Safety and body handling of IBI3013 after single and multiple doses in healthy adults and men with active non-segmental vitiligo or severe alopecia areata

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

This trial tests whether IBI3013 is safe and how the body processes it in healthy adults and in men with active non-segmental vitiligo or severe alopecia areata.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07554222 on ClinicalTrials.gov

What this trial studies

This multicenter, Phase 1 study has two parts: Part 1 gives single doses to healthy adult volunteers and follows them for up to 24 weeks, while Part 2 gives multiple doses to male participants with active non-segmental vitiligo or severe alopecia areata and follows them for up to 48 weeks. The trial compares IBI3013 to placebo and includes baricitinib tablets as a reference in some arms. Key measurements include safety, pharmacokinetics (how the drug is taken up and cleared), immunogenicity (antibody responses to the drug), and pharmacodynamics (biologic activity). Participants attend regular clinic visits for dosing, blood sampling, and clinical skin or hair assessments at the study site.

Who should consider this trial

Good fit: Ideal candidates are adults who meet the age and health criteria: healthy volunteers aged 18–45 for the single-dose part or men aged 18–65 (vitiligo) or 18–60 (alopecia areata) with active disease meeting the specified severity and duration for the multiple-dose part.

Not a fit: People who are female, outside the specified age, weight, BMI, or disease-duration/severity ranges, or who have contraindications to the study drugs may not be eligible or likely to benefit from this protocol.

Why it matters

Potential benefit: If successful, IBI3013 could become a new treatment option that improves skin repigmentation in vitiligo and hair regrowth in severe alopecia areata.

How similar studies have performed: Related approaches using JAK inhibitors such as baricitinib have shown benefit in alopecia areata and some vitiligo studies, so this program builds on existing clinical evidence.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: juan chen

Conditions Healthy; Active Non-segmental Vitiligo; Severe Alopecia Areata