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NCT05027802 · ClinicalTrials.gov registry record · Phase 3
A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies.
A Phase 3 study of Fibrodysplasia Ossificans Progressiva (FOP), sponsored by Ipsen.
- Completed
- Registry status
- Phase 3
- Development phase
- 61
- Enrollment target
- 13
- Study locations
NCT05027802: Completed Phase 3 study of Fibrodysplasia Ossificans Progressiva (FOP), sponsored by Ipsen.
NCT05027802 is a Phase 3 study of Fibrodysplasia Ossificans Progressiva (FOP) that has completed, run by Ipsen. The registered enrollment target is 61 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). The trial reports 13 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05027802, a Phase 3 study of Fibrodysplasia Ossificans Progressiva (FOP), has completed, sponsored by Ipsen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 61 participants
- Enrollment target
- 13
- Study locations
Study Summary
The main objective of this study is to further evaluate the safety and efficacy of palovarotene in adult and paediatric participants with FOP. The aim of the study is also to ensure treatment continuity to participants who have completed one of the parent studies (Study PVO-1A-301, Study PVO-1A-202 and Study PVO-1A-204) and who, in the investigator's judgement, may benefit from palovarotene therapy.
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or
Conditions Studied
Interventions
- DRUG Palovarotene
Study Locations (13)
Other
- Hospital Italiano de Buenos Aires - Buenos Aires
- Toronto General Hospital - Toronto
- Groupe Hospitalier Necker Enfants Malades - Paris
- Istituto Giannina Gaslini - Genoa
- Hospital Universitario Ramon y Cajal - Colmenar Viejo
- Norrlands Universitetssjukhus - Umeå
- Royal National Orthopaedic Hospital - London
Pennsylvania
- Children's Hospital of Philidelphia - Philadelphia
- The Perelman School of Medicine - The University of Pennsylvania - Philadelphia
California
- University of California San Francisco (UCSF) - San Francisco
Minnesota
- Mayo Clinic - Rochester
New South Wales
- Royal North Shore Hospital - Saint Leonards
São Paulo
- Hospital Israelita Albert Einstein - Morumbi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2022-03-14 |
| Est. Completion | 2024-11-30 |
| Phase | Phase 3 |
What the finished NCT05027802 record still lists
NCT05027802 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Fibrodysplasia Ossificans Progressiva (FOP) appearing as the primary indexed condition, and to 1 intervention - of which Palovarotene is the first listed.
NCT05027802 lists 13 locations in 6 states (Other, Pennsylvania, California).
Frequently Asked Questions
What is clinical trial NCT05027802 about?
NCT05027802 is a clinical study titled "A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies.". The main objective of this study is to further evaluate the safety and efficacy of palovarotene in adult and paediatric participants with FOP. The aim of the study is also to ensure treatment continuity to participants who have completed one of the parent studies (Study PVO-1A-301, Study PVO-1A-202...
What is the current status of trial NCT05027802?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 61 participants. The study started on 2022-03-14. Estimated completion is 2024-11-30.
What conditions does trial NCT05027802 study?
This clinical trial studies the following conditions: Fibrodysplasia Ossificans Progressiva (FOP).
What interventions are being tested in trial NCT05027802?
The interventions under investigation include: Palovarotene (DRUG).
Who is sponsoring clinical trial NCT05027802?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05027802 being conducted?
This trial has 13 study locations across California, Minnesota, Pennsylvania, New South Wales, São Paulo. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05027802's enrollment target sits among peer trials
61 1803rd of 2000 higher than 197 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
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