A Study to Assess Safety, Tolerability and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants With Fibrodysplasia Ossificans Progressiva (FOP)
Active, not recruiting · Phase 3 · NCT05394116
Conditions: Fibrodysplasia Ossificans Progressiva
At a glance
- Research payments reported, 2025
- $320,030
- U.S. investigators named
- 2
- Sites paid
- 2
- Planned or actual enrollment
- 63
About the trial
- Sponsor
- Regeneron Pharmaceuticals
- Tested
- Garetosmab (drug), Placebo (drug)
- Dates
- Started 2022-11-21; completion 2029-02-27
- Results posted
- Not yet
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)
From ClinicalTrials.gov, last updated 2026-07-17. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Regeneron Pharmaceuticals, Inc. reported $320,030 in research payments for this study in 2025 (66 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Deborah Krakow, MD Medical Genetics · Santa Monica, CA
- Kathryn Dahir, MD Endocrinology & Diabetes · Nashville, TN
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.