NCT03926611

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 311 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Detailed description

This was a global Phase 2b multicenter, randomized, double-blind, parallel-group, placebo-controlled study investigating the efficacy, safety and tolerability of six dosing groups of oral LOU064 in subjects with inadequately controlled CSU despite treatment with (second generation) H1-antihistamine. The study comprised of the 7 treatment arms: LOU064 10 mg q.d., LOU064 35 mg q.d., LOU064 100 mg q.d., LOU064 10 mg b.i.d, LOU064 25 mg b.i.d., LOU064 100 mg b.i.d. and placebo.

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
DRUG	LOU064 Arm 1	10 mg LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85
DRUG	LOU064 Arm 2	35 mg of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85
DRUG	LOU064 Arm 3	100 mg of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85
DRUG	LOU064 Arm 4	10mg bid of LOU064 orally, twice daily from Day 1 to 85
DRUG	LOU064 Arm 5	25 mg bid of LOU064 orally, twice daily from Day 1 to 85
DRUG	LOU064 Arm 6	100 mg bid of LOU064 orally, twice daily from Day 1 to 85
DRUG	Placebo arm	Matching placebo, orally, twice daily from Day 1 to 85

Timeline

• Start date: 2019-06-06
• Primary completion: 2021-01-14
• Completion: 2021-04-15
• First posted: 2019-04-24
• Last updated: 2022-04-29
• Results posted: 2022-02-16

Locations

82 sites across 17 countries: United States, Argentina, Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Japan, Netherlands, Poland, Russia, Slovakia, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study