NCT05394116

A Study to Assess Safety, Tolerability and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants With Fibrodysplasia Ossificans Progressiva (FOP)

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is researching an experimental drug called garetosmab. The study is focused on adult patients with fibrodysplasia ossificans progressiva (FOP). The aim of the study is to see how safe and effective the study drug is in patients with FOP. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Conditions

• Fibrodysplasia Ossificans Progressiva

Interventions

Type	Name	Description
DRUG	Garetosmab	Garetosmab is supplied as a liquid drug product and will be administered IV.
DRUG	Placebo	Placebo to match garetosmab, is supplied as a liquid solution without the monoclonal antibody (or the protein) and is administered IV.

Timeline

• Start date: 2022-11-21
• Primary completion: 2025-07-17
• Completion: 2029-02-27
• First posted: 2022-05-27
• Last updated: 2026-01-16

Locations

22 sites across 18 countries: United States, Australia, Brazil, Chile, China, Colombia, Finland, France, Hong Kong, Italy, Japan, Malaysia, Netherlands, Poland, South Africa, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study