Clinical Trial

Treatment Related to Antihistamines

Study 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

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

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

Additional Information

Official Study 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

Clinical Trial ID

NCT03926611

ParticipAid ID

dG6E5b