[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rheumatoid-arthritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rheumatoid-arthritis":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,167,0,25,[9,49,72,103,128,158,191,212,232,261,292,320,340,363,383,417,442,463,485,508,531,558,594,620,640],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100608438","phase-1-study-evaluating-safety-tolerability-pkpd-of-surovatamig-in-adult-ra-or-sle-participants-100608438",false,"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.","ALL","18 Years","65 Years",{"count":22,"type":23},48,"ESTIMATED","INTERVENTIONAL",[26],"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.",[29,30],"Rheumatoid Arthritis","Systemic Lupus Erythematosus",[32,33,34,35],"adult participants","rheumatoid arthritis","systemic lupus erythematosus","surovatamig","RECRUITING","2026-07-01",{"date":39,"type":40},"2026-07-02","ACTUAL",{"date":42,"type":40},"2025-12-02",{"date":44,"type":23},"2028-06-27",{"name":46,"class":47},"AstraZeneca","INDUSTRY",33,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":24,"phases":59,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"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.","75 Years",{"count":58,"type":23},30,[26],"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.",[30,29],[30,29],"2026-06-29",{"date":37,"type":40},{"date":66,"type":40},"2026-05-28",{"date":68,"type":23},"2029-01",{"name":70,"class":47},"AbbVie",10,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":102},"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":82,"type":23},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.",[29,30,86,87],"Systemic Sclerosis","Healthy Adult Volunteers",[89,90,91],"Autoimmune disease","multi-omic profiling","immunology","2026-06-26",{"date":94,"type":40},"2026-06-30",{"date":96,"type":40},"2026-06-23",{"date":98,"type":23},"2034-06-23",{"name":100,"class":101},"University Hospital, Montpellier","OTHER",1,{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":56,"enrollmentInfo":111,"targetDuration":4,"studyType":24,"phases":113,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},"100615687","phase-1-a-study-of-azd0120-in-autoimmune-diseases-100615687","NCT07295847","A Study of AZD0120 in Autoimmune Diseases","A Phase 1b, Open-label, Multi-cohort Study of AZD0120, an Autologous CD19\u002FBCMA Targeting Chimeric Antigen Receptor T-cell, in Adults With Autoimmune Diseases","AURORA","Inclusion Criteria:\n\n* Capable of giving signed informed consent.\n* Adequate physiological function and reserve at screening.\n* Able to comply with recommended medication washout period.\n* Participants who are suitable for the study as determined by medical evaluation and at the discretion of the investigator.\n* Willingness to remain on\u002Fstart appropriate, highly effective methods of birth control or other acceptable criteria.\n\nExclusion Criteria:\n\n* BMI at screening \\\u003C 18 or \\> 35kg\u002Fm2.\n* Any prior CAR T exposure.\n* Unable or unwilling to remain within proximity (\\~2 hours travel time) of the administering investigational site for the first 28 days post study drug administration.\n* Received a bone marrow or solid organ transplant at any time or on an active transplant waiting list.\n* Received any investigational drug within ≥ 5 half-lives or 4 weeks, whichever is longer, prior to screening.\n* Has certain heart conditions that could make it unsafe or unsuitable to take part in the study.\n* Requirement for supplemental oxygen at rest (except at night for sleep apnea) or mechanical ventilation.\n* Uncontrolled hypertension (\\> 160\u002F100 mmHg) or symptomatic hypertension.\n* Any central nervous system disease that may impact participants safety in the investigator's opinion.\n* Other concurrent autoimmune or autoinflammatory disease. Certain autoimmune\u002Fautoinflammatory diseases may be included after discussion with the medical monitor.\n* Evidence of clinically significant bleeding or active bleeding conditions within 90 days before screening\n* History of malignancy or ongoing treatment for prior malignancy. Certain malignancies may be excepted.\n* Known genetic inborn error of immunity and\u002For primary immunodeficiency.\n* Active viral, bacterial, or fungal infection, or any ongoing infection that requires systemic antimicrobial therapy in the 4 weeks prior to screening.\n* Seropositive for HIV.\n* Active viral hepatitis are excluded.\n* Active syphilis, positive for Treponema pallidum antibody.\n* Vaccinated with live, attenuated vaccine within 4 weeks prior to apheresis or lymphodepletion.\n* Not up-to-date on vaccinations per local\u002Fnational health authority or institutional guidelines for immune-compromised individuals.\n* Known life threatening allergies, hypersensitivity, or intolerance to AZD0120 or its excipients, including dimethyl sulfoxide.\n* Contraindications or hypersensitivity to fludarabine and cyclophosphamide.\n* Major surgery, or has surgery planned during the study.\n* Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 1 year after receiving study treatment (whichever is later).\n* Plans to father a child while enrolled in this study or within 1 year after receiving study treatment (whichever is later).\n* Any issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to provide informed consent or any condition in the opinion of the investigator, participation would not be in the best interest of the participant.\n\nOther protocol-defined eligibility criteria may apply.",{"count":112,"type":23},27,[26],"This trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA\u002FCD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM), or difficult-to-treat rheumatoid arthritis (D2T RA).",[86,116,29],"Idiopathic Inflammatory Myopathies",[86,116,29,118,119,120],"CAR-T","BCMA","CD19",{"date":63,"type":40},{"date":123,"type":40},"2026-01-09",{"date":125,"type":23},"2028-02-22",{"name":46,"class":47},18,{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":24,"phases":138,"briefSummary":139,"conditions":140,"keywords":141,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100531562","phase-1-study-of-single-doses-of-sbt777101-in-subjects-with-rheumatoid-arthritis-100531562","NCT06201416","Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects With Rheumatoid Arthritis","Regulate-RA","Inclusion Criteria:\n\n* Body mass index (BMI) \\\u003C35 kg\u002Fm\\^2, inclusive\n* Adult-onset, moderate-to-severe rheumatoid arthritis (RA)\n* Moderate-to-severe active disease\n* b\u002FtsDMARD failure criterion (≥2)\n* Swollen joint count ≥4\n* Clinical and\u002For ultrasound evidence of synovitis\n* Prior inadequate response to or unable to tolerate available RA therapies\n* Stable doses of RA medications for at least 30 days\n* Use of highly effective methods of contraception\n\nExclusion Criteria:\n\n* Major surgery within 12 weeks prior to screening or planned within 12 months after dosing\n* Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease\n* Recurrent infections or active infection\n* Active or untreated latent tuberculosis\n* Primary or secondary immunodeficiency\n* History of or current inflammatory joint disease other than RA","70 Years",{"count":22,"type":23},[26],"This study will test the safety and effects of SBT777101 when given as a single dose to subjects with rheumatoid arthritis. It is the first study of this treatment being done in humans. Increasing dose levels will be given after the safety at lower dose levels is shown. Following completion of the initial single ascending dose cohorts, the study may evaluate alternative administration regimens of SBT777101, including split-dose administration. In the split-dose cohort, participants may receive two intravenous infusions of SBT777101 derived from a single manufacturing process, administered approximately 6 weeks apart. The study will continue to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity.",[29],[33,142,143,144,145,146,147,148,149],"safety","regulatory T cells","CART","Treg","Inflammatory disease","autoimmune disease","autologous","cell therapy",{"date":94,"type":40},{"date":152,"type":40},"2024-03-06",{"date":154,"type":23},"2026-11",{"name":156,"class":47},"Sonoma Biotherapeutics, Inc.",9,{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":18,"minAge":165,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":24,"phases":168,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":182,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":102},"100645287","intra-articular-adelmidrol-2hyaluronic-acid-1-with-or-without-mumpea-in-knee-pain-due-to-joint-degeneration-100645287","NCT07680101","Intra-Articular Adelmidrol 2%\u002FHyaluronic Acid 1% With or Without m\u002FumPEA, in Knee Pain Due to Joint Degeneration.","Efficacy of Intra-articular Treatment With Adelmidrol 2% \u002F Hyaluronic Acid 1%, With or Without m\u002FumPEA, in Knee Pain Due to Joint Degeneration: a Bicentric, Prospective, Randomized Study.","Inclusion Criteria:\n\n* Age ≥ 40 years\n* Male or female\n* Diagnosis of unilateral or bilateral knee joint degeneration due to osteoarthritis or rheumatoid arthritis, Kellgren-Lawrence grade II-III\n* Duration of knee pain ≥ 6 months\n* Baseline WOMAC score ≥ 20\n* Drug therapy stabilized for at least 3 months in the case of patients with rheumatoid arthritis\n* Naïve to palmitoylethanolamide treatment\n* Signed informed consent\n\nExclusion Criteria:\n\n* Severe progressive systemic diseases\n* Contraindications to intra-articular knee injections\n* Intra-articular knee injections within 3 months prior to enrollment\n* Knee surgery within 6 months prior to enrollment\n* Systemic treatment with chondroprotectors within 1 month prior to enrollment\n* Systemic corticosteroid treatment within 1 month prior to enrollment\n* Chronic Non-Steroidal Anti-Inflammatory Drugs (NSAID) therapy\n* Pregnancy or breastfeeding\n* Known hypersensitivity to study treatments","40 Years",{"count":167,"type":23},80,[169],"NA","Degenerative knee joint diseases are characterized by chronic pain, inflammation, and functional impairment. In these conditions, mast cell density in the synovial membrane is increased, resulting in an excessive release of biological mediators involved in key mechanisms of neuroinflammation and in hyaluronic acid depolymerisation. Adelmidrol acts as a preventive antioxidant due to its radical scavenging activity, thus protecting hyaluronic acid from oxidative degradation and reducing mast cell degranulation. Furthermore, a reduction in endogenous Palmitoylethanolamide (PEA) levels also contributes to joint neuroinflammation and disease progression; therefore, its exogenous supplementation may represent a valuable supportive strategy.