At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 470 enrolled
Drug / intervention
LOU064 25 mg (b.i.d) +2 moredrug
Likely dose
LOU064 25 mg (b.i.d)from 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.
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
In Brief
A Phase 3 clinical trial evaluating LOU064 25 mg (b.i.d), Placebo, and 1 other intervention for Chronic Spontaneous Urticaria. Completed, enrolled 470 participants across 112 sites in 19 countries.
Detailed Summary
The purpose of this study was 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Spontaneous Urticaria
CountriesArgentina, Australia, Bulgaria, Colombia, Czechia, France, Hungary, India, Italy, Japan, Mexico, Puerto Rico, Russia, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedSep 2021
Enrollment StartNov 2021
Primary CompletionDec 2023
Study CompletionJan 2024
TodayJul 2026
First PostedSep 1, 2021
Enrollment StartNov 30, 2021
Primary CompletionDec 27, 2023
Study CompletionJan 19, 2024
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 4.8 years ago
Interventions
LOU064 25 mg (b.i.d)drug
LOU064 25 mg was administered by oral route twice a day (b.i.d) as a tablet.
Placebodrug
Placebo
LOU064 25 mg (b.i.d) as a tablet.drug
LOU064 25 mg was administered by oral route twice a day (b.i.d) as a tablet in open label phase.