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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

NCT05032157 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 455

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 25 mg b.i.d. in adult patients suffering from chronic spontaneous urticaria (CSU) inadequately controlled by second generation H1-antihistamines (H1-AHs) in comparison to placebo.

Conditions

Interventions

DRUG

LOU064 (blinded)

LOU064 (blinded) active treatment

DRUG

Placebo

Placebo

DRUG

LOU064 (open-label)

LOU064 (open-label) active treatment

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2023-12-18
Completion
2024-01-05
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Brazil
  • Canada
  • China
  • Denmark
  • Germany
  • India
  • Malaysia
  • Poland
  • Russia
  • Slovakia
  • South Africa
  • Switzerland
  • Taiwan
  • Thailand
  • United Kingdom
  • Vietnam

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 NCT05032157 on ClinicalTrials.gov