TEMPORARILY_NOT_AVAILABLENot Applicable

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

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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
✓. 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

Trial details

NCT IDNCT07301450

SponsorRegeneron Pharmaceuticals

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

View on ClinicalTrials.gov More Fibrodysplasia Ossificans Progressiva (FOP) trials