[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diffuse-cutaneous-systemic-sclerosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diffuse-cutaneous-systemic-sclerosis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,51,94,125,158,191,220,244,270,292],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100629321","phase-1-controlling-hyperactive-immunity-with-long-lived-lymphocytes-100629321",false,"NCT07473154","Controlling Hyperactive Immunity With Long-lived Lymphocytes","Phase I\u002FII Study of QEL-005 in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) and in Patients With Difficult to Treat Rheumatoid Arthritis (D2TRA).","CHILL","Inclusion Criteria:\n\n* Participants must be at least 18 years of age at the time of signing the informed consent.\n* Up to date vaccination status and no planned vaccinations for post 3 months infusion\n* Adequate haematological, liver and renal function\n* Willing to undergo annual influenza vaccination\n* Willing to enter a 15-year follow-up\n* Eastern Cooperative Oncology Group (ECOG) performance status grade \\\u003C 3\n* Able and willing to use a highly effective method of contraception\n* Stable dose of steroid prior to screening\n\nSpecific inclusion criteria for participants with difficult to treat rheumatoid Arthritis (D2TRA) only:\n\n* Diagnosis of Rheumatoid Arthritis (RA) per 2010 ACR-EULAR criteria\n* Diagnosis of D2TRA per 2021 EULAR criteria\n* Evidence of clinically active disease a defined by validated clinical or laboratory results consistent with standard definitions of active RA\n* Evidence of inflammation in target joints used for the DAS28 CRP assessment\n\nSpecific inclusion criteria for participants with diffuse cutaneous systemic sclerosis (dcSSc) only:\n\n* Diagnosis of dcSSc as per the 2013 ACR-EULAR criteria\n* Serologically positive for antinuclear antibodies\n* Failure to respond sufficiently to immunomodulatory disease modifying anti-rheumatic drugs (DMARDs).\n* Skin involvement with a total modified Rodnan Skin Score of at least 15\n* Evidence of lung fibrosis based on imaging or pulmonary function testing\n* Evidence of active disease based on a validated SSc activity assessment\n\nExclusion Criteria:\n\n* Presence of a significant medical condition(s), or clinically significant laboratory abnormality\n* History or concern of autoimmune diseases other than those under study\n* Active infection, or recurrent chronic infection requiring intervention\n* Immunodeficiency or receiving immunoglobulin replacement therapy\n* Past or current infection with hepatitis B or C, tuberculosis, syphilis, or HIV\n* Clinically significant cardiac dysfunction or severe pulmonary impairment\n* Use of investigational agents within a pre-defined period prior to study screening\n* Received a previous cell therapy\n* Received certain B cell related experimental therapies in a clinical trial with the past year\n* Any solid organ, bone marrow or stem cell transplant\n* History of malignancy in the past 5 years\n* Receiving prohibited medication that cannot be stopped at screening","ALL","18 Years",{"count":20,"type":21},16,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study is a Phase 1\u002F2, open-label clinical trial to test an experimental treatment called QEL-005 in adults with two autoimmune conditions: diffuse cutaneous systemic sclerosis (dcSSc) and difficult-to-treat rheumatoid arthritis (D2TRA). The main goals are to find out whether QEL-005 is safe, how well people tolerate it, and whether it may help reduce disease activity or improve symptoms.\n\nQEL-005 is made from a participant's own white blood cells (autologous cells). These cells are collected and then changed in a laboratory using genetic methods to create specialized immune cells called CAR-T regulatory cells that target a protein on B cells called CD19. These modified cells are then given back to the participant by intravenous (IV) infusion.\n\nTo take part, eligible participants will first have a procedure called leukapheresis, where some of their white blood cells are removed from the blood. The study team will use these cells to manufacture QEL005. After QEL005 is ready, participants will receive an IV infusion of their modified cells, stay in hospital overnight for monitoring, and will then be followed closely in the clinic.\n\nThroughout the trial, participants will have regular safety checks, which may include blood tests, imaging scans, questionnaires about symptoms and daily functioning, and biopsies taken from involved tissues, to help understand how QEL005 is working in the body. Detailed follow up will be for 1 year after QEL-005 infusion, and there is long-term follow up for a total of 15 years, which is standard for cell therapies. The information from this Phase 1\u002F2 study will help determine an appropriate dose and dosing schedule of QEL005 for future studies.",[28,29,30,31],"Diffuse Cutaneous Systemic Sclerosis","Rheumatoid Arthritis (RA)","Systemic Sclerosis (SSc)","Autoimmune Rheumatologic Disease",[33,34,35,36,37],"Regulatory T cells","Autologous","Genetically modified cells","Treg","Chimeric antigen receptor (CAR)","RECRUITING","2026-06-29",{"date":41,"type":42},"2026-06-30","ACTUAL",{"date":44,"type":42},"2026-04-10",{"date":46,"type":21},"2028-08",{"name":48,"class":49},"Quell Therapeutics Limited","INDUSTRY",6,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":70,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100587219","phase-1-a-safety-and-efficacy-study-evaluating-ctx112-in-adult-subjects-with-refractory-autoimmune-disease-100587219","NCT06925542","A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease","A Phase 1 Dose Evaluation Study of the Safety and Preliminary Efficacy of Anti-CD19 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX112) in Adult Subjects With Refractory Autoimmune Disease","Key Inclusion Criteria:\n\n1. Age ≥18 years and \\\u003C 70 years of age.\n2. Subjects must voluntarily sign a written informed consent and be willing and able to comply with all study requirements.\n3. Adequate hematologic, renal, liver, cardiac and pulmonary organ function.\n4. Subjects must agree to use acceptable methods of contraception.