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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Active Non-segmental Vitiligo; Severe Alopecia Areata
• Intervention / Treatment: Drug: placebo; Drug: Baricitinib tablets; Drug: IBI3013

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: juan chen; Phone Number: 021 3183 7200; Email: juan.chen01@innoventbio.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Recruiting
      • Huashan Hospital, Fudan University
      • Contact: Jing Zhang; Phone Number: 021-54602070; Email: Zhangj_fudan@163.com
      • Contact: Wenyu Wu; Phone Number: 021-54602070; Email: wwylcsy@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria

1. Part 1 - Healthy trial participants: Understand and voluntarily sign the informed consent form;
2. Part 1 - Healthy trial participants: Age between 18-45 years (inclusive), male or female;
3. Part 1 - Healthy trial participants: Weight between 50-120 kg (inclusive), and BMI between 17.0-28.0 kg/m2 (inclusive);
4. Part 2 - Active non-segmental vitiligo trial participants: 18-65 years old (inclusive), male;
5. Part 2 - Active non-segmental vitiligo trial participants: Diagnosed with non-segmental vitiligo for ≥3 months and <2 years;
6. 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;
7. Part 2 - : Male participants of reproductive potential agree to use highly effective contraception and avoid sperm donation for 6 months after the last dose.
8. Part 2 - Severe alopecia areata trial participants: 18-60 years old (inclusive), male;
9. 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 <4 years;
10. 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.

Exclusion criteria

1. All participants: Those who are allergic to any component of IBI3013;
2. All participants: Those who cannot tolerate subcutaneous injection;
3. 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;
4. All participants: Donated blood or lost ≥400 mL of blood within 3 months before screening;
5. All participants: History of herpes zoster or disseminated herpes simplex (single episode), or recurrent (more than one episode) localized herpes zoster;
6. All participants: Known history of active tuberculosis or clinical manifestations suggestive of tuberculosis, or positive interferon-gamma release assay unsuitable for participation;
7. 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;
8. All participants: Received specific treatment within the time frame specified in the protocol, or participated in other investigational drug studies within the specified time;
9. All participants: History of drug abuse, drug dependence, or positive drug screening results during the screening period within 12 months;
10. All participants: Pregnant or lactating women;
11. All participants: Coexisting diseases at screening or previously, deemed unsuitable for clinical trials;
12. Active non-segmental vitiligo/Severe alopecia areata trial participants: Previous or coexisting diseases, which may affect the efficacy or safety evaluation of the study as assessed by the investigator;
13. 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;
14. 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;
15. 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/IV) 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Baricitinib tablets; oral, 2mg, once daily	Drug: Baricitinib tablets; Baricitinib tablets
Placebo Comparator: placebo; subcutaneous injection/intravenous infusion,single or multiple dosing	Drug: placebo; placebo
Experimental: IBI3013; subcutaneous injection/intravenous infusion,single or multiple dosing	Drug: IBI3013; Recombinant anti-Interleukin-15 (IL-15) monoclonal antibody injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part 1: Number of participants with at least one treatment-emergent adverse event	up to 24 weeks
Part 1: Number of participants with at least one Serious treatment-emergent adverse event	up to 24 weeks
Part 2: Number of participants with at least one treatment-emergent adverse event	up to 48 weeks
Part 2: Number of participants with at least one Serious treatment-emergent adverse event	up to 48 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Part 1: Cmax following a single dose of IBI3013.	up to 24 weeks
Part 1: Tmax following a single dose of IBI3013.	up to 24 weeks
Part 1: AUC following a single dose of IBI3013.	up to 24 weeks
Part 1: Cmin following a single dose of IBI3013.	up to 24 weeks
Part 1: CL/F or CL following a single dose of IBI3013.	up to 24 weeks
Part 1: Vd/F or Vd following a single dose of IBI3013.	up to 24 weeks
Part 1: T1/2 following a single dose of IBI3013.	up to 24 weeks
Part 1: Positive rate of anti-drug antibody following a single dose of IBI3013.	up to Day85
Part 2: Cmax following multiple doses of IBI3013.	up to 48 weeks
Part 2: Tmax following multiple doses of IBI3013.	up to 48 weeks
Part 2: AUC following multiple doses of IBI3013.	up to 48 weeks
Part 2: Cmin following multiple doses of IBI3013.	up to 48 weeks
Part 2: CL/F following multiple doses of IBI3013.	up to 48 weeks
Part 2: Vd/F following multiple doses of IBI3013.	up to 48 weeks
Part 2: T1/2 following multiple doses of IBI3013.	up to 48 weeks
Part 2: Positive rate of anti-drug antibody following multiple doses of IBI3013.	up to 28 weeks

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Alopecia; Hypotrichosis; Hair Diseases; Skin and Connective Tissue Diseases; Alopecia Areata; baricitinib
• Other Study ID Numbers: CIBI3013A101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No