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

December 10, 2025 updated by: Regeneron Pharmaceuticals

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

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.

Study Overview

Status

Temporarily not available

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Key Inclusion Criteria:

  1. Adult patients with FOP who must have completed the double-blind treatment period of the parent study OPTIMA (R2477-FOP-2175 [NCT05394116]), as defined in the protocol
  2. If the patient has progression of disease with Cumulative Analogue Joint Involvement Scale (CAJIS) >19 at the time of EAP enrollment, the case will require discussion and evaluation between the treating physician and EAP Medical Director to determine final eligibility

Key Exclusion Criteria:

1. Patients participating in OPTIMA who are considered by the treating physician as inappropriate for this program for any reason

NOTE: Other protocol defined inclusion / exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Estimated)

December 24, 2025

Study Record Updates

Last Update Posted (Estimated)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R2477-FOP-2081

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

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CROs by country

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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