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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

November 21, 2022

Primary Completion Date

July 17, 2025

Study Completion Date

February 27, 2029

Conditions
Fibrodysplasia Ossificans Progressiva
Interventions
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.

Trial Locations (22)

2065

Royal North Shore Hospital, St Leonards

7700

University of Cape Town, Rondebosch

16147

IRCCS Istituto Giannina Gaslini, Genoa

28034

Hospital Universitario Ramon y Cajal, Madrid

34090

Hôpital Lapeyronie, Montpellier

37232

Vanderbilt University Medical Center, Nashville

50586

Hospital Kuala Lampur, Kuala Lumpur

75010

Hopital Lariboisiere, Paris

90095

University of California Los Angeles (UCLA) Medical Center, Los Angeles

140013

Clinica Universidad de La Sabana, Chía

200065

Tongji Hospital of Tongji University, Shanghai

4030000

Universidad de Concepcion, Concepción

22553838

Queen Mary Hospital, Hong Kong

05652-900

Hospital Israelita Albert Einstein, São Paulo

00029

HUS Children and Adolescents Park Hospital Clinical Trial Unit, Helsinki

466-8560

Nagoya University Hospital, Nagoya

879-5593

Oita University Hospital, Yufu

812-8582

Kyushu University Hospital, Fukuoka

1081 HV

Amsterdam University Medical Center, Amsterdam

35-326

Szpital Centrum Medyczne Medyk, Rzeszów

03080

Seoul National University Hospital, Seoul

HA7 4LP

Royal National Orthropaedic Hospital NHS Trust, Middlesex

All Listed Sponsors
lead

Regeneron Pharmaceuticals

INDUSTRY