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Phase 3 Randomized, Placebo-Controlled Study to Assess Safety, Tolerability, and Efficacy of Garetosmab in Patients With Fibrodysplasia Ossificans Progressiva

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Trial Profile

Phase 3 Randomized, Placebo-Controlled Study to Assess Safety, Tolerability, and Efficacy of Garetosmab in Patients With Fibrodysplasia Ossificans Progressiva

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 26 Mar 2025

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At a glance

  • Drugs Garetosmab (Primary)
  • Indications Fibrodysplasia ossificans progressiva
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms OPTIMA
  • Sponsors Regeneron Pharmaceuticals

    • Most Recent Events

    • 24 Mar 2025 Planned End Date changed from 25 Sep 2026 to 27 Feb 2029.
    • 24 Mar 2025 Planned primary completion date changed from 4 Aug 2025 to 31 Jul 2025.
    • 15 Nov 2024 Planned End Date changed from 2 Oct 2026 to 25 Sep 2026.

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