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A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis

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

Record History

The 50 most recent of 54 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Completion pushed from Feb 28, 2027 to Jul 21, 2027 Eligibility criteria expanded, about 45 words · Secondary endpoints: details revised at 2 of 9 entries · Site details revised at 7 of 190 sites Show 3 more changesShow less
    • Eligibility criteria expanded, about 45 words
    • Secondary endpoints: details revised at 2 of 9 entries
    • Site details revised at 7 of 190 sites
  2. Completion moved earlier from Jul 21, 2027 to Feb 28, 2027 Primary endpoint revised · Study sites revised (190)v53 Show 2 more changesShow less
    • Primary endpoint revised
    • Study sites revised (190)

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 189 to 190v52
  4. Study sites revised (189)v51 See this version in full on ClinicalTrials.gov ↗
  5. Site details revised at 2 of 189 sitesv50
Show 45 earlier versionsHide 45 earlier versions
  1. Site details revised at 2 of 189 sitesv49
  2. Study sites: 187 to 189v48
  3. Study sites: 189 to 187 Primary completion date: Jan 16, 2026 to Sep 17, 2025 · Completion date: Dec 18, 2026 to Jul 21, 2027v47 Show 2 more changesShow less
    • Primary completion date: Jan 16, 2026 to Sep 17, 2025
    • Completion date: Dec 18, 2026 to Jul 21, 2027
  4. Study sites: 190 to 189 Eligibility criteria expanded, about 28 words · Secondary endpoints revised (9)v46 Show 2 more changesShow less
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints revised (9)

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 193 to 190v45
  6. Study sites revised (193)v44 See this version in full on ClinicalTrials.gov ↗
  7. Study sites revised (193)v43 See this version in full on ClinicalTrials.gov ↗
  8. Site details revised at 2 of 193 sitesv42
  9. Study sites revised (193)v41 See this version in full on ClinicalTrials.gov ↗
  10. Site details revised at 1 of 193 sitesv40
  11. Study sites: 197 to 193v39
  12. Study sites: 199 to 197v38
  13. Study sites: 200 to 199v37
  14. Study sites: 201 to 200v36
  15. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 946 to confirmed 985 · Study sites: 223 to 201v35 Show 2 more changesShow less
    • Enrollment target: estimated 946 to confirmed 985
    • Study sites: 223 to 201
  16. Study sites: 215 to 223v34
  17. Study sites revised (215)v33 See this version in full on ClinicalTrials.gov ↗
  18. Study sites: 214 to 215 Interventions: fenebrutinib (Drug), ocrelizumab (Drug), placebo (Drug) to Fenebrutinib (Drug), Ocrelizumab (Drug), Placebo matched to fenebrutinib (Drug), Placebo matched to ocrelizumab (Drug) · Eligibility criteria expanded, about 143 wordsv32 Show 2 more changesShow less
    • Interventions: fenebrutinib (Drug), ocrelizumab (Drug), placebo (Drug) to Fenebrutinib (Drug), Ocrelizumab (Drug), Placebo matched to fenebrutinib (Drug), Placebo matched to ocrelizumab (Drug)
    • Eligibility criteria expanded, about 143 words

    See this version in full on ClinicalTrials.gov ↗

  19. Study sites: 212 to 214v31
  20. Study sites revised (212)v30 See this version in full on ClinicalTrials.gov ↗
  21. Study sites: 209 to 212v29
  22. Study sites: 207 to 209 Primary completion date: Oct 30, 2025 to Jan 16, 2026 · Completion date: May 17, 2028 to Dec 18, 2026v28 Show 2 more changesShow less
    • Primary completion date: Oct 30, 2025 to Jan 16, 2026
    • Completion date: May 17, 2028 to Dec 18, 2026
  23. Study sites: 199 to 207v27
  24. Study sites: 191 to 199v26
  25. Study sites: 181 to 191v25
  26. Study sites: 176 to 181v24
  27. Study sites: 168 to 176v23
  28. Study sites: 163 to 168v22
  29. Study sites: 157 to 163v21
  30. Study sites: 155 to 157v20
  31. Study sites: 152 to 155v19
  32. Study sites: 135 to 152v18
  33. Study sites: 132 to 135 Primary completion date: May 30, 2025 to Oct 30, 2025v17 Show 1 more changeShow less
    • Primary completion date: May 30, 2025 to Oct 30, 2025
  34. Study sites: 118 to 132v16
  35. Study sites: 106 to 118v15
  36. Study sites: 94 to 106v14
  37. Study sites: 85 to 94v13
  38. Study sites: 70 to 85v12
  39. Study sites: 52 to 70v11
  40. Study sites: 46 to 52v10
  41. Study sites: 32 to 46v9
  42. Study sites: 24 to 32v8
  43. Study sites: 15 to 24v7
  44. Study sites: 10 to 15v6
  45. Study sites: 16 to 10v5
  • 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.
A study to evaluate the efficacy and safety of fenebrutinib on disability progression in adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible participants will be randomized 1:1 to either daily oral fenebrutinib (and placebo) or intravenous (IV) ocrelizumab (and placebo) in a blinded fashion through an interactive voice or web-based response system (IxRS). 985 participants were enrolled and recruited globally. Participants who discontinue study medication early or discontinue from the study will not be replaced. The Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.
Trial Details
NCT Number NCT04544449
Lead Sponsor Hoffmann-La Roche
Conditions Multiple Sclerosis, Primary Progressive
Enrollment 985 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov