NCT05090891

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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 2 Years – 99 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Fibrodysplasia Ossificans Progressiva (FOP)

Interventions

Type	Name	Description
DRUG	INCB000928	INCBG000928 will be administered QD orally.
DRUG	Placebo	Placebo will be administered QD orally.

Timeline

• Start date: 2022-05-05
• Primary completion: 2027-07-30
• Completion: 2033-01-20
• First posted: 2021-10-25
• Last updated: 2025-12-05

Locations

27 sites across 17 countries: United States, Argentina, Australia, Brazil, Canada, Chile, China, France, Germany, Italy, Mexico, Netherlands, New Zealand, South Africa, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study