseases (e.g., multiple sclerosis, psoriasis, IBD, etc.).\n28. Subjects with SLE overlap syndromes such as scleroderma and mixed connective tissue disease.\n29. Subject with non-SLE concomitant illness, as determined by medical judgment, who is likely to require additional systemic glucocorticosteroid therapy during the study (e.g., asthma).\n30. Any condition would interfere with treatment outcomes of the study intervention or put participant at safety risk.\n31. Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding anytime from initiation of Screening until 16 weeks following last dose of study intervention.\n32. Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks prior to signing the ICF.\n33. Current alcohol, drug or chemical abuse, or a history of such abuse within 1 year before Week 0 (Day 1).\n34. Major surgery within 8 weeks before signing the ICF or elective major surgery planned during the study period.","70 Years",{"count":181,"type":22},245,[183],"PHASE3","The purpose of the SUNFLOWER study is to describe clinical outcomes, including DORIS remission, achieved following the initiation of anifrolumab 120 mg SC once weekly (QW) as add-on therapy to an anti-malarial, with or without GC; in patients not in LLDAS at enrolment.\n\nPatients will be naïve to any prior conventional immunosuppressant including prior biologic therapy at enrolment. The study will also employ a tapering protocol for a systematic approach to GC tapering, seeking to understand better the proportion of patients in remission who can successfully withdraw chronic GC completely.",[28],[105,187,188,189,190],"Immunosuppressant","Glucocorticoid","Anifrolumab","Remission",{"date":84,"type":33},{"date":193,"type":33},"2026-04-13",{"date":195,"type":22},"2029-01-26",{"name":69,"class":40},101,{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":17,"minAge":206,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":23,"phases":209,"briefSummary":210,"conditions":211,"keywords":212,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":225},"100563527","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-dapirolizumab-pegol-in-study-participants-with-moderately-to-severely-active-systemic-lupus-erythematosus-100563527","NCT06617325","A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus","PHOENYCS FLY","Inclusion Criteria:\n\n* Study participant must be ≥16 years of age, (≥18 years of age for China), unless restricted by local regulation, at the time of signing the Informed Consent form (ICF)\n* Study participants who have moderate to severe disease activity due to either persisting active systemic lupus erythematosus (SLE) or due to an acute worsening of SLE in the scope of frequent relapsing-remitting SLE despite stable standard of care(SOC) medication defined as:\n\n  a. Diagnosed with SLE at least 24 weeks before the Screening Visit by a qualified physician b. Classified by 2019 SLE European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for SLE c. With serological evidence for SLE at Screening as demonstrated by at least 1 of the following: i) Evidence for anti-dsDNA (defined as evidence for anti-dsDNA antibodies in central laboratory) ii) Either complement C3 \\\u003Clower limit of normal (LLN) OR complement C4 \\\u003CLLN as measured by central laboratory iii) Antinuclear antibodies with a titer of at least 1:80 confirmed by central laboratory in combination with evidence of at least 1 of the following SLE typical autoantibodies:\n  1. Anti-Smith (anti-Sm) antibodies (central laboratory or source verifiable history)\n  2. Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)\u002FAnti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory)\n  3. Historical evidence for anti-dsDNA antibodies\n  4. Anti-ribonucleoprotein (RNP) autoantibodies (central laboratory) d. Moderately to severely active defined as:\n\n     * British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade B in ≥2 organ systems and\u002For a BILAG 2004 Grade A in ≥1 organ systems at Screening and Baseline Visit AND\n     * Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥6 at the Screening Visit AND\n     * SLEDAI-2K without labs ≥4 at Baseline Visit e. Receiving the following standard of care (SOC) medications at stable dose:\n     * Antimalarial treatment in combination with glucocorticoids and\u002For immunosuppressants or as stand-alone treatment if justified OR\n     * Treatment with glucocorticoids and\u002For immunosuppressants if antimalarial treatment is not appropriate (ie, there is documented intolerance in medical history, documented lack of efficacy, contraindications, or lack of availability)\n\n     Exclusion Criteria:\n* Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric SLE) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life-threatening condition\n* Study participant has a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies. This includes systemic reactions due to latex allergy\n* Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ (after complete resection \\[eg, curettage, electrodesiccation\\] not later than 4 weeks prior to the Screening Visit \\[V1\\]), basal cell carcinoma, or dermatological squamous cell carcinoma\n* Study participant has a mixed connective tissue disease, scleroderma, and\u002For overlap syndrome of these diseases with SLE\n* Study participant has evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or during the study\n* Study participant has clinically significant active or latent infection\n* Study participant had a reactivated latent infection (eg, cytomegalovirus, herpes simplex virus, or herpes zoster infection) or opportunistic infection (including but not limited to, pneumocystis, cytomegalovirus, or severe herpes zoster infection) within 12 weeks prior to the first study medication infusion (Visit 2) or is currently receiving suppressive therapy for an opportunistic infection\n* Study participants who have received live\u002Flive attenuated vaccines within 6 weeks prior to the first study medication infusion\n* Study participant has used the prohibited medications within the time frame (Wash-Out Period) listed in the Protocol\n* Study participant has previously been randomized within this study or has previously been assigned to treatment with dapirolizumab pegol (DZP) in a study evaluating DZP\n* Study participant has participated in another study of an investigational medicinal product (IMP) within the previous 12 weeks or 5 half-lives of the IMP whatever is longer, or is currently participating in another study of an IMP\n* Study participant has chronic kidney failure stage 4, manifested by estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m2, or serum creatinine \\>2.5 mg\u002FdL, or participant has proteinuria \\>3g\u002Fday, or protein:creatinine ratio \\>340 mg\u002Fmmol at the Screening Visit","16 Years",{"count":208,"type":22},450,[183],"The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.",[28],[213,214,215,216],"Systemic lupus erythematosus","Dapirolizumab pegol","SLE","DZP","2026-06-25",{"date":107,"type":33},{"date":220,"type":33},"2024-11-21",{"date":222,"type":22},"2028-05-31",{"name":224,"class":40},"UCB Biopharma SRL",230,{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":233,"targetDuration":4,"studyType":23,"phases":235,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":143},"100557230","phase-1-a-study-of-imc-002-for-the-treatment-of-active-systemic-lupus-erythematosus-100557230","NCT06535412","A Study of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus","A Multi-center, Randomized, Double-blind, Placebo Control Phase 1b\u002FII Study to Evaluate the Safety and Efficacy of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* Has had a diagnosis of SLE for at least 12 weeks prior to the screening Visit.\n* SLEDAI-2000 score ≥8. For screening eligibility only, headache and fever items shall be excluded from SLEDAI-2K scoring. Skin lesions shall meet morphological and distributive characteristics of active cutaneous lupus, with a total active Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) score ≥2.\n* BILAG-2004 organ system scores of at least 1 A or 2 B at screening.\n* Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and\u002For immunosuppressive agent.\n* Other protocol defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Active or unstable neuropsychiatric SLE or lupus nephritis\n* Autoimmune or rheumatic disease other than SLE\n* Significant, uncontrolled medical conditions not related to SLE\n* Active and\u002For severe viral, bacterial or fungal infection\n* History of malignancy within 5 years\n* Other protocol defined exclusion criteria may apply.",{"count":234,"type":22},218,[54,25],"The purpose of this study is to evaluate the efficacy and safety of IMC-002 and IMM0306S in the treatment of active SLE.",[28],{"date":84,"type":33},{"date":240,"type":33},"2024-10-10",{"date":242,"type":22},"2028-12-17",{"name":244,"class":142},"ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.",{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":155,"phases":4,"briefSummary":253,"conditions":254,"keywords":255,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":143},"100644262","biomarker-development-for-autoimmune-disorders-involving-the-kidneys-100644262","NCT07666711","Biomarker Development for Autoimmune Disorders Involving the Kidneys","SILENT_LN","Inclusion Criteria:\n\n* Age 18 years or older\n* Established diagnosis of systemic lupus erythematosus according to accepted classification criteria\n* Receiving routine clinical care at Oslo University Hospital or another participating center\n* Able to provide informed consent according to the approved consent procedure\n* Willing and able to provide blood and\u002For urine samples for biomarker analysis\n* For the biopsy-validation analysis population: predefined increase or persistent elevation in one or more blood or urine biomarkers prompting structured renal assessment, with integrated medical assessment indicating suspected renal involvement, possible renal flare, unresolved uncertainty regarding renal inflammatory activity, or discordance between biomarker findings and conventional clinical measures\n\nExclusion Criteria:\n\n* Inability to provide valid informed consent, unless an approved alternative consent procedure applies\n* Known kidney disease not related to systemic lupus erythematosus that would prevent interpretation of lupus nephritis-related biomarker findings\n* Previous kidney transplantation\n* Active infection or acute medical instability that would interfere with study procedures or interpretation of biomarker findings in the time of sampling\n* For the biopsy-validation analysis population: kidney biopsy or re-biopsy is considered unsafe or inappropriate by the treating specialist\n* For the biopsy-validation analysis population: contraindication to native kidney biopsy according to local hospital procedures or specialist assessment\n* For the biopsy-validation analysis population: participant declines kidney biopsy, re-biopsy, or participation in the biopsy-validation component",{"count":154,"type":22},"SILENT-LN is a prospective observational cohort study of adults with systemic lupus erythematosus, including participants with no renal involvement, suspected renal involvement, active lupus nephritis, previous lupus nephritis, or inactive lupus nephritis. The study will measure pre-specified blood and urine biomarkers longitudinally during routine clinical care.\n\nThe study will evaluate whether blood and urine biomarker concentrations and biomarker panel scores are associated with active lupus nephritis, incident lupus nephritis, renal flare, treatment response, remission or inactive renal disease, kidney biopsy findings, and long-term renal outcomes.\n\nParticipants will provide blood and urine samples during routine clinical follow-up visits and at visits where renal involvement is clinically suspected. Clinical data, standard laboratory tests, disease activity assessments, kidney function measures, treatment information, and kidney biopsy findings, when available, will be recorded.\n\nA predefined increase or persistent elevation in blood or urine biomarker levels will trigger a structured renal assessment, and kidney biopsy or re-biopsy may be performed if the integrated clinical assessment indicates suspected renal involvement, renal flare, or uncertainty regarding renal inflammatory activity and the procedure is considered safe and clinically appropriate.\n\nThe study is currently conducted at Oslo University Hospital, Riks Hospital and may expand to additional centers following funding and regulatory approvals.",[106,28],[213,215,256,257,258,259,260,261,262,263,264,265,266,267,268],"Lupus nephritis","LN","Autoimmune kidney disease","Blood biomarkers","Urine biomarkers","Renal flare","Incident lupus nephritis","Active lupus nephritis","Treatment response","Renal remission","Kidney biopsy","Biomarker panel","Longitudinal monitoring","2026-06-24",{"date":84,"type":33},{"date":272,"type":22},"2026-06-15",{"date":274,"type":22},"2031-06-14",{"name":276,"class":142},"Oslo University Hospital",{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":179,"enrollmentInfo":284,"targetDuration":4,"studyType":23,"phases":286,"briefSummary":287,"conditions":288,"keywords":293,"overallStatus":295,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":143},"100644891","phase-1-a-study-of-c-car168-in-the-treatment-of-autoimmune-diseases-refractory-to-standard-therapy-100644891","NCT07676266","A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy","An Exploratory Clinical Study of Anti-CD20\u002FB-cell Maturation Antigen (BCMA) Chimeric Antigen Receptor Autologous T Cell Product (C-CAR168) in the Treatment of Autoimmune Diseases Refractory to Standard Therapy","Inclusion Criteria:\n\n* 18 to 70 years old at the time of signing the Informed Consent Form (ICF).\n* Diagnosed as Multiple sclerosis (MS)\u002FNeuromyelitis Optica Spectrum Disorders (NMOSD)\u002FMyasthenia Gravis (MG)\u002FSystemic Lupus Erythematosus (SLE)\u002F Systemic Sclerosis (SSc)\u002F Immune-Mediated Necrotizing Myopathy (IMNM) according to recognized diagnostic criteria for at least 6 months.\n* Prior treatment failure with standard therapy.\n* Adequate bone marrow, coagulation, cardiopulmonary, liver and renal function.\n\nExclusion Criteria:\n\n* Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive, Epstein-Barr Virus (EBV) DNA positive.\n* Uncontrolled active infection.\n* Live vaccine injection within 4 weeks prior to signing the ICF.\n* Major organ transplantation history or bone marrow\u002Fhematopoietic stem cell transplantation history.\n* Severe cardiovascular diseases within the past 6 months prior to screening.\n* A history of ≥ Grade 2 bleeding within 4 weeks prior to screening, or requiring long-term anticoagulants treatment.\n* Inadequate washing time for previous treatment.\n* Previously treated with CAR-T cell products or genetically modified T cell therapies.\n* Pregnant or lactating women.\n* Severe central nervous system diseases or pathological changes.\n* Malignancy history within 5 years prior to signing the ICF.\n* Any contraindication to lumbar puncture for MS or NMOSD.",{"count":285,"type":22},18,[54],"This is an investigator-initiated, single-center, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with autoimmune diseases refractory to standard therapy",[289,290,291,28,158,292],"Multiple Sclerosis (MS)","Myasthenia Gravis (MG)","Neuromyelitis Optica Spectrum Disorder","Immune-Mediated Necrotizing Myopathy",[294],"CD20\u002FBCMA-directed CAR-T cells","NOT_YET_RECRUITING",{"date":109,"type":33},{"date":298,"type":22},"2026-07",{"date":300,"type":22},"2028-10",{"name":302,"class":142},"The Affiliated Hospital of Qingdao University",{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":179,"enrollmentInfo":311,"targetDuration":4,"studyType":23,"phases":313,"briefSummary":314,"conditions":315,"keywords":316,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":332},"100586548","phase-1-a-study-to-investigate-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-azd5492-in-adult-participants-with-systemic-lupus-erythematosus-or-idiopathic-inflammatory-myopathies-or-rheumatoid-arthritis-100586548","NCT06916806","A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis.","An Open-label, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 Following Single-ascending Dose and Step-up Dose Administration to Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis","TITAN","Inclusion Criteria:\n\n1. Participant must be 18 to 70 years of age inclusive, at the time of signing the informed consent.\n2. Diagnosis of SLE:\n\n   1. Diagnosis of SLE according to the 2019 EULAR\u002FACR classification criteria for SLE\n   2. Positive for one or more of: anti-nuclear antibodies (titre ≥ 1:80), anti-dsDNA or anti-Sm at screening.\n   3. Active, moderate-severe disease at screening, defined as clinical SLEDAI-2K ≥ 4.\n   4. Intolerance to, or inadequate response following at least 3 months of use to, ≥ 3 available treatments, such as the following: corticosteroids, anti-malarial drugs, calcineurin inhibitor, methotrexate, azathioprine, leflunomide, mycophenolic acid or its derivatives, cyclophosphamide, belimumab, anifrolumab, telitacicept, or B-cell depleting monoclonal antibodies.\n3. Diagnosis of IIM:\n\n   1. Must have \"probable\" or \"definite\" diagnosis of PM or DM (excluding IBM and cancer associated myositis) according to the 2017 EULAR\u002FACR classification criteria for adult myositis.\n   2. Positive for ≥ 1 disease-specific autoantibody at screening.\n   3. MMT-8 score of ≤ 142\u002F150 and\u002For CDASI-A ≥ 6\n   4. Fulfill at least one of the following criteria of active disease at screening:\n\n   (i) One or more muscle enzyme elevation (CK, AST, ALT, aldolase, LDH) ≥ 1.3 × ULN (ii) If criterion 3(d)(i) is not met, then at least one of the following criteria must be met: a. Report from MRI performed within 3 months prior to screening with evidence of muscle inflammation b. Report from muscle biopsy performed within 3 months prior to screening that demonstrates active inflammation c. Report from electromyography performed within 3 months prior to screening that exhibits irritable myopathic pattern.\n\n   (e) Intolerance or inadequate response to corticosteroids and ≥2 other SoC treatments, used for at least 3 months each, for which at least one must be a biologic SoC, immunoglobulin or cyclophosphamide.\n4. Diagnosis of RA:\n\n   (a) Diagnosis of RA as defined by the 2010 EULAR\u002FACR classification criteria (b) Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory at screening: RF or ACPA (c) Moderate or severe disease activity defined as: (i) ≥6 tender joints and ≥6 swollen joints AND (ii) DAS28-CRP \\>3.2. (d) Intolerance to or inadequate response following approximately 3 month's treatment or longer to ≥2 b\u002FtsDMARDs (with different mechanisms of action) after failing csDMARD therapy (unless csDMARD therapy is contraindicated). There is no minimum duration for taking a treatment in cases of intolerance.\n\nExclusion Criteria:\n\n1. Any complications of the disease under study which are judged by the investigator to be life or organ threatening or to require treatments which are not permitted in the protocol, including but not limited to:\n\n   1. Active severe SLE-driven renal disease.\n   2. History of, or current diagnosis of, catastrophic or severe APS (for example diagnosis of an arterial or central\u002Fpulmonary venous clot) within 1 year prior to signing the ICF.\n   3. Rapidly progressive and\u002For severe ILD or ILD that requires oxygen supplementation\u002Ftherapy (of any type).\n   4. Inclusion Body Myositis or cancer associated myositis.\n2. Active severe, unstable or history of neuropsychiatric SLE.\n3. IIM: Pulmonary function tests at screening (or within one month of screening, provided participant confirms no change in respiratory symptoms in the interim) which meet any of the following criteria:\n\n   1. FVC ≤60% of predicted\n   2. DLCO ≤70% of predicted\n   3. Deterioration in either FVC or DLCO at screening compared to pulmonary function tests performed ≥3 months previously.\n4. Significant history of or at risk of severe infections.\n5. Participants with HIV infection.\n6. Participants with evidence of chronic or active hepatitis B defined as HBsAg positive or HBcAB positive\n7. Participants with evidence of chronic or active hepatitis C\n8. Participants with positive COVID-19 PCR.\n9. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection.\n10. Significant CNS pathology.\n11. Receipt of B-cell-depleting therapy including CD19 or CD20 directed monoclonal antibodies (including but not limited to, ocrelizumab, ofatumumab, obinutuzumab, or rituximab) \\\u003C3 months prior to Day 1.",{"count":312,"type":22},72,[54],"The purpose of this study is to measure the safety, tolerability, PK, and PD of AZD5492 administered subcutaneously in adult participants with SLE or IIM or RA\n\nStudy details include:\n\n• The study duration will be a minimum of 180 days in addition to the screening period.\n\nAdditional follow-up visits may be required up to 12 months from study start.\n\n* Depending on the study part they are assigned to, participants will be administered AZD5492 once (Part 1) or twice (Part 2).\n* Study visits will occur at:\n\nScreening, Days 1-4, 8, 15, 22, 30, 60, 90, 120, 150, and 180 in Part 1, Screening, Days 1-4, 8-11, 15, 22, 29, 43, 60, 90, 120, 150, and 180 in Part 2.",[28,129,57],[105,317,318,319,320,321,322,323,324,325],"Inflammatory Myopathy","Musculoskeletal Diseases","Neuromuscular Diseases","Nervous System Diseases","Muscular Diseases","Myositis","Dermatomyositis","Polymyositis","Arthritis",{"date":217,"type":33},{"date":328,"type":33},"2025-05-01",{"date":330,"type":22},"2027-09-15",{"name":69,"class":40},37,{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":341,"minAge":18,"maxAge":342,"enrollmentInfo":343,"targetDuration":4,"studyType":23,"phases":345,"briefSummary":347,"conditions":348,"keywords":349,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":356,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":143},"100561738","phase-4-prospective-registry-investigating-maternal-infant-and-lactation-outcomes-in-anifrolumab-users-100561738","NCT06594068","Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users","PRIMULA Lac (Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users): The AstraZeneca Lactation Study for Anifrolumab","PRIMULA Lac","Inclusion Criteria:\n\nMaternal:\n\n1. 18 years or older\n2. Signed informed consent to participate\n3. Diagnosis of moderate\u002Fsevere SLE\n4. Ongoing treatment with anifrolumab\n5. Has reached or will reach steady state (\\~85 days postpartum, equivalent to at least 3 consecutive previous IV doses or at least 12 previous SC doses during the post-partum period) with anifrolumab by the time of study Day 1 (pre-dose milk collection)\n6. Established lactation in the index post-partum period (breastfeeding or pumping for at least 4 weeks at time of Day 1 visit to ensure mature milk production)\n7. Willing to breastfeed or pump regularly during the study period to maintain milk supply and exclusively pump breast milk for the 24-hour period of breast milk collection on Day 1 post IV dose\n8. Plans to continue feeding infant breast milk at least throughout the duration of the study and is not weaning\n9. Must be exclusively breast milk-feeding their infant (or if not exclusively breast milk-feeding, not providing more than 1 supplemental bottle of formula per day) at the time of enrollment and throughout the study period\n10. Agrees to use only lanolin nipple cream during the sampling period\n\nInfant:\n\n1. Gestational age at delivery ≥32 weeks\n2. Birthweight \\> 10th percentile\n3. Weight \\> 10th percentile at the time of enrollment\n\nExclusion Criteria:\n\nMaternal:\n\n1. Received any investigational compound or approved biologic or biosimilar within 30 days or 5 half-lives (whichever is longer) prior to enrollment in the study\n2. Diagnosis of lupus nephritis in the last 12 months\n3. History of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from 1 or both breasts\n4. History of malignancy in the last 10 years\n5. History of mastectomy\n6. Evidence of mastitis or any other significant active infection at Day 1 (pre-dose)\n\nInfant:\n\n1\\. Any abnormality noted or clinically significant medical condition, including cardiac, pulmonary, and liver disease, glucose instability, or active infection at the time of screening that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the trial difficult or would put the infant participant at risk by participating in the study","FEMALE","130 Years",{"count":344,"type":22},16,[346],"PHASE4","Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users (PRIMULA Lac) is a Post Marketing Requirements (PMR) study designed to fulfill the FDA post-marketing requirements. The study will collect data about the presence of anifrolumab in human breast milk and serum (maternal and infant) among lactating individuals who are receiving anifrolumab therapeutically via intravenous (IV) or subcutaneous (SC) administration and evaluate exposure and effects on the breastfed infant.",[28],[350,351,352,353,354,355],"Chronic autoimmune disease","Immunosuppressants","Corticosteroids","Human monoclonal antibody (IgG1ƙ mAb)","Post Marketing Requirements (PMR) study","Systemic Lupus Erythematosus (SLE)",{"date":107,"type":33},{"date":358,"type":33},"2026-01-16",{"date":360,"type":22},"2027-08-31",{"name":69,"class":40},{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":155,"phases":4,"briefSummary":371,"conditions":372,"keywords":373,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":383,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":143},"100558459","follow-up-of-the-systemic-lupus-erythematosus-cohort-as-part-of-the-multidisciplinary-consultation-at-brest-chru-100558459","NCT06551389","Follow-up of the Systemic Lupus Erythematosus Cohort as Part of the Multidisciplinary Consultation at Brest CHRU","COLUPUS","Inclusion Criteria:\n\n* Any patient over 18 years old of the multidisciplinary consultation\n\nExclusion Criteria:\n\n* Opposition of patient",{"count":370,"type":22},300,"Systemic lupus erythematosus is a complex systemicautoimmune disease that can affect most organs of the human body.\n\nAlthough they are many recommendations on the diagnosis and managment of SLE, diagnosis and therapeutic managment is still challenging.\n\nA pluridisciplinary consultation grouping rheumatologist, nephrologist, dermatologist, gynecologist, internist and immunologists has been set up in 2009 at the university hospital of Brest.\n\nThe investigators would like to identify in a longitudinal cohort the occurrence of the different clinico-biological and immunological patterns of systemic lupus erythematosus patients during our multidisciplinary consultation.\n\nIt is now crucial to organize a standardized data collection of these patients in order to evaluate our pratices, to be able to study the epidemiology of SLE in our city, and to promote this initiative at national and international level.",[28],[374,375,376,377,378,379,380,381,382],"autoimmune diseases","joint diseases","cutaneous systemic diseases","musculoskeletal diseases","arthritis","rheumatoid","rheumatic diseases","connectivite tissue diseases","immune system diseases",{"date":217,"type":33},{"date":385,"type":33},"2020-10-13",{"date":387,"type":22},"2035-04",{"name":389,"class":142},"University Hospital, Brest",{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":397,"enrollmentInfo":398,"targetDuration":4,"studyType":23,"phases":400,"briefSummary":401,"conditions":402,"keywords":405,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":409,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":143},"100473094","phase-2-the-role-of-anifrolumab-in-improving-markers-of-vascular-risk-in-patients-with-systemic-lupus-erythematosus-sle---ifn-cvd-100473094","NCT05440422","The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD","The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged 18-80 years\n4. In good general health as evidenced by medical history or diagnosed with SLE diagnosed per American College of Rheumatology 1997 revised SLE classification criteria.\n5. Prednisone \\\u003C or equal to 10 mg\u002Fday for at least 2 weeks before screening and maintained throughout randomization (day 1)\n6. Stable standard of care lupus therapies for at least 4 weeks before screening and maintained through randomization (day 1)\n7. Abnormal cardio-ankle vascular index (CAVI) (based on 2 SD above median of healthy controls based on historical data from our own patient cohorts AND\u002FOR\n8. Abnormal Pulse wave velocity (PWV) using Sphygmocor. AND\u002FOR\n9. Abnormal target to background ratio (TBR) in various aortic territories and total aorta using FDG PET CT scan.\n10. Stable medications for diabetes, hypertension and\u002For statins for at least the previous 3 months. No changes of these medications or immunosuppressive drugs will be allowed during trial.\n11. For females and males of reproductive potential: use of highly effective contraception from screening and agreement to use such a method during study participation and for an additional 16 weeks after the end of study medication administration. For the purpose of this study abstinence will be considered as an effective form of contraception.\n12. Subjects must confirm receipt of prior vaccination against COVID-19 and Varicella Zoster. Verbal confirmation of vaccination receipt AND detectable antibodies in serum is acceptable in the absence of vaccine records.\n\n    EXCLUSION CRITERIA:\n\n    An individual who meets any of the following criteria will be excluded from participation in this\n\n    study:\n    * Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.\n    * Concurrent enrolment in another clinical study with an investigational product\n    * Major surgery within 8 weeks before signing the ICF or elective major surgery planned during the study period.\n    * Any of the following found at Screening:\n\n      * Aspartate aminotransferase (AST) \\>2.5 x upper limit of normal (ULN).\n      * Alanine aminotransferase (ALT) \\>2.0 x ULN.\n      * Total bilirubin \\>ULN (unless due to Gilbert's syndrome)\n      * Serum creatinine \\>2.5 mg\u002FdL (or \\>181 micromol\u002FL)\n      * Urine protein\u002Fcreatinine ratio \\>2.0 mg\u002Fmg (or \\>226.30 mg\u002Fmmol)\n      * Neutrophil count \\\u003C1000\u002FmicroL (or \\\u003C1.0 x 109\u002FL)\n      * Platelet count \\\u003C25000\u002FmicroL (or \\\u003C25 x 109\u002FL)\n      * Hemoglobin \\\u003C8 g\u002FdL (or \\\u003C80 g\u002FL), or \\\u003C7 g\u002FdL (or \\\u003C70 g\u002FL) if related to subject's SLE such as in active hemolytic anemia\n      * Glycosylated hemoglobin (HbA1c) \\>8% (or \\>0.08) at screening (diabetic subjects only)\n      * Positive SARS\u002FFlu A\u002FB\u002FRSV (Panther), PCR\n\n    Note: Abnormal screening test(s) which exclude the patient may be repeated once within 4 weeks of the Screening Visit. If the repeat test(s) does not meet the above criteria, then the patient may be included in the study and will not be considered a screen failure.\n    * Receipt of any of the following:\n\n      1. Azathioprine \\>200 mg\u002Fday\n      2. Mycophenolate mofetil \\> 3 g\u002Fday or mycophenolic acid \\>2.16 g\u002Fday\n      3. Oral, SC, or intramuscular methotrexate \\>25 mg\u002Fweek\n      4. Mizoribine \\>150 mg\u002Fday. Leflunomide more than 20 mg and any other immunosuppressant usage at the discretion of the PI.\n    * Receipt of any investigational product (small molecule or biologic agent) within 4 weeks or 5 half-lives prior to week 0 (day 1), whichever is greater.\n    * Receipt of any commercially available biologic agent within 5 half-lives prior to signing of the ICF\n    * Receipt of B cell depleting therapy (including but not limited to belimumab, ocrelizumab, ofatumumab, atacicept, Obinutuzumab, or rituximab), \\\u003C26 weeks prior to the signing of the consent for all B-cell depleting therapy or \\\u003C40 weeks prior to the signing of the ICF for atacicept.\n    * Receipt of any of the following: (a) Intra-articular, intramuscular or IV corticosteroids within 4 weeks prior to Day 1 (b) Any live or attenuated vaccine within 8 weeks prior to signing the ICF (administration of killed vaccines is acceptable)\n    * History or evidence of suicidal ideation within the past 6 months; or any suicidal behavior within the past 12 months based on screening or at baseline.\n    * Recent cardiac or stroke event (with in the last year prior to week 0 (day 1))\n    * Active SLE disease with SLEDAI 2K \\>6 at the time of screening.\n    * Active severe or unstable neuropsychiatric SLE including, but not limited to: aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; status epilepticus; cerebellar ataxia; and mononeuritis multiplex:\n\n      1. That would make the subject unable to fully understand the ICF OR\n      2. Where, in the opinion of the Principal Investigator (PI), protocol specified SOC is insufficient and utilization of a more aggressive therapeutic approach, such as adding IV cyclophosphamide and\u002For high dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated\n    * Active severe SLE-driven renal disease where, in the opinion of the PI, protocol specified standard of care (SOC) is insufficient and utilization of a more aggressive therapeutic approach, such as adding IV cyclophosphamide and\u002For high dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated.\n    * History of or current diagnosis of catastrophic or severe anti-phospholipid syndrome within 1 year prior to signing the ICF. Antiphospholipid syndrome adequately controlled by anticoagulant therapy for at least 3 months is acceptable.\n    * Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the subject to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at screening. Subjects refusing HIV testing during the screening period will not be eligible for study participation.\n    * Confirmed positive test for hepatitis B serology for:\n\n      1. Hepatitis B surface antigen (HBsAg), OR\n      2. Hepatitis B core antibody (HBcAb)\n      3. If positive for HBcAb, hepatitis B virus (HBV) DNA will be checked. If HBV DNA is detected above the lower limit of quantitation (LLOQ) at screening subject will be excluded\n\n    Note: Subjects who are only HBcAb positive at screening will be tested every month for HBV DNA. To remain eligible for the study, the subject s HBV DNA levels must remain below the LLOQ as per the central laboratory.\n    * Positive test for hepatitis C antibody along with detectable Hepatitis C viral RNA.\n    * Any severe herpes infection at any time prior to Week 0 (Day 1), including, but not limited to, disseminated herpes (ever), herpes encephalitis (ever), recurrent herpes zoster (defined as 2 episodes within 2 years) or ophthalmic herpes (ever)\n    * Any herpes zoster, cytomegalovirus (CMV) or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.\n    * Any of the following:\n\n      1. Clinically significant chronic infection (i.e., osteomyelitis, bronchiectasis, etc.) within 8 weeks prior to week 0 (day1) (chronic nail infections are allowed)\n      2. Any infection requiring hospitalization or treatment with IV antibiotics not completed at least 4 weeks prior to week 0 (day1)\n    * Any infection requiring oral antimicrobials (including antivirals) within 2 weeks prior to Day 1, except if taking antivirals\u002Fantimicrobials prophylactically.\n    * History of cancer, apart from:\n\n      1. Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy \\>=3 months prior to Week 0 (Day 1)\n      2. Cervical cancer in situ treated with apparent success with curative therapy \\>=1 year prior to Week 0 (Day 1).\n    * Pregnancy or lactation or intend to become pregnant anytime from initiation of Screening until completion of study.\n    * Spontaneous or induced abortion, still or live birth, or pregnancy \\\u003C= 4 weeks prior to week 0 (day1)\n    * Known allergic reactions to any component of the investigational product formulation or history of anaphylaxis to any human gamma globulin therapy.\n    * Tested positive for COVID-19 infection on the day of screening or up to 21 days prior to screening.","80 Years",{"count":399,"type":22},45,[25],"Background:\n\nPeople with systemic lupus erythematosus (SLE) are at risk of developing complications in their blood vessels. This can increase the risk of heart attacks or stroke. No medications have been effective at reducing this risk in people with lupus.\n\nObjective:\n\nTo test whether a drug (anifrolumab) can improve blood vessel function and reduce blood vessel inflammation in people with SLE.\n\nEligibility:\n\nPeople aged 18 to 80 years with SLE.\n\nDesign:\n\nParticipants will undergo screening. They will have a physical exam. They will have blood and urine tests. They will have a test of their heart function and a chest X-ray. They will answer questions about their SLE symptoms.\n\nParticipants will visit the clinic 9 times in 8 months. After screening, visits will be 4 weeks apart. Each visit may take up to 4 hours.\n\nParticipants will receive infusions from a tube attached to a needle inserted into a vein in the arm (IV). Some will receive anifrolumab. Others will receive a placebo treatment. They will not know which one they are getting.\n\nAt some visits they will have additional tests:\n\nCAVI (cardio-ankle vascular index) tests blood vessel function. Participants will lie still for 20 minutes. Small electrodes will be placed on both wrists with stickers. A microphone will be placed on their chest. Blood pressure cuffs will be wrapped around their ankles and arms.\n\nFDG-PET\u002FCT is an imaging procedure. Participants will receive a substance through an IV line. They will lie on a table for 110 minutes while a machine captures images of their body.",[28,403,404],"Cardiovascular Disease","Premature Atherosclerosis",[406,407,408],"Vascular Inflammation","Interferons","Vascular Function",{"date":217,"type":33},{"date":411,"type":33},"2023-12-07",{"date":413,"type":22},"2027-08-02",{"name":415,"class":416},"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","NIH",{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":424,"enrollmentInfo":425,"targetDuration":4,"studyType":23,"phases":427,"briefSummary":428,"conditions":429,"keywords":430,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":431,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":438},"100624403","phase-2-a-study-to-test-whether-different-doses-of-bi-3000202-help-people-with-systemic-lupus-erythematosus-sle-100624403","NCT07409181","A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)","Randomised, Placebo-controlled, Double-blind, Parallel-group Phase II Study to Evaluate the Efficacy and Safety of Oral BI 3000202 in Patients With Moderate to Severe Systemic Lupus Erythematosus (SLE)","Inclusion Criteria:\n\n1. Male and female adult patients from ≥18 years (or alternative age for adults based on local regulations) to \\\u003C75 years\n2. Confirmed Systemic Lupus Erythematosus (SLE) diagnosis meeting the European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria at least 24 weeks prior to screening\n3. At least one of the following positive at screening: Antinuclear Antibodies (ANA) ≥1:80 or anti-double-stranded Deoxyribonucleic Acid (dsDNA) antibody or anti-Smith antibody\n\n   \\- Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 points and clinical SLEDAI-2K score ≥4 points\n4. At least 1 British Isles Lupus Assessment Group (BILAG) A and\u002For 1 BILAG B grade at screening, with sufficient disease activity according to both investigator and adjudicator\n5. On SLE background therapy with a maximum of 1 immunosuppressant and\u002For 1 antimalarial for ≥8 weeks and at a stable dose for ≥4 weeks before screening and\u002For oral corticosteroids at a dose of ≤30 mg\u002Fday prednisone or equivalent, stable for ≥2 weeks before screening (Visit 1) Further inclusion criteria apply.\n\nExclusion Criteria:\n\n1. Drug-induced SLE\n2. Scleroderma (except linear scleroderma that does not interfere with assessments of SLE disease activity) or in the opinion of the investigator or adjudicator elements of other connective tissue disease that would interfere with interpretation of test results or SLE clinical assessments\n3. Active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition as defined by BILAG A criteria in the neuropsychiatric system, with the exception of mononeuritis\u002Fmononeuropathy multiplex, chorea, and polyneuropathy\n4. Lupus nephritis that may require a change in immune-modulating treatment or which demonstrates serum creatinine that is unstable or \\>2 × Upper Limit of Normal (ULN) and\u002For Urine Protein Creatinine Ratio (UPCR) that is unstable or \\> 3mg\u002Fmg (339 mg\u002Fmmol)\n5. Oral corticosteroids (prednisone or equivalent) \\>30 mg\u002Fday at screening Further exclusion criteria apply.","74 Years",{"count":426,"type":22},405,[25],"This study is open to adults with systemic lupus erythematosus (SLE). The purpose of this study is to find out whether a medicine called BI 3000202 helps people with SLE. The study tests different doses of BI 3000202 and aims to find the best dose for people with this condition.\n\nParticipants are put into 5 groups randomly, which means by chance. 4 groups get different doses of BI 3000202, and 1 group gets a placebo. Placebo tablets look like BI 3000202 tablets but do not contain any medicine. Participants take the tablets for 1 year. All participants also continue their regular treatment for SLE.\n\nParticipants are in the study for a bit longer than 1 year. During this time, they visit the study site regularly. Doctors check the participants' health and take note of any unwanted effects. They also compare the results between the groups to see if the treatment works.",[28],[105],{"date":269,"type":33},{"date":433,"type":33},"2026-04-20",{"date":435,"type":22},"2029-07-08",{"name":437,"class":40},"Boehringer Ingelheim",139,{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":341,"minAge":18,"maxAge":342,"enrollmentInfo":447,"targetDuration":4,"studyType":155,"phases":4,"briefSummary":448,"conditions":449,"keywords":450,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":452,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":143},"100596759","anifrolumab-pregnancy-study-100596759","NCT07049653","Anifrolumab Pregnancy Study","A Non-Interventional Multi-Database Post-Authorisation Study to Assess Pregnancy-Related Safety Data From Women With SLE Exposed to Anifrolumab","ROSE","Inclusion criteria for EXPOSED SOURCE POPULATION:\n\n* Women with a continuous enrolment in the database for ≥ 12 months prior to LMP2\n* Women diagnosed with SLE before pregnancy\n* Women exposed to anifrolumab (polytherapy, added to SLE SOC) during pregnancy and\u002For 16-week period prior to LMP2\n\nExclusion criteria for EXPOSED SOURCE POPULATION:\n\n\\- Pregnancies whose date of conception cannot be established\n\nInclusion criteria for UNEXPOSED SOURCE POPULATION:\n\n* Women with a continuous enrolment in the database for ≥ 12 months prior to LMP2\n* Women diagnosed with SLE before pregnancy\n* Women treated with SLE SOC during pregnancy\n\nExclusion criteria for UNEXPOSED SOURCE POPULATION:\n\n* Women treated with anifrolumab during pregnancy and\u002For 16-week period prior to LMP2\n* Pregnancies whose date of conception cannot be established\n\nInclusion criteria for EXPOSED and UNEXPOSED STUDY POPULATION:\n\n\\- Women with moderate\u002Fsevere SLE\n\nExclusion criteria for EXPOSED and UNEXPOSED STUDY POPULATION:\n\n* Women with a history of CM or chromosomal abnormalities (according to available records), before delivery\n* Women prescribed a confirmed teratogenic drug prior to LMP2 with a time period of 5-half-lives of relevant drug or during pregnancy",{"count":154,"type":22},"This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.",[28],[451],"pregnancy, anifrolumab, SLE",{"date":107,"type":33},{"date":454,"type":33},"2026-06-04",{"date":456,"type":22},"2030-12-10",{"name":69,"class":40},{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":341,"minAge":4,"maxAge":4,"enrollmentInfo":466,"targetDuration":468,"studyType":155,"phases":4,"briefSummary":469,"conditions":470,"keywords":471,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":143},"100566734","prospective-registry-investigating-maternal-and-infant-outcomes-in-anifrolumab-users-100566734","NCT06659029","Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users","PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users): The AstraZeneca Pregnancy Study for Anifrolumab","PRIMULA_Preg","Inclusion Criteria:\n\nExposed cohort\n\n1. Currently or recently (within 1 year of pregnancy outcome) pregnant\n2. Diagnosis of moderate\u002Fsevere SLE\n3. Consent to participate\n4. Authorization for their HCP(s) to provide data to the registry\n5. Exposure to at least 1 dose of anifrolumab at any time during pregnancy\n\nUnexposed cohort\n\n1. Currently or recently pregnant\n2. Diagnosis of moderate\u002Fsevere SLE\n3. Consent to participate\n4. Authorization for their HCP(s) to provide data to the registry\n5. Exposure to other products for the treatment of moderate\u002Fsevere SLE\n\nExclusion Criteria:\n\nExposed cohort\n\n1. Occurrence of pregnancy outcome prior to first contact (for enrollment) with the Virtual Research Coordination Center (retrospectively enrolled)\n2. Exposure to known teratogens and\u002For investigational medications during pregnancy\n\nUnexposed cohort\n\n1. Occurrence of pregnancy outcome prior to first contact with the Virtual Research Coordination Center (retrospectively enrolled)\n2. Exposure to known teratogens and\u002For investigational medications during pregnancy",{"count":467,"type":22},442,"21 Months","PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users) is a prospective, observational cohort study designed to evaluate the association between anifrolumab exposure during pregnancy and subsequent adverse maternal, fetal, and infant outcomes. This study will fulfil an FDA post-marketing requirement.",[28],[350,351,352,353,354,472,28],"Pregnancy",{"date":269,"type":33},{"date":475,"type":33},"2025-07-01",{"date":477,"type":22},"2031-04-15",{"name":69,"class":40},{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":152,"sex":17,"minAge":18,"maxAge":486,"enrollmentInfo":487,"targetDuration":4,"studyType":23,"phases":489,"briefSummary":490,"conditions":491,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":501},"100614235","phase-1-a-study-of-ly4298445-in-healthy-participants-and-participants-with-systemic-lupus-erythematosus-sle-or-rheumatoid-arthritis-ra-100614235","NCT07276958","A Study of LY4298445 in Healthy Participants and Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)","A Phase 1, Multicenter, Randomized, Placebo-Controlled, Participant-Blind, Single-Ascending Dose Study of LY4298445 in Healthy Participants and an Open-Label Single-Ascending Dose and Multiple-Ascending Dose Study of LY4298445 in Participants With Systemic Lupus Erythematosus or Rheumatoid Arthritis","Inclusion Criteria: Healthy Participants\n\nHealthy participants between the ages of 18 and 55 years.\n\n* Have body weight of at least 50 kilograms (kg) and body mass index (BMI) between 18 and 32 kilogram per square meter (kg\u002Fm²), inclusive.\n\nParticipants with Systemic Lupus Erythematosus (SLE)\n\n* Are 18 to 75 years of age, inclusive.\n* Have body weight between 45 and 145 kg, inclusive, and BMI between 18 and 35 kg\u002Fm², inclusive.\n* Have a clinical diagnosis of SLE according to the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria at least 6 months prior to screening.\n\nParticipants with Rheumatoid Arthritis (RA)\n\n* Are 18 to 75 years of age, inclusive.\n* Have body weight between 45 and 145 kg, inclusive, and BMI between 18 and 35 kg\u002Fm², inclusive.\n* Have a diagnosis of adult-onset RA for at least 6 months prior to screening, as defined by the 2010 ACR\u002FEULAR classification criteria\n* Have Disease Activity Score in 28 joints (DAS28)-high-sensitivity C-reactive protein (hsCRP) greater than or equal to 4.4.\n* Have positive test results for rheumatoid factor or anti-citrullinated peptide antibodies\n* Have had a history of failure (an inadequate response, intolerance, or loss of response) to at least 2 advanced therapies (biological disease-modifying antirheumatic drug \\[bDMARD\\] or targeted synthetic DMARD \\[tsDMARD\\]) after failing a conventional synthetic DMARD (csDMARD).\n\nExclusion Criteria:\n\n* Have known allergies to LY4298445, related compounds, or any components of the formulation\n* Are individuals assigned female at birth (AFAB) who are lactating or have a positive pregnancy test at screening or Day -1.\n* Have severe active lupus-associated renal disease (lupus nephritis) defined clinically and\u002For by\n\n  * urine protein\u002Fcreatinine ratio greater than 200 milligrams per millimole (mg\u002Fmmol) (as an estimate of approximate proteinuria greater than 2 reams (g) per day) or\n  * an estimated glomerular filtration rate (eGFR) less than 40 milliliters per minute (mL\u002Fmin)\u002F1.73 m² at screening, as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) 2021.\n  * requiring hemodialysis within 6 months prior to screening\n* Have active central nervous system lupus as defined by ACR nomenclature for neuropsychiatric lupus syndromes and as captured by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K); seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, and cerebrovascular accident, within 2 months prior to screening\n* Have a Class 4 RA according to the ACR revised criteria","55 Years",{"count":488,"type":22},63,[54],"The purpose of this study is to investigate the safety and tolerability of LY4298445 in healthy participants and in participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). Participation in the study will last up to approximately 52 weeks.",[492,28,57],"Healthy","2026-06-19",{"date":166,"type":33},{"date":496,"type":33},"2026-02-04",{"date":498,"type":22},"2028-03",{"name":500,"class":40},"Eli Lilly and Company",8,{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":509,"targetDuration":4,"studyType":23,"phases":511,"briefSummary":512,"conditions":513,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":514,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":521},"100620897","phase-1-a-clinical-study-of-mk-1045-in-people-with-lupus-or-rheumatoid-arthritis-mk-1045-004-100620897","NCT07363590","A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)","A Dose Escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-1045 in Participants With Systemic Lupus Erythematosus and Rheumatoid Arthritis","Inclusion Criteria:\n\n* Has a body mass index between 18 and 32 kg\u002Fm\\^2, inclusive\n* Systemic lupus erythematosus (SLE): Has a diagnosis of SLE for at least 6 months and met the European Alliance of Associations for Rheumatology (EULAR)\u002F American College of Rheumatology (ACR) 2019 classification criteria\n* SLE: Is taking at least one background therapy for SLE\n* RA: Has a diagnosis of RA for at least 6 months and meets the 2010 ACR-EULAR classification criteria for RA\n\nExclusion Criteria:\n\n* Has a known active infection (excluding fungal infection of nail beds), or any major episode of infection requiring hospitalization or treatment with anti-infectives within 8 weeks prior to the Day 1 dosing\n* History of serious recurrent or chronic infection\n* Is known to be infected with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus\n* Has evidence of active tuberculosis (TB), latent TB, or inadequately treated TB\n* Has a significant or uncontrolled medical disease in any organ system not related to RA or SLE\n* For RA participants, has a history of any arthritis with onset before age 17 years\n* Has a current inflammatory condition other than SLE or RA that could interfere with disease activity assessments\n* History of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\\u003C5 years before Day 1 dosing\n* Has had a major surgery within 3 months prior to Screening or has a major surgery planned during the study.\n* Has symptomatic heart failure (New York Heart Association class III or IV) or myocardial infarction or unstable angina pectoris within 6 months prior to Screening\n* Has a severe chronic pulmonary disease requiring oxygen therapy\n* Has current active lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease",{"count":510,"type":22},21,[54],"This study looks at a study medicine called MK-1045 in people with lupus and rheumatoid arthritis (RA). The main goal of the study is to learn about the safety of MK-1045 and if people tolerate it when they receive it at different dose levels (amounts).",[28,57],{"date":166,"type":33},{"date":516,"type":33},"2026-02-19",{"date":518,"type":22},"2029-07-16",{"name":520,"class":40},"Merck Sharp & Dohme LLC",17,{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":529,"targetDuration":4,"studyType":23,"phases":531,"briefSummary":532,"conditions":533,"keywords":534,"overallStatus":295,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":536,"startDateStruct":537,"completionDateStruct":538,"leadSponsor":540,"locationsCount":542},"100591739","phase-1-a-study-to-evaluate-the-safety-tolerability-cellular-kinetics-pharmacodynamics-and-efficacy-of-p-cd19cd20-allo1-in-participants-with-severe-treatment-refractory-systemic-lupus-erythematosus-sle-100591739","NCT06984341","A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Participants With Severe, Treatment-refractory Systemic Lupus Erythematosus (SLE)","A Phase I, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Patients With Severe, Treatment-refractory Systemic Lupus Erythematosus","Key Inclusion criteria:\n\n18-75 years old\n\nSLE diagnosis per 2019 EULAR\u002FACR classification criteria ≥ 24 weeks\n\nAutoantibody positive and low complement at screening\n\nTreatment refractory: Failed ≥ 2 treatments for at least 3 months\n\nHighly active disease:\n\nSLEDAI-2K ≥ 8 (excluding alopecia, headache, and fever; additional protocol-specified requirements to enhance specificity of findings)\n\nBILAG-2004 cat A in ≥ 1 organ system and\u002For cat B in ≥ 2 organ systems (excluding constitutional, musculoskeletal, and\u002For mucocutaneous organ systems for category B)\n\nPGA score ≥ 1.0 on a 0 to 3 VAS\n\nFor patients with lupus nephritis:\n\nBiopsy-proven Class III or IV (± Class V) active LN per 2018 ISN\u002FRPS criteria within 12 months of screening\n\nModified NIH activity index ≥ 1\u002F24\n\nUPCR ≥ 1g\u002Fg\n\nKey Exclusion criteria:\n\nParticipants who are pregnant, breastfeeding, or intend to become pregnant within the timeframe in which contraception is required\n\nPrior treatment with CAR T-cell therapy, B-cell-targeting T-cell-dependent bispecific antibody, gene therapy product, total body irradiation, allograft organ transplant, or hematopoietic stem cell transplant\n\nSignificant organ impairment (renal, hepatic, cardiac, or pulmonary) or uncontrolled medical disease which, in the investigator's opinion would preclude patient participation or that may require treatment with systemic corticosteroids or immunosuppressants during the study\n\nActive severe or unstable neuropsychiatric disease\n\nProtocol-specified active or chronic infections, recent major episode of infection\n\nHigh-risk medical conditions (e.g. high bleeding risk, history of cancer, recent major surgery, history of HLH\u002FMAS, substance abuse within the previous year)\n\nOther protocol-defined inclusion\u002Fexclusion criteria apply",{"count":530,"type":22},162,[54],"The purpose of this study is to evaluate the safety and tolerability of P-CD19CD20-ALLO1 in participants with highly active, severe, refractory SLE with or without lupus nephritis (LN). This study includes a dose-escalation stage followed by an expansion stage. It will also evaluate the cellular kinetics (CK), pharmacodynamics (PD), and efficacy of P-CD19CD20-ALLO1.",[28],[106,535],"CAR-T therapy",{"date":269,"type":33},{"date":109,"type":22},{"date":539,"type":22},"2033-11-01",{"name":541,"class":40},"Genentech, Inc.",2,{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":549,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":179,"enrollmentInfo":551,"targetDuration":4,"studyType":23,"phases":553,"briefSummary":554,"conditions":555,"keywords":556,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":571},"100621503","phase-1-a-study-of-gsk5926371-in-participants-with-b-cell-driven-autoimmune-rheumatic-diseases-ard-100621503","NCT07371468","A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)","A Phase 1, Open-label, Dose-escalation Study (ELEVATE-1) to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of a CD19\u002FCD20 T-cell Engager in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)","ELEVATE-1","Inclusion Criteria:\n\n* Part 1 will enroll adult participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA).\n* Part 2 will enroll adult participants with SLE, RA, idiopathic inflammatory myopathies (IIM) or Sjogren's disease (SjD).\n* Participants must be 18 to 70 years of age inclusive at the time of signing the informed consent form.\n* Body mass index (BMI) between 18-35 kilograms per square meter (kg\u002Fm\\^2) inclusive with a body weight of greater than or equal to (\\>=) 45 kilograms (kg).\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:\n* Is a participant of non-childbearing potential (PONCBP), OR\n* Is a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\\\u003C) 1 percent (%), 28 days prior to and during the study intervention period and for at least 28 weeks after the first dose of GSK5926371. The investigator should evaluate potential for contraceptive method failure (e.g. noncompliance, recently initiated) in relationship to the first dose of study intervention.\n\nA POCBP must have a negative highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before the first dose of study intervention.\n\nIf a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n\n\\- Signed and dated informed consent form indicating that the participant is willing and able to comply with hospitalization, clinic visits and scheduled study assessments as detailed in the protocol.\n\nExclusion Criteria:\n\n* Any acute, severe autoimmune disease-related flare before, or during the Screening Period (up to and including Day 1) that needs immediate treatment or is expected to require escalation of treatment to prohibited medications for the duration of the study.\n* Significant allergies to humanized monoclonal antibodies or significant sensitivity to any constituents of the study drug (including excipients).\n* Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n* Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to the autoimmune condition under study (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, or infectious diseases) and\u002For a planned surgical procedure, which, in the opinion of the investigator, could confound the results of the clinical study or put the participant at undue risk.\n* Have any other clinically significant abnormal laboratory value, that in the opinion of the investigator, is capable of significantly altering the absorption, metabolism, or elimination of the clinical study intervention; or constitutes a risk when taking the clinical study intervention or interferes with the interpretation of the clinical study data.\n* Participant has a diagnosis of primary or acquired immunodeficiency, except for selective IgA deficiency.\n* Have an acute or chronic infection including requiring management as follows:\n* An acute infection within 2 weeks of dosing on Day 1.\n* An active infection requiring current systemic antibiotic, antiviral or anti-fungal treatment with the exception of topical treatments for fungal nail infections. Prophylactic medications are permitted.\n* History of, or currently being treated for, a clinically significant recurrent or chronic infection (except for minor localized infections, for example tinea pedis).\n* Any opportunistic infections within past 3 years. Uncomplicated herpes zoster, localized herpes simplex virus, and oral candidiasis are not considered as opportunistic infections for this purpose.\n* Herpes zoster within 3 months before screening.\n* A serious infection requiring treatment with intravenous (IV)\u002Fintramuscular (IM) antibiotics and\u002For hospitalization if the last dose of antibiotics or the hospital discharge date was within 30 days of the first day of dosing (Day 1).\n* History of a serious infection associated with low serum immunoglobulin levels.\n* Evidence of active or latent tuberculosis (TB) as documented by medical history and examination (including chest X-rays \\[CXR\\], if available), and a positive (not indeterminate) TB test such as QuantiFERON-TB Gold Plus test. In cases where the QuantiFERON test is indeterminate, the participant may have the test repeated once, but if the test remains indeterminate further investigation may be required including CXR (posteroanterior \\[PA\\] and lateral) in order to exclude TB. Note: The QuantiFERON-TB Gold Plus test can only be used in countries where it is licensed, and the use of this test is dependent on previous treatment(s). This test may not be suitable if previous treatment(s) produced significant immunosuppression.\n* Confirmed progressive multifocal leukoencephalopathy (PML) within 12 months or has unexplained or deteriorating neurologic signs and symptoms.