A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
Who is this study for? Patients with fibrodysplasia ossificans progressiva
What treatments are being studied? INCB000928
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 99
Healthy Volunteers: f
View:
• Female and male participants:
‣ Cohort 1: ≥ 12 years of age.
⁃ Cohort 2: 6 to \< 12 years of age.
⁃ Cohort 3: 2 to \< 6 years of age (after eDMC review of interim 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.
Locations
United States
California
University of California San Francisco Medical Center
WITHDRAWN
San Francisco
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
Pennsylvania
Children'S Hospital of Philadelphia
RECRUITING
Philadelphia
Penn Medicine - Perelman Center For Advanced Medicine
ACTIVE_NOT_RECRUITING
Philadelphia
Other Locations
Argentina
Hospital Italiano de Buenos Aires
NOT_YET_RECRUITING
Ciudad Autonoma Buenos Aires
Australia
Murdoch Children'S Research Institute
RECRUITING
Parkville
Royal North Shore Hospital
COMPLETED
St Leonards
Brazil
Albert Einstein Israelite Hospital
RECRUITING
São Paulo
Canada
University Health Network Toronto General Hospital
ACTIVE_NOT_RECRUITING
Toronto
Chile
Centro de Estudios Reumatologicos
RECRUITING
Santiago
China
Beijing Childrens Hospital Capital Medical University
RECRUITING
Beijing
Childrens Hospital of Fudan University
RECRUITING
Shanghai
Shanghai Childrens Medical Center
RECRUITING
Shanghai
Tongji Hospital of Tongji University
RECRUITING
Shanghai
France
Ap-Hp Hopital Lariboisiere
RECRUITING
Paris
Hopital Necker-Enfants Malades
RECRUITING
Paris
Germany
Uniklinik Koln
RECRUITING
Cologne
Italy
Ospedale Pediatrico G. Gaslini
WITHDRAWN
Genova
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
RECRUITING
Rome
Mexico
Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra
RECRUITING
Tlalpan
Netherlands
Amsterdam Umc - Vu Medisch Centrum (Vumc)
RECRUITING
Amsterdam
New Zealand
Starship Childrens Hospital
RECRUITING
Auckland
Republic of Korea
Seoul National University Hospital
ACTIVE_NOT_RECRUITING
Seoul
South Africa
Groote Schuur Hospital Radiation Oncology
RECRUITING
Cape Town
Spain
Hospital Universitario Ramon Y Cajal
RECRUITING
Madrid
United Kingdom
Royal Manchester Childrens Hospital - Department of Paediatric Endocrinology
WITHDRAWN
Manchester
Royal National Orthopaedic Hospital
RECRUITING
Stanmore
Contact Information
Primary
Incyte Corporation Call Center (US)
medinfo@incyte.com
1.855.463.3463
Backup
Incyte Corporation Call Center (ex-US)
eumedinfo@incyte.com
+800 00027423
Time Frame
Start Date: 2022-05-05
Estimated Completion Date: 2033-01-20
Participants
Target number of participants: 98
Treatments
Experimental: Cohort 1
Participants (≥ 12 years of age) will receive INCB000928 or placebo as defined in the protocol for 24 weeks (double-blind period). Participants who complete the double-blind period will continue into open-label extension period for an additional 292 weeks.
Experimental: Cohort 2
Participants (6 to \< 12 years of age) will receive INCB000928 or placebo as defined in the protocol for 24 weeks (double-blind period). Participants who complete the double-blind period will continue into open-label extension period for an additional 292 weeks.
Experimental: Cohort 3
Participants (2 to \< 6 years of age) will receive INCB000928 or placebo as defined in the protocol for 24 weeks (double-blind period). Participants who complete the double-blind period will continue into open-label extension period for an additional 292 weeks.
Related Therapeutic Areas
Sponsors
Leads: Incyte Corporation