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NCT05394116 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess Safety, Tolerability and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants With Fibrodysplasia Ossificans Progressiva (FOP)
A Phase 3 study of Fibrodysplasia Ossificans Progressiva, sponsored by Regeneron Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 63
- Enrollment target
- 20
- Study locations
NCT05394116 is a Phase 3 study of Fibrodysplasia Ossificans Progressiva that is active but no longer recruiting, run by Regeneron Pharmaceuticals. The registered enrollment target is 63 participants, below the 88-participant average among 4 other Fibrodysplasia Ossificans Progressiva trials with a reported enrollment target (28% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT05394116, a Phase 3 study of Fibrodysplasia Ossificans Progressiva, is active but no longer recruiting, sponsored by Regeneron Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 63 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is researching an experimental drug called garetosmab. The study is focused on adult patients with fibrodysplasia ossificans progressiva (FOP). The aim of the study is to see how safe and effective the study drug is in patients with FOP. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Garetosmab
Study Locations (20)
Other
- Hospital Israelita Albert Einstein - São Paulo
- Tongji Hospital of Tongji University - Shanghai
- Hôpital Lapeyronie - Montpellier
- Hopital Lariboisiere - Paris
- Queen Mary Hospital - Hong Kong
- IRCCS Istituto Giannina Gaslini - Genoa
- Kyushu University Hospital - Fukuoka
- Hospital Kuala Lampur - Kuala Lumpur
- Seoul National University Hospital - Seoul
California
- University of California Los Angeles (UCLA) Medical Center - Los Angeles
Tennessee
- Vanderbilt University Medical Center - Nashville
New South Wales
- Royal North Shore Hospital - St Leonards
Bio Bio
- Universidad de Concepcion - Concepción
Cundinamarca
- Clinica Universidad de La Sabana - Chía
Stenbäckinkatu 11
- HUS Children and Adolescents Park Hospital Clinical Trial Unit - Helsinki
Aichi-ken
- Nagoya University Hospital - Nagoya
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2022-11-21 |
| Est. Completion | 2029-02-27 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05394116
The ClinicalTrials.gov registry entry for NCT05394116 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 88-participant average among 4 other Fibrodysplasia Ossificans Progressiva trials with a reported enrollment target (28% lower). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
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.
NCT05394116 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, California, Tennessee.
Frequently Asked Questions
What is clinical trial NCT05394116 about?
NCT05394116 is a clinical study titled "A Study to Assess Safety, Tolerability and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants With Fibrodysplasia Ossificans Progressiva (FOP)". This study is researching an experimental drug called garetosmab. The study is focused on adult patients with fibrodysplasia ossificans progressiva (FOP). The aim of the study is to see how safe and effective the study drug is in patients with FOP. The study is looking at several other research qu...
What is the current status of trial NCT05394116?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 63 participants. The study started on 2022-11-21. Estimated completion is 2029-02-27.
What conditions does trial NCT05394116 study?
This clinical trial studies the following conditions: Fibrodysplasia Ossificans Progressiva.
What interventions are being tested in trial NCT05394116?
The interventions under investigation include: Placebo (DRUG), Garetosmab (DRUG).
Who is sponsoring clinical trial NCT05394116?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05394116 being conducted?
This trial has 20 study locations across California, Tennessee, New South Wales, Bio Bio, Cundinamarca. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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