\n* History or positive test at Screening for human immunodeficiency virus (HIV).\n* History of clinically significant neurological or psychiatric disorder including history of epilepsy, dementia, increased risk of suicide as judged by the investigator or major depression deemed to interfere with study assessments, or a history of intracranial hemorrhage.\n* Solid or hematological malignancy or a history of malignancy (in the past 5 years) of except for basal cell or squamous cell in situ skin carcinomas, cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix that have been resected with no evidence of metastatic disease for 3 years. The investigator should also ensure that occult malignancy associated with the autoimmune condition under study has been adequately ruled out prior to screening (for example, malignancy-associated dermatomyositis).\n* History of hematological or solid organ transplant.\n* Live or live-attenuated vaccine(s) within 30 days before Screening or plans to receive such vaccines during the screening period or during the clinical study.\n* Current or prior treatment with any of the medications specified below during the relevant exclusion periods prior to Day 1. The following medications are prohibited from the periods before the study, until the last study visit:\n* IV or IM dose of corticosteroids within 5 weeks of Day 1.\n* Any T-cell engager (TCE) including blinatumomab, mosunetuzumab or other approved or investigational T cell engagers within 12 months of Day 1.\n* Chimeric antigen receptor (CAR)-T-cell treatment, at any time.\n* B-cell depleting agents, including but not limited to anti-CD20 (e.g. Rituximab, Obinutuzumab, Ocrelizumab), anti-CD38 (e.g. Daratumumab, TAK079, MOR202, isatuximab) within 4 months of Day 1.\n* Belimumab within 8 weeks of Day 1.\n* Anifrolumab within 8 weeks of Day 1.\n* Oral or IV cyclophosphamide within 12 weeks of Day 1.\n* Immune-Modulating Biologic agents, including anti-tumor necrosis factor (TNF) therapy (e.g., adalimumab and etanercept), abatacept, and interleukin (IL)-1 receptor antagonist \\[anakinra\\] or IL-6 receptor antagonist (tocilizumab) within 4 weeks of Day 1. Except infliximab, golimumab, and certolizumab within 8 weeks of Day 1. (NOTE: tocilizumab is permitted for cytokine release syndrome (CRS) Grade 3\u002F4 management after dosing)\n* Small molecule inhibitors, including tyrosine kinase 2 inhibitor (TYK2i, Deucravacitinib); inhibitors of Janus kinases (JAKis, baricitinib, tofacitinib, upadacitinib, filgotinib); or Bruton tyrosine kinase inhibitors (ibrutinib, fenebrutinib) within 4 weeks of Day 1.\n* IV immunoglobulin within 8 weeks of Day 1.\n* Plasmapheresis within 8 weeks of Day 1.\n* Current enrolment or past participation in any other clinical study involving an investigational study treatment (including investigational vaccines) within 3 months or 5 half-lives of the investigational drug or twice the duration of pharmacological activity (whichever is longer) before Day 1.\n* Contra-indications to prophylactic medications for CRS (corticosteroid, ant histamines and antipyretics), or CRS rescue medication (tocilizumab or IV corticosteroids).\n* Current drug or alcohol dependence, or a history of drug or alcohol abuse or dependence within 12 months before Day 1.\n* Alanine transaminase (ALT) greater than (\\>) 1.5 x upper limit of normal (ULN).\n* Total bilirubin \\> 1.5 x ULN; Participants with Gilbert's syndrome can be included with total bilirubin \\> 1.5 x ULN if direct bilirubin is \\> 1.5 x ULN.\n* Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones).\n* Presence of hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis B virus (HBV) deoxyribonucleic acid (DNA) at screening or within 3 months prior to first dose of study intervention.\n* Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention. Note: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative hepatitis C ribonucleic acid (RNA) test is obtained.\n* Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention. Note: Test is optional and participants with negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing.\n* Corrected QT (QTc) interval \\> 450 milliseconds (msec) or QTc interval \\> 480 msec for participants with bundle branch block. Frederica's formula (QT interval corrected using Fridericia's formula \\[QTcF\\]) should be used to calculate the corrected QT interval. If a single electrocardiogram (ECG) at screening shows QTcF \\> 450 msec (or \\> 480 msec for participants with bundle branch block), a mean of triplicate measurements should be used to confirm that participant meets exclusion criterion.",{"count":552,"type":22},44,[54],"This is a 2-part study of GSK5926371 in participants with autoimmune rheumatic diseases (ARD). In part 1, participants will receive different doses of GSK5926371 to find a suitable priming dose. In part 2, participants will receive GSK5926371 at doses based on data from part 1. The study is aimed at testing if GSK5926371 is safe, well-tolerated, how the body processes the study drug, how it works in the body, and whether it triggers any immune responses.",[28],[557,558,559,213,560,561,562],"GSK5926371","Autoimmune rheumatic disease","Dose escalation","Rheumatoid arthritis","Idiopathic inflammatory myopathies","Sjogren's disease","2026-06-18",{"date":166,"type":33},{"date":566,"type":33},"2026-02-10",{"date":568,"type":22},"2028-03-15",{"name":570,"class":40},"GlaxoSmithKline",19,{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":578,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":342,"enrollmentInfo":580,"targetDuration":4,"studyType":155,"phases":4,"briefSummary":582,"conditions":583,"keywords":584,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":593},"100592951","anifrolumab-malignancy-and-serious-infections-study-100592951","NCT07000110","Anifrolumab Malignancy and Serious Infections Study","A Non-Interventional Multi-Country Post-Authorisation Safety Study (PASS) to Assess the Incidence of Serious Infections & Malignancies in Systemic Lupus Erythematosus (SLE) Patients Exposed to Anifrolumab","SIMA","Inclusion Criteria:\n\n* First prescription of anifrolumab in the study period (no anifrolumab prescription prior to index date): date of first anifrolumab prescription will be the index date\n* A minimum data availability of 12 months prior to index date\n* Age ≥18 years at index date\n* SLE severity: patients with moderate to severe SLE at index date\n* SLE activity: patients with at least a flare (uncontrolled SLE) in the 6 months prior to index date\n\nExclusion Criteria:\n\n* A diagnosis of any malignancy prior to index date\n* A diagnosis of HIV\u002FAIDS or congenital immunodeficiency prior to index date\n* Organ or bone marrow transplant procedure prior to index date\n* A diagnosis of serious infection in the previous 6 months",{"count":581,"type":22},3195,"This is an observational study, in which the main research question is to evaluate the risk of malignancies and serious infections among moderate\u002Fsevere SLE patients who receive anifrolumab compared with a comparable population of moderate\u002Fsevere SLE patients on standard of care who do not initiate anifrolumab.",[28],[585],"malignancies, infections, anifrolumab",{"date":587,"type":33},"2026-06-22",{"date":589,"type":33},"2026-01-26",{"date":591,"type":22},"2031-11-30",{"name":69,"class":40},4,{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":4,"eligibilityCriteria":600,"healthyVolunteers":152,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":601,"targetDuration":4,"studyType":23,"phases":603,"briefSummary":604,"conditions":605,"keywords":606,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":622},"100560371","phase-1-a-study-of-gsk4527363-in-healthy-participants-systemic-lupus-erythematosus-sle-participants-healthy-chinese-and-japanese-participants-and-ctd-ild-participants-100560371","NCT06576271","A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants","A Phase 1, First-time-in-human, Four-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GSK4527363 in Healthy Participants (Part A), Participants With Active Systemic Lupus Erythematosus (Part B), Healthy Participants of Chinese and Japanese Descent (Part C) and Participants With Interstitial Lung Disease Associated With Connective Tissue Disease (Part D)","Inclusion criteria:\n\nFor Part A and Part C (Healthy Participants):\n\n* Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent form\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (vital signs and 12-lead ECG)\n* Part C only: Be of Japanese (Cohort C1) or Chinese (Cohort C2) ancestry i. Born in Japan (Cohort C1) or China mainland, Hong Kong or Taiwan (Cohort C2); and ii. Descendent of 2 ethnic Japanese (Cohort C1) or Chinese (Cohort C2) parents and 4 ethnic grandparents; and iii. Have lived outside Japan (Cohort C1) or China mainland, Hong Kong or Taiwan (Cohort C2) for less than 10 years at the time of screening\n* Body weight greater than or equals to (\\>=) 45 kilograms (kg)\n* Body mass index (BMI) within the range 18-32 kilograms per square meter (kg\u002Fm\\^2) (inclusive)\n* Male or female of non-childbearing potential\n\nFor Part B (SLE participants):\n\n* 18 to 65 years of age inclusive, at the time of signing the informed consent form\n* Documented clinical diagnosis of SLE according to the (European alliance of associations of rheumatology \\[EULAR\\]\u002F American College of Rheumatology \\[ACR\\] SLE classification criteria)\n* Body weight \\>= 45 kg\n* BMI within the range 18-32 kg\u002Fm\\^2 (inclusive)\n* Male or female\n* Capable of giving signed informed consent For Part D (CTD-ILD Participants)\n* Participants must be 18 to 65 years of age, at the time of signing the informed consent form\n* Documented clinical diagnosis of specific Connective Tissue Diseases in accordance with internationally recognised classification criteria\n* Documented clinical diagnosis of interstitial lung disease (ILD) as determined by historical High-resolution computed tomography (HRCT)\n* Participants must be on a stable dose of therapy to manage ILD and\u002For underlying connective tissue disease (CTD)\n* Body weight \\>= 45 kg\n* BMI within the range 18-32 kg\u002Fm\\^2 (inclusive)\n* Male or female\n* Capable of giving signed informed consent\n\nExclusion criteria:\n\nFor Part A and Part C (Healthy Participants):\n\n* History or presence or cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders\n* A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of study drug\n* Any acute infection (including upper respiratory tract infections and urinary tract infections) which has not fully resolved within four weeks before dosing\n* Symptomatic herpes zoster within 3 months prior to screening\n* Have a history of malignancy, or a strong family history of malignancies related to immunosuppression\n* Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions\n* Abnormal blood pressure\n* Evidence of active or latent Tuberculosis (TB)\n* Alanine transaminase (ALT) \\>=1.1\\* Upper limit of normal (ULN)\n* Total bilirubin \\>1.0\\*ULN; Participants with Gilbert's syndrome can be included with total bilirubin \\>=1.5\\*ULN as long as direct bilirubin is less than or equal to (\\\u003C=)1.5\\*ULN\n* Presence of Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study intervention\n* Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention\n* Positive Hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention\n* Positive Human immunodeficiency virus (HIV) antibody test at screening\n* Prior medical history of anaphylaxis\n* QT interval corrected for heart rate according to Fridericia's formula (QTcF) \\>450 milliseconds (msec)\n* Live vaccine(s) within 30 days before the dosing day or plans to receive such vaccines during the study\n\nFor Part B (SLE participants):\n\n* Any acute, severe lupus related flare during the Screening Period that needs immediate treatment\n* Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE which, in the opinion of the principal investigator (PI), could confound the results of the clinical study or put the participant at undue risk\n* Have an acute or chronic infection requiring management as follows:\n\n  i. Currently on any suppressive therapy for a chronic infection such as pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria ii. A serious infection requiring treatment with antibiotics and\u002For hospitalization if the last dose of antibiotics or the hospital discharge date was within 60 days of the first day of dosing (Day 1). Prophylactic anti-infective treatment is allowed\n* Evidence of active or latent TB\n* Confirmed Progressive Multifocal Leukoencephalopathy (PML) or unexplained new-onset or deteriorating neurologic signs and symptoms\n* ALT \\>2\\*ULN\n* Total bilirubin \\>1.5\\*ULN; Participants with Gilbert's syndrome can be included with total bilirubin \\>1.5\\*ULN as long as direct bilirubin is \\>1.5\\*ULN\n* Presence of HBsAg and\u002For HBcAb at screening or within 3 months prior to first dose of study intervention\n* Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention\n* Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention\n* History or positive test at Screening for HIV\n* QTcF \\>450 msec\n* Solid or hematological malignancy or a history of malignancy (in the past 5 years) of except for basal cell or squamous cell in situ skin carcinomas, Cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix that have been resected with no evidence of metastatic disease for 3 years\n* Live or live-attenuated vaccine(s) within 30 days prior to Screening\n\nFor Part D Participants:\n\n* A diagnosis of: ILD other than CTD-ILD and\u002For SLE\n* FVC \\\u003C= 45% predicted at Screening Pulmonary arterial hypertension, as determined by the Investigator, prior to Day 1\n* Major surgery (including joint surgery) within 3 months prior to Screening or planned during the duration of the study\n* Previous or planned major organ transplant (e.g. heart, lung, kidney, liver) or bone marrow transplant (e.g. autologous stem cell transplant)\n* Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to CTD-ILD (i.e., cardiovascular, metabolic, hematologic, GI, hepatic, renal, neurological, psychiatric, malignancy, or infectious diseases) which, in the opinion of the PI, could confound the results of the clinical study or put the participant at undue risk\n* Have an acute or chronic infection including requiring management\n* Evidence of active or latent TB\n* Confirmed PML or unexplained new-onset or deteriorating neurologic signs and symptoms\n* ALT \\>2\\*ULN\n* Total bilirubin \\>1.5\\*ULN; Participants with Gilbert's syndrome can be included with total bilirubin \\>1.5\\*ULN as long as direct bilirubin is \\>1.5\\*ULN\n* Presence of HBsAg and\u002For HBcAb at screening or within 3 months prior to first dose of study intervention\n* Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention\n* Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention\n* History or positive test at Screening for HIV\n* Solid or hematological malignancy or a history of malignancy (in the past 5 years) of except for basal cell or squamous cell in situ skin carcinomas, CIN or carcinoma in situ of the cervix that have been resected with no evidence of metastatic disease for 3 years\n* Live or live-attenuated vaccine(s) within 30 days prior to Screening or plans to receive such vaccines during the Screening period or during the clinical study",{"count":602,"type":22},142,[54],"This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of GSK4527363 in healthy participants (Part A), participants with active SLE (Part B), healthy participants of Chinese and Japanese descent (Part C), and participants with interstitial lung disease associated with connective tissue disease (Part D)",[28],[607,608,609,610,611,612,213,613,614],"Belimumab","First time in human study","GSK4527363","Healthy participants","Immunogenicity","Pharmacokinetics","Interstitial lung disease","Connective tissue disease","2026-06-17",{"date":587,"type":33},{"date":618,"type":33},"2024-09-02",{"date":620,"type":22},"2028-01-11",{"name":570,"class":40},28,{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":629,"eligibilityCriteria":630,"healthyVolunteers":12,"sex":17,"minAge":631,"maxAge":632,"enrollmentInfo":633,"targetDuration":4,"studyType":23,"phases":635,"briefSummary":636,"conditions":637,"keywords":638,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":644,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":649,"locationsCount":650},"100503442","phase-3-an-efficacy-and-safety-study-of-intravenous-anifrolumab-to-treat-systemic-lupus-erythematosus-in-pediatric-participants-100503442","NCT05835310","An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants","A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of IV Anifrolumab in Pediatric Participants 5 to \u003C 18 Years of Age With Moderate to Severe Active Systemic Lupus Erythematosus While on Background Standard of Care Therapy","BLOSSOM","Inclusion Criteria:\n\n* Participant's parent\u002Fcaregiver\u002Flegally authorized representative and participant (if required per local country regulation) capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Informed assent is to be provided by the participant per local country regulation.\n* Diagnosis of SLE according to the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) criteria for at least 3 months prior to signing the ICF.\n* At Screening, participant must have moderate to severe active SLE disease, as adjudicated by the Central Adjudication Committee, defined as:\n\n  (a) SLEDAI-2K activity of: (i) ≥ 6 points with at least 4 points (≥ 4 points) coming from the following clinical components ('Clinical' SLEDAI-2K score): arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, or vasculitis and excluding points attributed to a fever, SLE headache, and organic brain syndrome (ii) Clinical SLEDAI score of ≥ 4 points verified at Day 1 (b) BILAG-2004 activity of: (i) ≥ 1 BILAG A score; or (ii) ≥ 2 BILAG B scores (c) PGA score ≥ 1.0 on a 0 to 3 VAS\n* Participant should meet all of following tuberculosis (TB) criteria:\n\nA. No signs or symptoms of active TB B. No medical history or past physical examinations suggestive of active TB C. No recent contact with a person with active TB or if there has been such contact, referral to a TB specialist for evaluation and initiation of treatment for latent TB, if warranted, prior to the first administration of study intervention in accordance with local SoC D. No history of latent TB without documented completion of treatment prior to initial screening visit\n\n* Female participants of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at randomization.\n* Female participants of childbearing and male participants must adhere to the contraception methods.\n\nExclusion Criteria:\n\n* Known diagnosis of an IFN-mediated autoinflammatory interferonopathy.\n* History of, or current diagnosis of, clinically significant non-SLE-related vasculitides.\n* In participants aged 11 years and above: history or evidence of suicidal ideation.\n* History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF.\n* Any positive result on screening for human immunodeficiency virus.\n* Active hepatitis B surface antigen OR hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody and detectable HCV ribonucleic acid (RNA) or any active or recent case of Herpes Zoster infection.\n* Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.\n* History of severe COVID-19 infection requiring hospitalization, intensive care unit care, or assisted ventilation or any prior COVID-19 infection with unresolved sequelae. Any mild\u002Fasymptomatic COVID-19 infection (laboratory confirmed or suspected based on clinical symptoms).\n* Prior use of anifrolumab.\n* Prior treatment with directly acting cytotoxic B-cell depleting therapeutics (eg, rituximab) \\\u003C 26 weeks prior to ICF signature.\n* Blood transfusion or receipt of blood products except albumin within 4 weeks prior to signing the ICF.","5 Years","17 Years",{"count":634,"type":22},100,[183],"A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), Efficacy, and Safety of Anifrolumab in Children with Moderate to Severe Active Systemic Lupus Erythematosus (SLE)",[28],[28,215,639,189,640,641,642,643],"Monoclonal Antibody","Parallel-group treatment","Pediatric participants","Standard of care therapy","Intravenous",{"date":563,"type":33},{"date":646,"type":33},"2024-03-14",{"date":648,"type":22},"2030-01-09",{"name":69,"class":40},99]