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A Phase III Study of GS101 Injection to Dupixent®

RecruitingPhase 3Ages 18 Years - 75 YearsAllJiangsu Genscend Biopharmaceutical Co., Ltd
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In plain words

What the trial is, and whether it could suit you

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®

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • GS101 injection
  • DUPIXENT®
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Where

1 site
The First Hospital of China Medical University
Shenyang, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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