NCT07386743
Not yet recruiting
Phase 3
A Multicenter, Randomized, Double-blinded, Parallel, Positive-controlled, Phase III Comparative Study to Evaluate GS101 Injection Versus Dupixent® in Participants With Moderate-to-Severe Atopic Dermatitis
Jiangsu Genscend Biopharmaceutical Co., Ltd1 site in 1 country572 target enrollmentStarted: February 1, 2026Last updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Jiangsu Genscend Biopharmaceutical Co., Ltd
- Enrollment
- 572
- Locations
- 1
- Primary Endpoint
- Proportion of patients achieving EASI-75 at week 16
Overview
Brief Summary
This is a a multicenter, randomized, double-blinded, parallel, positive-controlled, Phase III comparative study to evaluate GS101 Injection versus Dupixent® in participants with moderate-to-severe atopic dermatitis. A total of 572 subjects are planned to be included and randomized at a ratio of 1:1 to receive GS101 injection or Dupixent®
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects, male or female, between the ages of 18 and 75 years (inclusive)
- •At the time of screening, the diagnosis of atopic dermatitis (AD) meets the Hanifin-Rajka criteria, with a disease history for at least 1 year prior to screening
- •During the screening period and at baseline, patients with moderate-to-severe atopic dermatitis, defined as meeting all of the following 3 criteria concurrently: a. IGA score ≥ 3; b. EASI score ≥ 16; c. BSA ≥ 10%.
Exclusion Criteria
- •Hypersensitivity or known allergy to the investigational product(s) or any of their excipients
- •Treatment with any investigational drug, medical device, or other biologic agent within 8 weeks prior to randomization or within 5 half-lives (if the half-life is known), whichever is longer
- •Receipt of any live or live-attenuated vaccine within 3 months prior to randomization, or planned receipt of such vaccines during the study period
Arms & Interventions
GS101 injection
Experimental
Intervention: GS101 injection (Drug)
Dupixent®
Active Comparator
Intervention: DUPIXENT® (Drug)
Outcomes
Primary Outcomes
Proportion of patients achieving EASI-75 at week 16
Time Frame: 16 weeks
EASI-75
Secondary Outcomes
- Proportion of patients achieving EASI-75(Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52)
- Proportion of patients achieving EASI-50(Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52)
- Proportion of patients achieving EASI-90(Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, and 52)
Investigators
Study Sites (1)
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