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 investigates the efficacy, safety, and tolerability of Remibrutinib compared to a placebo in adults with Chronic Inducible Urticaria (CINDU) inadequately controlled by H1-antihistamines. This study includes a site in El Paso, Texas, making it accessible for local participants.

STUDY GOALS

The primary aim is to evaluate if Remibrutinib can effectively manage CINDU symptoms. Secondary objectives include monitoring safety and tolerability.

LOCATION

El Paso, Texas: Western Sky Medical Research

INCLUSION CRITERIA for core period

  • Participants must be 18 years or older.

  • They must have a 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.

  • Specific positive response to 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 and 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.