GS101 injection: 300mg/2.0mL; an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W);subcutaneous injection
DUPIXENT®: 300mg/2.0mL; an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W); subcutaneous injection
Study 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®
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
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
Primary outcome measure(s)
Proportion of patients achieving EASI-75 at week 16 — 16 weeks EASI-75
Trial sites (1)
Facility
City
Region
Status
The First Hospital of China Medical University
Shenyang
Liaoning
More Jiangsu Genscend Biopharmaceutical Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.