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Clinical Trials in China / NCT05090891
Recruiting Phase 2

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

NCT05090891 · tracked via the Priya Life Science China tracker
Sponsor
Incyte Corporation
Phase
Phase 2
Started
2022-05-05
Last updated
2026-05-22

Condition(s) studied

Fibrodysplasia Ossificans Progressiva (FOP)

Investigational drug(s) / intervention(s)

INCB000928Placebo

INCB000928: INCBG000928 will be administered QD orally.

Placebo: Placebo will be administered QD orally.

Study 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).

Eligibility

Sex
ALL
Min age
2 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: * 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. 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.

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
Mayo Clinic Rochester Rochester Minnesota Recruiting
Children'S Hospital of Philadelphia Philadelphia Pennsylvania Recruiting
Penn Medicine - Perelman Center For Advanced Medicine Philadelphia Pennsylvania Active Not Recruiting
Hospital Italiano de Buenos Aires Buenos Aires Argentina Active Not Recruiting
Royal North Shore Hospital St Leonards New South Wales Completed
Murdoch Children'S Research Institute Parkville Victoria Active Not Recruiting
Albert Einstein Israelite Hospital São Paulo Brazil Active Not Recruiting
University Health Network Toronto General Hospital Toronto Ontario Active Not Recruiting
Centro de Estudios Reumatologicos Santiago Chile Active Not Recruiting
Beijing Childrens Hospital Capital Medical University Beijing China Recruiting
Tongji Hospital of Tongji University Shanghai China Recruiting
Shanghai Childrens Medical Center Shanghai China Recruiting
Childrens Hospital of Fudan University Shanghai China Recruiting
Ap-Hp Hopital Lariboisiere Paris France Recruiting
Hopital Necker-Enfants Malades Paris France Recruiting
Uniklinik Koln Cologne Germany Recruiting
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore Rome Italy Active Not Recruiting
Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Tlalpan Mexico Active Not Recruiting
Amsterdam Umc - Vu Medisch Centrum (Vumc) Amsterdam Netherlands Recruiting
Starship Childrens Hospital Auckland New Zealand Active Not Recruiting
Groote Schuur Hospital Radiation Oncology Cape Town South Africa Active Not Recruiting
Seoul National University Hospital Seoul South Korea Active Not Recruiting
Hospital Universitario Ramon Y Cajal Madrid Spain Recruiting
Royal National Orthopaedic Hospital Stanmore United Kingdom Active Not Recruiting

More Incyte Corporation trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05090891 on ClinicalTrials.gov ↗ ← All trials in China