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To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
NCT05090891 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05090891
The ClinicalTrials.gov registry entry for NCT05090891 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Incyte Corporation, which has 163 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05090891 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, Pennsylvania, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05090891?
The interventions under investigation include: Placebo (DRUG), INCB000928 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05090891?
This trial is sponsored by Incyte Corporation, which has 163 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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