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An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 20 → 34 locations Eligibility criteria expanded, about 6 words · Secondary endpoints: details revised at 4 of 4 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 4 of 4 entries
  2. Study sites: 19 to 20v5
  3. Trial sites expanded: 11 → 19 locations Primary and study completion dates: Oct 27, 2031 to Oct 24, 2031v4 Show 1 more changeShow less
    • Primary and study completion dates: Oct 27, 2031 to Oct 24, 2031
  4. Trial sites expanded: 4 → 11 locationsv3
  5. Recruitment opened Trial sites expanded: 0 → 4 locations · Start date changed from estimate of Jul 9, 2026 to Jul 10, 2026v2 Show 2 more changesShow less
    • Trial sites expanded: 0 → 4 locations
    • Start date changed from estimate of Jul 9, 2026 to Jul 10, 2026
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of remibrutinib (LOU064) in adult participants with moderate to severe hidradenitis suppurativa (HS) who have completed either of the preceding Phase 3 studies, CLOU064J12301 or CLOU064J12302.
Trial Details
NCT Number NCT07665437
Lead Sponsor Novartis Pharmaceuticals
Conditions Hidradenitis Suppurativa
Enrollment 710 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov