A Study to Assess Safety, Tolerability and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants With Fibrodysplasia Ossificans Progressiva (FOP)
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Fibrodysplasia Ossificans Progressiva
In brief
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)
Key facts
- Study ID
- NCT05394116
- Run by
- Regeneron Pharmaceuticals
- People needed
- 63
- Starts
- 2022-11-21
- Expected to finish
- 2029-02-27
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of California Los Angeles (UCLA) Medical Center — Los Angeles, California, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- Royal North Shore Hospital — St Leonards, New South Wales, Australia
- Hospital Israelita Albert Einstein — São Paulo, Brazil
- Universidad de Concepcion — Concepción, Biobio, Chile
- Tongji Hospital of Tongji University — Shanghai, China
- Clinica Universidad de La Sabana — Chía, Cundinamarca, Colombia
- HUS Children and Adolescents Park Hospital Clinical Trial Unit — Helsinki, Stenbäckinkatu 11, Finland
- Hôpital Lapeyronie — Montpellier, France
- Hopital Lariboisiere — Paris, France
- Queen Mary Hospital — Hong Kong, Hong Kong
- IRCCS Istituto Giannina Gaslini — Genoa, Italy
- Nagoya University Hospital — Nagoya, Aichi-ken, Japan
- Oita University Hospital — Yufu, Oita Prefecture, Japan
- Kyushu University Hospital — Fukuoka, Japan
- Hospital Kuala Lampur — Kuala Lumpur, Malaysia
- Amsterdam University Medical Center — Amsterdam, North Holland, Netherlands
- Szpital Centrum Medyczne Medyk — Rzeszów, Podkarpackie Voivodeship, Poland
- University of Cape Town — Rondebosch, Cape Town, South Africa
- Seoul National University Hospital — Seoul, South Korea
- Hospital Universitario Ramon y Cajal — Madrid, Spain
- Royal National Orthropaedic Hospital NHS Trust — Middlesex, Greater London, United Kingdom
Full record on ClinicalTrials.gov
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