\n5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, contraceptive guidelines, and other study procedures.\n6. Diagnosis of systemic lupus erythematosus (SLE), systemic sclerosis (SSc) or idiopathic inflammatory myopathy (IIM).\n\nFor systemic lupus erythematosus (SLE) subjects:\n\n\\- Diagnosis of SLE by a board-certified rheumatologist that conforms with 2019 ACR\u002FEULAR criteria. For lupus nephritis subjects, active, biopsy-proven proliferative lupus nephritis Class III or IV, either with or without the presence of Class V, and appropriate National Institutes of Health index activity score using the 2018 International Society of Nephrology\u002FRenal Pathology Society criteria.\n\nFor Systemic Sclerosis (SSc) subjects:\n\n\\- Diagnosis of diffuse cutaneous systemic sclerosis (dcSSC) or SSc-ILD that conforms with 2013 ACR\u002FEULAR criteria. Subjects should meet active skin or lung disease criteria.\n\nFor Idiopathic Inflammatory Myopathy (IIM) subjects:\n\n\\- Diagnosis with dermatomyositis (DM), polymyositis (PM) or myositis as part of rheumatologic overlap syndrome, antisynthetase (ASyS), or immune-mediated necrotizing myopathy (IMNM) that conforms with 2017 ACR\u002FEULAR criteria for inflammatory myopathies. Subjects must meet moderate severe, skin, or lung involvement criteria.\n\nKey Exclusion Criteria:\n\n1. Prior anti-CD19 therapy or any gene therapy\u002Fgenetically modified cell therapy.\n2. Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.\n3. Severe active or history of central nervous (CNS) involvement.\n4. History of a seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease or any autoimmune disease with CNS involvement other than SLE, SSc or IIM.\n5. Mixed connective tissue disease with no clear predominant disease.\n6. Presence of study disease manifestations or other conditions that are likely to pose increase safety risks and\u002For confound disease assessments, or pose significant risk to those receiving CAR T cell therapy.\n7. History of primary or secondary immunodeficiency.\n8. Presence or history of certain bacterial, viral or fungal infection.\n9. Malignancy in the last 5 years (with the exception of cancers deemed to be low likelihood for recurrence).\n10. Diagnosis of a genetic disorder associated with bone marrow failure or myelodysplastic syndrome.\n11. History or current diagnosis of catastrophic anti-phospholipid syndrome or anti phospholipid syndrome that requires ongoing anticoagulation.\n12. Pregnant or lactating.\n13. Presence or history of disease requiring treatment that is not compatible with the study protocol; presence or history of other conditions that are not compatible with the study protocol.","70 Years",{"count":60,"type":21},80,[24],"This is a single-arm, open-label, multicenter, ascending dose Phase 1 study evaluating the safety and preliminary efficacy of CTX112 in adult subjects with refractory autoimmune diseases, including active systemic lupus erythematosus (SLE), systemic sclerosis (SSc), or idiopathic inflammatory myopathy (IIM).",[64,65,66,67,68,69,28],"SLE (Systemic Lupus)","Lupus Erythematosus, Systemic","Lupus Nephritis","Systemic Sclerosis","Inflammatory Myopathy, Idiopathic","Myositis",[71,72,73,66,74,75,76,77,69,78,79,80,81,82,83],"CAR T","Lupus","SLE","Allogeneic","CD19","Cell Therapy","Scleroderma","Systemic sclerosis","Idiopathic Inflammatory Myopathy","Inflammatory Myopathy","Diffused Cutaneous Systemic Sclerosis","Gene Therapy","Autoimmune","2026-06-11",{"date":86,"type":42},"2026-06-15",{"date":88,"type":42},"2025-03-10",{"date":90,"type":21},"2031-12-31",{"name":92,"class":49},"CRISPR Therapeutics",14,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100570561","phase-1-us-zamto-cel-autoimmune-diseases-100570561","NCT06708845","US Zamto-cel Autoimmune Diseases","A Phase I Multicohort Trial of Zamtocabtagene Autoleucel (Zamto-Cel) in Subjects With Severe Refractory Autoimmune Diseases","General Key Inclusion\u002FExclusion Criteria Across All Cohorts\n\nInclusion Criteria:\n\n•Confirmed diagnosis of autoimmune disease (SLE-Non-renal, SLE-LN, SSc\u002F dcSSc)\n\nExclusion Criteria:\n\n* Prior gene therapy treatment\n* Active malignancy within past 5 years\n* Significant active fungal or bacterial infection\n* History or presence of CNS lupus or other CNS disease\n* eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m\\^2\n* Total bilirubin outside the normal range (unless congenital hyperbilirubinemia such as Gilbert syndrome has been confirmed).\n\nSystemic Lupus Erythematosus-Non-renal Key Inclusion\u002FExclusion Criteria\n\nInclusion Criteria:\n\n* Positive for at least 1 of the following autoantibodies at Screening: anti- double stranded DNA or anti-Smith\n* Systemic Lupus Erythematosus Disease Activity Index-2000 score ≥ 8 AND at least 1 British Isles Lupus Assessment Group (BILAG)-2004 Class A (severe manifestation) organ scores\n* Inadequate response to glucocorticoids and to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, or obinutuzumab\n\nExclusion Criteria:\n\n* Subjects with neuropsychiatric SLE.\n* Drug-induced SLE.\n\nSystemic Lupus Erythematosus - Lupus Nephritis Key Inclusion\u002FExclusion Criteria\n\nInclusion Criteria:\n\n* Positive for at least 1 of the following autoantibodies at Screening: anti- double stranded DNA or anti-Smith\n* Confirmed LN diagnosis by kidney biopsy during screening or within the previous 6 months, with severe active phase of the disease.\n* Progressing despite maintenance on maximally tolerated doses of renin- angiotensin system (RAS) blocking agents, unless allergic to or intolerant of ACE inhibitors and ARBs\n* Inadequate response to glucocorticoids and hydroxychloroquine and at least 1 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid derivatives, belimumab, azathioprine, methotrexate, rituximab, obinutuzumab, calcineurin inhibitor (cyclosporin, tacrolimus or voclosporin)\n\nExclusion Criteria:\n\n•Evidence of Rapidly progressive glomerulonephritis (defined as a doubling of serum creatinine within 3 months prior to enrollment) or as determined by the study investigator.