[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635556":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":11,"studyPopulation":11,"armGroups":63,"interventions":81,"overallOfficials":11,"centralContacts":90,"locations":96,"responsibleParty":118,"collaborators":11,"id":120,"slug":11,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":11,"eligibilityCriteria":125,"healthyVolunteers":126,"sex":127,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":11,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":11,"overallStatus":99,"whyStopped":11,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Innovent Biologics (Suzhou) Co. Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":11},[9,13,15,18],{"measure":10,"description":11,"timeFrame":12},"Part 1: Number of participants with at least one treatment-emergent adverse event",null,"up to 24 weeks",{"measure":14,"description":11,"timeFrame":12},"Part 1: Number of participants with at least one Serious treatment-emergent adverse event",{"measure":16,"description":11,"timeFrame":17},"Part 2: Number of participants with at least one treatment-emergent adverse event","up to 48 weeks",{"measure":19,"description":11,"timeFrame":17},"Part 2: Number of participants with at least one Serious treatment-emergent adverse event",[21,23,25,27,29,31,33,35,38,40,42,44,46,48,50,52],{"measure":22,"description":11,"timeFrame":12},"Part 1: Cmax following a single dose of IBI3013.",{"measure":24,"description":11,"timeFrame":12},"Part 1: Tmax following a single dose of IBI3013.",{"measure":26,"description":11,"timeFrame":12},"Part 1: AUC following a single dose of IBI3013.",{"measure":28,"description":11,"timeFrame":12},"Part 1: Cmin following a single dose of IBI3013.",{"measure":30,"description":11,"timeFrame":12},"Part 1: CL\u002FF or CL following a single dose of IBI3013.",{"measure":32,"description":11,"timeFrame":12},"Part 1: Vd\u002FF or Vd following a single dose of IBI3013.",{"measure":34,"description":11,"timeFrame":12},"Part 1: T1\u002F2 following a single dose of IBI3013.",{"measure":36,"description":11,"timeFrame":37},"Part 1: Positive rate of anti-drug antibody following a single dose of IBI3013.","up to Day85",{"measure":39,"description":11,"timeFrame":17},"Part 2: Cmax following multiple doses of IBI3013.",{"measure":41,"description":11,"timeFrame":17},"Part 2: Tmax following multiple doses of IBI3013.",{"measure":43,"description":11,"timeFrame":17},"Part 2: AUC following multiple doses of IBI3013.",{"measure":45,"description":11,"timeFrame":17},"Part 2: Cmin following multiple doses of IBI3013.",{"measure":47,"description":11,"timeFrame":17},"Part 2: CL\u002FF following multiple doses of IBI3013.",{"measure":49,"description":11,"timeFrame":17},"Part 2: Vd\u002FF following multiple doses of IBI3013.",{"measure":51,"description":11,"timeFrame":17},"Part 2: T1\u002F2 following multiple doses of IBI3013.",{"measure":53,"description":11,"timeFrame":54},"Part 2: Positive rate of anti-drug antibody following multiple doses of IBI3013.","up to 28 weeks",{"allocation":56,"interventionModel":57,"interventionModelDescription":11,"primaryPurpose":58,"observationalModel":11,"timePerspective":11,"maskingInfo":59},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":60,"maskingDescription":11,"whoMasked":61},"SINGLE",[62],"PARTICIPANT",[64,70,76],{"label":65,"type":66,"description":67,"interventionNames":68},"Baricitinib tablets","ACTIVE_COMPARATOR","oral, 2mg, once daily",[69],"Drug: Baricitinib tablets",{"label":71,"type":72,"description":73,"interventionNames":74},"placebo","PLACEBO_COMPARATOR","subcutaneous injection\u002Fintravenous infusion,single or multiple dosing",[75],"Drug: placebo",{"label":77,"type":78,"description":73,"interventionNames":79},"IBI3013","EXPERIMENTAL",[80],"Drug: IBI3013",[82,85,87],{"type":83,"name":71,"description":71,"armGroupLabels":84,"otherNames":11},"DRUG",[71],{"type":83,"name":65,"description":65,"armGroupLabels":86,"otherNames":11},[65],{"type":83,"name":77,"description":88,"armGroupLabels":89,"otherNames":11},"Recombinant anti-Interleukin-15 (IL-15) monoclonal antibody injection",[77],[91],{"name":92,"role":93,"phone":94,"phoneExt":11,"email":95},"juan chen","CONTACT","021 3183 7200","juan.chen01@innoventbio.com",[97],{"facility":98,"status":99,"city":100,"state":101,"zip":11,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":109,"contacts":110},"Huashan Hospital, Fudan University","RECRUITING","Shanghai","Shanghai Municipality","China","CN",{"type":105,"coordinates":106},"Point",[107,108],121.45806,31.22222,{"lat":108,"lon":107},[111,115],{"name":112,"role":93,"phone":113,"phoneExt":11,"email":114},"Jing Zhang","021-54602070","Zhangj_fudan@163.com",{"name":116,"role":93,"phone":113,"phoneExt":11,"email":117},"Wenyu Wu","wwylcsy@163.com",{"type":119,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100635556",false,"NCT07554222","Study to Evaluate the Safety, Tolerability and How IBI3013 is Taken up and Processed by the Body in Healthy Volunteers After Single-dose Administration, and in Non-segmental Vitiligo Patients and Alopecia Areata Patients After Multiple-dose Administration","Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single-dose Administration of IBI3013 in Healthy