Trials / Temporarily Not Available

Temporarily Not AvailableNCT07301450

An Expanded Access Program of Garetosmab in Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP)

An Expanded Access Program of Garetosmab in Patients With Fibrodysplasia Ossificans Progressiva

Status: Temporarily Not Available
Phase: —
Study type: Expanded Access
Enrollment: —

Sponsor: Regeneron Pharmaceuticals · Industry
Sex: All
Age: 18 Years
Healthy volunteers: —

Summary

The objective of this Expanded Access Program (EAP) is to provide garetosmab to patients with Fibrodysplasia Ossificans Progressiva (FOP) who have completed the double-blind treatment period of the parent study, OPTIMA (R2477-FOP-2175 \[NCT05394116\]), prior to marketing authorization approval, unless otherwise specified by country specific regulations for rare diseases.

Detailed description

The program will enroll approximately up to 55 patients, globally.

Conditions

Fibrodysplasia Ossificans Progressiva (FOP)

Interventions

Type	Name	Description
DRUG	Garetosmab	Administration as described in the protocol

Timeline

First posted: 2025-12-24
Last updated: 2025-12-24

Source: ClinicalTrials.gov record NCT07301450. Inclusion in this directory is not an endorsement.