\n\nThe objective of this clinical investigation is to compare the efficacy of intra-articular adelmidrol\u002Fhyaluronic acid treatment alone versus the same intra-articular treatment combined with oral micronized \u002Fultramicronized PEA in patients with knee joint degeneration due to osteoarthritis or rheumatoid arthritis.",[172,29],"Degenerative Joint Disease of Knee",[174,175,176,177,178,179,180,181],"Neuroinflammation","Palmitoylethanolamide","Adelmidrol","Hyaluronic Acid","Intra-Articular Injection","Knee Pain","Arthritis, Rheumatoid","Osteoarthritis, Knee","NOT_YET_RECRUITING","2026-06-25",{"date":39,"type":40},{"date":186,"type":23},"2026-06",{"date":188,"type":23},"2027-06",{"name":190,"class":101},"Universita di Verona",{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":24,"phases":200,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":211},"100603521","phase-2-a-study-to-assess-the-efficacy-and-safety-of-ro7790121-in-participants-with-moderate-to-severe-rheumatoid-arthritis-who-have-not-responded-to-or-who-cannot-tolerate-tumor-necrosis-factor-tnf-andor-janus-kinase-jak-inhibitors-100603521","NCT07137598","A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded to or Who Cannot Tolerate Tumor Necrosis Factor (TNF) and\u002For Janus Kinase (JAK Inhibitors)","A Phase II, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response or Intolerance to TNF and\u002For JAK Inhibitors","Inclusion Criteria:\n\n* Has moderate to severe active RA defined by the presence of \\>=6 swollen joints and \\>=6 tender joints at screening and baseline (based on 66\u002F68-joint count)\n* Diagnosis of RA for \\>=3 months and also fulfills the 2010 American College of Rheumatology (ACR)\u002FEuropean Alliance of Associations for Rheumatology (EULAR) classification criteria for RA\n* Demonstrated an inadequate response or loss of response to or intolerance to \\>=1 conventional synthetic disease-modifying antirheumatic drug (csDMARD)\n\nExclusion Criteria:\n\n* Have failed more than two TNF inhibitors or JAK inhibitors\n* Class IV RA according to ACR revised response criteria (Hochberg et al. 1992)\n* Past or current use of other biologic disease-modifying antirheumatic drugs (bDMARDs) (excluding TNF inhibitors) or rituximab\n* Treatment with investigational therapy within 4 weeks or within 5 half-lives of the investigational therapy, whichever is longer, prior to initiation of study treatment.\n* History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA\n* Has been treated with intra-articular, intramuscular, intravenous, trigger point or tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8 weeks prior to the first dose of study drug\n* History of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of the study drug (or its excipients) and\u002For other products in the same class\n* Any major surgery within 6 weeks prior to screening or a major surgery planned during the study\n* Any serious, chronic and\u002For unstable pre-existing medical, psychiatric, or other- condition\n* History of malignancy, with the exception non-metastatic basal cell or cutaneous squamous cell cancer adequately treated with electrodesiccation and curettage or resection or in situ cervical cancer adequately treated and cured\n* Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungal infections\n* History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection\n* History of organ transplant\n* Any identified confirmed congenital or acquired immunodeficiency\n* Abnormal laboratory values and liver function test",{"count":199,"type":23},160,[201],"PHASE2","This study will assess the efficacy and safety of Afimkibart (also known as RO7790121) compared with placebo in participants with moderate to severe rheumatoid arthritis (RA) who have an inadequate response or intolerance to TNF and\u002For JAK inhibitors.",[29],{"date":63,"type":40},{"date":206,"type":40},"2025-12-05",{"date":208,"type":23},"2027-10-08",{"name":210,"class":47},"Hoffmann-La Roche",53,{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":24,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":102},"100640867","phase-2-an-extension-study-to-assess-long-term-safety-and-efficacy-of-afimkibart-in-participants-with-rheumatoid-arthritis-100640867","NCT07620392","An Extension Study to Assess Long-Term Safety and Efficacy of Afimkibart in Participants With Rheumatoid Arthritis","An Extension Study to Evaluate the Long-term Safety and Efficacy of Afimkibart (RO7790121) in Patients With Rheumatoid Arthritis Who Participated in Previous Afimkibart Clinical Trials","dRAvite-LTE","Inclusion Criteria:\n\n* Completed the treatment period of the parent study\n* Agreement to adhere to the contraception requirements\n* Continued to be evaluated at the follow-up visit of the parent study and achieved improvement in the SJC66\u002FTJC68 relative to baseline\n\nExclusion Criteria:\n\n* Withdrawal of consent and\u002For premature discontinuation from parent study\n* Any permanent discontinuation of study drug in parent study\n* Use of a prohibited therapy during the parent study\n* Evidence of any new or uncontrolled concomitant disease that, in the investigator's judgment, would preclude participant participation in the trial",{"count":221,"type":23},120,[201],"The study will evaluate the long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response or intolerance to tumor necrosis factor (TNF) and\u002For Janus kinase (JAK) inhibitors, and who were previously treated with Afimkibart.",[29],"2026-06-24",{"date":92,"type":40},{"date":228,"type":40},"2026-06-03",{"date":230,"type":23},"2033-07-08",{"name":210,"class":47},{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":241,"conditions":242,"keywords":247,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":260},"100645227","post-market-clinical-follow-up-pmcf-study-evaluating-the-safety-and-efficacy-of-tpmed-shoulder-prosthesis-system-100645227","NCT07678034","Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System","A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System","Inclusion Criteria:\n\n* Individuals aged 18 years and older,\n* Male or female participants,\n* Participants who have undergone Reverse Shoulder Arthroplasty or Shoulder Hemiarthroplasty for any valid indication,\n* Participants in whose surgical procedure the Tipmed™ Shoulder Prosthesis System product configurations were utilized.\n* Participants who are not legally restricted (e.g., military personnel, convicts, or individuals under legal guardianship).\n* Participants who have voluntarily signed the written Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n* Concurrent participation in any other interventional clinical trial.",{"count":240,"type":23},54,"This study is designed as a prospective, multicenter, observational post-market clinical follow-up (PMCF) study to evaluate the safety and effectiveness of the Tipmed™ Shoulder Prosthesis System at 12 months postoperatively. The study population includes adult patients who undergo reverse shoulder arthroplasty (RSA) or shoulder hemiarthroplasty (HA) using the Tipmed™ implant systems due to various clinical indications such as osteoarthritis, rotator cuff arthropathy, or proximal humerus fractures. The main objective is to gather real-world clinical evidence on the 12-month post-operative safety profile, potential complications, and functional outcomes of the device during routine clinical practice.",[243,244,245,29,246],"Glenohumeral Osteoarthritis","Proximal Humerus Fracture","Rotator Cuff Arthropathy","Avascular Necrosis",[248,249,250,251,252],"Reverse Shoulder Arthroplasty","Shoulder Prosthesis","Shoulder Hemiarthroplasty","Post-Market Clinical Follow-Up (PMCF)","Modified Constant-Murley Score",{"date":37,"type":40},{"date":255,"type":40},"2025-06-16",{"date":257,"type":23},"2030-06-15",{"name":259,"class":47},"TIPMED Medical Device Manufacturing Ltd. Co.",4,{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":136,"enrollmentInfo":269,"targetDuration":4,"studyType":24,"phases":271,"briefSummary":272,"conditions":273,"keywords":274,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":291},"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":270,"type":23},72,[26],"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.",[30,116,29],[275,276,277,278,279,280,281,282,283,284],"Lupus","Inflammatory Myopathy","Musculoskeletal Diseases","Neuromuscular Diseases","Nervous System Diseases","Muscular Diseases","Myositis","Dermatomyositis","Polymyositis","Arthritis",{"date":183,"type":40},{"date":287,"type":40},"2025-05-01",{"date":289,"type":23},"2027-09-15",{"name":46,"class":47},37,{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":24,"phases":302,"briefSummary":303,"conditions":304,"keywords":305,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":313,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":319},"100614206","phase-2-a-study-to-investigate-efficacy-and-safety-of-azd1163-in-participants-with-rheumatoid-arthritis-100614206","NCT07276581","A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis","A Multicentre, Parallel-group, Phase II, Randomised, Double-blind, 4 Arm Study to Evaluate Efficacy and Safety of AZD1163 in Participants With Moderately-to-Severely Active Rheumatoid Arthritis (LaunchPAD-RA)","LaunchPAD-RA","* Inclusion\n\n  * Diagnosed with adult-onset RA as defined by the 2010 ACR\u002FEULAR classification criteria for at least 12 weeks prior to screening.\n  * Moderately-to-severely active RA as defined by: a. \\>= 6 swollen joints on 66SJC and \\>= 6 tender joints on 68TJC; b. CRP \\> upper limit of normal.\n  * Have a positive ACPA at screening.\n  * A history of inadequate response, or loss of response, or intolerance to: a. at least one csDMARD treatment, AND\u002FOR b. At least one and at most 2 TNFi.\n  * A history of at least 12 weeks treatment and \\>= 4 weeks stable on a csDMARD and\u002For SC TNFi prior to the day of randomisation.\n* Exclusion\n\n  * History or evidence of an alternate autoimmune or other condition that could confound the diagnosis of RA. Participants with RA and secondary Sjogren's disease are eligible.