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

NCT05030311 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 470

Last updated 2025-04-08

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2023-12-27
Completion
2024-01-19
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Bulgaria
  • Colombia
  • Czechia
  • France
  • Hungary
  • India
  • Italy
  • Japan
  • Mexico
  • Puerto Rico
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05030311 on ClinicalTrials.gov