Clinical Trial

A Study to Investigate the Safety, Pharmacokinetics (PK), and Efficacy of Garetosmab in Children and Adolescents With Fibrodysplasia Ossificans Progressiva (FOP)

Study acronym: OPTIMA-2
Not Yet Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This study is researching an experimental drug called garetosmab, referred to as "study drug". The study is focused on children and adolescent participants with FOP. The aim of the study is to see how safe, tolerable, and effective the study drug is. The study is looking at several other research questions, including: * What side effects may happen from taking 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 study drug less effective or could lead to side effects)
Trial Details
NCT Number NCT07559513
Lead Sponsor Regeneron Pharmaceuticals
Conditions Fibrodysplasia Ossificans Progressiva (FOP)
Enrollment 18 participants
Start Date 2026-07-30
Primary Completion 2028-12-10 (estimated)
Study Completion 2029-12-21 (estimated)
Updated on ClinicalTrials.gov 2026-04-30