[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643042":3},{"organization":4,"outcomesModule":7,"designInfo":13,"detailedDescription":19,"studyPopulation":11,"armGroups":20,"interventions":26,"overallOfficials":11,"centralContacts":32,"locations":38,"responsibleParty":57,"collaborators":11,"id":59,"slug":11,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":11,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":11,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":11,"overallStatus":77,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Keymed Biosciences Co.Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Treatment-Emergent Adverse Events",null,"Throughout study (Up to 52 weeks)",{"allocation":14,"interventionModel":15,"interventionModelDescription":11,"primaryPurpose":16,"observationalModel":11,"timePerspective":11,"maskingInfo":17},"NA","SINGLE_GROUP","TREATMENT",{"masking":18,"maskingDescription":11,"whoMasked":11},"NONE","An open-label, multicenter, multiple ascending dose study evaluating safety, tolerability,PK\u002FADA profile and efficacy of CM336 administered subcutaneously in active primary Sjogren's Syndrome.",[21],{"label":22,"type":23,"description":11,"interventionNames":24},"CM336 dose escalation","EXPERIMENTAL",[25],"Biological: CM336",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"BIOLOGICAL","CM336","Participants will receive CM336 via subcutaneous injection in ascending dose cohorts",[22],[33],{"name":34,"role":35,"phone":36,"phoneExt":11,"email":37},"Qian Jia","CONTACT","86+028-88610620","clinicaltrial@keymedbio.com",[39],{"facility":40,"status":11,"city":41,"state":42,"zip":11,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Peking Union Medical College Hospital","Beijing","Beijing Municipality","China","CN",{"type":46,"coordinates":47},"Point",[48,49],116.39723,39.9075,{"lat":49,"lon":48},[52,54],{"name":53,"role":35,"phone":36,"phoneExt":11,"email":37},"Xiaofeng Zeng",{"name":55,"role":56,"phone":11,"phoneExt":11,"email":11},"Xiaofeng Zeng, Chief physician","PRINCIPAL_INVESTIGATOR",{"type":58,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":69,"type":70},30,"ESTIMATED","INTERVENTIONAL",[73],"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.",[76],"Primary Sjögren's Syndrome (pSS)","NOT_YET_RECRUITING","2026-06-10",{"date":80,"type":81},"2026-06-12","ACTUAL",{"date":83,"type":70},"2026-06",{"date":85,"type":70},"2029-02",{"name":5,"class":6},1]