A Study to Investigate the Safety, Pharmacokinetics (PK), and Efficacy of Garetosmab in Children and Adolescents With Fibrodysplasia Ossificans Progressiva (FOP)
← catalyst calendarNCT07559513 · readout in 844 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 3
Status
Not yet recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
18estimated
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-07-30 | estimated | When the study began enrolling |
| Primary completion | 2028-12-10 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-12-21 | estimated | The whole study's end, after follow-up |
| First posted | 2026-04-30 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Fibrodysplasia Ossificans Progressiva (FOP)
Intervention
- Drug: garetosmab — also filed as REGN2477
Primary outcomes
what the primary-completion date above is the date OFOccurrence of Treatment-Emergent Adverse Event (TEAEs)
measured Baseline to week 28
Occurrence of TEAEs
measured Baseline to week 56
Severity of TEAEs
measured Baseline to week 28
Severity of TEAEs
measured Baseline to week 56
Concentrations of functional garetosmab in serum
measured Through week 56
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