At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 455 enrolled
Drug / intervention
LOU064 (blinded) +2 moredrug
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.
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 (blinded), Placebo, and 1 other intervention for Chronic Spontaneous Urticaria. Completed, enrolled 455 participants across 122 sites in 18 countries.
Detailed Summary
The purpose of this study was to establish the efficacy, safety, and tolerability of Remibrutinib 25 mg b.i.d. in adult patients suffering from chronic spontaneous urticaria (CSU) inadequately controlled by second generation H1-antihistamines (H1-AHs) in comparison to placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Spontaneous Urticaria
CountriesAustria, Brazil, Canada, China, Denmark, Germany, India, Malaysia, Poland, Russia, Slovakia, South Africa, Switzerland, Taiwan, Thailand, United Kingdom, United States, Vietnam
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedSep 2021
Enrollment StartDec 2021
Primary CompletionDec 2023
Study CompletionJan 2024
TodayJul 2026
First PostedSep 2, 2021
Enrollment StartDec 1, 2021
Primary CompletionDec 18, 2023
Study CompletionJan 5, 2024
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 4.8 years ago
Interventions
LOU064 (blinded)drug
LOU064 (blinded) active treatment
Placebodrug
Placebo
LOU064 (open-label)drug
LOU064 (open-label) active treatment