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

> **NCT05394116** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Regeneron Pharmaceuticals** · enrollment: 63 (actual)

## Conditions studied

- Fibrodysplasia Ossificans Progressiva

## Interventions

- **DRUG:** Garetosmab
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT05394116
- **Lead sponsor:** Regeneron Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2022-11-21
- **Primary completion:** 2025-07-17
- **Final completion:** 2029-02-27
- **Target enrollment:** 63 (ACTUAL)
- **Last updated:** 2026-01-16


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05394116

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05394116, "A Study to Assess Safety, Tolerability and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants With Fibrodysplasia Ossificans Progressiva (FOP)". Retrieved via AI Analytics 2026-07-09 from https://api.ai-analytics.org/clinical/NCT05394116. Licensed CC0.

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