Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07067463 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 65 to 67
  2. Study sites: 63 to 65 Eligibility criteria expanded, about 16 words · Secondary endpoints: details revised at 2 of 12 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 2 of 12 entries
  3. Study sites: 62 to 63v33
  4. Study sites: 61 to 62v32
  5. Study sites: 59 to 61v31
  6. Study sites: 58 to 59v30
  7. Trial sites expanded: 55 → 58 locationsv29
  8. Trial sites expanded: 50 → 53 locationsv28
  9. Study sites: 50 to 53v27
  10. Study sites: 48 to 50v26
  11. Study sites: 47 to 48v25
  12. Study sites: 46 to 47v24
  13. Study sites: 45 to 46v23
  14. Study sites: 44 to 45v22
  15. Study sites: 42 to 44v21
  16. Study sites: 41 to 42v20
  17. Trial sites expanded: 34 → 40 locationsv19
  18. Study sites: 34 to 40v18
  19. Study sites: 33 to 34v17
  20. Trial sites expanded: 27 → 32 locationsv16
  21. Study sites: 27 to 32v15
  22. Study sites: 25 to 27v14
  23. Study sites: 24 to 25v13
  24. Study sites: 23 to 24v12
  25. Study sites: 21 to 23v11
  26. Trial sites expanded: 17 → 21 locationsv10
  27. Study sites: 16 to 17v9
  28. Study sites: 15 to 16v8
  29. Study sites: 14 to 15v7
  30. Study sites: 12 to 14v6
  31. Study sites: 11 to 12v5
  32. Study sites: 9 to 11v4
  33. Study sites: 2 to 9 Start date changed from estimate of Dec 2025 to Mar 23, 2026v3 Show 1 more changeShow less
    • Start date changed from estimate of Dec 2025 to Mar 23, 2026
  34. Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd. to Zenas BioPharma (USA), LLC Trial status: Not Yet Recruiting to Recruiting · Start date: Sep 2025 to Dec 2025 · Study sites: 0 to 2v2 Show 3 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 2025 to Dec 2025
    • Study sites: 0 to 2
  35. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 PPMS. Patients will be treated for approximately 30 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 705 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.
Trial Details
NCT Number NCT07067463
Lead Sponsor Zenas BioPharma (USA), LLC
Conditions Multiple Sclerosis (MS) Primary Progressive
Enrollment 705 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov