To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Double Blind Period: Occurrence of new heterotopic ossification (HO) lesions from baseline — Week 24
HO will be assessed by low dose whole-body computed tomography (WBCT) (excluding the head) compared to baseline during the double-blind period.
Trial sites (24)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Spain
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 Spain