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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 placebo controlled treatment period of 24 weeks, open-label treatment with remibrutinib period of 28 weeks, treatment free follow-up period of 4 weeks. 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


NCT number NCT05032157
Study type Interventional
Source Novartis
Contact Novartis Pharmaceuticals
Phone 1-888-669-6682
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date November 30, 2021
Completion date March 1, 2024

See also
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Recruiting NCT04612725 - A Study to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO) Phase 2
Active, not recruiting NCT04109313 - Open-label, Multicenter, Extension Study to Evaluate Long-term Safety and Tolerability of LOU064 in Subjects With CSU Phase 2
Active, not recruiting NCT03580369 - A Phase III Study of Efficacy and Safety of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines Phase 3
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Terminated NCT04159701 - A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria Phase 2
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Active, not recruiting NCT03580356 - A Phase III Study of Efficacy and Safety of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines. Phase 3