To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
Fibrodysplasia Ossificans Progressiva (FOP)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).
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
12 and up
Participation Criteria
Inclusion Criteria:
* Female and male adults and adolescents ≥ 12 years of age with a 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 precludes participation.
* Any clinically significant medical condition other than FOP that would, in the investigator's judgment, interfere with full participation in the study, pose a significant risk to the participant, or interfere with interpretation of study data.
* Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
* HIV, HBV, or HCV infection. Note:
* Further exclusion criteria apply.
Study Location
University Health Network Toronto General Hospital
University Health Network Toronto General HospitalToronto, Ontario
Canada
Contact Study Team
- Study Sponsored By
- Incyte Corporation
- Participants Required
- More Information
- Study ID:
NCT05090891