CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 71 enrolled
Drug / intervention
LOU064drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05048342
NCT05048342Phase 3Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted Sep 17, 2021·Updated Apr 8, 2025

In Brief

A Phase 3 clinical trial evaluating LOU064 for Chronic Spontaneous Urticaria. Completed, enrolled 71 participants across 13 sites.

Detailed Summary

The purpose of this study was to evaluate the safety, tolerability and efficacy of remibrutinib (LOU064) in adult Japanese patients chronic spontaneous urticaria (CSU), who remain symptomatic despite treatment by H1-antihistamine (H1-AH) at locally label approved doses, for a duration of 52 weeks of treatment with remibrutinib and a post-treatment follow-up period of up to 4 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Spontaneous Urticaria
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedSep 17, 2021
Enrollment StartJan 15, 2022
Primary CompletionDec 8, 2023
Study CompletionDec 9, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.8 years ago

Interventions

LOU064drug

Each patient took one film-coated tablet in the morning and one film-coated tablet in the evening (except the morning dose at the PK sampling visits, which were to be taken on site during the visit).