\n  * Have received or planning to receive any biologic DMARDs (except for TNFi) or targeted synthetic DMARDs.",{"count":301,"type":23},320,[201],"Phase II study in participants with moderately-to-severely active rheumatoid Arthritis (RA) to evaluate efficacy and safety of AZD1163.",[29],[306,307,308,309,310,311,312],"Rheumatoid arthritis","AZD1163","placebo-controlled","double-blind","csDMARDs","TNFi","PAD2\u002F4 inhibitor",{"date":225,"type":40},{"date":315,"type":40},"2025-12-15",{"date":317,"type":23},"2028-08-18",{"name":46,"class":47},144,{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":24,"phases":329,"briefSummary":330,"conditions":331,"keywords":332,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":333,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":339},"100590824","phase-2-a-study-to-evaluate-different-targeted-therapies-for-patients-with-rheumatoid-arthritis-100590824","NCT06972446","A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis","A Phase 2, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis","Inclusion Criteria:\n\n* At any time prior to the Screening Visit, participant must have been treated for \\> or = 3 months with at least 1 b\u002FtsDMARD therapy but continued to exhibit active RA, or had to discontinue due to intolerability or toxicity, irrespective of treatment duration. The maximum cap for prior use of b\u002FtsDMARD is 2.\n* Participant must be on a stable dose of methotrexate (MTX)\n\nExclusion Criteria:\n\n* Participant is taking nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen\u002Fparacetamol, low-potency opioids (tramadol, codeine, hydrocodone, alone or in combination with acetaminophen), oral corticosteroids (equivalent to ≤ 10 mg\u002Fday of prednisone), or inhaled corticosteroids for stable medical conditions unless they have been on stable doses for ≥ 1 week prior to Baseline Visit.\n* History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than rheumatoid arthritis.",{"count":328,"type":23},180,[201],"Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies for the treatment of moderately to severely active Rheumatoid Arthritis (RA).\n\nThis study currently includes 3 substudies evaluating different treatments in participants with RA. Substudy 1 will evaluate lutikizumab monotherapy (treatment given alone) compared to placebo (looks like the study treatment but contains no medicine). Substudy 2 will evaluate ravagalimab monotherapy compared to placebo and Substudy 3 will evaluate lutikizumab and ravagalimab combination therapy (treatments given together) compared to placebo. Approximately 180 participants who have failed 1 or 2 biologic\u002Ftargeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies will be enrolled in the study at approximately 65 sites worldwide.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. 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.",[29],[29],{"date":183,"type":40},{"date":335,"type":40},"2025-06-20",{"date":337,"type":23},"2027-11",{"name":70,"class":47},101,{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":80,"sex":18,"minAge":19,"maxAge":347,"enrollmentInfo":348,"targetDuration":4,"studyType":24,"phases":350,"briefSummary":351,"conditions":352,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":362},"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":349,"type":23},63,[26],"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.",[353,30,29],"Healthy","2026-06-19",{"date":96,"type":40},{"date":357,"type":40},"2026-02-04",{"date":359,"type":23},"2028-03",{"name":361,"class":47},"Eli Lilly and Company",8,{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":56,"enrollmentInfo":370,"targetDuration":4,"studyType":24,"phases":372,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":382},"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":371,"type":23},21,[26],"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).",[30,29],{"date":96,"type":40},{"date":377,"type":40},"2026-02-19",{"date":379,"type":23},"2029-07-16",{"name":381,"class":47},"Merck Sharp & Dohme LLC",17,{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":24,"phases":392,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":416},"100348403","phase-1-testing-an-immunotherapy-anti-cancer-drug-nivolumab-for-advanced-cancers-in-patients-with-autoimmune-disorders-aim-nivo-100348403","NCT03816345","Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO","A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)","Inclusion Criteria:\n\n* Patients can have either histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable, or have a malignancy for which a PD-1\u002FPD-L1 inhibitor has been approved in the adjuvant setting, as well as the neoadjuvant or perioperative setting in which such treatment is considered standard of care or has been approved. Eligible tumor types include solid tumors and malignancies in which there is known evidence of clinical activity for single agent PD-1 or PD-L1 antibodies. Nivolumab or other PD1\u002FPD-L1 inhibitors are FDA-approved for the treatment of melanoma, non-small cell lung cancer (NSCLC), Merkel cell cancer, bladder cancer, renal cell carcinoma (RCC), gastric cancer, hepatocellular carcinoma (HCC), cervical cancer, head and neck cancer, Hodgkin lymphoma (HL), metastatic small cell lung cancer (SCLC), and any solid tumor with microsatellite instability (MSI)-high status confirmed. Patients with HL are eligible but must follow standard response criteria. Additional tumor types may be eligible on a case by case basis upon discussion with principal investigator (PI)\n\n  * Patients enrolling on the trial for adjuvant use will be restricted to those with histology for which a PD-1\u002FPD-L1 inhibitor has been approved in the adjuvant setting including but not limited to NSCLC, melanoma, RCC, cervical cancer, and bladder cancer\n  * Patients enrolled on the study can receive Nivolumab with other FDA-approved combinations according to the FDA package insert, including, but not limited to ipilimumab, cabozantinib or chemotherapy\n* Patients who have previously received other forms of immunotherapy (high-dose \\[HD\\] IL-2, IFN, CTLA-4) are allowed. Patients must not have received cytokine immunotherapy for at least 4 weeks before nivolumab administration. Patients who have received prior anti-CTLA4 will be allowed and the washout period is 6 weeks\n* Age \\>= 18 years; children are excluded from this study but may be eligible for future pediatric phase 1 combination trials\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky \\>= 60)\n* Life expectancy of greater than 12 weeks\n* Leukocytes \\>= 1,000\u002FmcL\n* Absolute neutrophil count \\>= 500\u002FmcL\n* Platelets \\>= 50,000\u002FmcL\n* Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 5 x institutional ULN or =\\\u003C 8 x institutional ULN for patients with liver metastases or an autoimmune disease that is contributing to the elevation of these values\n* Creatinine ULN OR glomerular filtration rate (GFR) \\>= 30 mL\u002Fmin (if using the Cockcroft-Gault formula)\n* Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated\n* If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required for at least 4 weeks (or scheduled assessment after the first cycle of treatment), and a risk-benefit analysis (discussion) by the patient and the investigator favors participation in the clinical trial\n* The effects of nivolumab on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product\n\n  * Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception\n  * WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), tubal ligation, or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU\u002FmL\n  * These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days, and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days\n  * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately. Patients can resume treatment upon termination of a pregnancy or the completion of a successful pregnancy\n* Ability to understand and the willingness to sign a written informed consent document\n* Patients with more than one autoimmune disease are eligible. The treating physician would determine which autoimmune disease is dominant and the patient would be treated under that specific cohort (Please note: Patients with more than one autoimmune disease should receive assessments for all previously diagnosed autoimmune diseases. For example, a patient with psoriasis and IBD might be enrolled in the IBD cohort. Disease assessments for both psoriasis and IBD should be obtained, as per protocol. Case report forms \\[CRFs\\] for all relevant autoimmune diseases should be utilized. However, all additional cohort requirements will be considered optional and only the assessments from the assigned cohort will be considered mandatory)\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients with known SSc or DM according to updated classification criteria (Van den Hoogan et al., Arthritis Rheum 2013;65(11):2737-47; Lundberg et al., A\\&R in press). Overlap features are permitted, but patients must meet criteria for a \"primary diagnosis\" of DM or SSc\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for DM or SSc unless specifically excluded\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients must have a baseline computed tomography (CT) of the chest (within 6 months of study entry)\n* RA-SPECIFIC INCLUSION: Rheumatologist-diagnosed RA requiring prior treatment with disease-modifying antirheumatic drugs (DMARDs) before patient was diagnosed with current malignancy. We recommend, but do not require, documentation for meeting 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria for RA\n* RA-SPECIFIC INCLUSION: Prednisone up to 10 mg\u002Fday will be allowed. Intraarticular steroids will be allowed for the treatment of new symptomatic joints\n* RA-SPECIFIC INCLUSION: Nonsteroidal anti-inflammatory drugs (NSAIDs) will be allowed\n* SLE-SPECIFIC INCLUSION: SLE diagnosed by a rheumatologist. The patient should meet the revised 1997 American College of Rheumatology (ACR) classification criteria for SLE, but this is not mandatory\n* ULCERATIVE COLITIS (UC)-SPECIFIC INCLUSION: Diagnosis of UC must be made by endoscopy with biopsies\n* UC-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administration\n* UC-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (antigen \\[Ag\\] negative, antibody \\[core (c)Ab\\] negative, antibody \\[surface (s)Ab\\] positive or negative) and Mycobacterium tuberculosis (purified-protein- derivative \\[PPD\\] or enzyme-linked immunospot assay \\[ELISpot or T-spot\\]) or be on appropriate anti-microbial treatment for these infections\n* UC-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission, defined as a Mayo Clinic score (MCS) of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 either without medications, or treated with 5-ASA derivative, probiotic, or prior fecal transplant\n* UC-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on 