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ACTIVE NOT RECRUITING Phase 2

A Study to Evaluate RO7204239 in Participants With Facioscapulohumeral Muscular Dystrophy

NCT05548556 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 51 participants
Start Date 2023-02-07
Est. Completion 2026-10-23
Phase Phase 2

Sponsor

Hoffmann-La Roche

758 total trials

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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. It is categorized as Phase 2, 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 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 758 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 Facioscapulohumeral Muscular Dystrophy (FSHD) appearing as the primary indexed condition, and to 2 interventions — of which Placebo 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: NCT05548556 reports 10 study locations spanning 8 distinct geographic areas — top geographies include Other, California, Colorado. 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 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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05548556?

The interventions under investigation include: Placebo (DRUG), RO7204239 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05548556?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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