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A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 49 → 52 locations
  2. Trial sites expanded: 46 → 49 locations
  3. Study sites: 44 to 46 Eligibility criteria expanded, about 18 words · Secondary endpoints: details revised at 1 of 10 entries · Study description expanded, about 5 words Show 3 more changesShow less
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 1 of 10 entries
    • Study description expanded, about 5 words
  4. Trial sites expanded: 39 → 44 locationsv21
  5. Study sites: 38 to 39v20
  6. Study sites: 37 to 38v19
  7. Trial sites expanded: 34 → 37 locationsv18
  8. Trial sites expanded: 30 → 34 locationsv17
  9. Study sites: 28 to 30v16
  10. Study sites: 27 to 28v15
  11. Study sites: 25 to 27v14
  12. Trial sites expanded: 20 → 23 locationsv13
  13. Study sites: 20 to 23v12
  14. Study sites: 19 to 20v11
  15. Trial sites expanded: 13 → 18 locationsv10
  16. Study sites: 13 to 18v9
  17. Study sites: 12 to 13v8
  18. Trial sites expanded: 9 → 12 locationsv7
  19. Study sites: 8 to 9v6
  20. Trial sites expanded: 5 → 8 locationsv5
  21. Trial sites expanded: 1 → 5 locations Start date changed from estimate of Mar 2026 to Mar 23, 2026v4 Show 1 more changeShow less
    • Start date changed from estimate of Mar 2026 to Mar 23, 2026
  22. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v3 Show 1 more changeShow less
    • Study sites: 0 to 1
  23. Enrollment target: 330 to 990v2
  24. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with non-active Secondary Progress MS. Patients will be treated for approximately 24 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.
Trial Details
NCT Number NCT07299019
Lead Sponsor Zenas BioPharma (USA), LLC
Conditions Secondary Progressive Multiple Sclerosis
Enrollment 990 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov