To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
- Conditions
- Fibrodysplasia Ossificans Progressiva (FOP)
- Registration Number
- NCT05090891
- Lead Sponsor
- Incyte Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria:<br><br> - Female and male adults and adolescents = 12 years of age with a diagnosis of FOP.<br><br> - Willingness to avoid pregnancy or fathering children based on the criteria below.<br><br> - Willing and able to undergo low-dose WBCT (excluding the head) imaging without<br> requiring intubation.<br><br> - Further inclusion criteria apply.<br><br>Exclusion Criteria:<br><br> - Pregnant or breast-feeding.<br><br> - CAJIS score = 24.<br><br> - FOP disease severity that in the investigator's opinion precludes participation.<br><br> - Any clinically significant medical condition other than FOP that would, in the<br> investigator's judgment, interfere with full participation in the study, pose a<br> significant risk to the participant, or interfere with interpretation of study data.<br><br> - Chronic or current active infectious disease requiring systemic antibiotic,<br> antifungal, or antiviral treatment.<br><br> - HIV, HBV, or HCV infection. Note:<br><br> - Further exclusion criteria apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Double Blind Period: Total volume of new heterotopic ossification (HO)
- Secondary Outcome Measures
Name Time Method Double-blind Period: Total number of new flares;Double-blind Period: Proportion of participants with a clinically meaningful improvement in the flare-related symptoms;Number of Participants with Treatment Emergent Adverse Events (TEAE)