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A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (AD) Who Are on Background Topical Corticosteroids and Have Had an Inadequate Response to Prior Biologic Therapy or Oral Janus Kinase (JAK) Inhibitor Treatment

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Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (AD) Who Are on Background Topical Corticosteroids and Have Had an Inadequate Response to Prior Biologic Therapy or Oral Janus Kinase (JAK) Inhibitor Treatment

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 24 May 2025

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At a glance

  • Drugs Amlitelimab (Primary) ; Corticosteroids; Pimecrolimus; Tacrolimus
  • Indications Atopic dermatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms AQUA
  • Sponsors Sanofi

Most Recent Events

  • 19 Sep 2024 Planned primary completion date changed from 20 Mar 2026 to 10 Mar 2026.
  • 15 Mar 2024 Status changed from not yet recruiting to recruiting.
  • 09 Feb 2024 New trial record

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