[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-sjgrens-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-sjgrens-syndrome":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,76,99,128,153],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100591369","phase-2-efficacy-and-safety-of-imvt-1402-in-adult-participants-with-primary-sjogrens-disease-with-moderate-to-severe-systemic-disease-activity-100591369",false,"NCT06979531","Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity","A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity","Inclusion Criteria:\n\n* Participants with a diagnosis of primary SjD for at least 12 months prior to the Screening Visit and meet classification criteria for primary SjS according to the 2016 American College of Rheumatology\u002F European League Against Rheumatism Classification Criteria for Primary Sjogren's Syndrome at the time of screening.\n* Participants with moderate to severe systemic disease activity as determined by a clinESSDAI total score ≥ 5 at the Screening Visit.\n* Participants are seropositive for antibodies to Sjogren's Syndrome A (SSA)\u002FAnti-Sjogren's Syndrome A (Ro) at the Screening Visit.\n* Participants have residual salivary flow as measured by stimulated whole salivary flow rate ≥ 0.01 milliliters per minute (mL\u002Fmin) at the Screening Visit.\n\nAdditional inclusion criteria are defined in the protocol.\n\nExclusion Criteria:\n\n* Participants with a diagnosis of secondary SjD, inadequately treated fibromyalgia, other confirmed connective tissue, rheumatic, or systemic inflammatory autoimmune disease including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis, or polymyositis, that in the opinion of the Investigator, is likely to interfere with the ability to assess primary SjD manifestations.\n* Participants with a history of clinically significant monoclonal gammopathy, including but not limited to monoclonal gammopathy of undetermined significance, history of multiple myeloma or non-Hodgkin's lymphoma, or have an active malignancy or history of malignancy within 5 years prior to the Screening Visit.\n\nAdditional exclusion criteria are defined in the protocol.","ALL","18 Years","74 Years",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase 2b, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy and safety of IMVT-1402 in adult participants with moderate to severe systemic primary Sjogren's disease (SjD).",[27],"Primary Sjögren's Syndrome",[29,30,31],"Sjogren Disease","IMVT-1402","Imeroprubart","RECRUITING","2026-08-11",{"date":35,"type":36},"2026-08-12","ACTUAL",{"date":38,"type":36},"2025-06-30",{"date":40,"type":21},"2029-07",{"name":42,"class":43},"Immunovant Sciences GmbH","INDUSTRY",121,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100650827","phase-1-a-study-of-qls2404-injection-in-healthy-participants-and-participants-with-rheumatic-autoimmune-diseases-100650827","NCT07751315","A Study of QLS2404 Injection in Healthy Participants and Participants With Rheumatic Autoimmune Diseases","A Phase Ia\u002FIb Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of QLS2404 Injection in Healthy Participants and Participants With Rheumatic Autoimmune Diseases","Inclusion Criteria:\n\n* Ia\n* Participants who understand and comply with the study procedures and methods, voluntarily participate in this trial, provide written informed consent, and are able to complete the study in accordance with the protocol requirements.\n* Male or female participants aged ≥18 and ≤45 years on the date of signing the informed consent form.\n* Body mass index (BMI) at screening ≥19 kg\u002Fm² and ≤26 kg\u002Fm², with body weight ≥45 kg.\n* Participants assessed by the investigator to be in good health based on medical history, physical examination, vital signs, and laboratory test results during the screening period.\n* Ib\n* Participants who voluntarily sign the informed consent form before the initiation of any study-related procedures, are able to communicate effectively with the investigator, understand and are willing to strictly comply with the requirements of this clinical study protocol, and complete the study.\n* Male or female participants aged ≥18 and ≤65 years at the time of signing the informed consent form.