LOU064 (blinded)
Sponsors
Novartis Pharmaceuticals
Conditions
Chronic Spontaneous Urticaria
Phase 3
A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1-antihistamines
CompletedNCT05032157
Start: 2021-12-01End: 2024-01-05Updated: 2025-04-08
An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib
Active, not recruitingNCT05513001
Start: 2022-12-09End: 2027-08-02Updated: 2026-03-11
24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
Active, not recruitingNCT05677451
Start: 2023-07-11End: 2032-03-30Updated: 2026-07-20