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A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 14 words Secondary endpoints: details revised at 2 of 2 entries Show 1 more changeShow less
    • Secondary endpoints: details revised at 2 of 2 entries
  2. Trial sites expanded: 4 → 7 locationsv5
  3. Enrollment increased: 80 → 100 participants Study sites: 3 to 4v4 Show 1 more changeShow less
    • Study sites: 3 to 4
  4. Study sites: 1 to 3 Start date changed from estimate of Jul 29, 2026 to Jul 30, 2026v3 Show 1 more changeShow less
    • Start date changed from estimate of Jul 29, 2026 to Jul 30, 2026
  5. Recruitment opened Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Novartis
555 trials monitored
See 31 trials at risk
This Phase 2 study aims to evaluate whether Bruton's tyrosine kinase (BTK) inhibition with remibrutinib can produce a clinically meaningful reduction in inflammatory lesions in adults with moderate-to-severe papulopustular rosacea, while also assessing safety and tolerability of remibrutinib in this indication.
Trial Details
NCT Number NCT07681271
Lead Sponsor Novartis Pharmaceuticals
Conditions Papulopustular Rosacea
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov