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A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)

Study acronym: FENopta
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion pushed from Dec 26, 2026 to Jun 30, 2027 Eligibility criteria expanded, about 19 words · Secondary endpoints: details revised at 5 of 6 entries · Publications: details revised at 1 of 1 entry Show 3 more changesShow less
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 5 of 6 entries
    • Publications: details revised at 1 of 1 entry
  2. Completion date: Dec 30, 2026 to Dec 26, 2026 Study sites revised (17)v34 Show 1 more changeShow less
    • Study sites revised (17)

    See this version in full on ClinicalTrials.gov ↗

  3. Eligibility criteria expanded, about 3 wordsv33 See this version in full on ClinicalTrials.gov ↗
  4. 3 versions Re-verified since Aug 8, 2025, no change to tracked fieldsv30-v32
  5. Completion date: Dec 2, 2026 to Dec 30, 2026v29
Show 27 earlier versionsHide 27 earlier versions
  1. Study sites revised (17)v28 See this version in full on ClinicalTrials.gov ↗
  2. 3 versions Re-verified since Jun 17, 2024, no change to tracked fieldsv25-v27
  3. Results first posted: Jun 12, 2024 Secondary endpoints: details revised at 2 of 6 entriesv24 Show 1 more changeShow less
    • Secondary endpoints: details revised at 2 of 6 entries
  4. Primary endpoint revised Secondary endpoints: 4 to 6v23 Show 1 more changeShow less
    • Secondary endpoints: 4 to 6

    See this version in full on ClinicalTrials.gov ↗

  5. 2 versions Re-verified since Dec 21, 2023, no change to tracked fieldsv21-v22
  6. Study sites revised (17)v20 See this version in full on ClinicalTrials.gov ↗
  7. Re-verified, no change to tracked fieldsv19
  8. Primary completion date changed from estimate of Mar 31, 2023 to Mar 29, 2023v18
  9. Re-verified, no change to tracked fieldsv17
  10. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 102 to confirmed 109 · Site details revised at 17 of 17 sitesv16 Show 2 more changesShow less
    • Enrollment target: estimated 102 to confirmed 109
    • Site details revised at 17 of 17 sites
  11. Primary completion date: Apr 1, 2023 to Mar 31, 2023 Completion date: Sep 26, 2024 to Dec 2, 2026 · Interventions: fenebrutinib (Drug), placebo (Drug) to Fenebrutinib (Drug), Placebo (Drug) · Eligibility criteria expanded, about 18 words · 2 morev15 Show 5 more changesShow less
    • Completion date: Sep 26, 2024 to Dec 2, 2026
    • Interventions: fenebrutinib (Drug), placebo (Drug) to Fenebrutinib (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints revised (4)
    • Primary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  12. Site details revised at 1 of 17 sitesv14
  13. Primary completion date: Nov 25, 2022 to Apr 1, 2023v13
  14. Study sites: 15 to 17v12
  15. Study sites: 12 to 15v11
  16. Study sites: 11 to 12v10
  17. Study sites: 9 to 11v9
  18. Study sites: 7 to 9v8
  19. Study sites: 5 to 7v7
  20. Study sites: 4 to 5v6
  21. Study sites: 3 to 4v5
  22. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date changed from estimate of Jan 28, 2022 to Mar 1, 2022v4 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of Jan 28, 2022 to Mar 1, 2022
  23. Re-verified, no change to tracked fieldsv3
  24. Start date: Nov 29, 2021 to Jan 28, 2022v2
  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.
This is a study evaluating the effect of fenebrutinib on brain magnetic resonance imaging (MRI) in participants with RMS. The safety and pharmacokinetics of fenebrutinib will also be evaluated. Participants will be randomized to receive either fenebrutinib or placebo. This study consists of two parts: Double-blind treatment (DBT) phase and an optional Open-label extension (OLE) phase.
Trial Details
NCT Number NCT05119569
Lead Sponsor Hoffmann-La Roche
Conditions Relapsing Multiple Sclerosis
Enrollment 109 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov