drugset / Trial / NCT07559513

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

NCT07559513 ↗

Phase 3 Not yet recruiting 18 enrolled Regeneron Pharmaceuticals
Non-randomizedSingle-groupOpen-labelTreatment

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. For United States: Ages 4 to less than 18 years; for non-US sites only: Ages 2 to less than 18 years. 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)

Timeline

Start
2027-02-02
Primary completion
2030-07-08
Completion
2030-07-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Garetosmab Monoclonal antibody — —