CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 229 enrolled
Drug / intervention
LOU064drug
Likely dose
LOU064 50mgfrom 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/NCT04109313
NCT04109313Phase 2Completed
CompareCT.gov

An Open-label, Multicenter, Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Eligible Subjects With CSU Who Have Participated in CLOU064A2201

Novartis Pharmaceuticals·interventional·Posted Sep 30, 2019·Updated Jun 20, 2024

In Brief

A Phase 2 clinical trial evaluating LOU064 for Chronic Spontaneous Urticaria. Completed, enrolled 229 participants across 69 sites in 15 countries.

Detailed Summary

The main objective to assess the long-term safety and tolerability of LOU064 in patients with chronic spontaneous urticaria (CSU) who have participated in study CLOU064A2201 (NCT03926611)

Study Details

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

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedSep 30, 2019
Enrollment StartOct 24, 2019
Primary CompletionSep 9, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 6.8 years ago

Interventions

LOU064drug

Participants with a UAS7≥16 at Week 12 or Week 16 in the CLOU064A2201, as well as participants who experienced a relapse during the 12-week observational period, were administered LOU064 50mg capsules b.i.d. (i.e. two capsules of LOU064 50mg in the morning and two capsules of LOU064 50mg in the evening) from Day 1 up to Week 52 of the Treatment period.