\n* Body mass index (BMI) at screening ≥18 kg\u002Fm² and ≤35 kg\u002Fm².\n* Participants with systemic lupus erythematosus must meet the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for SLE and be diagnosed with systemic lupus erythematosus; the diagnosis must have been established at least 6 months prior to signing the informed consent form.\n* Participants with primary Sjögren's syndrome must meet the 2016 ACR\u002FEULAR classification criteria for primary Sjögren's syndrome and be diagnosed with primary Sjögren's syndrome; the diagnosis must have been established at least\n* months prior to signing the informed consent form.\n\nExclusion Criteria:\n\n* Ia\n* QTcF interval corrected by electrocardiogram (ECG) ≥450 ms at screening; and any other ECG abnormalities that, in the investigator's opinion, may pose an unacceptable risk to the participant.\n* Participants with a history of, or current, chronic or serious diseases of the musculoskeletal, neuropsychiatric, endocrine, circulatory, respiratory, digestive, urinary, reproductive, or other systems, who are considered by the investigator to be unsuitable for participation in the clinical trial.\n* Participants who have lost more than 400 mL of blood due to blood donation or other reasons within 3 months prior to screening.\n* Participants who are considered by the investigator to be unsuitable for participation in the clinical trial or unable to complete this study for other reasons.\n* Ib\n* Any disease or condition that, in the investigator's opinion, may interfere with the evaluation of study drug efficacy, participant safety assessment, or interpretation of study results.\n* Participants who have participated in any cell therapy, gene therapy clinical trial, or medical device clinical trial within 3 months prior to screening.\n* Participants who have received Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to screening.\n* Participants who have received any live attenuated vaccine within 1 month prior to screening or who require live attenuated vaccination during study participation.\n* Participants who are breastfeeding or have a positive serum human chorionic gonadotropin (hCG) test during the screening period.",true,"65 Years",{"count":55,"type":21},64,[57],"PHASE1","This study consists of a randomized, double-blind, placebo-controlled Phase Ia part and an open-label Phase Ib part. The Phase Ia part is a single ascending-dose study of subcutaneous QLS2404 Injection in healthy participants, designed to evaluate the safety and tolerability of QLS2404 Injection in healthy participants. The Phase Ib part is a multiple ascending-dose study of subcutaneous QLS2404 Injection in participants with systemic lupus erythematosus and primary Sjögren's syndrome, designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of QLS2404 Injection.",[60,27],"Systemic Lupus Erythematosus",[62,63,64,65],"systemic lupus erythematosus","primary Sjögren's syndrome","SLE","pSS","NOT_YET_RECRUITING","2026-08-06",{"date":69,"type":36},"2026-08-07",{"date":33,"type":21},{"date":72,"type":21},"2028-06-30",{"name":74,"class":43},"Qilu Pharmaceutical Co., Ltd.",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100648974","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-icp-488-in-participants-with-primary-sjgrens-syndrome-100648974","NCT07727486","A Study to Evaluate the Efficacy and Safety of ICP-488 in Participants With Primary Sjögren's Syndrome","A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of Oral ICP-488 in Participants With Primary Sjögren's Syndrome (pSjS)","Inclusion Criteria\n\n1. Aged 18 to 70 years inclusive.\n2. The disease duration (from the date of diagnosis) prior to screening shall be at least 24 weeks and no more than 5 years..\n3. The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at screening is ≥ 5.\n4. At screening, the stimulated whole salivary flow (SWSF) ≥ 0.05 mL\u002Fmin OR unstimulated whole salivary flow (UWSF) ≥ 0.01 mL\u002Fmin.\n5. Positive for anti-Sjögren's-syndrome-related antigen A (anti-SSA\u002FRo) antibodies at screening.\n6. Stable treatment regimen that can be continued until the end of study treatment (Week 48).\n7. Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception correctly during the study treatment period and for 1 month (28 days) after the last dose.\n8. Male participants with a WOCBP partner must agree to use protocol-specified contraceptive methods during the study treatment period and for 3 days after the last dose.\n\nExclusion Criteria\n\n1. SjS secondary to other systemic autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, or systemic sclerosis).\n2. Other autoimmune or inflammatory diseases that could interfere with the assessment of treatment response in SjS.\n3. Presence of any other medical condition associated with SjS symptoms.\n4. Participants with a history of any clinically significant disease other than pSjS.\n5. Significant ECG abnormalities at screening requiring treatment.\n6. Participants with gastrointestinal diseases or gastrointestinal surgery present within 3 months prior to the screening visit that could affect the absorption of the study drug.\n7. Current or past history of bleeding disorders or diseases related to platelet dysfunction.\n8. Severe infection (bacterial, fungal, or viral) requiring hospitalization within 60 days prior to screening.\n9. Participants with any uncontrolled clinically significant laboratory abnormality that, in the opinion of the investigator, could affect the interpretation of study data or the participant's participation in the study.\n10. Participants considered by the investigator to be unsuitable for participation in this study for any reason.","70 Years",{"count":85,"type":21},240,[24],"This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of ICP-488 in participants with primary Sjögren's syndrome (pSjS).",[27],"2026-07-23",{"date":91,"type":36},"2026-07-27",{"date":93,"type":21},"2026-08",{"date":95,"type":21},"2029-03",{"name":97,"class":43},"Beijing InnoCare Pharma Tech Co., Ltd.",22,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":109,"conditions":110,"keywords":111,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":127},"100286048","autoreactive-anti-rossa-ige-to-determine-primary-sjgrens-syndromes-disease-activity-100286048","NCT03003572","Autoreactive Anti-Ro\u002FSSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity","I GET DRY","Inclusion Criteria:\n\n* Primary Sjögren's syndrome according to the American-European Consensus Criteria)\n* Informed and having signed the study consent form\n\nExclusion Criteria:\n\n* Secondary Sjögren's syndrome\n* Other systemic autoimmune disease (e.g. rheumatoid arthritis, AntiNeutrophil Antibodies (ANCA) -associated vasculitis, mixed connective tissue disease…)\n* Incapacity or refusal to sign the informed consent form\n* Incapacity or refusal to perform the follow-up examinations required by the study\n* Has received abatacept, sifalimumab, rontalizumab, anifrolumab, belimumab, Tumor Necrosis Factor (TNF) antagonists or interferon during the 6 months prior to the inclusion\n* Has any current signs or symptoms of active infection",{"count":107,"type":21},185,"OBSERVATIONAL","Primary Sjögren's syndrome (pSS) can affect various organs, sometimes leads to life-threatening conditions and is always responsible for a decreased quality of life. Its evolution is chronic, with flares and relapses, and the need for reliable biomarkers to be carried out routinely is major in patients' follow-up. Because of the existence of autoreactive immunoglobulins E (IgE) in autoimmune diseases, the recently described role for anti-Ro\u002FSSA antibodies in inducing interferon alpha (IFNα) signaling and the specific pharmacologic properties of IgE, anti-Ro\u002FSSA IgE should be an interesting biomarker to determine pSS's activity. The aim of the study is to evaluate whether the proportion of anti-Ro\u002FSSA IgE positive patients is higher in patients with active disease (i.e. Eular Sjögren Syndrome Disease Activity Index≥ 5). All consecutive patients with pSS (new or already known diagnosis) will be included, Anti-Ro\u002FSSA IgE titers will be determined, the disease's features will be collected (including Eular Sjögren Syndrome Disease Activity Index\u002FEular Sjogren's Syndrome Patient Reported Index).",[27],[112,113,114,115,116],"Sjögren's syndrome","Immunoglobulin E","Anti-Ro\u002FSSA","Autoimmune disease","Biomarker","2026-05-05",{"date":119,"type":36},"2026-05-06",{"date":121,"type":36},"2018-03-27",{"date":123,"type":21},"2027-06",{"name":125,"class":126},"Centre Hospitalier Universitaire de Saint Etienne","OTHER",8,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":83,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":139,"conditions":140,"keywords":141,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":75},"100437812","phase-4-the-efficacy-and-safety-of-iguratimod-igu-in-the-treatment-of-primary-sjgrens-syndrome-100437812","NCT04981145","The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome","The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome: a Multi-center, Prospective, Open Study","Inclusion Criteria:\n\n* Diagnosed with pSS by meeting the 2016 ACR\u002FEULAR Classification Criteria.\n* The patient complained of dry mouth and eyes.\n* Positive anti-SSA\u002FRo-60 antibody at screening.\n* IgG≥16 g\u002FL.\n* No hormone, immunosuppressant, biological agents or other treatments were received within 4 weeks before screening;\n* Pregnancy test of is negative. Use effective contraceptives during the trial (female)\n* Those who did not participate in any drug trial within 12 weeks before enrollment\n\nExclusion Criteria:\n\n* Pregnant or lactating or planning to get pregnant during the duration of the study.\n* Complicated with other CTD\n* Complicated with malignancy\n* mental illness, a history of alcohol abuse, immunodeficiency, uncontrolled infections, and drug or other substance abuse\n* serious systemic damage, glucocorticoids, other immunosuppressants and biological agents should be added to control the condition: Heart, liver (transaminase\u002Fbilirubin \\>1.5 times the upper normal limit), kidney (Cr≥133mmol\u002FL), lung (FVC % \\\u003C 60%), blood (white blood cell \\\u003C3×109\u002FL, HGB\\\u003C80g\u002FL, PLT\\\u003C80×109\u002FL), etc.\n* Fundus\u002Fvisual field lesions;\n* Allergic to any component of the study drug (IGU and\u002For HCQ);\n* the investigator considers the patient to be unsuitable for entry into the study",{"count":136,"type":21},78,[138],"PHASE4","A multi-center, prospective, open-label, randomized controlled study of efficacy and safety of Iguratimod in patients with Primary Sjögren's syndrome",[27],[142,112,143],"Primary Sjögren's syndrome","Iguratimod","2024-10-11",{"date":146,"type":36},"2024-10-16",{"date":148,"type":36},"2022-01-14",{"date":150,"type":21},"2025-07",{"name":152,"class":126},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":161,"targetDuration":163,"studyType":108,"phases":4,"briefSummary":164,"conditions":165,"keywords":166,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":75},"100288887","the-assess-national-multi-center-prospective-cohort-100288887","NCT03040583","The ASSESS National Multi-center Prospective Cohort","Assessment of Systemic Complications (Signs) and Evolution From Patients With Sjögren's Syndrome (ASSESS)","ASSESS","Inclusion Criteria:\n\n* aged of 18 years or more\n* Primary Sjögren's Syndrome Patients who have already participated to the study ASSESS\n\nExclusion Criteria:\n\n* secondary Sjögren's Syndrome (SJ) associated with other autoimmune diseases",{"count":162,"type":21},395,"20 Years","The ASSESS national multi-center prospective cohort (Assessment of Systemic complications (Signs) and Evolution in Sjögren's Syndrome \"SS\") was set up in 2006 thanks to a grant of the French Ministry of Health. Fifteen centers for autoimmune diseases consecutively included consecutive patients with Primary Sjögren's Syndrome \"pSS\" fulfilling American-European Consensus Criteria (AECG) between 2006 and 2009. The study was approved by the Ethics Committee of Bichat Hospital in 2006. All patients gave their informed written consent. This study was followed for 5 years with the grant of the French Ministry of Health and this study will be extended for 20 years by French Society of Rheumatology (SFR). On an annual basis for a duration of 20 years, a thorough standardized paper case report form (CRF) was filled prospectively by clinicians.",[27],[167,168],"Primary Sjögren's syndrome (PSS)","auto-immune diseases","2020-03-12",{"date":171,"type":36},"2020-03-13",{"date":173,"type":4},"2016-09",{"date":175,"type":21},"2030-09",{"name":177,"class":126},"Assistance Publique - Hôpitaux de Paris"]