Adult Trial Participants and Multiple-dose Administration in Active Non-segmental Vitiligo Trial Participants and Severe Alopecia Areata Trial Participants - a Randomized, Double-blind, Placebo-controlled, Dose-escalation Study","Inclusion criteria\n\n1. Part 1 - Healthy trial participants: Understand and voluntarily sign the informed consent form;\n2. Part 1 - Healthy trial participants: Age between 18-45 years (inclusive), male or female;\n3. Part 1 - Healthy trial participants: Weight between 50-120 kg (inclusive), and BMI between 17.0-28.0 kg\u002Fm2 (inclusive);\n4. Part 2 - Active non-segmental vitiligo trial participants: 18-65 years old (inclusive), male;\n5. Part 2 - Active non-segmental vitiligo trial participants: Diagnosed with non-segmental vitiligo for ≥3 months and \\\u003C2 years;\n6. Part 2 - Active non-segmental vitiligo trial participants: Total affected BSA 3-50%, and facial affected BSA ≥ 0.5%; T-VASI 3-50 (inclusive), and F-VASI ≥0.5; ≥1 active lesion;\n7. Part 2 - : Male participants of reproductive potential agree to use highly effective contraception and avoid sperm donation for 6 months after the last dose.\n8. Part 2 - Severe alopecia areata trial participants: 18-60 years old (inclusive), male;\n9. Part 2 - Severe alopecia areata trial participants: Meet the following severe alopecia areata criteria: a) SALT ≥50% (i.e., AA-IGA 3-4 grade) b) No spontaneous remission in the past 6 months (spontaneous remission defined as SALT reduction by ?10 points) c) Current duration of severe alopecia areata ≥6 months and \\\u003C4 years;\n10. All participants: Participants of reproductive potential agree to use highly effective contraception and avoid sperm or egg donation for 6 months after the last dose.\n\nExclusion criteria\n\n1. All participants: Those who are allergic to any component of IBI3013;\n2. All participants: Those who cannot tolerate subcutaneous injection;\n3. All participants: History of live or attenuated live vaccine within 30 days prior to randomization, or expected to receive such vaccines during the study period until 3 months after the last dose of the investigational drug;\n4. All participants: Donated blood or lost ≥400 mL of blood within 3 months before screening;\n5. All participants: History of herpes zoster or disseminated herpes simplex (single episode), or recurrent (more than one episode) localized herpes zoster;\n6. All participants: Known history of active tuberculosis or clinical manifestations suggestive of tuberculosis, or positive interferon-gamma release assay unsuitable for participation;\n7. All participants: Abnormal vital signs, serum virology tests, laboratory tests, ECG, or other examinations with clinical significance, and deemed unsuitable for the study by the investigator;\n8. All participants: Received specific treatment within the time frame specified in the protocol, or participated in other investigational drug studies within the specified time;\n9. All participants: History of drug abuse, drug dependence, or positive drug screening results during the screening period within 12 months;\n10. All participants: Pregnant or lactating women;\n11. All participants: Coexisting diseases at screening or previously, deemed unsuitable for clinical trials;\n12. Active non-segmental vitiligo\u002FSevere alopecia areata trial participants: Previous or coexisting diseases, which may affect the efficacy or safety evaluation of the study as assessed by the investigator;\n13. Active non-segmental vitiligo trial participants: Coexisting segmental, undetermined type, or mixed-type vitiligo, or other skin pigmentation disorders, or other skin-related abnormalities that may affect the assessment of the study;\n14. Severe alopecia areata trial participants: Currently diagnosed with primary diffuse AA or ophiasis AA; or other types of hair loss that may interfere with AA evaluation;\n15. Severe alopecia areata trial participants: Previously received oral JAK inhibitors with poor response; 16. Severe alopecia areata trial participants: Acute myocardial infarction, unstable ischemic heart disease, stroke, chronic heart failure (NYHA class III\u002FIV) within 12 weeks prior to screening; or previous history of deep vein thrombosis, or high risk of deep vein thrombosis as assessed by the investigator; or severe neuropsychiatric disorder, deemed unsuitable for the study by the investigator.",true,"ALL","18 Years","80 Years",{"count":131,"type":132},160,"ESTIMATED","INTERVENTIONAL",[135],"PHASE1","A multicenter clinical study to evaluate the safety, PK characteristics, immunogenicity characteristics, and PD characteristics of IBI3013 in healthy trial participants and active non-segmental vitiligo trial participants and severe alopecia areata trial participants. The study is divided into 2 parts, with Part 1 involving healthy trial participants lasting up to 24 weeks, and Part 2 involving active non-segmental vitiligo trial participants and severe alopecia areata trial participants lasting up to 48 weeks.",[138,139,140],"Healthy","Active Non-segmental Vitiligo","Severe Alopecia Areata","2026-04-23",{"date":143,"type":144},"2026-04-28","ACTUAL",{"date":146,"type":144},"2026-04-18",{"date":148,"type":132},"2028-12-31",{"name":5,"class":6},1]