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A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines — REMIX-1  

Chronic Spontaneous Urticaria Clinical Trial

Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of Remibrutinib (LOU064) to Investigate the Efficacy, Safety and Tolerability for 52 Weeks in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines

Clinical Trial Summary

The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) in adult participants suffering from chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines in comparison to placebo.

Clinical Trial Description

This is a global, multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase 3 study investigating the safety, tolerability, and efficacy of remibrutinib in adult participants with CSU inadequately controlled by second generation H1-antihistamines. Inadequate control of CSU by H1-antihistamines is defined as: - The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of second generation H1-antihistamines during this time period - UAS7 score (range 0-42) ≥ 16, ISS7 score (range 0-21) ≥ 6 and HSS7 score (range 0-21) ≥ 6 during the 7 days prior to randomization (Day 1). The study consists of four periods, the total study duration is up to 60 weeks. Screening period of up to 4 weeks, double-blind treatment period of 24 weeks, open-label treatment period of 28 weeks and 4 weeks of treatment-free follow up. Eligible participants will be randomly assigned to the treatment arms in a 2:1 ratio. The study population will consist of approximately 450 female and male adult participants (300 in the active arm and 150 in the placebo arm) with CSU inadequately controlled by second generation H1-antihistamines at least at locally label approved dose. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05030311
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 3
Start date November 30, 2021
Completion date January 19, 2024
View Details
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