Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED 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.

NCT05027802 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 61 participants
Start Date 2022-03-14
Est. Completion 2024-11-30
Phase Phase 3

Sponsor

Ipsen

205 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05027802

The ClinicalTrials.gov registry entry for NCT05027802 describes a study currently listed as completed. It is categorized as Phase 3, 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 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ipsen, which has 205 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 1 intervention — of which Palovarotene 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: NCT05027802 reports 13 study locations spanning 6 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 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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05027802?

The interventions under investigation include: Palovarotene (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05027802?

This trial is sponsored by Ipsen, which has 205 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial