Fibrodysplasia Ossificans Progressiva (FOP)NCT07301450
An Expanded Access Program of Garetosmab in Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP)
A study testing Garetosmab in people with Fibrodysplasia Ossificans Progressiva (FOP), run by Regeneron Pharmaceuticals.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrodysplasia Ossificans Progressiva (FOP)
- What is being tested?
- Garetosmab
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the detailed description
The program will enroll approximately up to 55 patients, globally.
- Being tested
- Garetosmab
- Medical subject headings
- Myositis Ossificans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GaretosmabDrug
Also called REGN2477
Administration as described in the protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrodysplasia Ossificans Progressiva (FOP)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301450
- Sponsor's protocol ID
- R2477-FOP-2081
- Status last verified
- Dec 2025
- First submitted
- 11 Feb 2025
- Last updated
- 24 Dec 2025
- Results posted
- No