\n\nSystemic Sclerosis\u002FDiffuse Cutaneous Systemic Sclerosis Cohort Key Inclusion\u002F Exclusion Criteria\n\nInclusion Criteria:\n\n* Active disease defined as:\n* Modified Rodnan skin score (mRSS) ≥ 16 units, in the prior 6 months, with 1 or more of the following:\n\n  * Increase in mRSS by ≥ 3 units or 10%\n  * Involvement of 1 new body area with increase in mRSS by ≥ 2 units\n  * Involvement of 2 new body areas with increase by ≥ 1 mRSS unit OR\n* Progressive interstitial lung disease (ILD) defined as:\n\n  \\- Worsening of respiratory symptoms and an increased extent of fibrosis evaluated by high-resolution computed tomography\n* Lack of response to standard therapy (e.g., failure of ≥ 2 immunosuppressive therapies)\n\nExclusion Criteria:\n\n* \"Active\" gastric antral vascular ectasia, as evidenced by bleeding (ie, on esophagogastroduodenoscopy) in the past 6 months or as per Investigator's assessment.\n* History of SSc renal crisis within 1 year prior to Screening; presence of kidney impairment due to conditions other than SSc",{"count":102,"type":21},48,[24],"AID is a phase I multi-cohort study to assess the safety and tolerability of zamtocabtagene autoleucel (zamto-cel) in patients with refractory autoimmune diseases (SLE-Non renal, SLE-LN, SSc\u002FdcSSc) after receiving standard therapy.",[66,106,30,28],"Systemic Lupus Erythematosus",[108,71,109,110,111,112,113,114,115,72],"Chimeric antigen receptor","Zamtocabtagene autoleucel","Autoimmune Disease","Immune System Diseases","SLE-Non renal","SLE-LN","SSc","dcSSc","2026-06-09",{"date":84,"type":42},{"date":119,"type":21},"2026-07",{"date":121,"type":21},"2028-07",{"name":123,"class":49},"Miltenyi Biomedicine GmbH",1,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":133,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":136,"phases":4,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":124},"100643010","tl1a-inhibition-in-systemic-sclerosis-related-skin-fibrosis-and-immunological-alterations-a-proof-of-concept-in-vitro-study-fibrostop-100643010","NCT07642297","TL1A Inhibition in Systemic Sclerosis-Related Skin Fibrosis and Immunological Alterations: A Proof-of-Concept In Vitro Study (FIBROSTOP)","The Potential Pharmacological Role of the TNF-Like Ligand 1A (TL1A) Inhibition in Modulating Systemic Sclerosis (SSc)-Related Skin Fibrosis and Immunological Alterations: A Proof-of-Concept, In Vitro, Study","FIBROSTOP","Inclusion Criteria:\n\nFor both SSc and healthy control populations:\n\n* Signed written informed consent\n* Age ≥18 years at the time of consent\n\nFor SSc population only:\n\n* Diagnosis of SSc according to ACR\u002FEULAR 2013 classification criteria\n* Diffuse cutaneous SSc subtype (LeRoy et al., 1988)\n* Disease onset (defined as the first non-Raynaud symptom) within 5 years prior to recruitment\n* No new initiation of immunosuppressive therapy (including methotrexate, mycophenolate mofetil, cyclophosphamide, rituximab, tocilizumab, or prednisone \\>20 mg\u002Fday) within the 2 months preceding recruitment\n* Ongoing immunosuppressive therapy must be at a stable dose for at least 1 month prior to enrollment\n\nExclusion Criteria:\n\n* Coexisting active or treated skin diseases (e.g., atopic dermatitis), except for SSc\n* Diagnosis of other systemic autoimmune rheumatic diseases, including overlap syndromes (e.g., SSc + dermatomyositis)\n* History or current signs\u002Fsymptoms of severe or uncontrolled non-rheumatic diseases\n* Active malignancy or history of malignancy within the previous 5 years (except adequately treated non-melanoma skin cancer or in situ cervical carcinoma)\n* Chronic or recurrent infections, including viral hepatitis B\u002FC, HIV, or untreated tuberculosis\n* Severe active infection or major surgery within 8 weeks before enrollment\n* Non-serious skin infections within 8 weeks before enrollment\n* Limited cutaneous SSc or SSc sine scleroderma\n* SSc patients unable to undergo therapeutic stabilization due to severe organ complications\n* Pregnancy or lactation\n* Inability to provide informed consent",true,{"count":135,"type":21},20,"OBSERVATIONAL","Systemic Sclerosis (SSc) is a rare autoimmune connective tissue disease characterized by microvascular injury, immune activation, and progressive fibrosis of the skin and internal organs. Diffuse cutaneous SSc (dcSSc), particularly in its early phase, is associated with aggressive fibrotic evolution and high morbidity. Despite advances in immunomodulatory therapy, no treatment has proven capable of consistently halting or reversing fibrosis, highlighting the need for new mechanistic targets.\n\nTL1A (TNF-like ligand 1A) is a cytokine of the TNF superfamily expressed by endothelial and immune cells, which interacts with death receptor 3 (DR3) to regulate immune activation, endothelial dysfunction, and tissue remodeling. Elevated TL1A levels have been observed in SSc patients and correlate with disease activity. TL1A has also been shown to promote lung fibrosis in preclinical models.\n\nThe FIBROSTOP study is a proof-of-concept, in vitro, interventional study on biological samples aimed at elucidating the immunological and fibrotic mechanisms regulated by TL1A, and at assessing whether TL1A inhibition can reverse pathogenic processes in SSc.\n\nTen (n=10) patients with early diffuse cutaneous SSc and ten (n=10) age- and sex-matched healthy controls will be enrolled at a single center (Fondazione Policlinico Universitario Campus Bio-Medico, Rome). Each participant will undergo a single visit (T0) involving peripheral blood sampling and skin biopsy. No follow-up visits are planned.\n\nThe study pursues three co-primary objectives: (1) evaluating the role of TL1A and its inhibition in modulating T lymphocyte activity; (2) assessing the effects of TL1A and its inhibition on endothelial cell activation and function; (3) investigating the impact of TL1A and its inhibition on fibrotic remodeling in ex vivo SSc skin cultures using single-cell RNA sequencing.\n\nThe findings may inform future targeted antifibrotic interventions in SSc and other fibrotic diseases.",[30,28,139],"Skin Fibrosis",[141,142,143,144,77,145,146,147],"TL1A","TNF-like ligand 1A","DR3","Fibrosis","T lymphocytes","Endothelial cells","skin biopsy","NOT_YET_RECRUITING","2026-06-04",{"date":84,"type":42},{"date":152,"type":21},"2026-09-01",{"date":154,"type":21},"2028-09-01",{"name":156,"class":157},"Fondazione Policlinico Universitario Campus Bio-Medico","OTHER",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":165,"targetDuration":4,"studyType":22,"phases":167,"briefSummary":168,"conditions":169,"keywords":170,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":190},"100552204","phase-2-a-clinical-study-to-evaluate-ianalumab-in-participants-with-diffuse-cutaneous-systemic-sclerosis-100552204","NCT06470048","A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis","A Randomized, Double-blind, Parallel Group, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety and Tolerability of Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis","Key Inclusion Criteria:\n\n* Male and female participants \\>= 18 and =\\\u003C 70 years (at the time of the screening visit).\n* Diagnosis of systemic sclerosis, as defined by the 2013 American College of Rheumatology\u002F European League Against Rheumatism (ACR\u002FEULAR) classification criteria for SSc (van den Hoogen et al 2013) and meet the dcSSc subset classification according to LeRoy (LeRoy 1988)\n* Disease duration of =\\\u003C 60 months (defined as time from the first non-Raynaud phenomenon manifestation, e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea)\n* mRSS units of \\>= 15 and =\\\u003C 45 at the time of the screening visit\n* Active disease that meets at least one of the following criteria at screening:\n\n  * Disease duration of =\\\u003C 18 months defined as time from the first non-Raynaud phenomenon manifestation\n  * Increase in mRSS of \\>= 3 units compared with the most recent assessment performed within the previous 6 months\n  * Involvement of one new body area and an increase in mRSS of \\>= 2 units compared with the most recent assessment performed within the previous 6 months\n  * Involvement of two new body areas within the previous 6 months\n  * Elevated acute phase reactants (ESR) \\>= 30 mm\u002Fhr or high-sensitivity C-reactive protein (hsCRP) \\>= 6 mg\u002FL)\n  * Presence of SSc-interstitial lung disease (ILD) and ATA autoantibody positivity\n  * Modified EUSTAR disease activity index (mDAI) ≥ 2.5\n* Participant must be positive for at least one of the following autoantibodies:\n\n  * anti-topoisomerase I (ATA) (also known as anti-SCL-70)\n  * anti-RNA polymerase III (anti-RNAP3)\n  * anti-nuclear antibody (ANA) (≥ 1:80) Participants who are positive only for ANA (while being negative for both ATA \u002Fanti-RNAP3) will be limited to 30% of the overall randomized study population.\n\nKey Exclusion Criteria:\n\n* Rheumatic disease other than dcSSc, including limited cutaneous disease (lcSSc) or sine scleroderma at the screening visit. Secondary Sjogren's disease and scleroderma myopathy are not exclusionary.\n* Positive anti-centromere antibody (ACA+) without positive ATA or anti-RNAP3 autoantibody result at the screening visit\n* Previous improvement (decrease) in mRSS \\> 10 units\n* Pulmonary disease with FVC ≤ 50% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO, corrected for hemoglobin) ≤ 40% of predicted at the screening visit\n* WHO Functional Class 3 or higher assessment for pulmonary arterial hypertension (PAH, as defined on right heart catheterization), receiving IV therapy for PAH or evidence of other moderately severe pulmonary disease\n* Participants treated with cyclophosphamide within 12 weeks prior to Baseline.\n* Prior use of a B-cell depleting therapy other than ianalumab (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) administered within 36 weeks prior to randomization, or as long as B cell count is less than the lower limit of normal or baseline value prior to receipt of B cell-depleting therapy (whichever is lower).\n* Treatment with biologic agents, such as intravenous immunoglobulin or monoclonal antibodies, including marketed drugs, within 12 weeks or 5 half-lives (whichever is longer) prior to baseline visit, unless explicitly allowed in inclusion criteria.\n* Treatment with any investigational agent within ≤ 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of the baseline visit.\n* Use of anti-fibrotic agents including colchicine, D-penicillamine, pirfenidone, or tyrosine kinase inhibitors (e.g., nintedanib, nilotinib, imatinib, dasatinib) in the 4 weeks prior to baseline visit. Patients with SSc-ILD requiring antifibrotics for management of ILD during the study, as per investigator judgement, should be excluded.\n* Previous treatment with chlorambucil, bone marrow transplantation or total lymphoid irradiation.\n* Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate \\\u003C 1% per year) while taking study treatment and for 6 months after stopping study treatment.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":166,"type":21},200,[25],"The purpose of this study is to evaluate efficacy, safety and tolerability of s.c. ianalumab administered in participants with diffuse cutaneous systemic sclerosis relative to placebo",[28],[171,172,173,174,175,176,177,178,179,180,181],"Diffuse Cutaneous Systemic Sclerosis (dcSSc)","Diffuse Scleroderma","Diffuse Systemic Sclerosis","Scleroderma, Diffuse","Scleroderma, Progressive","Sclerosis, Progressive Systemic","Sudden Onset Scleroderma","B cell depletion","Revised Composite Response Index in Systemic Sclerosis 25 (rCRISS25)","modified Rodnan skin score","forced vital capacity",{"date":183,"type":42},"2026-06-05",{"date":185,"type":42},"2024-10-09",{"date":187,"type":21},"2034-07-31",{"name":189,"class":49},"Novartis Pharmaceuticals",128,{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":201,"conditions":202,"keywords":203,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":50},"100615059","phase-2-encompassc-evaluation-of-mtx-474-in-participants-with-diffuse-cutaneous-systemic-sclerosis-dcssc-100615059","NCT07287670","EncompaSSc: Evaluation of MTX-474 in Participants With Diffuse Cutaneous Systemic Sclerosis (dcSSc)","A Phase 2 Randomized, Double-blind, Placebo-Controlled Study to Assess the Safety and Efficacy of MTX-474 in the Treatment of Participants With Diffuse Cutaneous Systemic Sclerosis (dcSSc)","Inclusion Criteria:\n\n1. Diagnosis of diffuse cutaneous systemic sclerosis, classified according to 2013 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR)\n2. Participant is either:\n\n   1. Within 2 years of their first non-Raynaud's symptom and their mRSS is \\>7; OR\n   2. \\>2 and ≤5 years from their first non-Raynaud's symptom, their mRSS is between 10 and 30, they are negative for the RNA polymerase 3 autoantibody, and (1) they have never had any previous spontaneous improvement in skin thickening of ≥4 points by mRSS on exams performed by the same clinician, or (2) they were never clinically noted to have a meaningful spontaneous reduction in skin thickness if mRSS was never done; OR\n   3. \\>5 and ≤10 years from their first non-Raynaud's symptom, their mRSS is between \\>15 and ≤25, they are negative for the RNA polymerase 3 autoantibody, and (1) they have never had any previous spontaneous improvement in skin thickening of ≥4 points by mRSS, or (2) were never clinically noted to have a meaningful spontaneous reduction in skin thickness if mRSS was never done.\n3. Participant is ≥18 years of age at time of signing the ICF.\n4. Able to understand the study and provide a signed, written ICF\n5. Able to read and understand the language of the ICF and other study-related materials\n6. Forced vital capacity (FVCpp) of ≥45 pp10\n7. Have diffusing capacity of the lungs for carbon monoxide (DLCO) of ≥30 percent predicted at Screening\n8. Willing and able to complete all protocol-required study visits and procedures\n9. Participants of childbearing potential must have a negative serum pregnancy test at Screening.\n10. All participants with reproductive potential must agree to use and follow medically approved, highly effective methods of contraception during treatment and until 5 half-lives or 125 days after the last dose, whichever is longer\n\nExclusion Criteria:\n\n1. Concomitantly have another serious medical illness, which, in the opinion of the Investigator, would interfere with the participant's ability to complete the study\n2. Participant is currently on immunosuppressive therapy, systemic glucocorticoids or other antifibrotic agents detailed as follows:\n\n   1. Immunosuppresive agents: Cyclophosphamide (IV or oral if used in the 6 months prior to Screening), calcineurin inhibitors (if used in the 30 days prior to Screening), azathioprine (if used in the 30 days prior to Screening), Janus-kinase inhibitors (if used in the 30 days prior to Screening), rituximab (if used in the 6 months prior to Screening), tocilizumab (if used in the 60 days prior to Screening) or any other biologic Disease-Modifying Antirheumatic Drugs (DMARD, if used in the last 30 days or 3 half-lives prior to Screening, whichever is longer)\n   2. Antifibrotic agents: nintedanib or pirfenidone (if used in the 30 days prior to Screening). Also, exclusionary if used within 3 months of Screening are tyrosine-kinase inhibitors with recognized anti-fibrotic activity (imatinib, nilotinib, etc.)\n   3. Systemic glucocorticoids: equivalent doses of prednisone greater than 10 mg\u002Fday (≤10 mg\u002Fday allowed). Has received any pulse intramuscular (IM) or intravenous (IV) steroid within 1 month of Screening\n   4. Other agents:\n\n   i. mycophenolate mofetil unless on a stable dose for at least 6 months prior to Screening and there are no plans to adjust the dose during the study; ii. mycophenolic acid unless on a stable dose for at least 6 months prior to Screening and there are no plans to adjust the dose during the study; iii. hydroxychloroquine unless on a stable dose for at least 3 months prior to Screening and there are no plans to adjust the dose during the study; and iv. methotrexate unless on a stable dose for at least 3 months prior to Screening and there are no plans to adjust the dose during the study.\n3. Previous or planned hematopoietic stem cell or solid organ transplantation\n4. Previous treatment with chimeric antigen receptor (CAR)-T\u002FCAR-NK therapy\n5. Clinically significant PAH as determined by the Investigator at, or prior to first day of dosing (Baseline)\n6. Current use of PAH medication (endothelin receptor antagonists, prostacyclin analogues, soluble guanylate cyclase stimulators) excluding calcium channel blockers and phosphodiesterase-5 inhibitors\n7. Pregnant or currently breastfeeding\n8. Aspartate transaminase (AST) or alanine transaminase (ALT) \\>2.0 upper limit of normal\n9. Creatinine clearance \\\u003C45mL\u002Fmin\n10. History of myocardial infarction, angina or congestive heart failure\n11. International normalized ratio \\>2 or partial thromboplastin time \\>1.5 × upper limit of normal\n12. Active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C\n13. History of clinically significant thrombotic event within 12 months prior to Screening\n14. Positive anticentromere antibody\n15. Systemic sclerosis renal crisis within 12 months prior to Screening\n16. Confirmed diagnosis of overlap syndrome, systemic lupus erythematosus with anti-double strand (ds)DNA antibody, rheumatoid arthritis with anti-cyclic citrullinated peptide (anti-CCP) antibody, or systemic sclerosis mimics (eosinophilic fasciitis, scleromyxedema) at the time of inclusion in the study\n17. Known malignancy or history of malignancy within 5 years of Screening other than non-melanoma skin cancer and in situ cervical cancer\n18. Major surgery within 8 weeks prior to Screening or planned surgery during study period\n19. Unable to routinely access veins for blood draws and IV infusions\n20. Currently receiving another experimental agent or participating in another clinical trial. If a participant has recently received another experimental agent, then the last dose must have been at least 5 half-lives or 30 days (whichever is longer) prior to Screening\n21. History of myocardial infarction, angina or congestive heart failure",{"count":199,"type":21},85,[25],"A Phase 2 Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-474 in Participants with Diffuse Cutaneous Systemic Sclerosis (dcSSc)",[28],[204,205,28,206,115,207,208,209,210,211],"MTX-474-S201","MTX-474","dcSSc