A STUDY TO INVESTIGATE EFFICACY, SAFETY, AND TOLERABILITY OF REMIBRUTINIB COMPARED WITH PLACEBO IN ADULTS WITH CINDU INADEQUATELY CONTROLLED BY H1-ANTIHISTAMINES

STUDY OVERVIEW

This clinical trial, sponsored by Novartis Pharmaceuticals, aims to evaluate the efficacy, safety, and tolerability of Remibrutinib compared to a placebo in adults with Chronic Inducible Urticaria (CINDU) that is inadequately controlled by H1-antihistamines. The study includes a site in El Paso, Texas, making it accessible for local participants.

STUDY GOALS

  • Primary Objective: Determine if Remibrutinib effectively manages CINDU symptoms.

  • Secondary Objectives: Monitor the safety and tolerability of Remibrutinib.

LOCATION

INCLUSION CRITERIA FOR CORE PERIOD

  • Participants must be 18 years or older.

  • Confirmed diagnosis of symptomatic dermographism, cold urticaria, or cholinergic urticaria for at least 4 months.

  • Inadequate control with standard antihistamine medication at the time of enrollment.

  • Positive response to specific provocation tests for each subtype of urticaria.

    • Positive ice-cube test for cold urticaria at screening.

    • Presence of sweating during the pulse-controlled ergometry test for cholinergic urticaria.

INCLUSION CRITERIA FOR OPEN-LABEL EXTENSION (OLE)

  • Participants who completed the Core period up to Week 52 are willing to continue.

EXCLUSION CRITERIA FOR CORE PERIOD

  • Previous use of Remibrutinib or similar drugs.

  • Concurrent chronic spontaneous urticaria (CSU) at screening.

  • Familial forms of the target urticaria.

  • Other specific types of urticaria or skin diseases that might affect study results.

There are no exclusion criteria for the Open-Label Extension.

For more information, visit ClinicalTrials.gov.