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A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines

NCT05976243 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 362

Last updated 2026-03-03

No results posted yet for this study

Summary

This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in patients with CINDU, with an optional Open-label Extension (OLE).

The purpose of the core period (52 weeks of treatment) of this study is to evaluate the efficacy, safety, and tolerability of remibrutinib (LOU064) vs. placebo in adults suffering from CINDU inadequately controlled by H1-antihistamines (H1-AHs).

The purpose of the OLE period is to collect long-term efficacy, safety, and tolerability data on remibrutinib in participants after having completed the Core period

Conditions

Interventions

DRUG

Remibrutinib

Remibrutinib treated groups and arms

OTHER

Placebo

Placebo treated groups and arms

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-12-07
Primary Completion
2026-05-22
Completion
2029-06-15
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • China
  • Colombia
  • France
  • Germany
  • Hong Kong
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Singapore
  • Slovakia
  • South Korea
  • Spain
  • Thailand
  • Turkey (Türkiye)
  • 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 NCT05976243 on ClinicalTrials.gov