NCT05030311

A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of Remibrutinib (LOU064) to Investigate the Efficacy, Safety and Tolerability for 52 Weeks in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 470 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) in adult participants suffering from chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines in comparison to placebo.

Detailed description

This was a global Phase III multi-centered, randomized,double-blind, parallel-group, placebo-controlled study investigating the safety, tolerability, and efficacy of remibrutinib (25 mg b.i.d.) in adult patients with CSU inadequately controlled by second generation H1-antihistamines (H1-AHs). The study consisted of four periods, the total study duration was up to 60 weeks: Screening period of up to 4 weeks, Double-blind placebo-controlled treatment period of 24 weeks, Open-label treatment period with remibrutinib period of 28 weeks, and treatment-free follow-up period of 4 weeks. The planned sample size was approximately 450 patients randomized in 2:1 ratio to remibrutinib or placebo arm (300 in the remibrutinib arm and 150 in placebo arm).

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
DRUG	LOU064 25 mg (b.i.d)	LOU064 25 mg was administered by oral route twice a day (b.i.d) as a tablet.
DRUG	Placebo	Placebo
DRUG	LOU064 25 mg (b.i.d) as a tablet.	LOU064 25 mg was administered by oral route twice a day (b.i.d) as a tablet in open label phase.

Timeline

• Start date: 2021-11-30
• Primary completion: 2023-12-27
• Completion: 2024-01-19
• First posted: 2021-09-01
• Last updated: 2025-04-08
• Results posted: 2024-12-02

Locations

112 sites across 19 countries: United States, Argentina, Australia, Bulgaria, Colombia, Czechia, France, Hungary, India, Italy, Japan, Mexico, Puerto Rico, Russia, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study