[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"active-non-segmental-vitiligo\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:active-non-segmental-vitiligo":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"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":21,"type":22},160,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30],"Healthy","Active Non-segmental Vitiligo","Severe Alopecia Areata","RECRUITING","2026-04-23",{"date":34,"type":35},"2026-04-28","ACTUAL",{"date":37,"type":35},"2026-04-18",{"date":39,"type":22},"2028-12-31",{"name":41,"class":42},"Innovent Biologics (Suzhou) Co. Ltd.","INDUSTRY"]