Fibrodysplasia Ossificans Progressiva (FOP)
Conditions
Brief 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.
Interventions
DRUGGaretosmab
Administration as described in the protocol
Sponsors
Regeneron Pharmaceuticals
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
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 /
Outcome results
None listed