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A Study to Evaluate RO7204239 in Participants With Facioscapulohumeral Muscular Dystrophy

NCT05548556 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2026-04-30

No results posted yet for this 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

  • Facioscapulohumeral Muscular Dystrophy (FSHD)

Interventions

DRUG

Placebo

Participants will receive subcutaneous (SC) placebo every 4 weeks (Q4W)

DRUG

RO7204239

Participants will receive SC RO7204239 Q4W

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-07
Primary Completion
2025-05-02
Completion
2026-10-23
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • Italy
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05548556 on ClinicalTrials.gov