participants","Adult","mRSS","EncompaSSc","monoclonal antibody","EphrinB2","2026-06-03",{"date":149,"type":42},{"date":215,"type":42},"2026-04-16",{"date":217,"type":21},"2028-12",{"name":219,"class":49},"Mediar Therapeutics",{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":22,"phases":229,"briefSummary":231,"conditions":232,"keywords":233,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":124},"100588040","phase-3-safety-and-efficacy-of-baricitinib-on-skin-tightening-in-diffuse-cutaneous-systemic-sclerosis-a-comparative-study-with-methotrexate-100588040","NCT06936215","Safety and Efficacy of Baricitinib on Skin Tightening in Diffuse Cutaneous Systemic Sclerosis: A Comparative Study With Methotrexate","BardSSc","Inclusion Criteria:\n\n* 1\\. Diagnosis of diffuse cutaneous systemic sclerosis, as classified using the 2013 American College of Rheumatology\n\n  2\\. Diffuse cutaneous systemic sclerosis as defined by 2001 LeRoy and Medsger 3. Disease duration ≤ 60 months (defined as time from the first non-Raynaud phenomenon manifestation) 4. mRSS score ≥ 10 at baseline\n\nExclusion Criteria:\n\nSubjects with any of the following characteristics\u002Fconditions will not be included in the study:\n\n1. Rheumatic disease other than systemic sclerosis. it is acceptable to include patients with fibromyalgia and scleroderma-associated myopathy\n2. Limited cutaneous systemic sclerosis or sine scleroderma at the screening visit\n3. Major surgery (including joint surgery) within 8 weeks prior to screening visit\n4. Any infected ulcer prior to treatment\n5. Subjects with any serious bacterial infection (e.g.,chronic pyelonephritis, osteomyelitis, or bronchiectasis) .\n6. Oral corticosteroids \\>10 mg\u002Fday of prednisone or equivalent.\n7. Mycophenolate mofetil \\> 2 grams\u002Fday prior to baseline\n8. Pulmonary disease with FVC ≤ 50% of predicted, or DLCO (uncorrected for hemoglobin) ≤ 40% of predicted\n9. Current clinical, radiographic, or laboratory evidence of active TB.\n10. Positive for hepatitis B surface antigen at or within 30 days of screening.\n11. Positive for hepatitis C antigen at or within 30 days of screening.\n12. Current or recent history of uncontrolled clinically significant renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease.\n13. Pregnant or breastfeeding female subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in the protocol for the duration of the study and for at least 28 days after discontinuation of study drug.\n14. History of any malignancy in the last 5 years\n15. History of SSc Renal Crisis within the 6 months prior to baseline.\n16. Patients with a history of anaphylaxis to Baricitinib or methotrexate\n17. Any of the following lab results at screening:\n\n    * Hemoglobin \\\u003C8 g\u002Fdl\n    * White Blood Cell count \\\u003C3.0 x 109\u002FL;\n    * Absolute Neutrophil count \\\u003C1.2 x 109\u002FL;\n    * Platelet count \\\u003C100 x 109\u002FL;\n    * Absolute Lymphocyte count \\\u003C0.75 x 109\u002FL.\n    * ALT \\> 3 × the upper limit of normal (ULN) of normal at screening\n    * Estimated glomerular filtration rate \\[GFR\\] \\\u003C60mL\u002Fmin\u002F1.73 m2",{"count":228,"type":21},24,[230],"PHASE3","Systemic sclerosis (SSc) is a systemic autoimmune disease. It causes progressive skin tightening, pulmonary fibrosis, organ damage and many other physical dysfunctions. It is divided into two types, limited cutaneous systemic sclerosis (lcSSc) and diffuse cutaneous systemic sclerosis (dcSSCc). Skin involvement in systemic sclerosis is assessed by modified Rodnan skin score (mRSS). Methotrexate is a drug used in the treatment of skin tightening in SSc but has inconsistent response . Janus kinase (JAK) inhibitors are a class of drugs that may be used in skin involvement in dcSSc. Among them, baricitinib, a JAK 1\u002F2 inhibitor, has shown some efficacy in dcSSc. The aim of this study is to assess the efficacy and safety of baricitinib on skin tightening in dcSSc patients. This open label randomized clinical trial will be conducted in department of rheumatology, BSMMU. Systemic sclerosis will be diagnosed by ACR\u002FEULAR classification criteria 2013. Among them who have diffuse cutaneous involvement will be considered primary entry criteria for this study. Consecutive sampling method will be applied. Participants will be divided into two groups, group A and group B. Group A will be put on tab. baricitinib 4 mg daily and group B will be put on tab. methotrexate 25 mg weekly with folic acid 5 mg weekly. All participants will be assessed for mRSS, CDAI at baseline and laboratory tests like CBC, ESR, CRP, SGPT, serum creatinine, CXR P\u002FA view etc. Follow up will be done at 4, 12, 24 weeks. Response to treatment will be assessed by modified Rodnan skin score. Primary endpoint of efficacy will be assessed by the end of 24th week. adverse effects will be assessed by history, physical examination and investigations. The data will be analyzed by SPSS version 25. results will be recorded using means and standard deviations. Result will be compared among groups with a 95% confidence interval and a p-value 0f\\\u003C0.05. The degrees of statistical significance between groups will be analyzed by unpaired t test (for quantitative normally distributed data) and Mann Whitney U test for skewed distribution. Qualitative data in between groups will be analyzed by chi square test. Probabilities of association will be assessed by Spearman's rank correlation coefficient. P value of \\\u003C 0.05 will be regarded as statistically significant.",[28],[234],"Baricitinib in diffuse cutaneous systemic sclerosis","2025-04-12",{"date":237,"type":42},"2025-04-20",{"date":239,"type":42},"2024-01-01",{"date":241,"type":21},"2025-05",{"name":243,"class":157},"Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh",{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":22,"phases":253,"briefSummary":254,"conditions":255,"keywords":256,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":124},"100438232","phase-2-extracorporeal-photopheresis-in-early-diffuse-cutaneous-systemic-sclerosis-100438232","NCT04986605","Extracorporeal Photopheresis in Early Diffuse Cutaneous Systemic Sclerosis","The Effectiveness of ECP in Diffuse Cutaneous Systemic Sclerosis","Inclusion Criteria:\n\n1. Patients with SSc, aged 18 years or older, and:\n2. Subjects must meet the ACR\u002FEULAR classification criteria for SSc (2013).\n3. Early dcSSc (within 5 years of first non-Raynaud's phenomenon symptom) or any other dcSSc patients who have at least one of the signs of disease activity: mRSS of 15 or more, presence of tendon friction rubs, elevated inflammatory markers thought to be due to active dcSSc and not related to other issues such as infection or ILD with FVC% predicted \\\u003C80% or HRCT showing ILD thought to be from SSc.\n4. Able to give informed consent.\n\nExclusion Criteria:\n\n1. Poor pulmonary function (FVC\\\u003C40% and\u002For DLCO\\\u003C30%).\n2. Class IV PAH or PH.\n3. Clinically significant cardiac disease.\n4. Significant concurrent, uncontrolled medical condition including, but not limited to, renal, cardiac, hepatic, pancreatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease; and cancer (i.e. co-existing melanoma, basal cell, or squamous cell skin carcinoma).\n5. Chronic or ongoing active infectious disease requiring systemic treatment, including active tuberculosis (TB) infection.\n6. Seropositivity for human immunodeficiency virus (HIV) at study entry.\n7. Active viral infection with viral replication of hepatitis B or C virus at study entry.\n8. Thrombophilia.\n9. Contraindications to heparin including history of heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis (HITTS), history of thrombocytopenia with pentosan polysulfate, known hypersensitivity to heparin or pork products.\n10. Low Platelet count (less than 100,000 per mm3).\n11. Aphakia (absence or loss of the eye's lens and has not been replaced with an artificial lens), because of the significantly increased risk of retinal damage due to the absence of lenses.\n12. Severe anemia (hemoglobin \\\u003C70g\u002FL).\n13. High white blood cell count (greater than 25000 mm3).\n14. A history of surgical spleen removal.\n15. A history of a light sensitive disease state, i.e. lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum and albinism.\n16. Previous idiosyncratic reactions to psoralen compounds.\n17. Patients who are using photosensitizing drugs such as anthralin, coal tar or coal tar derivatives, griseofulvin, phenothiazines, nalidixic acid, halogenated salicylanilides (bacteriostatic soaps), sulfonamides, tetracyclines, thiazides, and certain organic staining dyes such as methylene blue, toluidine blue, rose bengal and methyl orange.\n18. Treatment with more than 2 immunosuppressants (including mofetil mycophenolate, methotrexate, cyclophosphamide, biologics) at study entry.\n19. Pregnancy, breast feeding or child bearing potential without practicing highly effective contraception (and partners for men in the study).\n20. Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder).\n21. Participation in another clinical trial within six weeks before randomization in this study.\n22. Previous use of Extracorporeal photopheresis.",{"count":252,"type":21},15,[25],"The purpose of this study is to assess feasibility, safety and preliminary efficacy of Extracorporeal Photopheresis in the treatment of active diffuse cutaneous systemic sclerosis (dcSSc). This pilot study will help to determine if further study (a RCT) is justified.",[28],[257,258,259,260,261],"systemic sclerosis","scleroderma","extracorporeal photopheresis","connective tissue diseases","skin diseases",{"date":263,"type":42},"2025-03-13",{"date":265,"type":21},"2025-07-01",{"date":267,"type":21},"2027-07",{"name":269,"class":157},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's",{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":277,"targetDuration":4,"studyType":22,"phases":279,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":291},"100544908","phase-2-efficacy-and-safety-of-telitacicept-in-the-treatment-of-systemic-sclerosis-100544908","NCT06375005","Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis","The Efficacy and Safety of Telitacicept in the Treatment of Early Diffuse Cutaneous Systemic Sclerosis: a Multicenter, Open-label, Randomized Controlled Study","Inclusion Criteria:\n\n* Men or women aged 18-70 years old.\n* Systemic sclerosis, as defined by ACR\u002FEULAR (American College of Rheumatology\u002FEuropean League Against Rheumatism) 2013 criteria.\n* dcSSc (diffuse cutaneous systemic sclerosis) according to the LeRoy criteria.\n* Disease duration of ≤ 18 months (defined as time from the first non-Raynaud's phenomenon manifestation).\n* ≥ 10 mRSS units at the screening visit.\n* Negative serum pregnancy test in a woman of childbearing potential at the screening visit.\n* Ability to render informed consent in accordance with institutional guidelines.\n\nExclusion Criteria:\n\n* Limited scleroderma.\n* Disease duration of greater than 3 years.\n* Rheumatic autoimmune disease other than SSc.\n* Systemic sclerosis-like illness associated with environmental agents such as vinyl chloride, or bleomycin.\n* Any prior history of renal crisis.\n* Intermediate- or high-risk pulmonary arterial hypertension.\n* Pulmonary disease with FVC \\\u003C 50% of predicted or DLCO (hemoglobin-corrected) \\\u003C 40% of predicted at screening or requires oxygen therapy.\n* Underwent major surgery within 8 weeks prior to randomization or planned major surgery during the trial period.\n* Use of immunosuppressive therapies, including methotrexate, azathioprine, hydroxychloroquine, leflunomide, tacrolimus, sirolimus, and mycophenolate mofetil within 4 weeks prior to randomization, and cyclophosphamide within 3 months prior to randomization.\n* Use of other anti-fibrotic agents, including colchicine, D-penicillamine, thalidomide, nintedanib, pirfenidone, tyrosine kinase inhibitors (imatinib, nilotinib, dasatinib) within 4 weeks prior to randomization.\n* Use of corticosteroids at doses exceeding the equivalent of prednisone 10 mg daily, or intravenous and intramuscular corticosteroid injections within 4 weeks prior to randomization.