Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT07301450
Status:
TEMPORARILY_NOT_AVAILABLE
Last Update Posted:
2025-12-24
First Post:
2025-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Expanded Access Program of Garetosmab in Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP)
Sponsor:
Regeneron Pharmaceuticals
Organization:
Study Overview
Official Title:
An Expanded Access Program of Garetosmab in Patients With Fibrodysplasia Ossificans Progressiva
Status:
TEMPORARILY_NOT_AVAILABLE
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: