Actively Recruiting
To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
Led by Incyte Corporation · Updated on 2025-12-05
98
Participants Needed
27
Research Sites
559 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female and male participants aged 12 years and older (Cohort 1), 6 to under 12 years (Cohort 2), or 2 to under 6 years (Cohort 3 after interim data review)
- Clinical diagnosis of fibrodysplasia ossificans progressiva (FOP)
- Willingness to avoid pregnancy or fathering children as required
- Ability and willingness to undergo low-dose whole-body CT imaging (excluding the head) without intubation
- Further inclusion criteria apply
You will not qualify if you...
- Pregnant or breastfeeding
- CAJIS score 24 or higher
- FOP disease severity preventing study participation as judged by the investigator
- Any other significant medical condition that would interfere with participation or pose risk
- Current or chronic active infection requiring systemic antibiotic, antifungal, or antiviral treatment
- Infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV)
- Further exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
University of California San Francisco Medical Center
San Francisco, California, United States, 94143
Withdrawn
2
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
3
Children'S Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
4
Penn Medicine - Perelman Center For Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Active, Not Recruiting
5
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, Argentina, C1199ABB
Not Yet Recruiting
6
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 02065
Completed
7
Murdoch Children'S Research Institute
Parkville, Victoria, Australia, 03052
Actively Recruiting
8
Albert Einstein Israelite Hospital
São Paulo, Brazil, 05652-900
Actively Recruiting
9
University Health Network Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Active, Not Recruiting
10
Centro de Estudios Reumatologicos
Santiago, Chile, 7501126
Actively Recruiting
11
Beijing Childrens Hospital Capital Medical University
Beijing, China, 100045
Actively Recruiting
12
Tongji Hospital of Tongji University
Shanghai, China, 200065
Actively Recruiting
13
Shanghai Childrens Medical Center
Shanghai, China, 200127
Actively Recruiting
14
Childrens Hospital of Fudan University
Shanghai, China, 201102
Actively Recruiting
15
Ap-Hp Hopital Lariboisiere
Paris, France, 75010
Actively Recruiting
16
Hopital Necker-Enfants Malades
Paris, France, 75015
Actively Recruiting
17
Uniklinik Koln
Cologne, Germany, 50931
Actively Recruiting
18
Ospedale Pediatrico G. Gaslini
Genova, Italy, 16147
Withdrawn
19
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Rome, Italy, 00168
Actively Recruiting
20
Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra
Tlalpan, Mexico, 14389
Actively Recruiting
21
Amsterdam Umc - Vu Medisch Centrum (Vumc)
Amsterdam, Netherlands, 1081 HV
Actively Recruiting
22
Starship Childrens Hospital
Auckland, New Zealand, 01023
Actively Recruiting
23
Groote Schuur Hospital Radiation Oncology
Cape Town, South Africa, 07925
Actively Recruiting
24
Seoul National University Hospital
Seoul, South Korea, 03080
Active, Not Recruiting
25
Hospital Universitario Ramon Y Cajal
Madrid, Spain, 28034
Actively Recruiting
26
Royal Manchester Childrens Hospital - Department of Paediatric Endocrinology
Manchester, United Kingdom, M13 9PL
Withdrawn
27
Royal National Orthopaedic Hospital
Stanmore, United Kingdom, HA7 4LP
Actively Recruiting
Research Team
I
Incyte Corporation Call Center (US)
CONTACT
I
Incyte Corporation Call Center (ex-US)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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