To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva

• Status: Not yet recruiting
• Trial end date: 2024-10-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

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.