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NCT05090891 · ClinicalTrials.gov registry record · Phase 2
To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
A Phase 2 study of Fibrodysplasia Ossificans Progressiva (FOP), sponsored by Incyte Corporation.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 98
- Enrollment target
- 20
- Study locations
NCT05090891: Recruiting Phase 2 study of Fibrodysplasia Ossificans Progressiva (FOP), sponsored by Incyte Corporation.
NCT05090891 is a Phase 2 study of Fibrodysplasia Ossificans Progressiva (FOP) that is actively recruiting participants, run by Incyte Corporation. The registered enrollment target is 98 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05090891, a Phase 2 study of Fibrodysplasia Ossificans Progressiva (FOP), is actively recruiting participants, sponsored by Incyte Corporation.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 98 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
HO will be assessed by low dose whole-body computed tomography (WBCT) (excluding the head) compared to baseline during the double-blind period.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG INCB000928
Study Locations (20)
Other
- Hospital Italiano de Buenos Aires - Ciudad Autonoma Buenos Aires
- Albert Einstein Israelite Hospital - São Paulo
- Centro de Estudios Reumatologicos - Santiago
- Beijing Childrens Hospital Capital Medical University - Beijing
- Tongji Hospital of Tongji University - Shanghai
- Shanghai Childrens Medical Center - Shanghai
- Childrens Hospital of Fudan University - Shanghai
- Ap-Hp Hopital Lariboisiere - Paris
- Hopital Necker-Enfants Malades - Paris
- Uniklinik Koln - Cologne
- Ospedale Pediatrico G. Gaslini - Genova
- Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore - Rome
- Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra - Tlalpan
Pennsylvania
- Children'S Hospital of Philadelphia - Philadelphia
- Penn Medicine - Perelman Center For Advanced Medicine - Philadelphia
California
- University of California San Francisco Medical Center - San Francisco
Minnesota
- Mayo Clinic Rochester - Rochester
New South Wales
- Royal North Shore Hospital - St Leonards
Victoria
- Murdoch Children'S Research Institute - Parkville
Ontario
- University Health Network Toronto General Hospital - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2022-05-05 |
| Est. Completion | 2033-01-20 |
| Phase | Phase 2 |
What NCT05090891 shows while recruiting
NCT05090891 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).
The record links to 1 condition, with Fibrodysplasia Ossificans Progressiva (FOP) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05090891 names 20 study sites across 7 states, led by Other, Pennsylvania, California.
Frequently Asked Questions
What is clinical trial NCT05090891 about?
NCT05090891 is a clinical study titled "To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva". 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).
What is the current status of trial NCT05090891?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2022-05-05. Estimated completion is 2033-01-20.
What conditions does trial NCT05090891 study?
This clinical trial studies the following conditions: Fibrodysplasia Ossificans Progressiva (FOP).
What interventions are being tested in trial NCT05090891?
The interventions under investigation include: Placebo (DRUG), INCB000928 (DRUG).
Who is sponsoring clinical trial NCT05090891?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05090891 being conducted?
This trial has 20 study locations across California, Minnesota, Pennsylvania, New South Wales, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05090891's enrollment target sits among peer trials
98 743rd of 2000 higher than 1,256 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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