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Long-Term Safety & Efficacy of Apitegromab in Patients With SMA Who Completed Previous Trials of Apitegromab

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

Record History

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  1. Study sites revised (49)v30
  2. Re-verified, no change to tracked fieldsv29
  3. Enrollment target: estimated 260 to confirmed 238
    • Study completion date: Jan 1, 2027 to May 2, 2029
    • Study title revised
    • Eligibility criteria expanded, about 5 words
    v28
  4. Study sites: 47 to 49v27
  5. Study sites: 43 to 47v26
Show 24 earlier versionsHide 24 earlier versions
  1. Study sites: 41 to 43v25
  2. Study sites: 40 to 41v24
  3. Study sites: 39 to 40v23
  4. Study sites: 38 to 39v22
  5. Study sites: 36 to 38v21
  6. Study sites: 35 to 36v20
  7. Study sites: 33 to 35v19
  8. Study sites: 30 to 33v18
  9. Study sites: 29 to 30v17
  10. Study sites: 26 to 29v16
  11. Study sites: 24 to 26v15
  12. Study sites: 19 to 24v14
  13. Study sites: 18 to 19v13
  14. Study sites: 16 to 18v12
  15. Study sites: 15 to 16v11
  16. Study sites: 14 to 15v10
  17. Study sites: 15 to 14v9
  18. Study sites: 10 to 15v8
  19. Study sites: 8 to 10v7
  20. Study sites: 7 to 8v6
  21. Study sites: 4 to 7v5
  22. Study sites: 2 to 4v4
  23. Study sites: 1 to 2v3
  24. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 27 to 1
    • Start date changed from estimate of Apr 24, 2023 to Apr 17, 2023
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The ONYX study is an Open-Label, Multicenter, Extension study that will evaluate the long-term safety and efficacy of Apitegromab in Patients with Type 2 and Type 3 SMA who have completed TOPAZ or SAPPHIRE.
Trial Details
NCT Number NCT05626855
Lead Sponsor Scholar Rock, Inc.
Conditions
(from sponsor)		 Spinal Muscular Atrophy, Spinal Muscular Atrophy Type 3, Spinal Muscular Atrophy Type 2, SMA, Neuromuscular Diseases, Muscular Atrophy, Atrophy, Muscular Atrophy, Spinal +2 more
Related terms Atrophy, Muscular Atrophy, Muscular Atrophy, Spinal, Neuromuscular Diseases, Neuromuscular Manifestations, Spinal Muscular Atrophies of Childhood
Enrollment 238 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov