To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Fibrodysplasia Ossificans Progressiva (FOP)
In brief
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).
Key facts
- Study ID
- NCT05090891
- Run by
- Incyte Corporation
- People needed
- 98
- Starts
- 2022-05-05
- Expected to finish
- 2033-01-20
- Last updated by the study team
- 2026-05-22
Who can join
Age: 2 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Female and male participants:
- 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.
- 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.
You may not qualify if…
- 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.
Where it is running
- Mayo Clinic Rochester — Rochester, Minnesota, United States (enrolling)
- Children'S Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
- Beijing Childrens Hospital Capital Medical University — Beijing, China (enrolling)
- Tongji Hospital of Tongji University — Shanghai, China (enrolling)
- Shanghai Childrens Medical Center — Shanghai, China (enrolling)
- Childrens Hospital of Fudan University — Shanghai, China (enrolling)
- Ap-Hp Hopital Lariboisiere — Paris, France (enrolling)
- Hopital Necker-Enfants Malades — Paris, France (enrolling)
- Uniklinik Koln — Cologne, Germany (enrolling)
- Amsterdam Umc - Vu Medisch Centrum (Vumc) — Amsterdam, Netherlands (enrolling)
- Hospital Universitario Ramon Y Cajal — Madrid, Spain (enrolling)
- Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra — Tlalpan, Mexico
- Royal National Orthopaedic Hospital — Stanmore, United Kingdom
- Starship Childrens Hospital — Auckland, New Zealand
- Groote Schuur Hospital Radiation Oncology — Cape Town, South Africa
- Penn Medicine - Perelman Center For Advanced Medicine — Philadelphia, Pennsylvania, United States
- Hospital Italiano de Buenos Aires — Buenos Aires, Argentina
- Royal North Shore Hospital — St Leonards, New South Wales, Australia
- Murdoch Children'S Research Institute — Parkville, Victoria, Australia
- Albert Einstein Israelite Hospital — São Paulo, Brazil
- University Health Network Toronto General Hospital — Toronto, Ontario, Canada
- Centro de Estudios Reumatologicos — Santiago, Chile
- Seoul National University Hospital — Seoul, South Korea
- Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore — Rome, Italy
Full record on ClinicalTrials.gov
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