A Phase III Study of GS101 Injection to Dupixent®

StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Recruitment opened
    • Start date changed from estimate of Feb 2026 to Jan 29, 2026
    • Eligibility criteria expanded, about 6 words
    • Site details revised
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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®
Trial Details
NCT Number NCT07386743
Lead Sponsor Jiangsu Genscend Biopharmaceutical Co., Ltd
Conditions
(from sponsor)		 Atopic Dermatitis (AD)
Related terms Dermatitis, Atopic
Enrollment 572 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov