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

Fibrodysplasia Ossificans Progressiva Clinical Trial

Official title:
Phase 3 Randomized, Placebo-Controlled Study to Assess Safety, Tolerability, and Efficacy of Garetosmab in Patients With Fibrodysplasia Ossificans Progressiva

Clinical Trial 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 your 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)

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Fibrodysplasia Ossificans Progressiva
Clinical Trial Details
NCT number NCT05394116
Study type Interventional
Source Regeneron Pharmaceuticals
Contact Clinical Trials Administrator
Phone 844-734-6643
Email clinicaltrials@regeneron.com
Status Recruiting
Phase Phase 3
Start date November 21, 2022
Completion date June 12, 2026
View Details
See also
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Completed NCT02979769 - An Open-Label Extension Study of Palovarotene to Prevent Heterotopic Ossification in People With Fibrodysplasia Ossificans Progressiva (FOP) in France Phase 2
Completed NCT02066324 - Urine Sample Collection From FOP Patients N/A
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Completed NCT04665323 - An International Cross-sectional Survey to Evaluate the Burden of Fibrodysplasia Ossificans Progressiva (FOP) on Patients and Their Families.
Completed NCT03188666 - A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva Phase 2
Terminated NCT02521792 - In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) Subjects Phase 2
Completed NCT02322255 - A Natural History Study of Fibrodysplasia Ossificans Progressiva (FOP)
Recruiting NCT05039515 - A Study to Assess the Effectiveness and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP). Phase 2
Recruiting NCT04307953 - Saracatinib Trial TO Prevent FOP Phase 2
Not yet recruiting NCT06089616 - A Study to Document and to Further Describe Long-term Safety and Effectiveness of Palovarotene in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
Completed NCT04818398 - Study of Single-Ascending Doses of DS-6016a in Healthy Japanese Subjects Phase 1