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 adult patients with Fibrodysplasia Ossificans Progressiva (FOP), including patients who have completed the double-blind treatment period of the parent study, OPTIMA (R2477-FOP-2175 [NCT05394116]), prior to marketing authorization approval. 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
- Are there results?
- None posted in the registry
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 male and female patients with FOP, including patients who have completed the double-blind treatment period of the OPTIMA study (R2477-FOP-2175 [NCT05394116]).
- 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. Participants who participated in OPTIMA and 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 adult patients with Fibrodysplasia Ossificans Progressiva (FOP), including patients who have completed the double-blind treatment period of the parent study, OPTIMA (R2477-FOP-2175 [NCT05394116]), prior to marketing authorization approval.
Read the detailed description
The program will enroll approximately up to 50 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, PASATRU™, garetosmab-grts
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
- Oct 2026
- First submitted
- 11 Feb 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded Access Program of Garetosmab in Patients With Fibrodysplasia Ossificans Progressiva
- ClinicalTrials.gov ID
- NCT07301450
- Acronym / sponsor ID
- R2477-FOP-2081
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this Expanded Access Program (EAP) is to provide garetosmab to adult patients with Fibrodysplasia Ossificans Progressiva (FOP), including patients who have completed the double-blind treatment period of the parent study, OPTIMA (R2477-FOP-2175 [NCT05394116]), prior to marketing authorization approval.
Detailed description
The program will enroll approximately up to 50 patients, globally.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult male and female patients with FOP, including patients who have completed the double-blind treatment period of the OPTIMA study (R2477-FOP-2175 [NCT05394116]).
- 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 (2 listed)
- 1. Participants who participated in OPTIMA and are considered by the treating physician as inappropriate for this program for any reason
- NOTE: Other protocol defined inclusion / exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GaretosmabAlso: REGN2477, PASATRU™, garetosmab-grtsAdministration as described in the protocol | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Garetosmab in people with Fibrodysplasia Ossificans Progressiva (FOP), run by Regeneron Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.