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To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
Sponsor: Incyte Corporation
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).
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
Key Details
Gender
All
Age Range
2 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
98
Start Date
2022-05-05
Completion Date
2033-01-20
Last Updated
2025-12-05
Healthy Volunteers
No
Interventions
INCB000928
INCBG000928 will be administered QD orally.
Placebo
Placebo will be administered QD orally.
Locations (27)
University of California San Francisco Medical Center
San Francisco, California, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Children'S Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Penn Medicine - Perelman Center For Advanced Medicine
Philadelphia, Pennsylvania, United States
Hospital Italiano de Buenos Aires
Ciudad Autonoma 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
Beijing Childrens Hospital Capital Medical University
Beijing, China
Tongji Hospital of Tongji University
Shanghai, China
Shanghai Childrens Medical Center
Shanghai, China
Childrens Hospital of Fudan University
Shanghai, China
Ap-Hp Hopital Lariboisiere
Paris, France
Hopital Necker-Enfants Malades
Paris, France
Uniklinik Koln
Cologne, Germany
Ospedale Pediatrico G. Gaslini
Genova, Italy
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Rome, Italy
Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra
Tlalpan, Mexico
Amsterdam Umc - Vu Medisch Centrum (Vumc)
Amsterdam, Netherlands
Starship Childrens Hospital
Auckland, New Zealand
Groote Schuur Hospital Radiation Oncology
Cape Town, South Africa
Seoul National University Hospital
Seoul, South Korea
Hospital Universitario Ramon Y Cajal
Madrid, Spain
Royal Manchester Childrens Hospital - Department of Paediatric Endocrinology
Manchester, United Kingdom
Royal National Orthopaedic Hospital
Stanmore, United Kingdom