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A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD)

Trial Profile

A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Mar 2025

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At a glance

  • Drugs Rocatinlimab (Primary)
  • Indications Atopic dermatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms ROCKET-IGNITE
  • Sponsors Amgen

Most Recent Events

  • 08 Mar 2025 According to an Amgen media release, results from this trial will be presented at upcoming congresses or published in peer-reviewed journals.
  • 08 Mar 2025 Primary endpoint has been met. (Achievement of 75% reduction from baseline in Eczema Area and Severity Index (EASI) score at Week 24), according to an Amgen media release.
  • 08 Mar 2025 Primary endpoint has been met. (Achievement of a Validated Investigators Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with 2 point reduction from baseline at Week 24), according to an Amgen media release.

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