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Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 Weeks

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Primary and study completion moved earlier from Jul 17, 2028 to Jun 2, 2028 · Start date changed from estimate of Nov 9, 2026 to Sep 21, 2026 · Study sites: 0 to 1 Show 3 more changesShow less
    • Primary and study completion moved earlier from Jul 17, 2028 to Jun 2, 2028
    • Start date changed from estimate of Nov 9, 2026 to Sep 21, 2026
    • Study sites: 0 to 1
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
The purpose of this open-label study is to assess the efficacy and safety of a novel treatment algorithm for sequencing remibrutinib and omalizumab in the treatment of adult participants with chronic spontaneous urticaria (CSU) who are inadequately controlled by second-generation H1-antihistamines (sgH1-AH).
Trial Details
NCT Number NCT07816328
Lead Sponsor Novartis Pharmaceuticals
Conditions Chronic Spontaneous Urticaria
Enrollment 382 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov