A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
Incyte Corporation
Summary
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).
Eligibility
- Age range
- 2–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Female and male participants: * Cohort 1: ≥ 12 years of age. * Cohort 2: 6 to \< 12 years of age. * Cohort 3: 2 to \< 6 years of age (after eDMC review of interim data from Cohort 2). * Clinical diagnosis of FOP. * Willingness to avoid pregnancy or fathering children based on the criteria below. * Willing and able to undergo low-dose WBCT (excluding the head) imaging without requiring intubation. * Further inclusion criteria apply. Exclusion Criteria: * Pregnant or breast-feeding. * CAJIS score ≥ 24. * FOP disease severity that in the investigator's opinion prec…
Interventions
- DrugINCB000928
INCBG000928 will be administered QD orally.
- DrugPlacebo
Placebo will be administered QD orally.
Locations (27)
- University of California San Francisco Medical CenterSan Francisco, California
- Mayo Clinic RochesterRochester, Minnesota
- Children'S Hospital of PhiladelphiaPhiladelphia, Pennsylvania
- Penn Medicine - Perelman Center For Advanced MedicinePhiladelphia, Pennsylvania
- Hospital Italiano de Buenos AiresCiudad Autonoma Buenos Aires
- Royal North Shore HospitalSt Leonards, New South Wales