[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635556":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":29,"centralContacts":35,"locations":41,"responsibleParty":63,"collaborators":29,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":29,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":29,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":29,"overallStatus":44,"whyStopped":29,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Innovent Biologics (Suzhou) Co. Ltd.","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Baricitinib tablets","ACTIVE_COMPARATOR","oral, 2mg, once daily",[13],"Drug: Baricitinib tablets",{"label":15,"type":16,"description":17,"interventionNames":18},"placebo","PLACEBO_COMPARATOR","subcutaneous injection\u002Fintravenous infusion,single or multiple dosing",[19],"Drug: placebo",{"label":21,"type":22,"description":17,"interventionNames":23},"IBI3013","EXPERIMENTAL",[24],"Drug: IBI3013",[26,30,32],{"type":27,"name":15,"description":15,"armGroupLabels":28,"otherNames":29},"DRUG",[15],null,{"type":27,"name":9,"description":9,"armGroupLabels":31,"otherNames":29},[9],{"type":27,"name":21,"description":33,"armGroupLabels":34,"otherNames":29},"Recombinant anti-Interleukin-15 (IL-15) monoclonal antibody injection",[21],[36],{"name":37,"role":38,"phone":39,"phoneExt":29,"email":40},"juan chen","CONTACT","021 3183 7200","juan.chen01@innoventbio.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":29,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Huashan Hospital, Fudan University","RECRUITING","Shanghai","Shanghai Municipality","China","CN",{"type":50,"coordinates":51},"Point",[52,53],121.45806,31.22222,{"lat":53,"lon":52},[56,60],{"name":57,"role":38,"phone":58,"phoneExt":29,"email":59},"Jing Zhang","021-54602070","Zhangj_fudan@163.com",{"name":61,"role":38,"phone":58,"phoneExt":29,"email":62},"Wenyu Wu","wwylcsy@163.com",{"type":64,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100635556","phase-1-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-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":77,"type":78},160,"ESTIMATED","INTERVENTIONAL",[81],"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.",[84,85,86],"Healthy","Active Non-segmental Vitiligo","Severe Alopecia Areata","2026-04-23",{"date":89,"type":90},"2026-04-28","ACTUAL",{"date":92,"type":90},"2026-04-18",{"date":94,"type":78},"2028-12-31",{"name":5,"class":6},1]