GS101 Injection Compared With Dupixent in Moderate-to-Severe Atopic Dermatitis
Compares GS101 injection with Dupixent in adults with moderate-to-severe atopic dermatitis.
Plain-language title generated from the registry record
Registry title: A Phase III Study of GS101 Injection to Dupixent®
Key facts
- Where
- Shenyang, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07386743, who can take part
Where in China
- The First Hospital of China Medical UniversityShenyang, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jiangsu Genscend Biopharmaceutical Co., Ltd
- Trial code
- NCT07386743
- Record updated
- 15 October 2026
- Original description
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®Read full original descriptionShow less
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
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®
Inclusion: 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: 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.