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NCT05039515 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Effectiveness and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP).
A Phase 2 study of Fibrodysplasia Ossificans Progressiva, sponsored by Clementia Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 113
- Enrollment target
- 20
- Study locations
NCT05039515: Active Phase 2 study of Fibrodysplasia Ossificans Progressiva, sponsored by Clementia Pharmaceuticals.
NCT05039515 is a Phase 2 study of Fibrodysplasia Ossificans Progressiva that is active but no longer recruiting, run by Clementia Pharmaceuticals. The registered enrollment target is 113 participants, above the 76-participant average among 4 other Fibrodysplasia Ossificans Progressiva trials with a reported enrollment target (49% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05039515, a Phase 2 study of Fibrodysplasia Ossificans Progressiva, is active but no longer recruiting, sponsored by Clementia Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 113 participants
- Enrollment target
- 20
- Study locations
Study Summary
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by the presence of bone in soft tissue where bone normally does not exist, known as Heterotopic Ossification (HO). It is often associated with painful, recurrent episodes of soft tissue swelling (flare-ups) that lead to abnormal stiffening and immobility (ankyloses) of major joints with cumulative and irreversible loss of movement and disability. This study will evaluate the efficacy of 2 dosing regimens of IPN60130 in inhibiting new HO volume compared with placebo (a dummy treatment) in adult and paediatric participants with FOP. It will be assessed by a scan (provides internal images of the body) called low dose Whole Body Computed Tomography (WBCT), excluding head. Adults and participants 5 years of age or older are also eligible for a sub study to evaluate HO lesions assessed by another type of scan, Fluorine-18-labelled natrium fluoride Positron Emission Tomography-Computed Tomography (\[18F\]NaF PET-CT ).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG IPN60130
Study Locations (20)
Other
- Hospital Italiano de Buenos Aires - Buenos Aires
- Royal North Shore Hospital - New South Wales - Sydney
- University Hospitals Leuven - Leuven
- University of Alberta, Alberta Health Services (AHS) - Edmonton
- University Health Network (UHN), Toronto General Hospital (TGH) - Toronto
- Children's Hospital Capital Institute of Pediatrics (CIP) - Beijing
- Peking Union Medical College Hospital - Beijing
- Shangai Children Medical Center - Shanghai
- Tongi University - Tongi Hospital - Shanghai
- Groupe Hospitalier Necker Enfants Malades - Paris
- Hopital Lariboisiere - Paris
- Irccs Gaslini Institute - Genoa
- Nagoya University Hospital - Nagoya
- Aichi Children's Health and Medical Center - Ōbu
- The University of Tokyo Hospital - Tokyo
- Instituto Nacional De Rehabilitacion - Mexico City
Pennsylvania
- The Children's Hospital of Philadelphia - Philadelphia
- The Perelman School of Medicine - The University of Pennsylvania - Philadelphia
California
- University of California San Francisco (UCSF) - San Francisco
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2021-12-01 |
| Est. Completion | 2029-03-30 |
| Phase | Phase 2 |
What the registry record for NCT05039515 still lists
NCT05039515 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, above the 76-participant average among 4 other Fibrodysplasia Ossificans Progressiva trials with a reported enrollment target (49% higher).
The record links to 1 condition, with Fibrodysplasia Ossificans Progressiva appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05039515 names 20 study sites across 4 states, led by Other, Pennsylvania, California.
Frequently Asked Questions
What is clinical trial NCT05039515 about?
NCT05039515 is a clinical study titled "A Study to Assess the Effectiveness and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP).". Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by the presence of bone in soft tissue where bone normally does not exist, known as Heterotopic Ossification (HO). It is often associated with painful, recurrent episodes of soft tissue swelling (flare-up...
What is the current status of trial NCT05039515?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 113 participants. The study started on 2021-12-01. Estimated completion is 2029-03-30.
What conditions does trial NCT05039515 study?
This clinical trial studies the following conditions: Fibrodysplasia Ossificans Progressiva.
What interventions are being tested in trial NCT05039515?
The interventions under investigation include: Placebo (DRUG), IPN60130 (DRUG).
Who is sponsoring clinical trial NCT05039515?
This trial is sponsored by Clementia Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05039515 being conducted?
This trial has 20 study locations across California, Minnesota, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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