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

NCT07554222 | Recruiting Phase 1

• 1 other identifier: CIBI3013A101
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Active Non-segmental Vitiligo; Severe Alopecia Areata

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (16)

• 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

Study Arms (3)

Baricitinib tablets

ACTIVE COMPARATOR

oral, 2mg, once daily

Drug: Baricitinib tablets

placebo

PLACEBO COMPARATOR

subcutaneous injection/intravenous infusion,single or multiple dosing

Drug: placebo

IBI3013

EXPERIMENTAL

subcutaneous injection/intravenous infusion,single or multiple dosing

Drug: IBI3013

Interventions

placebo DRUG

placebo

placebo

Baricitinib tablets DRUG

Baricitinib tablets

Baricitinib tablets

IBI3013 DRUG

Recombinant anti-Interleukin-15 (IL-15) monoclonal antibody injection

IBI3013

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• All participants: Those who are allergic to any component of IBI3013;
• All participants: Those who cannot tolerate subcutaneous injection;
• 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;
• All participants: Donated blood or lost ≥400 mL of blood within 3 months before screening;
• All participants: History of herpes zoster or disseminated herpes simplex (single episode), or recurrent (more than one episode) localized herpes zoster;
• All participants: Known history of active tuberculosis or clinical manifestations suggestive of tuberculosis, or positive interferon-gamma release assay unsuitable for participation;
• 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;
• All participants: Received specific treatment within the time frame specified in the protocol, or participated in other investigational drug studies within the specified time;
• All participants: History of drug abuse, drug dependence, or positive drug screening results during the screening period within 12 months;
• All participants: Pregnant or lactating women;
• All participants: Coexisting diseases at screening or previously, deemed unsuitable for clinical trials;
• 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;
• 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;
• 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;
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Alopecia Areata

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

juan chen

CONTACT

021 3183 7200; juan.chen01@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 28, 2026
• Study Start: April 18, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

CN (1)