To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
Recruiting
Phase 2
Interventional Study
Fibrodysplasia Ossificans Progressiva (FOP)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 2 – 99
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 98 (estimated)
- Sponsor
- Incyte Corporation · Industry
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About This Trial
This Phase 2, Randomized, Double-Blind, Placebo-Controlled Study is intended to evaluate the Efficacy, Safety, and Tolerability and PK of INCB000928 administered to participants with a clinical diagnosis of fibrodysplasia ossificans progressiva (FOP).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Female and male participants:
* Cohort 1: ≥ 12 years of age.
* Cohort 2: 6 to \< 12 years of age.
* Cohort 3: 2 to \< 12 years of age (after eDMC review of safety data from Cohort 2).
* Clinical diagnosis of FOP.
* Willingness to avoid pregnancy or fathering children ba…
Contacts