Trials / Active Not Recruiting
Active Not RecruitingNCT05548556
A Study to Evaluate RO7204239 in Participants With Facioscapulohumeral Muscular Dystrophy
A Phase II, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Pharmacodynamics, Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7204239 in Participants With Facioscapulohumeral Muscular Dystrophy
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Participants will receive subcutaneous (SC) placebo every 4 weeks (Q4W) |
| DRUG | RO7204239 | Participants will receive SC RO7204239 Q4W |
Timeline
- Start date
- 2023-02-07
- Primary completion
- 2025-05-02
- Completion
- 2026-10-23
- First posted
- 2022-09-21
- Last updated
- 2026-03-20
Locations
10 sites across 4 countries: United States, Denmark, Italy, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05548556. Inclusion in this directory is not an endorsement.