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Study identifier: NCT05394116 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Active Not Recruiting

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

Condition: Fibrodysplasia Ossificans Progressiva  ·  Sponsor: Regeneron Pharmaceuticals

PhasePhase 3
Planned participants63
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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)

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Locations (22)

University of California Los Angeles (UCLA) Medical CenterLos Angeles, California, United States
Vanderbilt University Medical CenterNashville, Tennessee, United States
Royal North Shore HospitalSt Leonards, New South Wales, Australia
Hospital Israelita Albert EinsteinSão Paulo, Brazil
Universidad de ConcepcionConcepción, Biobio, Chile
Tongji Hospital of Tongji UniversityShanghai, China
Clinica Universidad de La SabanaChía, Cundinamarca, Colombia
HUS Children and Adolescents Park Hospital Clinical Trial UnitHelsinki, Stenbäckinkatu 11, Finland
Hôpital LapeyronieMontpellier, France
Hopital LariboisiereParis, France
Queen Mary HospitalHong Kong, Hong Kong
IRCCS Istituto Giannina GasliniGenoa, Italy

+ 10 more locations — full list on the registry record.

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