6-mercaptopurine, azathioprine, methotrexate, or rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohort\n* UC-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either be A) in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on a biologic therapy targeting tumor necrosis alpha (TNF-α) (infliximab, adalimumab, golimumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease defined as a MCS of 3-5 and no subscore higher than 2, and an endoscopic subscore of \\\u003C 2 on one of the medications or combination of medications defined for the Moderate or Mild cohort\n* CROHN'S DISEASE (CD)-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administration\n* CD-SPECIFIC INCLUSION: If patients have prior known disease in the stomach or small intestines, appropriate endoscopic evaluation (esophagogastroduodenoscopy\u002Fvideo capsule endoscopy) and\u002For imaging (computed tomography or magnetic resonance enterography) must also be current within 4 weeks prior to nivolumab administration\n* CD-SPECIFIC INCLUSION: Deep enteroscopy techniques, such as double balloon enteroscopy, will not be required\n* CD-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (sAg negative, cAb negative, sAb positive or negative) and M. tuberculosis (PPD or ELISpot or T-spot) or be on appropriate anti-microbial treatment for these infections\n* CD-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission as defined by a Crohn's Disease Activity Index (CDAI) \\\u003C 150 either without treatment or on a 5-ASA derivative, probiotic, antibiotics, or following fecal transplant\n* CD-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission as defined by a CDAI \\\u003C 150 on 6-mercaptopurine, azathioprine, methotrexate, rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohort\n* CD-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either A) be in clinical remission as defined by a CDAI \\\u003C 150 on biologic therapy targeting TNF-α (infliximab, adalimumab, certolizumab pegol), IL-12\u002F23p40 (ustekinumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease as defined by a CDAI of 150 to 220 on one of medications or combination of medications defined for the Moderate or Mild cohort\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For other autoimmune diseases that cannot be classified, the eligibility criteria will be determined by the managing rheumatologist or other autoimmune disease specialist, based on the clinical judgement and current American College of Radiology (ACR) classification guidelines or other relevant guidelines, as per the disease category in question\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For giant cell arteritis (GCA), patients must have had positive temporal artery biopsy for GCA and abnormal erythrocyte sedimentation rate (ESR) at time of diagnosis\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For polymyalgia rheumatica (PMR), patients must have clinical diagnosis in addition to elevated inflammatory markers including (ESR, C reactive protein \\[CRP\\])\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: Patients can be in remission (with no glucocorticoids or immunosuppressive medications) or have low-moderate activity, which is defined as being on prednisone ≤ 10 mg or equivalent\n* MS-SPECIFIC INCLUSION: Patients must meet 2017 McDonald criteria for the diagnosis of MS (Thompson AJ, et al. Diagnosis of multiple sclerosis: 2017 revision of the McDonald criteria. Lancet Neurol. 17(2):162-173.)\n* MS-SPECIFIC INCLUSION: Patients with MS can be in remission and can have a history of being on immunomodulatory agents, but at the time of entry into the clinical trial, patients should be off any concurrent MS therapy for at least 2 weeks. Patients receiving concomitant interferon gamma (IFN-γ treatment) will be permitted in the study\n* SJS-SPECIFIC INCLUSION: SjS diagnosed by a rheumatologist or oral medicine provider. The patient should meet the American-European Consensus Criteria for Sjögren's Syndrome (Vitali, et al., 2002). If on treatment, the patient may only be on hydroxychloroquine and prednisone ≤ 10 mg or equivalent\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients with known PsO as diagnosed by a dermatologist or PsA by a rheumatologist and\u002For by Classification for Psoriatic Arthritis (CASPAR) criteria (Tillett et al., 2012)\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients must have stable disease as determined by the investigator with no change in systemic therapy and\u002For biologic therapy for at least 3 months, except for those on tumor necrosis factor (TNF) inhibitors. In the case of TNF inhibition, patients may have transitioned to an alternative biologic therapy with stable disease for at least 4 weeks. For PsA, no change in corticosteroid therapy for at least 1 month prior to baseline and dose must be 10 mg or less\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for PsO or PsA unless specifically excluded\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (AEs) due to agents administered more than 4 weeks earlier have not resolved or stabilized. Palliative (limited-field) radiation therapy (RT) is permitted (2 week washout from start of treatment), if all of the following criteria are met:\n\n  * Repeat imaging demonstrates no new sites of bone metastases\n  * The lesion being considered for palliative radiation is not a target lesion\n* Patients with prior therapy with an anti-PD-1 or anti-PD-L1\n* Patients with prior allogeneic hematologic transplant\n* Patients who are receiving any other anticancer investigational agents\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* UC-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment\n* UC-SPECIFIC EXCLUSION: Prior colectomy\n* UC-SPECIFIC EXCLUSION: Concurrent primary sclerosing cholangitis (PSC). Patients with PSC can be enrolled on the Other Autoimmune Diseases Cohorts\n* UC-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup\n* CD-SPECIFIC EXCLUSION: Known untreated abscesses, untreated and symptomatic strictures, short gut physiology, or isolated jejunal disease\n* CD-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment\n* CD-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup\n* MS-SPECIFIC EXCLUSION: Patients with MS cannot have medical contraindications to gadolinium-enhanced magnetic resonance imaging (MRI)",{"count":391,"type":23},300,[26],"This phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in treating patients with autoimmune disorders and cancer that has spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced), to other places in the body (metastatic) or cannot removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Cabozantinib is a type of tyrosine kinase inhibitor and a type of angiogenesis inhibitor. Chemotherapy drugs, such as platinum containing therapies and fluoropyrimidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab alone and in combination with other treatments, including ipilimumab, cabozantinib, platinum containing therapy, or fluoropyrimidine, may be safe, tolerable, and\u002For effective in treating patients with autoimmune disorders and advanced, metastatic, or unresectable cancer.",[395,396,282,397,398,399,400,401,402,29,403,30,404,405],"Autoimmune Disease","Crohn Disease","Hematopoietic and Lymphoid Cell Neoplasm","Inflammatory Bowel Disease","Malignant Solid Neoplasm","Multiple Sclerosis","Psoriasis","Psoriatic Arthritis","Sjogren Syndrome","Systemic Scleroderma","Ulcerative Colitis","2026-06-16",{"date":408,"type":40},"2026-06-17",{"date":410,"type":40},"2019-07-16",{"date":412,"type":23},"2028-03-30",{"name":414,"class":415},"National Cancer Institute (NCI)","NIH",52,{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":18,"minAge":424,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":24,"phases":427,"briefSummary":429,"conditions":430,"keywords":431,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":102},"100317580","phase-3-treatment-of-rheumatoid-arthritis-with-dmards-predictors-of-response-100317580","NCT03414502","Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response","Treatment of Rheumatoid Arthritis With Disease-modifying Antirheumatic Drugs (DMARDs): Predictors of Response","INCLUSION CRITERIA:\n\n* Diagnosed rheumatoid arthritis (RA) with 4 of 7 American College of Rheumatology criteria\n\n  * Morning stiffness for at least 1 hour for at least 6 weeks\n  * Swelling of 3 or more joints for at least 6 weeks\n  * Swelling of wrist, metacarpophalangeal (MCP), or proximal interphalangeal joints for 6 or more weeks\n  * Symmetric joint swelling\n  * Hand x-rays with erosions or bony decalcifications\n  * RA nodules\n  * Rheumatoid factor (RF) positive\n* \\>19 yrs old at RA diagnosis\n* Active disease with at least 1 swollen joint\n* Starting new DMARD medication(s) (abatacept, adalimumab, azathioprine, barcitinib, certolizumab, etanercept, golimumab, hydroxychloroquine, infliximab, leflunomide, methotrexate, minocycline, rituximab, sarilumab, sulfasalazine, tofacitinib)\n* If on other DMARDS, must be on stable dose for ≥ 6 wks\n* If on glucocorticoids, must be on stable dose for 2 wks (\\\u003C 10mg of Prednisone\u002Fday or equivalent)\n* Able to adhere to study visit schedule: enrollment (8 wks \\& 16 wks +\u002F- 2 wks)\n* Hemoglobin (Hgb) \\> 9g\u002Fdl\n* Platelets \\>100\n* Creatinine \\\u003C1.6\n* Aspartate transferase (AST) or alanine aminotransferase (ALT) at or below 1.2 x upper limit\n* Albumin up to 1.0 g\u002FdL below lower limit of normal\n\nEXCLUSION CRITERIA:\n\n* Pregnant or breastfeeding women\n* Men and women of child bearing potential unwilling to practice effective method of contraception","19 Years",{"count":426,"type":23},400,[428],"PHASE3","Rheumatoid arthritis (RA) is a common disease with approximately 1% prevalence. RA is also a chronic, progressive disease with no cure. Current treatment goals are to minimize pain, limit joint damage, and prevent loss of function. Drugs used to treat RA include non-steroidal anti-inflammatory drugs (NSAIDS), glucocorticoids, and disease-modifying anti-rheumatic drugs (DMARDs), including biologics. Methotrexate (MTX) is the DMARD of choice in the treatment of RA, because it has been shown to be both well-tolerated and effective in achieving clinical response and slowing radiographic progression of disease. However, this drug alone results in remissions in only a small subset of patients and reliable predictors of DMARD response have yet to be identified.