[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sjgrens-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sjgrens-disease":119},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,86],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"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",false,"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.",true,"ALL","18 Years","75 Years",{"count":21,"type":22},63,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","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).",[28,29,30,31],"Rheumatoid Arthritis","Systemic Lupus Erythematosus","Systemic Sclerosis","Sjögren's Disease",[33],"Autoimmune disease","NOT_YET_RECRUITING","2026-06-11",{"date":37,"type":38},"2026-06-16","ACTUAL",{"date":40,"type":22},"2026-09-15",{"date":42,"type":22},"2028-11-20",{"name":44,"class":45},"Otsuka Pharmaceutical Development & Commercialization, Inc.","INDUSTRY",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":4},"100637425","phase-3-two-arm-double-blind-phase-iii-study-assessing-efficacy-and-safety-of-ianalumab-versus-placebo-in-participants-with-sjgrens-disease-with-high-symptom-burden-100637425","NCT07621809","Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden","A Randomized, Double-blind, Placebo-controlled, 2-arm Multicenter Phase III Study to Assess the Efficacy and Safety of Ianalumab in Participants With Sjogren's Disease With High Symptom Burden (THALASSA)","THALASSA","Inclusion Criteria:\n\n* Male or female participants ≥ 18 years of age or as per country-specific legal adult age, whichever is higher\n* Classification of Sjögren's disease according to ACR\u002FEULAR 2016 criteria.\n* Seropositive for anti-Ro\u002FSSA antibodies at screening\n* SSSD oral dryness score ≥ 5 and overall SSSD summary score ≥5 collected over 14 consecutive days during the Screening 2 period\n* Screening ESSDAI biologic and\u002For hematologic domain \\> 0 Note: laboratory abnormalities for scoring must be confirmed as associated with Sjögren's disease and not be due to other underlying conditions.\n* Stimulated whole salivary flow (sSF) rate \\> 0.3 mL\u002Fmin at screening\n* Participants taking hydroxychloroquine (≤ 400 mg\u002Fday) are allowed to continue their medication, and must have been on a stable dose for at least 4 weeks prior to screening, which should be maintained throughout the 52 weeks of the blinded treatment period.\n* Predniso(lo)ne ≤ 5 mg\u002Fday or equivalent are allowed for up to 16 weeks post-randomization.\n\nExclusion Criteria:\n\n* Presence of another autoimmune rheumatic disease that is active and constitutes the principal illness, specifically:\n* Systemic sclerosis (SSc)\n* Any other associated connective tissue disease (e.g., lupus nephritis (LN), large vessel vasculitis (LVV), Sharp syndrome (mixed connective tissue disease)) that is active and requires immunosuppressive treatment outside the scope of this trial and would impede on Sjögren's disease organ domain assessments.\n* Concurrent diagnosis or history of fibromyalgia or overlapping inflammatory diseases\n* Prior treatment with B-cell-depleting therapy (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) within:\n* 36 weeks prior to randomization, or\n* As long as B-cell count is less than the lower limit of normal (LLN) or baseline value prior to receipt of previous B-cell-depleting therapy (whichever is lower) at Screening.\n* Prior treatment with ianalumab\n* Prior treatment with any of the following within the given period prior to Screening:\n* Within 5 half-lives prior to Screening: iscalimab (anti-CD 40 mAb), belimumab (anti-BAFF mAb), abatacept (CTLA4-Fc Ig), anti-tumor necrosis factor alpha (TNFα) biologic agents, immunoglobulins (i.v.\u002Fs.c.), plasmapheresis, any other investigational biologic medicines under investigation for Sjögren's disease\n* Within 4 weeks OR drug-specific 5 half-lives elimination period (if longer than 4 weeks) prior to screening: i.v. or oral cyclophosphamide, mycophenolate mofetil (MMF), methotrexate, azathioprine, i.v. or oral cyclosporine A or any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors).\n* History of hypersensitivity to any of the study drugs or their excipients, or to drugs of similar chemical classes (e.g., mAb of IgG1 class) or to any of the constituents of the study drug formulation (sucrose, L-histidine hydrochloride\u002FL-histidine, polysorbate 20).",{"count":55,"type":22},570,[57],"PHASE3","The purpose of this study is to demonstrate the efficacy and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren's disease who have high symptom burden.",[60],"Sjögren´s Disease",[62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,52],"Sjögren´s disease","ianalumab","VAY736","high symptom burden","B cell depleting therapy","BAFF receptor","BAFF-R","ESSDAI","ESSPRI","SSSD","monoclonal antibody","dryness","fatigue","autoimmune disease","sicca syndrome","2026-05-26",{"date":79,"type":38},"2026-06-02",{"date":81,"type":22},"2026-07-15",{"date":83,"type":22},"2033-08-13",{"name":85,"class":45},"Novartis Pharmaceuticals",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":118},"100614838","phase-1-a-phase-1-open-label-study-to-evaluate-safety-in-healthy-participants-and-participants-with-autoimmune-diseases-100614838","NCT07284797","A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases","A Phase 1, First-in-Human, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of XmAb657 in Healthy Participants and in Participants With Autoimmune Diseases","Inclusion Criteria:\n\nHealthy participants - Adult participants in good health\n\nIdiopathic inflammatory myopathy (IIM) participants - Adult participants that meet the 2017 European Alliance of Association Rheumatology (EULAR)\u002FAmerican College of Rheumatology (ACR) Classification Criterion for IIM\n\nSystemic sclerosis (SSc) participants - Adult participants that meet the 2013 ACR\u002FEULAR Classification Criteria for SSc\n\nSjogren's Disease participants that meet the 2016 ACR\u002FEULAR Classification Criteria for Primary Sjogren's Syndrome\n\nAll participants - Use of highly effective methods of contraception\n\nExclusion Criteria:\n\n* Major surgery within 12 weeks prior to dosing or planned within the study\n* Recurrent infections or active clinically significant infection\n* Active or untreated latent tuberculosis\n* Cancer or history of cancer or lymphoproliferative disease within the previous 5 years\n* Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease\n\nNote: Additional, more specific inclusion\u002Fexclusion criteria are defined in the protocol.",{"count":94,"type":22},60,[25],"The purpose of this study is to determine the safety and tolerability of XmAb657 in healthy participants and participants with autoimmune diseases. Participants will be given XmAb657 subcutaneously (SC) by injection under the skin.",[98,99,30,31],"Healthy","Idiopathic Inflammatory Myopathies",[101,102,103,104,105,106,107],"Myopathy","Myositis","Scleroderma","Autoimmune Diseases","IIM","SjD","SSc","RECRUITING","2026-05-20",{"date":111,"type":38},"2026-05-22",{"date":113,"type":38},"2026-02-24",{"date":115,"type":22},"2028-10",{"name":117,"class":45},"Xencor, Inc.",1,"Sjögrens Disease"]