Clinical Trial

Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria

Recruiting Phase 2
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Summary
The purpose of this study is to explore the effect and Mechanism of Action (MoA) of remibrutinib (LOU064) vs. placebo on clinical outcomes in participants with Chronic Urticaria (CU), including both Chronic Spontaneous Urticaria (CSU) and Chronic Inducible Urticaria (CINDU).
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2025-03-06; most recent amendment 2026-07-14.
Status change: Not Yet Recruiting → Recruiting 2025-05-27
Trial Details
NCT Number NCT06865651
Lead Sponsor Novartis Pharmaceuticals
Conditions Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
Enrollment 44 participants
Start Date 2025-05-22
Primary Completion 2027-08-23 (estimated)
Study Completion 2027-09-28 (estimated)
Updated on ClinicalTrials.gov 2026-07-15