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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 with moderate-to-severe atopic dermatitis. It compares GS101 injection with Dupixent®.
- Age
- 18 to 75 years (inclusive)
- Sex
- Men and women
- Disease stage
- Atopic dermatitis meeting the Hanifin-Rajka criteria, present for at least 1 year, and moderate-to-severe: IGA score ≥ 3, EASI score ≥ 16 and BSA ≥ 10%.
- Earlier treatment
- No investigational drug, medical device or other biologic agent within 8 weeks before randomization or within 5 half-lives (if known), whichever is longer. No live or live-attenuated vaccine within 3 months before randomization.
Main reasons for not taking part
- Known allergy to the study drugs or any of their excipients
- Investigational drug, device or biologic within 8 weeks before randomization (or 5 half-lives, whichever is longer)
- Live or live-attenuated vaccine within 3 months before randomization
- Planned live or live-attenuated vaccine during the study
Read by machine on 9 November 2026.
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, ChinaContact: Xinghua Gao, M.D.Taking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.