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

N/ATemporarily Not AvailableNCT07301450

Regeneron Pharmaceuticals

Overview

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.

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

Study Type

EXPANDED_ACCESS

Conditions

Fibrodysplasia Ossificans Progressiva (FOP)

Interventions

GaretosmabDRUG

Administration as described in the protocol

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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