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NCT05548556 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate RO7204239 in Participants With Facioscapulohumeral Muscular Dystrophy
A Phase 2 study of Facioscapulohumeral Muscular Dystrophy (FSHD), sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 10
- Study locations
NCT05548556 is a Phase 2 study of Facioscapulohumeral Muscular Dystrophy (FSHD) that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 51 participants. The trial reports 10 study locations across 8 states.
The verdict
NCT05548556, a Phase 2 study of Facioscapulohumeral Muscular Dystrophy (FSHD), is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 10
- Study locations
Study Summary
The purpose of this study is to evaluate the pharmacodynamics, safety, tolerability, pharmacokinetics, and efficacy of RO7204239, a humanized monoclonal antibody that binds to human latent myostatin, in ambulant adult participants with facioscapulohumeral muscular dystrophy (FSHD).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG RO7204239
Study Locations (10)
Other
- Rigshospitalet - København Ø
- National Hospital for Neurology and Neurosurgery, - London
- Royal Victoria Infirmary - Newcastle upon Tyne
California
- University of Irvine Medical Center (UCIMC) - Orange
Colorado
- Regents of the University of Colorado - Aurora
Kansas
- University of Kansas Medical Center - Fairway
Maryland
- Kennedy Krieger Institute - Baltimore
Virginia
- Virginia Commonwealth University Medical Center - Richmond
Lazio
- Policlinico Universitario Agostino Gemelli - Rome
Lombardy
- Asst Grande Ospedale Metropolitano Niguarda - Milan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2023-02-07 |
| Est. Completion | 2026-10-23 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05548556
The ClinicalTrials.gov registry entry for NCT05548556 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Facioscapulohumeral Muscular Dystrophy (FSHD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05548556 reports 10 study locations spanning 8 distinct geographic areas - top geographies include Other, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT05548556 about?
NCT05548556 is a clinical study titled "A Study to Evaluate RO7204239 in Participants With Facioscapulohumeral Muscular Dystrophy". The purpose of this study is to evaluate the pharmacodynamics, safety, tolerability, pharmacokinetics, and efficacy of RO7204239, a humanized monoclonal antibody that binds to human latent myostatin, in ambulant adult participants with facioscapulohumeral muscular dystrophy (FSHD).
What is the current status of trial NCT05548556?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2023-02-07. Estimated completion is 2026-10-23.
What conditions does trial NCT05548556 study?
This clinical trial studies the following conditions: Facioscapulohumeral Muscular Dystrophy (FSHD).
What interventions are being tested in trial NCT05548556?
The interventions under investigation include: Placebo (DRUG), RO7204239 (DRUG).
Who is sponsoring clinical trial NCT05548556?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05548556 being conducted?
This trial has 10 study locations across California, Colorado, Kansas, Maryland, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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