To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-99
SponsorIncyte Corporation
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- INCB000928
- Placebo
Treatment groups
98 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov