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A Study to Investigate the Safety and Efficacy of RO7204239 in Combination With Risdiplam (RO7034067) in Participants With Spinal Muscular Atrophy

Study acronym: MANATEE
StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 53 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial sites reduced: 35 → 30 locations Final enrollment: 97 participants (planned 259)v53 Show 1 more changeShow less
    • Final enrollment: 97 participants (planned 259)
  2. Primary and study completion moved earlier from Feb 27, 2029 to Oct 28, 2026 Site details revised at 1 of 35 sitesv52 Show 1 more changeShow less
    • Site details revised at 1 of 35 sites
  3. Site details revised at 4 of 35 sitesv51
  4. Site details revised at 3 of 35 sitesv50
  5. Re-verified, no change to tracked fieldsv49
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites revised (35)v48 See this version in full on ClinicalTrials.gov ↗
  2. Primary completion date: Mar 31, 2028 to Feb 27, 2029 Completion date: Mar 27, 2029 to Feb 27, 2029v47 Show 1 more changeShow less
    • Completion date: Mar 27, 2029 to Feb 27, 2029
  3. Trial status: Recruiting to Active, Not Recruiting Site details revised at 35 of 35 sitesv46 Show 1 more changeShow less
    • Site details revised at 35 of 35 sites
  4. Trial status: Active, Not Recruiting to Recruiting Site details revised at 35 of 35 sitesv45 Show 1 more changeShow less
    • Site details revised at 35 of 35 sites
  5. Study sites revised (35)v44 See this version in full on ClinicalTrials.gov ↗
  6. Primary completion date: Jun 27, 2026 to Mar 31, 2028 Completion date: Jun 27, 2026 to Mar 27, 2029v43 Show 1 more changeShow less
    • Completion date: Jun 27, 2026 to Mar 27, 2029
  7. Trial status: Recruiting to Active, Not Recruiting Site details revised at 35 of 35 sitesv42 Show 1 more changeShow less
    • Site details revised at 35 of 35 sites
  8. Re-verified, no change to tracked fieldsv41
  9. Site details revised at 2 of 35 sitesv40
  10. Study sites: 34 to 35v39
  11. Site details revised at 5 of 34 sitesv38
  12. Site details revised at 2 of 34 sitesv37
  13. Study sites: 31 to 34v36
  14. Site details revised at 2 of 31 sitesv35
  15. Site details revised at 4 of 31 sitesv34
  16. Study sites: 28 to 31v33
  17. Study sites: 26 to 28v32
  18. Study sites: 25 to 26v31
  19. Study sites: 22 to 25v30
  20. Study sites: 18 to 22v29
  21. Study sites: 14 to 18v28
  22. Study sites: 13 to 14v27
  23. Site details revised at 1 of 13 sitesv26
  24. Study sites: 11 to 13v25
  25. Eligibility criteria expanded, about 10 wordsv24 See this version in full on ClinicalTrials.gov ↗
  26. 4 versions Re-verified since Apr 6, 2023, no change to tracked fieldsv20-v23
  27. Primary endpoints revised (18) Enrollment target: 180 to 259 · Primary and study completion dates: Dec 15, 2026 to Jun 27, 2026 · Eligibility criteria expanded, about 358 wordsv19 Show 3 more changesShow less
    • Enrollment target: 180 to 259
    • Primary and study completion dates: Dec 15, 2026 to Jun 27, 2026
    • Eligibility criteria expanded, about 358 words

    See this version in full on ClinicalTrials.gov ↗

  28. Study sites: 9 to 11v18
  29. Study sites: 8 to 9v17
  30. 2 versions Re-verified since Nov 1, 2022, no change to tracked fieldsv15-v16
  31. Study sites: 7 to 8v14
  32. Re-verified, no change to tracked fieldsv13
  33. Study sites: 5 to 7v12
  34. Re-verified, no change to tracked fieldsv11
  35. Start date changed from estimate of Jun 6, 2022 to Jun 2, 2022 Site details revised at 1 of 5 sitesv10 Show 1 more changeShow less
    • Site details revised at 1 of 5 sites
  36. Start date: Apr 30, 2022 to Jun 6, 2022 Study sites: 1 to 5v9 Show 1 more changeShow less
    • Study sites: 1 to 5
  37. Trial status: Not Yet Recruiting to Recruiting Start date: Mar 31, 2022 to Apr 30, 2022 · Study sites: 15 to 1 · Eligibility criteria expanded, about 41 wordsv8 Show 3 more changesShow less
    • Start date: Mar 31, 2022 to Apr 30, 2022
    • Study sites: 15 to 1
    • Eligibility criteria expanded, about 41 words

    See this version in full on ClinicalTrials.gov ↗

  38. Start date: Feb 28, 2022 to Mar 31, 2022v7
  39. Start date: Feb 14, 2022 to Feb 28, 2022v6
  40. Re-verified, no change to tracked fieldsv5
  41. Study Status, Eligibilityv4
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
Risdiplam works by helping the body produce more survival motor neuron (SMN) protein throughout the body. This means fewer motor neurons - nerve cells that pass impulses from nerves to muscles to cause movement - are lost, which may improve how well muscles work in people with SMA. RO7204239 is an investigational anti-myostatin antibody that is designed to target myostatin. Myostatin plays an important role in the regulation of skeletal muscle size by controlling growth. Inhibiting myostatin may help muscles grow in size and strength. RO7204239 in combination with risdiplam, which is designed to increase the amount of SMN protein throughout the body, has the potential to further improve motor function and clinical outcomes for people living with SMA. This trial will study the safety and efficacy of RO7204239 in combination with risdiplam in patients with spinal muscular atrophy (SMA). The trial has two parts; Part 1 is the dose-finding part in SMA patients that are either ambulant (aged 2-10 years) or non-ambulant (aged 5-10 years) within separate cohorts, and Part 2 is the pivotal part in SMA patients aged 2-25 years that are ambulant.
Trial Details
NCT Number NCT05115110
Lead Sponsor Hoffmann-La Roche
Conditions Spinal Muscular Atrophy (SMA)
Enrollment 97 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov