CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 311 enrolled
Drug / intervention
LOU064 Arm 1 +6 moredrug
Likely dose
LOU064 Arm 1 10 mgfrom 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/NCT03926611
NCT03926611Phase 2Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Placebo- Controlled Phase 2b Dose-finding Study to Investigate the Efficacy, Safety and Tolerability of LOU064 in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines

Novartis Pharmaceuticals·interventional·Posted Apr 24, 2019·Updated Apr 29, 2022

In Brief

A Phase 2 clinical trial evaluating LOU064 Arm 1, LOU064 Arm 2, and 5 other interventions for Chronic Spontaneous Urticaria. Completed, enrolled 311 participants across 82 sites in 17 countries.

Detailed Summary

This was a multicenter, randomized, double-blind and placebo-controlled phase 2b dose-finding study to assess the efficacy and safety of LOU064 in adults chronic spontaneous urticaria (CSU) patients inadequately controlled by H1-antihistamines

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Spontaneous Urticaria
CountriesArgentina, Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Japan, Netherlands, Poland, Russia, Slovakia, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 24, 2019
Enrollment StartJun 6, 2019
Primary CompletionJan 14, 2021
Study CompletionApr 15, 2021
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.2 years ago

Interventions

LOU064 Arm 1drug

10 mg LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85

LOU064 Arm 2drug

35 mg of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85

LOU064 Arm 3drug

100 mg of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85

LOU064 Arm 4drug

10mg bid of LOU064 orally, twice daily from Day 1 to 85

LOU064 Arm 5drug

25 mg bid of LOU064 orally, twice daily from Day 1 to 85

LOU064 Arm 6drug

100 mg bid of LOU064 orally, twice daily from Day 1 to 85

Placebo armdrug

Matching placebo, orally, twice daily from Day 1 to 85