A Study to Evaluate RO7204239 in Participants With Facioscapulohumeral Muscular Dystrophy

Study acronym: MANOEUVRE
StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Trial completed
  2. Study completion date: Oct 23, 2026 to Oct 9, 2026
  3. Study sites: 10 to 9
    • Eligibility criteria expanded, about 20 words
  4. 2 versions Re-verified since Apr 24, 2026, no change to tracked fieldsv33-v34
  5. Primary completion date: Apr 23, 2025 to May 2, 2025v32
Show 30 earlier versionsHide 30 earlier versions
  1. Re-verified, no change to tracked fieldsv31
  2. Enrollment target: estimated 48 to confirmed 51
    • Primary completion date: May 2, 2025 to Apr 23, 2025
    • Study completion date: Nov 2, 2026 to Oct 23, 2026
    v30
  3. Primary completion date changed from estimate of Nov 2, 2026 to May 2, 2025v29
  4. Re-verified, no change to tracked fieldsv28
  5. Primary completion date: May 2, 2025 to Nov 2, 2026
    • Study completion date: Oct 30, 2026 to Nov 2, 2026
    v27
  6. Study sites revised (10)v26
  7. 2 versions Re-verified since Jul 19, 2024, no change to tracked fieldsv24-v25
  8. Primary completion date: Jun 15, 2024 to May 2, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 15, 2025 to Oct 30, 2026
    • Site details revised at 10 of 10 sites
    v23
  9. Site details revised at 4 of 10 sitesv22
  10. Site details revised at 3 of 10 sitesv21
  11. Study sites: 9 to 10v20
  12. Re-verified, no change to tracked fieldsv19
  13. Study sites: 8 to 9v18
  14. Re-verified, no change to tracked fieldsv17
  15. Study sites: 7 to 8v16
  16. Study sites: 6 to 7v15
  17. Study sites: 5 to 6v14
  18. Study sites: 4 to 5v13
  19. Re-verified, no change to tracked fieldsv12
  20. Study sites: 3 to 4v11
  21. Study sites: 2 to 3v10
  22. Study sites: 1 to 2v9
  23. 2 versions Re-verified since Mar 2, 2023, no change to tracked fieldsv7-v8
  24. Start date: Jan 13, 2023 to Feb 7, 2023v6
  25. Start date: Dec 20, 2022 to Jan 13, 2023v5
  26. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 15, 2022 to Dec 20, 2022
    • Study sites: 0 to 1
    v4
  27. 2 versions Re-verified since Oct 14, 2022, no change to tracked fieldsv2-v3
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Roche/Genentech
367 trials monitored
See 31 trials at risk
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).
Trial Details
NCT Number NCT05548556
Lead Sponsor Hoffmann-La Roche
Conditions
(from sponsor)		 Facioscapulohumeral Muscular Dystrophy (FSHD)
Related terms Muscular Dystrophy, Facioscapulohumeral
Enrollment 51 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov