A Proof-of-Concept Study of IBI3002 in Patients With Moderate to Severe Atopic Dermatitis

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT07399067
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • IBI3002 — DRUG
    IBI3002 will be administered subcutaneously at the assigned dose level and dosing interval.
  • Placebo — DRUG
    Matched placebo will be administered subcutaneously at the same schedule as IBI3002.
  • Dupilumab — DRUG
    Dupilumab 300mg Q2w, with a loading dose of 600mg, will be administered subcutaneously.

Study Details

The primary objective of this Phase 2 study is to evaluate the efficacy and safety of IBI3002 in patients with moderate to severe Atopic Dermatitis (AD).

Key Dates

Start date
Feb 6, 2026
Status verified
Feb 2026
Primary completion
Mar 23, 2027
Completion
May 27, 2027

Study Design

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

Arms

  • Experimental: IBI3002 Dose Level 2 with Dosing Interval 2
    Participants will receive IIBI3002 Dose Level 2subcutaneously according to the study schedule.
  • Placebo Comparator: Placebo
    Matched placebo will be administered subcutaneously according to the study schedule.
  • Experimental: IBI3002 Dose Level 3 with Dosing Interval 2
    Participants will receive IBI3002 Dose Level 3 subcutaneously according to the study schedule.
  • Experimental: IBI3002 Dose Level 1 with Dosing Interval 1
    Participants will receive IBI3002 Dose Level 1subcutaneously according to the study schedule.
  • Experimental: IBI3002 Dose Level 1 with Dosing Interval 2
    Participants will receive IBI3002 Dose Level 1 subcutaneously according to the study schedule.
  • Active Comparator: Dupilumab
    Participants will receive dupilumab 300mg Q2w subcutaneously, with a loading dose of 600mg.

Primary Outcome Measure

Percentage change from baseline in the Eczema Area and Severity Index (EASI) score at Week 16 [ Time Frame: Week 16 ]

Central Contacts

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