To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasi… (NCT05090891) | Clinical Trial Compass
RecruitingPhase 2
To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
United States, Argentina98 participantsStarted 2022-05-05
Plain-language 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).
Who can participate
Age range2 Years – 99 Years
SexALL
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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 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.
What they're measuring
1
Double Blind Period: Occurrence of new heterotopic ossification (HO) lesions from baseline