MedTrace Logo

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

NCT05394116 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2026-01-16

No results posted yet for this study

Summary

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)

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-21
Primary Completion
2025-07-17
Completion
2029-02-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Chile
  • China
  • Colombia
  • Finland
  • France
  • Hong Kong
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • Poland
  • South Africa
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05394116 on ClinicalTrials.gov