A Study to Document and to Further Describe Long-term Safety and Effectiveness of Palovarotene in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
← catalyst calendarNCT06089616 · readout in 3,395 d
Sponsored by Ipsen (industry) · IPN.PA — their whole pipeline →.
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
100estimated
Sites
5
Countries
Canada, United States
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 | 2024-12-05 | actual | When the study began enrolling |
| Primary completion | 2035-12-05 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2035-12-05 | estimated | The whole study's end, after follow-up |
| First posted | 2023-10-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-02 | 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
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants With Treatment-emergent Adverse Events (TEAEs), whether or not they are considered as related to palovarotene
measured From Baseline up to 30 days after the last palovarotene dose.
Percentage of Participants With Serious and Non-serious treatment-related TEAEs
measured From Baseline up to 30 days after the last palovarotene dose.
Percentage of Participants With all serious TEAEs, whether or not they are considered as related to the palovarotene
measured From Baseline up to 30 days after the last palovarotene dose.
Percentage of Participants With nonserious TEAEs whether or not they are considered as related to the palovarotene.
measured From Baseline up to 30 days after the last palovarotene dose.
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