The Examination of Safety and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants With Fibrodysplasia Ossificans Progressiva (FOP)

• Status: Not yet recruiting
• Trial end date: 2026-03-08

Summary

The study population consists of patients with Fibrodysplasia ossificans progressiva (FOP).

Key primary objectives are:

1. To assess the effect of high dose garetosmab versus placebo on the formation of new heterotopic ossification (HO) lesions from baseline to week 56, as determined by low-dose computed tomography (CT)

2. To assess the safety and tolerability of garetosmab versus placebo from baseline to week 56

Key Secondary Objectives:

1. To assess the effect of high dose garetosmab versus placebo on the number per participant of clinician-assessed flare-up episodes to week 56

2. To assess the effect of low dose garetosmab versus placebo on the formation of new HO lesions from baseline to week 56 as determined by CT

3. To assess the effect of low dose garetosmab versus placebo on the number per patient of clinician-assessed flare-up episodes to week 56

• Phase: Phase 3

Details

• Lead Sponsor: Regeneron Pharmaceuticals