\n* Use of Intravenous Immunoglobulin (IVIG) within 12 weeks within 4 weeks prior to randomization.\n* Prior use of belimumab, rituximab, or other B-Cell depleting therapies ever.\n* Use of other biologics or small molecule targeted therapies, including anakinra within 1 week prior to randomization, ixekizumab within 2 weeks prior to randomization, and infliximab, certolizumab pegol, golimumab, adalimumab, abatacept, tocilizumab within 8 weeks prior to randomization, and janus kinase inhibitors within 2 weeks prior to randomization.\n* Prior use of other cell depletion therapies.\n* Concurrent serious medical condition which in the opinion of the investigator makes the patient inappropriate for this study such as severe central nervous system disease，severe heart failure, arrhythmia, unstable atherosclerotic cardiovascular disease, severe GI involvement, severe hypertension or severe diabetes.\n* Abnormal results in hepatitis B or hepatitis C testing indicating active or chronic infection.\n* Active tuberculosis (TB) or latent TB infection.\n* Seropositive for human immunodeficiency virus (HIV) or known history of HIV infection.\n* Known active bacterial, viral, fungal, mycobacterial, or other infection，including major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening.\n* Primary or secondary immunodeficiency.\n* IgA deficiency (\\\u003C10 mg\u002FdL) or IgG deficiency (\\\u003C400 mg\u002FdL).\n* Participation in another clinical research study involving the evaluation of another investigational drug within 3 months of entry into this study.\n* Any of the following at the screening visit: Hemoglobin \\\u003C8.0 g\u002FdL; WBC \\\u003C3 x 10\\^9\u002FL; Neutrophil \\\u003C1.5 x 10\\^9\u002FL; platelets \\\u003C75 x 10\\^9\u002FL; serum ALT or AST \\> 1.5 x ULN; TBil \\> ULN; eGFR \\\u003C 40mL\u002Fmin\u002F1.73m\\^2.\n* Malignant disease within 5 years prior to screening, with the exception of excised\u002Fcured local basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix;\n* Immunization with a live\u002Fattenuated vaccine within 4 weeks prior to randomization.\n* Pregnant or breast feeding women or women of childbearing potential not willing to use adequate contraception.\n* History of allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies.\n* Immunization with a live\u002Fattenuated vaccine within 4 weeks prior to randomization.\n* Patients anticipated to be non-compliant with the protocol requirements or expected not to complete the trial as planned (e.g., those with psychiatric disorders, history of alcohol abuse, drug abuse, or substance misuse).",{"count":278,"type":21},38,[25],"This study is a prospective, open-label, randomized, controlled, multi-center clinical trial. The aim of this study is to investigate the efficacy and safety of Telitacicept in adults with early diffuse cutaneous systemic sclerosis (dcSSc), with Mycophenolate Mofetil (MMF) administered as a background treatment.",[28],"2025-02-09",{"date":284,"type":42},"2025-02-11",{"date":286,"type":42},"2025-01-06",{"date":288,"type":21},"2027-12-31",{"name":290,"class":157},"Second Affiliated Hospital, School of Medicine, Zhejiang University",9,{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":22,"phases":301,"briefSummary":302,"conditions":303,"keywords":304,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":124},"100450766","phase-2-open-label-extension-study-of-brentuximab-vedotin-in-early-dcssc-100450766","NCT05149768","Open Label Extension Study of Brentuximab Vedotin in Early dcSSc","An Open Label Extension Study of Brentuximab Vedotin Treatment in Active Diffuse Cutaneous Systemic Sclerosis (Diffuse Scleroderma)","Inclusion Criteria:\n\n1. Patients with diffuse cutaneous systemic sclerosis enrolled in the Phase II Adcetris study (BV201708) at St. Joseph's Health centre, aged 18 years or older, and:\n2. Worsening mRSS of ≥ 4 points as compared to mRSS score at the end of treatment visit (week 48) in the initial study (BV201708).\n3. Able to give informed consent.\n\nExclusion Criteria:\n\n1. Poor pulmonary function (FVC\\\u003C40% and\u002For DLCO\\\u003C30%).\n2. Pregnancy, breast feeding or child bearing potential without practicing highly effective contraception (and partners for men in the study).\n3. Clinically significant pulmonary hypertension requiring drug therapy.\n4. Clinically significant cardiac disease.\n5. Chronic or ongoing active infectious disease requiring systemic treatment.\n6. Seropositivity for human immunodeficiency virus (HIV).\n7. Active tuberculosis (TB) infection.\n8. Active viral infection with viral replication of hepatitis B or C virus.\n9. Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, pancreatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease; and cancer.\n10. Peripheral neuropathy at screening Grade 2 or higher.\n11. Known or suspected hypersensitivity to components of the treatment\n12. Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)\n13. Any of the following laboratory abnormalities at screening:\n\n    * Absolute neutrophils count \\\u003C2.0 x 109\u002FL\n    * Hemoglobin \\\u003C85 g\u002FL\n    * Platelet count \\\u003C 100 x 109\u002FL\n    * AST\u002FSGOT or ALT\u002FSGPT \\>2.0 UNL\n14. Participation in another clinical trial within six weeks before randomization in this study, with the exception of continuation from the initial study BV201708.\n15. Use of rituximab within the previous 4 months.\n16. Immunization with a live\u002F attenuated vaccine less than 4 weeks prior to the baseline visit.\n17. Current or history of progressive multifocal leukoencephalopathy (PML).",{"count":300,"type":21},11,[25],"The purpose of this study is to assess safety and efficacy of Brentuximab vedotin, a CD30-directed antibody-drug conjugate, in patients with active diffuse cutaneous systemic sclerosis (dcSSc) who relapsed after discontinuation of Brentuximab vedotin.",[28],[257,258,305,306,307,308,261,309],"brentuximab vedotin","CD30-directed antibody-drug conjugate","antirheumatic agents","antineoplastic agents","immunologic factors","2024-11-14",{"date":312,"type":42},"2024-11-18",{"date":314,"type":42},"2024-02-14",{"date":316,"type":21},"2026-07-01",{"name":269,"class":157}]