A Study to Assess Safety, Tolerability and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants With Fibrodysplasia Ossificans Progressiva (FOP)
← catalyst calendarSponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
63actual
Sites
22
Countries
Australia, Brazil, Chile +15
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-11-21 | actual | When the study began enrolling |
| Primary completion | 2025-07-17 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-02-27 | estimated | The whole study's end, after follow-up |
| First posted | 2022-05-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Fibrodysplasia Ossificans Progressiva
Interventions
- Drug: Garetosmab — also filed as REGN2477
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFNumber of new HO lesions
measured At Week 56
Incidence and severity of treatment-emergent adverse events of special interest (AESIs)
measured Baseline to Week 56
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