[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-sjgrens-syndrome-pss\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-sjgrens-syndrome-pss":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,64,86,115],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100643042","phase-1-cm336-for-active-sjogrens-syndrome-study-100643042",false,"NCT07642843","CM336 for Active Sjogren's Syndrome Study","Evaluation of CM336 Injection for Active Sjogren's Syndrome: an Open-Label Phase Ib Study","Inclusion Criteria:\n\n* Male or female, aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF), and willing to comply with the study protocol requirements.\n* Body weight ≥ 45 kg at screening.\n* Voluntary compliance with the protocol requirements for permitted\u002Fprohibited concomitant therapies.\n* Definitive diagnosis of primary Sjögren's disease (SjD) according to the 2016 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria, and meeting all of the following requirements:\n\n  1. Seropositive for at least one SjD-related autoantibody.\n  2. Prior treatment with at least two systemic therapies for SjD symptoms.\n  3. Active disease at screening, defined as Clinical EULAR Sjögren's Syndrome Disease Activity Index(ClinESSDAI) ≥ 5.\n* No better therapeutic alternative available for the study participant.\n\nExclusion Criteria:\n\n* Presence of other systemic autoimmune diseases besides primary Sjögren's disease.\n* Presence of other autoimmune or inflammatory diseases.\n* Presence of any other medical condition with clinical manifestations overlapping with primary Sjögren's disease or that may interfere with result interpretation.\n* Presence of active, life-threatening, or organ-threatening SjD complications at screening.\n* History of severe allergic reactions (as judged by the investigator), or history of hypersensitivity to monoclonal antibodies or any component of CM336.\n* Presence of congenital immunodeficiency, or acquired immunodeficiency not related to the participant's autoimmune disease or its medical treatment.\n* Positive HIV antibody, positive Treponema pallidum antibody, or history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n* History of tuberculosis infection.\n* Active infection requiring intravenous anti-infective treatment within 3 months before first dose of study drug, or oral anti-infective treatment within 2 weeks before first dose of study drug.\n* History of disseminated herpes zoster, or ocular\u002FCentral Nervous System herpes zoster, or systemic herpes simplex or symptomatic herpes zoster infection within 3 months before first dose of study drug.\n* Deep vein thrombosis or pulmonary embolism within 6 months before first dose of study drug.\n* History of severe cardiovascular or cerebrovascular disease, including but not limited to:\n\n  1. Unstable arrhythmia, unstable angina pectoris.\n  2. New York Heart Association (NYHA) functional class III or IV.\n  3. Uncontrolled hypertension (average systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg on two measurements despite optimal treatment).\n  4. Fridericia-corrected QT interval(QTcF) \\>450 ms for males or \\>470 ms for females\n* History of pulmonary arterial hypertension with WHO functional class II or above.\n* Presence of uncontrolled asthma or chronic obstructive pulmonary disease (COPD); uncontrolled diabetes mellitus; uncontrolled thyroid or other endocrine disorders; uncontrolled psychiatric disorders.\n* Presence of any of the following during screening:\n\n  1. Neutrophil count \\\u003C1×10⁹\u002FL, platelet count \\\u003C100×10⁹\u002FL, or hemoglobin \\\u003C80 g\u002FL (applicable only to patients without hematologic involvement).\n  2. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>2× upper limit of normal (ULN).\n  3. estimated Glomerular Filtration Rate(eGFR) \\\u003C40 mL\u002Fmin\u002F1.73m² (2021 Chronic Kidney Disease Epidemiology Collaboration formula).\n  4. Prothrombin time (PT) or activated partial thromboplastin time (APTT) \\>1.5×Upper Limit of Normal.\n* Major surgery within 3 months before screening or planned during the study period (requiring hospitalization and general anesthesia, excluding diagnostic procedures).\n* History of malignancy within 5 years before first dose of study drug (except cured basal cell carcinoma, squamous cell carcinoma of the skin, and cervical carcinoma in situ without evidence of recurrence).\n* Prior treatment with any anti-B-cell maturation antigen targeted therapy (including cell therapy or antibody therapy, etc.).\n* Receipt of prohibited medications within the corresponding timeframes.","ALL","18 Years","75 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CM336 in adult participants with active primary Sjogren's Syndrome.",[27],"Primary Sjögren's Syndrome (pSS)","NOT_YET_RECRUITING","2026-06-10",{"date":31,"type":32},"2026-06-12","ACTUAL",{"date":34,"type":21},"2026-06",{"date":36,"type":21},"2029-02",{"name":38,"class":39},"Keymed Biosciences Co.Ltd","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":40},"100604095","a-study-of-yiqi-yangyin-formula-in-the-treatment-of-primary-sjogrens-syndrome-100604095","NCT07145060","A Study of Yiqi Yangyin Formula in the Treatment of Primary Sjogren's Syndrome","A Randomized Controlled Study of Yiqi Yangyin Formula in the Treatment of Primary Sjogren's Syndrome","Inclusion Criteria:\n\n* Patients aged18-75 years old (including the critical value), gender not limited;\n* Patients meeting the classification criteria of primary Sjogren's syndrome in ACR\u002FEULAR 2016;\n* Patients with dry mouth VAS ≥4 and ESSDAI score \\\u003C 5;\n* Patients with positive autoantibodies (ANA or anti-SSA antibodies or anti-SSB antibodies or RF) and\u002For hyperimmunoglobulinemia or increased erythrocyte sedimentation rate;\n* Patients meeting the syndrome of qi and Yin deficiency in traditional Chinese medicine;\n* The subjects were informed and voluntarily signed the informed consent form.\n\nExclusion Criteria:\n\n* Patients with a history of hypersensitivity or intolerance to any investigational therapeutic drug;\n* Patients diagnosed with secondary Sjogren's syndrome or combined with other connective tissue diseases;\n* Patients with severe lesions in the heart, brain, lungs, liver, kidneys, hematopoietic system, etc., as well as those with malignant tumors or infectious diseases;\n* Patients who are pregnant, preparing for pregnancy or breastfeeding;\n* Patients who have used cholinergic drugs or artificial tears\u002Fsaliva in last 1 week;\n* Patients who have used hydroxychloroquine, total glycosides of Paeonia lactide, Iguratimod, cyclophosphamide, cyclosporine A, tacrolimus, and azathioprine in last 1 month;\n* Patients who have used glucocorticoids, methotrexate or mycophenolate mofetil in last 3 months;\n* Patients who have used Leflunomide in last 6 months;\n* Patients who have used rituximab in last 6 months, or have used other biological agents (such as tofacitinib) other than rituximab in last 3 months;\n* Patients who have participated in or are currently receiving any other experimental drugs or experimental medical devices within the past three months;\n* Other situations that researchers consider ineligible for inclusion (such as cognitive impairment, taking psychotropic drugs).",{"count":49,"type":21},105,[51],"NA","This project aims to conduct a prospective, randomized, double-blind, controlled clinical study to clarify the efficacy and safety of the YiQi YangYin Formula in treating patients with primary Sjogren's syndrome (pSS) presenting with Qi and Yin deficiency syndrome, with the expectation of providing a scientific basis for the research and development of new traditional Chinese medicine drugs for the effective treatment of pSS.",[27],"2025-08-20",{"date":56,"type":32},"2025-08-28",{"date":58,"type":21},"2025-09-01",{"date":60,"type":21},"2028-03-31",{"name":62,"class":63},"China-Japan Friendship Hospital","OTHER",{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":40},"100582359","phase-2-therapeutic-effect-of-upadacitinib-in-primary-sjgrens-syndrome-100582359","NCT06862284","Therapeutic Effect of Upadacitinib in Primary Sjögren's Syndrome","Efficacy, Safety and Immunological Effect of Upadacitinib in the Treatment of Primary Sjögren's Syndrome","Inclusion Criteria:\n\n1. Male or female \\>18 years of age at screening visits\n2. Participants with diagnosis of pSS according to the 2016 ACR\u002FEULAR criteria\n3. Participants have an ESSDAI score ≥ 5\n4. Participants must be on a stable dose of prednisone (≤10mg\u002Fday), antimalarials or equivalent, and cholinergic stimulants prior to Baseline.\n5. Participants previously on other immunosuppressive drugs (methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, iguratimod) should have withdrawn drug for at least 8 weeks (56 days) at the time of screening\n6. If the subject has evidence of new latent tuberculosis (TB) infection, the subject must initiate and complete a minimum of 2 weeks (or per local guidelines, whichever is longer) of an ongoing TB prophylaxis before continuing to receive the study drug.\n7. If female, the subject must be postmenopausal, OR permanently surgically sterile, OR for women of childbearing potential practicing at least one protocol-specified method of birth control, that is effective from Study Day 1 through at least 30 days after the last dose of study drug.\n8. The patient must be informed in writing of the consent to participate in the trial and the patient is expected to be able to comply with the requirements of the study follow-up plan and other protocols.\n\nExclusion Criteria:\n\nAny subject meeting any of the following criteria should be excluded:\n\n1. Pregnant or breastfeeding female.\n2. Diagnosis of other autoimmune disease, or other sicca syndrome.\n3. Laboratory value abnormality:\n\n(1)Serum aspartate transaminase (AST) or alanine transaminase (ALT) \\> 3.0 × upper limit of normal (ULN); (2)Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula \\\u003C 40 mL\u002Fmin\u002F1.73m\\^2; (3)Total white blood cell count (WBC) \\\u003C 2,000\u002FμL; (4)Absolute neutrophil count (ANC) \\\u003C 1,000\u002FμL; (5)Platelet count \\\u003C 50,000\u002FμL; (6)Absolute lymphocytes count \\\u003C 500\u002FμL; (7)Hemoglobin \\\u003C 8 g\u002FdL.\n\n4\\. Ongoing infections at Week 0 that have not been successfully treated.\n\n5\\. Infection with HIV ( HIV antibody positive serological test ) or hepatitis C ( hepatitis C antibody positive serological test ). If the serum reaction is positive, it is recommended to consult a doctor with expertise in the treatment of HIV or hepatitis C virus infection.\n\n6\\. History of any known malignancy in the last 5 years (except non-melanoma skin cancer, non-melanoma skin cancer or cervical tumors that have not recurred within 3 months after surgical cure prior to screening).\n\n7\\. Underlying cardiac, pulmonary, metabolic, renal, hepatic, gastrointestinal, hematological or neurological conditions, chronic or latent infectious diseases, or immune deficiency which places the patient at an unacceptable risk for participation in the study.\n\n8\\. Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tocilizumab, sirukumab, sarilumab, upadacitinib, tofacitinib, baricitinib, ruxolitinib, peficitinib, and filgotinib).\n\n9\\. Exposure to biological DMARDs in two months before screening.\n\n10\\. Enrollment in another interventional clinical study while participating in this study.\n\n11\\. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive the study drug.","65 Years",{"count":20,"type":21},[74],"PHASE2","This study is designed to explore the efficacy and safety of upadacitinib and clarify the influence on immune function in the treatment of primary Sjögren's Syndrome.",[27],"2025-03-06",{"date":79,"type":32},"2025-03-11",{"date":81,"type":21},"2025-03-10",{"date":83,"type":21},"2027-08-31",{"name":85,"class":63},"Peking University People's Hospital",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":97,"conditions":98,"keywords":99,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100447942","phase-2-new-clinical-end-points-in-patients-with-primary-sjgrens-syndrome-100447942","NCT05113004","New Clinical End-points in Patients With Primary Sjögren's Syndrome","NEw Clinical Endpoints in Patients With Primary Sjögren's Syndrome (pSS): an Interventional Trial Based on stratifYing Patients","NECESSITY","Inclusion Criteria:\n\n* Cohort 1\n* Having given written informed consent prior to undertaking any study-related procedures.\n* Patients with pSS according to ACR\u002FEULAR 2016 criteria or AECG 2002 criteria\n* With a high level of symptoms (ESSPRI ≥ 5) and low systemic disease activity (ESSDAI \\\u003C 5).\n* Negative pregnancy test (serum at screening)\n* Use highly reliable contraception during research treatment from the screening and for two years after stopping treatment.\n* Cohort 2\n* Having given written informed consent prior to undertaking any study-related procedures.\n* Patients with pSS according to ACR\u002FEULAR 2016 criteria or AECG 2002 criteria\n* With moderate\u002Fhigh systemic disease activity, as defined by ESSDAI ≥ 5.\n* Negative pregnancy test (serum at screening)\n* Use highly reliable contraception during research treatment from the screening and for two years after stopping treatment\n\nExclusion Criteria:\n\n* For both cohorts:\n* Age \\\u003C 18 years\n* Pregnant or breastfeeding women or women wanted to conceive either during or within two years after the end of the treatment period\n* Women of childbearing potential not using highly effective methods of contraception (as defined in section 6.3)\n* Participation in another interventional trial\n* Contra-indication to HCQ: pre-existing retinopathy, hypersensitivity to HCQ or to any of the excipients of the specialty used\n* Contra-indication to MMF: hypersensitivity to mycophenolate mofetil, acid mycophenolic, mycophenolate sodium or to any of the excipients of the specialty used\n* Contra-indication tor LEF: hypersensitivity to the active substance, the main active metabolite teriflunomide or to any excipients of the specialty used.\n* Concomitant treatment with corticosteroids more than 10 mg\u002Fday of prednisone equivalent at screening or inclusion (randomisation)\n* Concomitant treatment with other immunomodulators including methotrexate, azathioprine, cyclophosphamide, cyclosporine and tacrolimus\n* Previous treatment with HCQ, LEF, MMF in the last 3 months\n* Previous treatment with rituximab, other B-cell targeted biologic therapy or cyclophosphamide in the last 6 months\n* Previous treatment with anti-TNF, abatacept, tocilizumab or belimumab or any other biologic in the setting of a past clinical trial in the last 3 months\n* Severe life-threatening systemic involvement requiring cyclophosphamide or high dose corticosteroids, or any drug considered as an exclusion criteria\n* Impairment of other severe immunodeficiency states\n* Patients with active malignancy or history of malignancy within the last 5 years except non-melanoma skin cancer\n* Patients with history of gastrointestinal tract ulceration, hemorrhage and perforation\n* Patients with history of cardiomyopathy\n* Patients with known hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome\n* Serious infection in the past month\n* Evidence of active tuberculosis infection\n* Active HCV (positive PCR)\n* Active HBV infection (positivity for HBS antigen, or positivity for anti-HBC antibody without any HBS antigen)\n* HIV infection (positive serology)\n* Positive SARS-Cov2 PCR (if vaccinated for COVID-19, no PCR is required; if history of COVID-19 infection, positive serology is sufficient)\n* Cytopenia defined as neutrophils \\\u003C 1.0 G\u002FL, lymphocytes \\\u003C 0.5 G\u002FL, Hb \\\u003C 10 g\u002Fdl or platelets \\\u003C 100 G\u002FL\n* Moderate to severe renal insufficiency (GFR \\\u003C 30 ml\u002Fmin)\n* Severe hypogammaglobulinemia defined as gamma globulins or IgG \\\u003C 5 g\u002Fl Reduced hepatic function: AST or ALT \\> 2x ULN (re-testing is allowed, see section 5.10)\n* Prolonged ECG's corrected QT interval (\\>500 ms)\n* Known history of maculopathy\n* Patients will be informed of the risk of alcohol consumption and will be recommended to avoid alcohol during the entire study\n* Not affiliated to a social security regime (specific for France)",{"count":95,"type":21},300,[74],"There are no approved treatments for pSS and the clinical endpoints currently used in clinical trials are inadequate to capture all aspects of the disease that should be evaluated in clinical trials. The newly developed composite endpoint: Sjögren's Tool for Assessing Response to treatment (STAR) will allow a more specific and meaningful assessment of treatment efficacy in pSS.\n\nBecause of the heterogeneity of the disease and of the central role of the interplay between B- and T-cells in the pathogenesis, it is worth to evaluate combination of conventional synthetic immunomodulatory drugs targeting both B- and T-cells.",[27],[100,101,102,103],"dry eye","Oral Dryness and Saliva Altered","Eular Sjögren Syndrome Disease Activity index","Primary Sjögrens's syndrome","RECRUITING","2024-10-31",{"date":107,"type":32},"2024-11-01",{"date":109,"type":32},"2022-01-20",{"date":111,"type":21},"2025-10-01",{"name":113,"class":63},"Assistance Publique - Hôpitaux de Paris",7,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":124,"phases":4,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":40},"100338093","diagnostic-suspicion-of-primitive-syndrome-sjgrens--brest-cohort-100338093","NCT03681964","Diagnostic Suspicion of Primitive Syndrome Sjögren's : Brest Cohort","DIApSS","Inclusion Criteria:\n\n* Patients with suspected pSS underwent a standardised evaluation\n\nExclusion Criteria:\n\n* Opposition of patient",{"count":123,"type":21},100,"OBSERVATIONAL","This study aims to evaluate the diagnosis performance of several item used for the classification, the diagnosis and the prognostic of pSS (primary Sjogren syndrome)",[27],"2018-09-21",{"date":129,"type":32},"2018-09-24",{"date":131,"type":32},"2015-09-28",{"date":133,"type":21},"2030-09-28",{"name":135,"class":63},"University Hospital, Brest"]