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A Study to Evaluate the Efficacy and Safety of Taldefgrobep Alfa in Participants With Spinal Muscular Atrophy

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

Record History

The 50 most recent of 73 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Study completion pushed from Jun 2026 to Dec 2027v73
  2. Study completion date: Jan 2026 to Jun 2026v72
  3. Re-verified, no change to tracked fieldsv71
  4. Primary completion date changed from estimate of Jan 2025 to Sep 25, 2024
    • Study completion date: Jan 2025 to Jan 2026
    • Secondary endpoints expanded, about 84 words
    • Eligibility criteria expanded, about 1 word
    v70
  5. Study sites: 58 to 53v69
Show 45 earlier versionsHide 45 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 225 to confirmed 269
    • Site details revised at 58 of 58 sites
    v68
  2. Site details revised at 1 of 58 sitesv67
  3. Site details revised at 1 of 58 sitesv66
  4. Site details revised at 3 of 58 sitesv65
  5. Site details revised at 2 of 58 sitesv64
  6. Site details revised at 1 of 58 sitesv63
  7. Site details revised at 3 of 58 sitesv62
  8. Site details revised at 1 of 58 sitesv61
  9. Site details revised at 1 of 58 sitesv60
  10. Site details revised at 1 of 58 sitesv59
  11. Site details revised at 1 of 58 sitesv58
  12. Site contacts updated at 2 of 58 sitesv57
  13. Site contacts updated at 1 of 58 sitesv56
  14. Site details revised at 2 of 58 sitesv55
  15. Site details revised at 1 of 58 sitesv54
  16. Site details revised at 1 of 58 sitesv53
  17. Study sites revised (58)v52
  18. Study sites: 59 to 58v51
  19. Site details revised at 1 of 59 sitesv50
  20. Site details revised at 1 of 59 sitesv49
  21. Site details revised at 2 of 59 sitesv48
  22. Site details revised at 1 of 59 sitesv47
  23. Site details revised at 6 of 59 sitesv46
  24. Site contacts updated at 1 of 59 sitesv45
  25. Site details revised at 1 of 59 sitesv44
  26. Site details revised at 1 of 59 sitesv43
  27. Study sites: 62 to 59v42
  28. Site details revised at 1 of 62 sitesv41
  29. Site details revised at 2 of 62 sitesv40
  30. Site details revised at 1 of 62 sitesv39
  31. Site details revised at 1 of 62 sitesv38
  32. Study sites: 60 to 62v37
  33. Site contacts updated at 2 of 60 sitesv36
  34. Study sites revised (60)v35
  35. Site details revised at 1 of 60 sitesv34
  36. Site details revised at 1 of 60 sitesv33
  37. Site details revised at 1 of 60 sitesv32
  38. Interventions: Placebo (Drug), tadefgrobep alfa (Drug), tadefgrobep alfa (Drug) to Placebo (Drug), taldefgrobep alfa (Drug), taldefgrobep alfa (Drug)v31
  39. Site details revised at 1 of 60 sitesv30
  40. Site details revised at 1 of 60 sitesv29
  41. Site details revised at 1 of 60 sitesv28
  42. Site details revised at 1 of 60 sitesv27
  43. Site details revised at 1 of 60 sitesv26
  44. Site details revised at 1 of 60 sitesv25
  45. Site details revised at 1 of 60 sitesv24
  • 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.
This trial will study the efficacy and safety of taldefgrobep alfa as an adjunctive therapy for participants who are already taking a stable dose of nusinersen and/or risdiplam and/or have a history of onasemnogene abeparvovec, compared to placebo.
Trial Details
NCT Number NCT05337553
Lead Sponsor Biohaven Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Spinal Muscular Atrophy, Neuromuscular Diseases, SMA
Related terms Muscular Atrophy, Spinal, Neuromuscular Diseases
Enrollment 269 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov