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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: Active Phase 2 study of Facioscapulohumeral Muscular Dystrophy (FSHD), sponsored by Hoffmann-La Roche.

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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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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).

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
Hoffmann-La Roche

909 total trials

What the registry record for NCT05548556 still lists

NCT05548556 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).

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 lists 10 locations in 8 states (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.

Similar trials for Facioscapulohumeral Muscular Dystrophy (FSHD)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05548556's enrollment target sits among peer trials

51 1190th of 2000 higher than 806 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05548556, the US trial registry maintained by the National Library of Medicine. NCT05548556 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.