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

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT07554222
Phase
PHASE1
Status
Recruiting
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Conditions

  • Active Non-segmental Vitiligo
  • Healthy
  • Severe Alopecia Areata

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • placebo — DRUG
    placebo
  • Baricitinib tablets — DRUG
    Baricitinib tablets
  • IBI3013 — DRUG
    Recombinant anti-Interleukin-15 (IL-15) monoclonal antibody injection

Study Details

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.

Key Dates

Start date
Apr 18, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Baricitinib tablets
    oral, 2mg, once daily
  • Placebo Comparator: placebo
    subcutaneous injection/intravenous infusion,single or multiple dosing
  • Experimental: IBI3013
    subcutaneous injection/intravenous infusion,single or multiple dosing

Primary Outcome Measure

Part 1: Number of participants with at least one treatment-emergent adverse event [ Time Frame: up to 24 weeks ]

Central Contacts

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