Last updated: November 3, 2023
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting
Phase
2
Condition
N/ATreatment
INCB000928
Placebo
Clinical Study ID
NCT05090891
INCB 00928-201
Ages 12-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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.
Study Design
Total Participants: 60
Treatment Group(s): 2
Primary Treatment: INCB000928
Phase: 2
Study Start date:
May 05, 2022
Estimated Completion Date:
December 02, 2024
Study Description
Connect with a study center
Royal North Shore Hospital
St Leonards, 02065
AustraliaActive - Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
SpainActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905
United StatesActive - Recruiting
Mayo Clinic Rochester
Rochester, Minnesota 55905
United StatesActive - Recruiting
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