A Study to Evaluate the Equivalence of IBI3027 and Dupilumab Injection in Participants With Moderate to Severe Atopic Dermatitis

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT07754786
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Dupilumab Injection — DRUG
    The participants in Dupilumab injection treatment group will be treated with IBI3027. On Day 1, a loading dose of 600 mg will be administered, followed by a Q2W schedule, with 300 mg each time, until Week 44
  • IBI3027 — DRUG
    The participants in IBI3027 treatment group will be treated with IBI3027. On Day 1, a loading dose of 600 mg will be administered, followed by a Q2W schedule, with 300 mg each time, until Week 44

Study Details

This study is expected to include approximately 520 patients with moderate to severe AD, and they will be randomly assigned to the treatment group (IBI3027) and the control group (Dupilumab Injection ) in a 1:1 ratio. Study period: It includes a screening period (4 weeks), a treatment period (44 weeks), and a follow-up period (8 weeks). After screening is completed, participants will be randomly grouped in a 1:1 ratio. On Day 1 (D1), they will receive a loading dose of either IBI3027 or Dupilumab Injection 600 mg by subcutaneous injection (SC), followed by 300 mg each time, SC administration, once every 2 weeks (Q2W), until the last administration on W44. After the treatment is completed, a 8-week safety follow-up will be conducted.

Key Dates

First listed
Aug 10, 2026
Start date
Oct 20, 2026
Status verified
Aug 2026
Primary completion
Jul 1, 2028
Completion
Aug 26, 2028

Study Design

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

Arms

  • Active Comparator: Dupilumab Injection treatment group
    This group of subjects will be treated with Dupilumab injection. On Day 1, a loading dose of 600 mg will be administered, followed by 300 mg every two weeks until Week 44.
  • Experimental: IBI3027 treatment group
    This group of subjects will be treated with IBI3027. On Day 1, a loading dose of 600 mg will be administered, followed by a Q2W schedule, with 300 mg each time, until Week 44.

Primary Outcome Measure

The proportion of participants who achieved EASI-75 [ Time Frame: Week 16 ]

Central Contacts

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