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

Phase 2

• Conditions: rare connective tissue disease; 10028396

• Registration Number: NL-OMON54122
• Lead Sponsor: Incyte Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

-Female and male adults and adolescents >= 12 years of age.
-Clinical diagnosis of FOP (based on findings of congenital malformation of the
great
toes, episodic soft-tissue swelling, and/or progressive HO).
- Participant-reported FOP disease activity within 1 year of the screening
visit. This is
defined as pain, swelling, and other signs and symptoms associated with FOP
flare-ups or
worsening of joint function or radiographic progression of HO (increase in site
or number
of HO lesions) with or without an association with flare-up episodes.

Exclusion Criteria

-CAJIS score >= 24.
-FOP disease severity that in the investigator's opinion precludes
participation (eg,
ankyloses of most or all joints, symptomatic thoracic insufficiency syndrome, or
recurrent respiratory infections).
-History of uncontrolled or unstable cardiovascular, respiratory, renal,
gastrointestinal,
endocrine, hematopoietic, psychiatric, and/or neurological disease within 6
months of
screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Total volume of new HO as assessed by low dose WBCT (excluding the head) at<br /><br>Week 24.</p><br>