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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: 07 Nov 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

  • 17 Sep 2025 According to Regeneron Pharmaceuticals, Inc. media release, Based on these data and the safety profile, the Independent Data Monitoring Committee (IDMC) recommended those receiving placebo be transitioned to garetosmab as soon as possible; U.S. regulatory submission of garetosmab in adults planned for year-end 2025.with global regulatory submissions slated for 2026. These data are also planned for future presentation and publication.
  • 17 Sep 2025 Results presented at Regeneron Pharmaceuticals media release.
  • 17 Sep 2025 Primary endpoint (Number of new HO lesions adjudicated as positive based on computed tomography (CT)) has been met, as per Regeneron media release.

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