\n\nThis study is open-label of 16-weeks duration to identify factors that help predict clinical responses to disease-modifying antirheumatic drugs (DMARD) therapies for rheumatoid arthritis (RA) participants. All participants will receive a starting dose of DMARD medication(s) which may be adjusted by the investigator as needed. If a participant becomes intolerant of a DMARD medication, the participant will be withdrawn at the discretion of the investigator. Necessary withdrawals prior to week 16 visits will be considered end of study. Otherwise, end of study data as well as study serum will be collected at week 16. A portion of the blood collected at baseline, week 8 and week 16 for the optional addendum portion of the study is for future research and will be utilized attempting to look to detect the generation of superoxide radicals. These radicals have been shown to be associated with inflammation and may correlate with the progression of RA, which if confirmed, should decrease the levels of these radicals signaling response to treatment.",[29],[432,433],"Methotrexate","DMARD","2026-06-15",{"date":408,"type":40},{"date":437,"type":40},"2007-12-10",{"date":439,"type":23},"2029-03",{"name":441,"class":101},"University of Nebraska",{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":80,"sex":18,"minAge":19,"maxAge":56,"enrollmentInfo":449,"targetDuration":4,"studyType":24,"phases":450,"briefSummary":451,"conditions":452,"keywords":454,"overallStatus":182,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":4},"100642293","phase-1-a-trial-in-healthy-adult-participants-and-adults-with-autoimmune-disease-to-test-how-hbm7020-is-tolerated-and-absorbed-in-the-body-100642293","NCT07649265","A Trial in Healthy Adult Participants and Adults With Autoimmune Disease to Test How HBM7020 is Tolerated and Absorbed in the Body","A Phase 1 Open-Label, Multicenter Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of HBM7020 in Healthy Adult Participants and Adults With Seropositive Autoimmune Disease","Key Inclusion Criteria for Healthy Participants (Part 1)\n\n1. Participants who are of non-childbearing potential or are using acceptable contraception.\n2. Body mass index (BMI) and body weight within an acceptable range.\n3. Good general health based on medical history, physical examination, electrocardiogram (ECG), and laboratory assessments.\n\nKey Disease-Agnostic Inclusion Criteria for Patient Participants (Part 1)\n\n1. BMI and body weight within an acceptable range.\n2. Adequate hematologic, renal, hepatic, immunologic, and lymphocyte parameters.\n\nKey Disease-Specific Inclusion Criteria for Patient Participants (Part 1)\n\n1. Confirmed autoimmune disease with appropriate supporting autoantibody findings.\n2. Stable background therapy prior to dosing.\n3. Active moderate to severe disease consistent with protocol-defined disease activity criteria for:\n\n   * Systemic lupus erythematosus (SLE)\n   * Systemic sclerosis (SSc)\n   * Rheumatoid arthritis (RA)\n   * Sjögren's disease (SjD)\n\nKey Inclusion Criteria for Rescreening Participants (Part 2)\n\n1. Meets Part 1 disease-agnostic inclusion criteria.\n2. Stable background autoimmune therapy prior to dosing.\n3. Ongoing active moderate to severe disease based on protocol-defined disease-specific criteria.\n\nKey Exclusion Criteria for Parts 1 and 2\n\n1. Pregnant or breastfeeding participants.\n2. Recent vaccination within protocol-defined timelines.\n3. Clinically significant medical history or abnormal physical examination findings.\n4. Clinically significant cardiovascular abnormalities, including blood pressure, heart rate, syncope, or ECG findings.\n5. Prior or recent therapies or conditions that may interfere with study participation or safety evaluations.\n6. Severe pulmonary, renal, or cardiac disease, or clinically significant pulmonary hypertension.",{"count":349,"type":23},[26],"This first-in-human study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of HBM7020. The study will enroll healthy participants at low doses, followed by participants with moderate to severe autoimmune diseases with predominant B-cell involvement. Eligible participants include patients with systemic lupus erythematosus (SLE), systemic sclerosis (SSc), Sjögren's disease (SjD), and rheumatoid arthritis (RA).",[29,30,86,453],"Sjögren's Disease",[89],"2026-06-11",{"date":406,"type":40},{"date":458,"type":23},"2026-09-15",{"date":460,"type":23},"2028-11-20",{"name":462,"class":47},"Otsuka Pharmaceutical Development & Commercialization, Inc.",{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":56,"enrollmentInfo":470,"targetDuration":4,"studyType":24,"phases":472,"briefSummary":473,"conditions":474,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":484},"100585450","phase-1-study-of-gs-0151-in-participants-with-rheumatoid-arthritis-100585450","NCT06902519","Study of GS-0151 in Participants With Rheumatoid Arthritis","A Phase 1b, Randomized, Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of GS-0151 in Adult Participants With Rheumatoid Arthritis","Key Inclusion Criteria:\n\nMedical History\u002FPhysical Characteristics; All Cohorts:\n\n* Individuals must not be on a biologic disease-modifying antirheumatic drug (b\u002FtsDMARD) on Day 1 and must have discontinued all b\u002FtsDMARDs (including biosimilars and generics) at least 4 weeks prior to Day 1 with the exception of B cell-depleting agents (eg, rituximab), which must be discontinued for at least 6 months prior to Day 1.\n* Ongoing treatment with at least 1 but no more than 2 protocol-permitted conventional synthetic disease-modifying antirheumatic drug (csDMARDs) for at least 12 weeks, at a stable dose for at least 6 weeks prior to Day 1 and remain stable throughout the treatment period:\n\n  1. Use of oral, intramuscular (IM), or subcutaneous(ly) (SC) methotrexate 7.5 to 25 mg\u002Fweek. Individuals on methotrexate must be receiving folic or folinic acid supplementation at a stable dose.\n  2. Oral hydroxychloroquine ≤ 400 mg\u002Fday or chloroquine ≤ 250 mg\u002Fday.\n  3. Oral sulfasalazine 1 to 3 g\u002Fday.\n  4. Oral leflunomide 10 to 20 mg\u002Fday.\n* Use of oral corticosteroids of no more than 10 mg prednisone or equivalent per day is allowed if the dose is stable for at least 14 days prior to Day 1. Inhaled corticosteroids for stable medical conditions are allowed but must have been at a stable dose for at least\n\n  1 week prior to the first dose of study drug. Occasional topical corticosteroids are permitted.\n* Where nonsteroidal anti-inflammatory drug (NSAIDs) or acetaminophen are used, the dose must be stable for at least 1 week prior to Day 1\n* Individuals must have discontinued all high-potency opiates at least 1 week prior to Day 1.\n\nCohort 3 Only:\n\n* Individuals must meet all of the following cohort-specific inclusion criteria, in addition to meeting the inclusion criteria for all individuals , to be eligible for participation in Part B:\n\nModerately to severely active RA defined by the following:\n\nScreening and Day 1:\n\n1. 6 or more tender joints on the tender joint count based on 68 joints (TJC68), AND.\n2. 6 or more swollen joints on the swollen joint count based on 66 joints (SJC66). The distal interphalangeal joints should be evaluated but not included in the total count to determine eligibility.\n\n   Screening Only\n3. Have a hsCRP ≥ ULN\n\n   * Inadequate response or intolerance to at least 1 but no more than 3 b\u002FtsDMARDs with no more than 2 mechanisms of action. A lack of response is defined as documented continued or recurrent disease activity after at least 12 weeks of treatment of RA. Intolerance is defined as any documented adverse effect associated with a b\u002FtsDMARD used according to its respective label.\n\nLaboratory Assessments:\n\nCohort 3 Only:\n\n* Anti-cyclic citrullinated peptide antibody (Anti-CCP) positive and\u002For rheumatoid factor (RF) positive\n\nKey Exclusion Criteria:\n\nMedical Conditions; All Cohorts:\n\n* Have a diagnosis of any generalized musculoskeletal disorder that would interfere with study procedures or assessments per the discretion of the investigator.\n* History of opportunistic infection or immunodeficiency syndrome that would put the individual at risk, as per investigator's judgment.\n* Active infection that is clinically significant, per investigator's judgment, or any infection requiring hospitalization or treatment with intravenous anti-infectives within 60 days of screening; or any infection requiring oral anti-infective therapy within 30 days of screening.\n* History of or current moderate to severe congestive heart failure (New York Heart Association class III or IV), or within the last 6 months prior to screening.\n* History of lymphoproliferative disease or possible current lymphoproliferative disease.\n* History of organ or bone marrow transplant.\n* Have a history of major surgery (requiring regional block or general anesthesia) within the last 12 weeks prior to screening or planned major surgery during the study.\n* History of an infected joint prosthesis or other implanted device with the prosthesis or device still in situ.\n* Clinically significant ECG abnormalities at screening, including electrocardiographic interval between the beginning of the Q wave and termination of the T wave, representing the time for both ventricular depolarization and repolarization to occur (QT) interval corrected for heart rate using the Fridericia formula (QTcF) \\> 450 msec, or hypokalemia if recurrent or persistent \\\u003C 3.0 mmol\u002FL, or family history of long QT syndrome\n\nPrior\u002FConcurrent Therapy or Clinical Study Experience:\n\n* Administration of a live attenuated vaccine 4 weeks prior to Day 1 or planned throughout the study.\n* Participation in any investigational drug\u002Fdevice clinical study within 4 weeks or 5 half-lives prior to screening, whichever is longer. Exposure to investigational biologics should be discussed with the sponsor.\n\nDiagnostic Assessments; All Cohorts:\n\n* Any positive tuberculosis (TB) test using interferon-gamma release assay (IGRA) performed by central laboratory at screening. Tests with inconclusive results may be repeated one time. If an inconclusive test is repeated and is returned with inconclusive results a second time, the individual will be excluded from the study. Individuals with a history of latent or active TB who have been treated with a full course of treatment, as per local guidelines, are eligible without the need for an IGRA at screening. Appropriate documentation of prior treatment is required.\n* Evidence of active hepatitis C virus (HCV) infection. Individuals with positive HCV Ab at screening require reflex testing for HCV ribonucleic acid (RNA). Individuals with positive HCV Ab but negative HCV RNA viral load are eligible per investigator judgment and require HCV viral load monitoring on Day 85 and Day 169.\n* The results of the following laboratory tests performed at the central laboratory at screening meet any of the criteria below (out-of-range laboratory values may be rechecked 1 time, per investigator's judgment, before individual is considered a screen failure):\n\n  1. Hemoglobin \\\u003C 10.0 g\u002FdL (SI: \\\u003C 100 g\u002FL)\n  2. White blood cells \\\u003C 3.0 x 10\\^3 cells\u002Fmm\\^3 (SI: \\\u003C 3.0 x 10\\^9 cells\u002FL)\n  3. Neutrophils \\\u003C 1.5 x 10\\^3 cells\u002Fmm\\^3 (SI: \\\u003C 1.5 x 10\\^9 cells\u002FL)\n  4. Lymphocytes \\\u003C 1.0 x 10\\^3 cells\u002Fmm\\^3 (SI: \\\u003C 1.0 x 10\\^9 cells\u002FL)\n  5. Platelets \\\u003C 100 x 10\\^3 cells\u002Fmm\\^3 (SI: \\\u003C 100 x 10\\^9 cells\u002FL)\n  6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 x upper limit of normal (ULN)\n  7. Total bilirubin level ≥ 2 x ULN unless the individual has been diagnosed with Gilbert's disease and this is clearly documented\n  8. Creatinine clearance \\\u003C 50 mL\u002Fmin (SI: \\\u003C 0.83 mL\u002Fs) based on the Cockcroft-Gault formula\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply",{"count":471,"type":23},75,[26],"The goal of this clinical study is to learn more about the study drug GS-0151. The study is done to find how safe, well-tolerated the drug is. This will also assess how the drug is absorbed, modified, distributed and cleared from the body (the pharmacokinetics (PK) of the drug), when given multiple times to participants with rheumatoid arthritis (RA).\n\nThe primary objectives of this study is to assess the safety and tolerability of multiple ascending doses of GS-0151 in participants with RA and to characterize the PK of GS-0151 following multiple doses of GS-0151 in participants with RA.",[29],"2026-06-08",{"date":477,"type":40},"2026-06-09",{"date":479,"type":40},"2025-05-14",{"date":481,"type":23},"2027-03",{"name":483,"class":47},"Gilead Sciences",35,{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":492,"targetDuration":4,"studyType":24,"phases":494,"briefSummary":495,"conditions":496,"keywords":497,"overallStatus":182,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":504,"leadSponsor":506,"locationsCount":102},"100643440","phase-2-faecal-microbiota-transplantation-in-patients-with-refractory-rheumatoid-arthritis-100643440","NCT07639177","Faecal Microbiota Transplantation in Patients With Refractory Rheumatoid Arthritis","Efficacy and Safety of Lyophilised Oral Faecal Microbiota Transplantation in Patients With Active Refractory Rheumatoid Arthritis- A Randomized Controlled Study","Inclusion Criteria:\n\n1. Age 18-65 years with informed consent;\n2. Fulfill the 2010 ACR\u002FEULAR classification criteria for rheumatoid arthritis;\n3. Positive RF or anti-CCP antibody on screening;\n4. Active disease status with swollen joint count(SJC)≥3 and tender joint count(TJC)≥3 and ESR \\>25 mm\u002Fhr or hypersensitive C-reactive protein \\> 10 mg\u002FL;\n5. Having received csDMARDs including but not limited to methotrexate (at a stable dose of 7.5 - 20 mg\u002Fweek) for 3 months or longer prior to screening and willing to continue current regimen for the duration of the study;\n6. Other csDMARDs (e.g. Leflunomide, Iguratimod, Sulfasalazine, Hydroxychloroquine, Tripterygium Wilfordii, etc.) taking before screening with dosage stablized for 3 months or longer are permitted and should continue during the duration of the study;\n7. Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA;\n8. If taking non-steroidal anti-inflammatory drugs (NSAIDs), must be at a stable dose for at least two weeks prior to screening;\n9. Female subjects must have a negative pregnancy test unless they are surgically sterile or have been post-menopausal for at least one year (12 consecutive months without menses) ;\n10. Participants with fertility must use a medically effective form of contraception and agree to continue its use during the study or at least 3 monts after the last dose of study intervention.\n11. Willing to suspend the use of other adjuvant treatment for the duration of the study including acupuncture, massage, etc.\n\nExclusion Criteria:\n\n1. Pregnant, lactating or further fertility requirements\n2. History of any inflammatory rheumatological disorders other than RA;\n3. Having used biologics or small-molecular targeting agents in 6 months prior to screening;\n4. Taking oral glucocorticoid (GC) or get GC injection (intra-articular or parenteral) in one month prior to screening;\n5. Severe, progressive, or uncontrolled visceral disease including cardiac, pulmonary, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine or neurologic disease;\n6. Severe enteritis, intestinal obstruction or bleeding, or history of gastrointestinal surgery.\n7. Active infection in recent 3 months or persistent chronic infection, including HIV, HCV, HBV, tuberculosis;\n8. Malignancy or history of malignancy;\n\n8\\. Other conditions that investigators consider inappropriate for this study.",{"count":493,"type":23},40,[201],"In this 24-week, single center, randomized, double-blind, placebo-controlled study, the efficacy and safety of lyophilised oral fecal microbiota transplantation in patients with active refractory rheumatoid arthritis will be evaluated.",[29],[498,499],"Faecal Microbiota Transplantation","Refractory Rheumatoid Arthritis","2026-06-05",{"date":502,"type":40},"2026-06-10",{"date":434,"type":23},{"date":505,"type":23},"2028-12-31",{"name":507,"class":101},"Peking Union Medical College Hospital",{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":515,"targetDuration":4,"studyType":24,"phases":517,"briefSummary":518,"conditions":519,"keywords":520,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":524,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":157},"100606163","phase-1-a-study-to-evaluate-the-safety-tolerability-and-drug-levels-of-bms-986454-in-participants-with-rheumatoid-arthritis-100606163","NCT07171983","A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis","A 2-Part, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986454 in Participants With Rheumatoid Arthritis","Inclusion Criteria:\n\n* Participants with Rheumatoid Arthritis must have onset after age 18.\n* Participants who meet 2010 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) classification criteria for RA.\n* Participants must have evidence of swelling in at least 1 joint of the hand or wrist by clinical examination at screening and Day -1.\n* Participants must have been an incomplete responder to prior methotrexate (MTX) treatment.\n\nExclusion Criteria:\n\n* Participants must not have any significant medical condition, with the exception of Rheumatoid Arthritis (including but not limited to, neurological, GI, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders) that, in the Investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.\n* Participants must not have any condition aside from RA that confounds the ability to interpret data from the study.\n* Participants must not have severe Rheumatoid Arthritis as assessed by Disease Activity Score 28 c-reactive protein (DAS28-CRP) at screening or Day -1.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":516,"type":23},46,[26],"The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986454 in participants with Rheumatoid Arthritis",[29],[521,395,522,523],"Rheumatoid Arthritis (RA)","Chronic Inflammatory Disease","Methotrexate-Inadequate Responders (MTX-IR)",{"date":475,"type":40},{"date":526,"type":40},"2026-02-27",{"date":528,"type":23},"2027-08-25",{"name":530,"class":47},"Bristol-Myers Squibb",{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":18,"minAge":538,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":24,"phases":541,"briefSummary":542,"conditions":543,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":557},"100564627","emphasys-cup-positioning-in-tha-with-non-invasive-navigation-velys-hip-navigation-vhn-100564627","NCT06631638","EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))","Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Non-Invasive Navigation","Inclusion Criteria:\n\n1. All hip replacement component devices are to be used according to the approved indications.\n2. The subject is undergoing a standard of care primary uncemented hip replacement with the EMPHASYS cup and a CORAIL, EMPHASYS or ACTIS stem via the posterolateral, anterolateral, or direct lateral approach with the subject in the lateral decubitus position.\n3. The subject is a candidate for implantation utilizing the VELYS Hip Navigation system with CUPTIMIZE advanced\n4. Individuals who are able to speak, read, and comprehend the Informed Participant Consent Document and willing and able to provide consent for participation in the study and have authorized the transfer of his\u002Fher information to DePuy Synthes.\n5. Individuals who are willing and able to complete follow-up as specified by the study protocol.\n6. Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires (i.e., FJS-12, EQ-5D-5L and Hip Evaluation) as specified by the study protocol.\n7. Individuals who are not bedridden per the discretion of the investigator.\n8. Individuals who are a minimum age of 21 years at the time of consent\n\nExclusion Criteria:\n\n1. Active local or systemic infection.\n2. Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.\n3. Poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and\u002For the lack of adequate bone to support the implant(s).\n4. Charcot's or Paget's disease.\n5. The Subject is a woman who is pregnant or lactating.\n6. Subject had a contralateral amputation.\n7. Previous partial hip replacement in affected hip.\n8. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.\n9. Contralateral hip was replaced less than 6 months prior to surgery date.\n10. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.\n11. Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.\n12. Subject has a medical condition with less than 2 years of life expectancy.\n13. Subject, in the opinion of the Investigator, is a drug or alcohol abuser or has a psychological disorder that could affect their ability to complete subject reported questionnaires or be compliant with follow-up requirements.","21 Years",{"count":540,"type":23},118,[169],"The purpose of this research is to gather clinical and radiographic (X-ray) information about EMPHASYS™ acetabular shell (also called a hip 'cup') placement in total hip replacement surgery using a non-invasive surgical navigation system called VELYS™ hip navigation system with CUPTIMIZE™ Advanced Hip-Spine Analysis software.\n\nData collected in this study will be compared with data collected from implantations using different cup positioning instrumentation and techniques to assess performance.",[544,545,29,546,547,548],"Osteoarthritis","Traumatic Arthritis","Congential Hip Dysplasia","Avascular Necrosis of the Femoral Head","Certain Cases of Ankylosis","2026-06-04",{"date":500,"type":40},{"date":552,"type":40},"2025-10-24",{"date":554,"type":23},"2027-12-31",{"name":556,"class":47},"DePuy Orthopaedics",5,{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":562,"acronym":563,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":565,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":567,"conditions":568,"keywords":578,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":587,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":102},"100598885","eacvi-study-on-multimodality-cardiovascular-imaging-of-inflammatory-cardiovascular-diseases-100598885","NCT07077304","EACVI Study on Multimodality Cardiovascular Imaging of Inflammatory Cardiovascular Diseases","EACVI-INFLAME","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Ability to provide informed non-opposition\n3. Referred for a CMR and\u002For nuclear imaging exam\n\nAND a suspicion of one of the following ICARDs :\n\n1. Suspected Myocarditis (acute or chronic, and whatever the aetiologies)\n2. Suspected Myocardial Infarction with Non-Obstructive Coronary Arteries (MINOCA)\n3. Suspected Tako-Tsubo\n4. Suspected Pericarditis (acute or chronic, and whatever the aetiologies)\n5. Suspected Connective tissue disease with cardiovascular involvement:\n\n   * Systemic sclerosis\n   * Systemic lupus erythematosus\n   * Antiphospholipid syndrome\n   * Idiopathic inflammatory myopathies\n   * Rheumatoid arthritis, spondylarthritis\n6. Suspected Vasculitis with cardiovascular involvement:\n\n   * Small-vessel vasculitis (ANCA…)\n   * Large vessel vasculitis (Behcet disease, Takayasu…)\n7. Suspected Inflammatory disease with cardiovascular involvement:\n\n   * Sarcoidosis\n   * Still disease\n\nExclusion Criteria:\n\n1. Inability to provide non-opposition\n2. History of heart transplant",{"count":566,"type":23},5000,"Inflammatory Cardiovascular Diseases and Autoimmune Rheumatic Diseases (ICARDs) encompass cardiovascular involvement in connective tissue diseases, vasculitis, and primary inflammatory cardiac processes affecting all layers of the heart. ICARDs are associated with increased cardiovascular morbidity and mortality, independently of traditional risk factors, via multiple pathophysiological mechanisms.\n\nDiagnosis and prognosis are challenged by the heterogeneity of clinical presentations. Multimodality cardiovascular imaging - including cardiovascular magnetic resonance (CMR), transthoracic echocardiography, and positron emission tomography (PET) - plays a central role in detecting and characterizing inflammatory involvement, and may offer prognostic insights.\n\nGiven the limited data on the diagnostic and prognostic utility of these imaging modalities in ICARDs, the EACVI-INFLAME study aims to assess the prevalence of confirmed cardiovascular involvement in patients with suspected or established ICARDs undergoing CMR and\u002For cardiac PET in a multicentric international cohort.",[569,570,571,86,30,116,29,572,573,574,575,576,577],"Myocarditis","ANCA Associated Vasculitis","Pericarditis","Spondylarthritis","Behcet Disease","Takayasu Arteritis","Sarcoidosis","Still Disease","Tako Tsubo Cardiomyopathy",[579,580,581,582,583,584,585,586],"Cardiovascular disease","Auto-immune disease","Auto-inflammatory disease","Rheumatic disease","CMR","PET","multimodality imaging","ICARD",{"date":500,"type":40},{"date":589,"type":40},"2025-11-19",{"date":591,"type":23},"2028-10-30",{"name":593,"class":101},"Assistance Publique - Hôpitaux de Paris",{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":4,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":601,"enrollmentInfo":602,"targetDuration":4,"studyType":24,"phases":604,"briefSummary":605,"conditions":606,"keywords":607,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":102},"100643569","phase-2-desloratadine-as-adjunct-therapy-for-rheumatoid-arthritis-100643569","NCT07632872","Desloratadine as Adjunct Therapy for Rheumatoid Arthritis","Effect of Desloratadine as Add-On Therapy in Rheumatoid Arthritis","Inclusion Criteria:\n\n* Patients with active rheumatoid arthritis according to the 2010 American College of Rheumatology and European League Against Rheumatism classification criteria.\n* Disease Activity Score in 28 joints (DAS28) greater than 2.6.\n* Age between 18 and 60 years.\n* Male and female patients.\n* Patients receiving methotrexate in addition to standard conventional therapy.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Patients with renal or hepatic disease.\n* Known hypersensitivity to the study medications.\n* Current use of antioxidant supplements.\n* History of psychiatric disorders.\n* Use of oral prednisolone at a dose greater than 15 mg per day.\n* Current treatment with biological disease modifying antirheumatic drugs.\n* Pregnant or breastfeeding patients.\n* History of cardiac arrhythmias or prolonged QT interval.\n* Use of medications known to prolong the QT interval.","60 Years",{"count":603,"type":23},60,[201],"Rheumatoid arthritis is a chronic inflammatory disease that causes joint pain, swelling, and reduced physical function. Although standard disease-modifying antirheumatic drugs are effective for many patients, some individuals continue to have active disease.\n\nThe purpose of this study is to evaluate the effectiveness and safety of adding desloratadine to standard therapy in patients with active rheumatoid arthritis. Participants will receive either desloratadine or placebo in addition to their usual treatment.\n\nThe study will assess changes in disease activity and inflammatory markers over a follow-up period of approximately 12 weeks. The results of this study may help determine whether desloratadine could be a useful add-on treatment option for patients with rheumatoid arthritis.",[521,29],[608,306,609,610,611],"Desloratadine","Add-on therapy","Inflammation","Randomized controlled trial","2026-06-02",{"date":475,"type":40},{"date":615,"type":40},"2026-05-23",{"date":617,"type":23},"2027-01",{"name":619,"class":101},"Horus University",{"id":621,"slug":622,"hasResults":12,"nctId":623,"briefTitle":624,"officialTitle":624,"acronym":4,"eligibilityCriteria":625,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":601,"enrollmentInfo":626,"targetDuration":4,"studyType":24,"phases":628,"briefSummary":629,"conditions":630,"keywords":631,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":634,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":102},"100643188","phase-2-effect-of-roflumilast-as-add-on-therapy-in-rheumatoid-arthritis-100643188","NCT07632846","Effect of Roflumilast as Add-On Therapy in Rheumatoid Arthritis","Inclusion Criteria:\n\n* Patients with active rheumatoid arthritis according to the 2010 American College of Rheumatology and European League Against Rheumatism classification criteria.\n* Disease Activity Score in 28 joints (DAS28) greater than 2.6.\n* Age between 18 and 60 years.\n* Male and female patients.\n* Patients receiving methotrexate in addition to standard conventional therapy.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Exclusion Criteria:\n* Patients with renal or hepatic disease.\n* Known hypersensitivity to the study medications.\n* Current use of antioxidant supplements.\n* History of psychiatric disorders.\n* Use of oral prednisolone at a dose greater than 15 mg per day.\n* Current treatment with biological disease modifying antirheumatic drugs.\n* Pregnant or breastfeeding patients.\n* History of cardiac arrhythmias or prolonged QT interval.\n* Use of medications known to prolong the QT interval",{"count":627,"type":23},50,[201],"Rheumatoid arthritis is a chronic inflammatory disease that causes joint pain, swelling, and reduced physical function. Although standard disease-modifying antirheumatic drugs are effective for many patients, some individuals continue to have active disease.\n\nThe purpose of this study is to evaluate the effectiveness and safety of adding roflumilast to standard therapy in patients with active rheumatoid arthritis. Participants will receive either roflumilast or placebo in addition to their usual treatment.\n\nThe study will assess changes in disease activity and inflammatory markers over a follow-up period of approximately 12 weeks. The results of this study may help determine whether roflumilast could be a useful add-on treatment option for patients with rheumatoid arthritis.",[29,521],[632,306,611,633,609],"Roflumilast","Phosphodiesterase-4 inhibitor",{"date":475,"type":40},{"date":636,"type":40},"2026-05-19",{"date":638,"type":23},"2026-12",{"name":619,"class":101},{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":645,"acronym":4,"eligibilityCriteria":646,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":56,"enrollmentInfo":647,"targetDuration":4,"studyType":24,"phases":649,"briefSummary":650,"conditions":651,"keywords":653,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":667,"startDateStruct":668,"completionDateStruct":670,"leadSponsor":672,"locationsCount":382},"100572489","phase-1-a-phase-12-study-of-nkx019-in-subjects-with-immune-mediated-diseases-ntrust-2-100572489","NCT06733935","A Phase 1\u002F2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)","A Phase 1\u002F2 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With Immune-Mediated Diseases","General Inclusion Criteria:\n\n1. Age ≥18 and ≤75\n2. Signed informed consent form and ability to adhere to the study visit schedule and comply with other protocol requirements\n3. Women of childbearing potential must have negative pregnancy tests at screening and baseline, and agree to abstinence or acceptable birth control from 2 weeks prior to the first dose through 1 year after the last dose\n4. For participants taking corticosteroids, the prednisone (or equivalent) dose must be ≤20 mg\u002Fday at 2 weeks prior to Screening and stable for ≥ 14 days before start of Screening\n5. For participants on immunosuppressives or immunomodulators (other than corticosteroids), all doses must be stable for ≥ 4 weeks prior to Screening\n6. eGFR as calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation of ≥45 mL\u002Fmin\u002F1.73 m2 at screening\n\nSSc Inclusion Criteria:\n\n1. Meets the 2013 American College of Rheumatology (ACR)\u002FEuropean Alliance of Associations for Rheumatology (EULAR) classification criteria for SSc\n2. Meet criteria a and\u002For b:\n\n   a. Severe skin involvement defined as mRSS ≥ 30 or active skin disease defined as mRSS ≥ 15 at screening and one or more of the following within the prior 6 months of screening:\n\n   i. An increase in mRSS of ≥ 3 units\n\n   ii. Involvement of 1 new body area with ≥ 2 mRSS units\n\n   iii. 2 new body areas with ≥ 1 mRSS unit\n\n   b. Moderate to severe Interstitial Lung Disease (ILD) defined by evidence of ILD on High-resolution computed tomography (HRCT) and FVC \\\u003C 70% of predicted or DLCO (hemoglobin or alveolar volume corrected) \\\u003C 70% of predicted or ILD on HRCT and progressive ILD meeting at least 2 of the following 3 criteria within the prior 6 months of screening:\n\n   i. Worsening respiratory symptoms\n\n   ii. Evidence of progression on HRCT, or\n\n   iii. Evidence of absolute decline in FVC ≥ 5%\n3. 10 years or less since the first non-Raynaud's sign or symptom\n4. Inadequate response or intolerance to at least one treatment, including cyclophosphamide, methotrexate, MMF\u002Fmycophenolic acid, nintedanib, rituximab, or tocilizumab\n\nIIM Inclusion Criteria:\n\n1. Diagnosis for IIM as per 2017 ACR\u002FEULAR Classification Criteria\n2. One positive myositis antibody\n3. Activity defined as manual muscle testing (MMT-8) score \\\u003C136\u002F150\n4. Creatinine kinase or aldolase ≥ 1.5 x ULN and Clinician Global Assessment ≥ 2 cm with at least one of the following:\n\n   1. Evidence on magnetic resonance imaging (MRI) of active myositis within the last 6 months\n   2. Electromyography (EMG) with active myositis within the last 6 months\n   3. Muscle Biopsy of active myositis within last 6 months\n   4. Global extramuscular activity score ≥2 cm per Clinician global assessment (CGA) using a visual analog scale (VAS) (0-100 mm)\n\n   Note: Participants with DM or ASyS may be eligible despite CK or aldolase \\\u003C1.5 × ULN, provided they have a Clinician Global Assessment ≥2 cm and meet at least one of criteria (a)-(d) above OR have a CDASI score of ≥20.\n5. Inadequate response to treatment defined as ≥ 3 months failure (or intolerance) to at least 2 immunosuppressive therapies (including glucocorticoids)\n\nAAV:\n\n1. Meets the 2022 ACR\u002FEULAR classification criteria for Granulomatosis with Polyangiitis (GPA) (Robson 2022) or Microscopic Polyangiitis (MPA) (Suppiah 2022)\n2. Relapsed or refractory AAV despite repeated treatment with immunosuppressive agents or requiring prolonged and\u002For repeated courses of unacceptable doses of glucocorticoids to maintain disease control\n3. Positive test for anti-proteinase-3 (PR3-ANCA) or anti-myeloperoxidase (MPO-ANCA) at screening\n4. Have at least one \"major\" item, or at least 3 other items, or at least 2 renal items on the BVAS version 3\n\nRA Inclusion Criteria:\n\n1. Documented diagnosis of RA, meeting the 2010 ACR\u002FEULAR classification criteria\n2. Rheumatoid Factor (RF) or Anti-Citrullinated Protein Antibody (ACPA) positive\n3. CRP \\>3 mg\u002FL\n4. Inadequate response, defined as failure to achieve a clinically meaningful improvement (eg, ACR50 response or DAS28-low disease activity \\[ie, DAS28 \\>3.2\\]) after at least 12 weeks of therapy with the following:\n\n   1. At least 1 conventional synthetic DMARD (csDMARD) (eg, methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) AND\n   2. Either of the following:\n\n   i. At least 2 biologic (b) DMARDs (eg, TNF inhibitors, abatacept, anti-IL-6 or anti-IL-6R, rituximab) with distinct mechanisms of action (MoAs)\n\n   OR\n\n   ii. At least 1 bDMARD and at least 1 targeted synthetic DMARD (tsDMARD) (eg, JAK inhibitor)\n\n   AND\n\n   c. Have failed no more than 3 biologics or tsDMARDs with unique mechanisms of action\n5. Minimum of 6 swollen joint counts (SJCs) and 6 tender joint counts (TJCs) according to joint assessment\n\nGeneral Exclusion Criteria:\n\n1. eGFR \\\u003C 45 ml\u002Fmin\u002F1.73m2\n2. Currently requiring renal dialysis or expected to require dialysis during the study period\n3. Previous solid organ or hematopoietic cell transplant or planned transplant within study treatment period\n4. Congenital or acquired immunodeficiency resulting in severe infection or those receiving chronic immunoglobulin replacement therapy\n5. Liver disease or dysfunction, including cirrhosis and\u002For bilirubin ≥ 3 times the upper limit of normal\n6. Pulmonary comorbidity including chronic obstructive pulmonary disease or asthma requiring daily oral steroids, resting hypoxemia (\\\u003C92% oxygen saturation via pulse oximetry) on room air, or significant smoking history (i.e. \\>10 pack\u002Fyear) with active pulmonary disease\n7. Participants with ILD with any of the following:\n\n   1. Requires supplemental oxygen therapy\n   2. FVC \\\u003C45% of predicted\n   3. Diffusing capacity of the lung (DLCO) corrected for alveolar volume (AV) or Hemoglobin (Hgb) ≤ 40% of predicted at screening (per Investigator or Sponsor judgement)\n\n   i. If the participant has a historical FVC value within the last year that exceeds the 45% threshold, discuss with the Medical Monitor should the Screening FVC be \\\u003C45% predicted\n8. Bone marrow insufficiency unrelated to active underlying autoimmune disease with white blood cell count \\\u003C 3,000\u002Fmm\\^3; hemoglobin levels ≤ 9 g\u002FdL; absolute neutrophil count (ANC) ≤ 1500\u002Fmm\\^3; platelet count ≤ 100,000\u002Fmm\\^3, and blood transfusion within 60 days prior to LD\n9. Major cardiac disease, abnormalities, or interventions as defined by, but not limited to:\n\n   1. Uncontrolled angina or unstable life-threatening arrhythmias\n   2. History of myocardial infarction within 12 weeks prior to the first dose of NKX019\n   3. Any prior coronary artery bypass graft surgery\n   4. ≥ Class III New York Heart Association (NYHA) congestive heart failure (CHF), significantly decreased ejection fraction (EF ≤ 40%), or severe cardiac insufficiency\n   5. Prolongation of the QT interval corrected for heart rate (QTc) (Fridericia) interval of \\> 480 msec\n   6. Peripheral artery bypass graft surgery, pulmonary embolism, or other ≥ Grade 2 thrombotic or embolic events within 12 weeks prior to the first dose of NKX019\n10. Active bleeding disorders\n11. Any overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes (eg, anti-GBM antibody glomerulonephritis or any condition for additional immunosuppression is indicated); clinically significant conditions that could cause a secondary nephropathy (eg, infections, liver disease, tumors or drugs); or kidney biopsy-confirmed significant renal disease other than disease under study (eg, diabetic nephropathy, hypertensive nephropathy). Overlapping conditions for which the condition or treatment is not expected to affect assessments or outcomes (eg, Sjögren's syndrome, rheumatoid arthritis) are not excluded\n12. Pregnancy, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions\n13. Current infection requiring active systemic anti-infective therapy or recent acute infection requiring systemic therapy within 30 days of planned LD\n14. History of positive HIV test at screening, Hepatitis B or C positive at screening, active tuberculosis (TB) or latent TB requiring suppressive therapy\n15. Major surgery within 28 days prior to the first dose of NKX019 or any surgery from which the participant has not recovered or has ongoing complications\n16. Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Participants with cervical dysplasia that is cervical intraepithelial neoplasia but have been treated with conization or loop electrosurgical excision procedure and have had a normal repeat Papanicolaou test are allowed\n17. Prior cellular therapy including mesenchymal, CAR-T or CAR-NK cells\n18. Central nervous system (CNS) comorbidity or any autoimmune disease with CNS involvement within 90 days prior to the first dose of NKX019 as well as evidence of CNS related autoimmune manifestations within 1 year prior to screening\n\nSSc Exclusion Criteria:\n\n1. Moderate-to-severe Pulmonary arterial hypertension (PAH) on right heart catheterization requiring PAH specific treatment. Those participants with mild PAH (as defined by the 2022 ECS\u002FERS Guidelines, \\[Humbert 2023\\]) well controlled on therapy can be enrolled\n2. Gastrointestinal (GI) dysmotility requiring total parenteral nutrition (TPN)\n3. Renal crisis or Pericardial tamponade within 6 months prior to enrollment\n4. Current gangrene of a digit\n\nIIM Exclusion Criteria:\n\n1. Evidence of severe chronic proximal muscle involvement of upper or lower extremities, based on Magnetic Resonance Imaging (MRI) defined as:\n\n   1. ≥15% fibro-fatty replacement in core muscle groups (including gluteus and vastus musculature), and\u002For\n   2. ≥15% muscle atrophy in these regions Participants will also be excluded if the combined extent of fibro-fatty replacement and muscle atrophy exceeds 30% in aggregate\n2. MMT-8 of ≤ 80\n3. Findings of muscular inflammation or myopathy due to another cause, such as inclusion body myositis, cancer-associated myositis (myositis diagnosed within 2 years of cancer), amyloid myopathy, muscular dystrophy, metabolic myopathies, or myositis in the context of significant overlap with another systemic IIM rheumatologic disease (overlap myositis), except with Sjögren's syndrome\n4. Generalized severe musculoskeletal or neuro-muscular conditions other than IIM\n5. Immune-mediated necrotizing myopathy\n\nAAV Exclusion Criteria:\n\n1. Alveolar hemorrhage requiring invasive pulmonary ventilation support\n2. Required dialysis or plasma exchange within 12 weeks prior to screening\n3. Any other known disease that may interfere with the assessments including eosinophilic GPA (Churg-Strauss), anti-glomerular basement membrane, systemic lupus erythematosus, IgA vasculitis (Henoch Schönlein), rheumatoid vasculitis, or cryoglobulinemic vasculitis",{"count":648,"type":23},240,[26,201],"This is a Phase 1\u002F2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with autoimmune diseases.",[86,116,652,29],"Antineutrophil Cytoplasmic Antibody-Associated Vasculitis",[120,654,655,656,657,658,659,660,661,662,663,281,664,86,116,665,666,29],"CAR","Allogeneic","NKX019","Natural Killer Cells","Interleukin-15","IL-15","Cell Therapy","Immunotherapy","Adoptive cell therapy","Scleroderma","AAV","Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis","Ntrust-2",{"date":549,"type":40},{"date":669,"type":40},"2024-11-04",{"date":671,"type":23},"2028-10",{"name":673,"class":47},"Nkarta, Inc."]