Remibrutinib Open Label Roll-over Post-trial Access Protocol

StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Trial sites expanded: 40 → 43 locations
    • Enrollment target: 648 to 650
    • Eligibility criteria expanded, about 6 words
  2. Study sites: 40 to 42
  3. Study sites: 39 to 40
    • Eligibility criteria expanded, about 4 words
  4. Trial sites expanded: 36 → 39 locationsv11
  5. Trial sites expanded: 33 → 36 locationsv10
  6. Trial sites expanded: 26 → 33 locationsv9
  7. Enrollment increased: 212 → 648 participants
    • Trial sites expanded: 13 → 26 locations
    v8
  8. Trial sites expanded: 7 → 13 locationsv7
  9. Study sites: 6 to 7v6
  10. Study sites: 4 to 6v5
  11. Study sites: 3 to 4v4
  12. Study sites: 1 to 3v3
  13. Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 10, 2026 to Apr 16, 2026
    v2
  14. Study First Submitted
  • 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.
Novartis
556 trials monitored
See 32 trials at risk
Multi-center, open-label roll-over post-trial access protocol to provide remibrutinib treatment and collect long-term safety for up to three years for participants who are currently receiving remibrutinib treatment in a Novartis-sponsored study, who are benefiting from treatment with remibrutinib, and are unable to access remibrutinib treatment outside of a clinical study.
Trial Details
NCT Number NCT07456891
Lead Sponsor Novartis Pharmaceuticals
Conditions
(from sponsor)		 Indication of the Parent Protocol
Enrollment 650 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov