A Study to Evaluate Efficacy and Safety of IBI356 in Participants With Moderate to Severe Atopic Dermatitis

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT07330934
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    Dupilumab by subcutaneous injection
  • Placebo — DRUG
    Placebo by subcutaneous injection
  • IBI356 — DRUG
    IBI356 by subcutaneous injection

Study Details

This is a multi-center, randomized, double-blind, parallel, placebo-controlled phase 2 clinical study. A total of 403 adult participants with moderate to severe AD are planned to be enrolled to evaluate efficacy, safety, PK characteristics, immunogenicity, and changes in PD characteristics of IBI356.

Key Dates

Start date
Dec 31, 2025
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: IBI356 dose 4
    Participants receive IBI356 through W16
  • Experimental: IBI356 dose 2
    Participants receive IBI356 through W16
  • Experimental: Dupilumab
    Participants receive dupilumab through W16
  • Experimental: IBI356 dose 5
    Participants receive IBI356 through W16
  • Experimental: IBI356 dose 1
    Participants receive IBI356 through W16
  • Placebo Comparator: Placebo
    Participants receive placebo through W16
  • Experimental: IBI356 dose 3
    Participants receive IBI356 through W16

Primary Outcome Measure

Percent change from baseline in Eczema Area and Severity Index (EASI) score [ Time Frame: week 24 ]

Central Contacts

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