A Safety and Efficacy Study of Remibrutinib in the Treatment of CSU in Japanese Adults Inadequately Controlled by H1-antihistamines — BISCUIT  

Chronic Spontaneous Urticaria Clinical Trial

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

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of remibrutinib (LOU064) in adult Japanese chronic spontaneous urticaria (CSU) participants inadequately controlled by second generation H1-antihistamines.

Clinical Trial Description

This is a Phase 3 multi-center, open-label, single arm study investigating the safety, tolerability and efficacy of remibrutinib in participants with CSU inadequately controlled by second generation H1-antihistamines. Inadequate control of CSU by second generation 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

• Urticaria Activity Score (UAS7) score (range 0-42) ≥ 16, Itch Severity Score (ISS7) score (range 0-21) ≥ 6 and Hives Severity Score (HSS7) score (range 0-21) ≥ 6 during the 7 days prior to baseline (Day 1).

The study consists of three periods, the total study duration is up to 60 weeks: screening period of up to 4 weeks, open-label treatment period of 52 weeks, and a treatment free follow-up period of 4 weeks. ;

Related Conditions & MeSH terms

• Chronic Spontaneous Urticaria
• Chronic Urticaria
• Urticaria

• NCT number: NCT05048342
• Study type: Interventional
• Source: Novartis
• Status: Completed
• Phase: Phase 3
• Start date: January 15, 2022
• Completion date: December 9, 2023