[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658167":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":33,"armGroups":45,"interventions":56,"overallOfficials":66,"centralContacts":71,"locations":77,"responsibleParty":97,"collaborators":33,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":102,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":33,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":123,"whyStopped":33,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in MMTT-stimulated C-peptide AUC at Week 52","Change from baseline in C-peptide area under the curve (AUC) during a mixed-meal tolerance test (MMTT) after 52 weeks of treatment.","From Baseline to Week 52",[14,18,21,24,27,30],{"measure":15,"description":16,"timeFrame":17},"Change from baseline in MMTT-stimulated C-peptide AUC at Week 26","Change from baseline in C-peptide area under the curve (AUC) during a mixed-meal tolerance test (MMTT) after 26 weeks of treatment.","From Baseline to Week 26",{"measure":19,"description":20,"timeFrame":12},"Change from baseline in HbA1c at Week 52","Change from baseline in glycated hemoglobin (HbA1c) after 52 weeks of treatment.",{"measure":22,"description":23,"timeFrame":12},"Change from baseline in daily insulin dose at Week 52","Change from baseline in daily insulin dose after 52 weeks of treatment",{"measure":25,"description":26,"timeFrame":12},"Change from baseline in TIR assessed by CGM at Week 52","Change from baseline in time-in-range (TIR) assessed by continuous glucose monitoring (CGM) after 52 weeks of treatment.",{"measure":28,"description":29,"timeFrame":12},"Cumulative severe hypoglycemic events from baseline to Week 52","Total number of severe hypoglycemic events that occurred during 52 weeks of treatment.",{"measure":31,"description":32,"timeFrame":12},"Change from baseline in lymphocyte subpopulation quantified by flow cytometry at week 52","Peripheral Blood Mononuclear Cell (PBMC) will be isolated and lymphocyte subpopulation will be quantified at baseline and Week 52",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":39,"maskingDescription":33,"whoMasked":40},"QUADRUPLE",[41,42,43,44],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[46,51],{"label":47,"type":48,"description":33,"interventionNames":49},"Ivarmacitinib 8 mg group","EXPERIMENTAL",[50],"Drug: Ivarmacitinib",{"label":52,"type":53,"description":33,"interventionNames":54},"Placebo control group","PLACEBO_COMPARATOR",[55],"Drug: Placebo",[57,62],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":33},"DRUG","Ivarmacitinib","Oral tablet, administered at a fixed dose of 8mg once daily for 52 weeks.",[47],{"type":58,"name":63,"description":64,"armGroupLabels":65,"otherNames":33},"Placebo","Oral tablet matching active Ivarmacitinib in appearance and scheduling, without active ingredients, taken once daily for 52 weeks.",[52],[67],{"name":68,"affiliation":69,"role":70},"Huijie Zhang","Fudan University","PRINCIPAL_INVESTIGATOR",[72],{"name":73,"role":74,"phone":75,"phoneExt":33,"email":76},"jingjing jiang, PhD","CONTACT","13402003919","jiang.jingjing@zs-hospital.sh.cn",[78],{"facility":79,"status":33,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"Zhongshan Hospital, Fudan University","Shanghai","Shanghai Municipality","200032","China","CN",{"type":86,"coordinates":87},"Point",[88,89],121.45806,31.22222,{"lat":89,"lon":88},[92,95],{"name":93,"role":74,"phone":94,"phoneExt":33,"email":76},"jingjing jiang, phD","86-021-64041990",{"name":96,"role":70,"phone":33,"phoneExt":33,"email":33},"Huijie Zhang, phD",{"type":98,"investigatorFullName":68,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"SPONSOR_INVESTIGATOR","Chief Physician","100658167","phase-2-jak1-inhibitor-ivarmacitinib-for-improving-pancreatic-islet-function-in-t1d-100658167",false,"NCT07845955","JAK1 Inhibitor Ivarmacitinib for Improving Pancreatic Islet Function in T1D","INhibiting JAK1 to Save Pancreatic Islet Function in Recently Established T1D(INSPIRE-T1D)","INSPIRE-T1D","Inclusion Criteria:\n\n1. Confirmed diagnosis of type 1 diabetes mellitus.\n2. Able to complete randomization and initiate treatment with the study drug within 100 days of being formally diagnosed with type 1 diabetes.\n3. Peak stimulated C-peptide level ≥ 0.2 pmol\u002FmL during the mixed-meal tolerance test performed in the screening period.\n4. Tested positive for at least one type 1 diabetes-associated autoantibody.\n\nExclusion Criteria:\n\n1. Presence of any autoimmune disease other than type 1 diabetes mellitus, except for stable autoimmune thyroid disease.\n2. Presence of active infection and\u002For fever.\n3. Known current or prior infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), or serological evidence of such infection at screening.\n4. Active pulmonary tuberculosis, malignancy, etc.\n5. Severe hepatic impairment (AST or ALT \\>3 × upper limit of normal), or severe renal impairment or end-stage renal disease (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²).\n6. Prior exposure to immunomodulatory agents, including baricitinib, ivarmacitinib, IL-1 receptor antagonists, tocilizumab (anti-IL-6 monoclonal antibody), infliximab (anti-TNF-α monoclonal antibody), interferons, etc.\n7. Severe cardiovascular disease such as angina pectoris, myocardial infarction, or stroke within the previous 6 months.\n8. Severe gastrointestinal disease.\n9. Surgical procedure performed within the past 6 months.\n10. Medical, psychological, or social conditions that, in the opinion of the investigator, may interfere with trial safety or proper completion.","ALL","10 Years","40 Years",{"count":112,"type":113},132,"ESTIMATED","INTERVENTIONAL",[116],"PHASE2","This is a double-blind, randomized, placebo-parallel-controlled, multicenter study. The objective is to evaluate the efficacy and safety of Ivarmacitinib 8 mg administered for 52 weeks in preserving pancreatic β cell function in subjects with newly-onset type 1 diabetes mellitus. The study consists of a screening period (V1, up to 2 weeks), a 52-week double-blind treatment period (V2 to V14), and a 4-week safety follow-up period (V15).",[119],"T1DM - Type 1 Diabetes Mellitus",[121,122,59],"Type 1 Diabetes Mellitus","JAK1 Inhibitor","NOT_YET_RECRUITING","2026-09-27",{"date":126,"type":127},"2026-09-29","ACTUAL",{"date":129,"type":113},"2026-09-30",{"date":131,"type":113},"2029-12-31",{"name":68,"class":6},1]