common.study.topics.clinical

Treatment Related to Antihistamines

common.study.values.description

Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines

This is 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

common.study.values.location

participant.ui.study.affiliations-map.online-study.header-virtual

participant.ui.study.affiliations-map.online-study.text

participant.ui.study.affiliations-map.legend.locations participant.ui.study.affiliations-map.legend.selected

common.study.values.methods

Pharmaceutical medication involved common.study.methods.has-drugs-yes
Recruiting patients only common.study.methods.is-healthy-yes

Drug - LOU064 Arm 1

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

Drug - LOU064 Arm 2

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

Drug - LOU064 Arm 3

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

Drug - LOU064 Arm 4

Low dose of LOU064 orally, twice daily from Day 1 to 85

Drug - LOU064 Arm 5

Medium dose of LOU064 orally, twice daily from Day 1 to 85

Drug - LOU064 Arm 6

High dose of LOU064 orally, twice daily from Day 1 to 85

Drug - Placebo arm

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

participant.views.study.view.additional

participant.views.study.view.scientific-title

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

common.study.values.clinical-trial-id

NCT03926611

participant.views.study.view.id

dG6E5b