An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib

STUDY OVERVIEW

This global, multicenter Phase 3b extension study by Novartis Pharmaceuticals aims to gather long-term efficacy, safety, and tolerability data on remibrutinib in adults with Chronic Spontaneous Urticaria (CSU), who completed the preceding Phase 3 studies. It comprises two epochs: the first includes a 24-week randomized withdrawal phase or open-label treatment, followed by subsequent 24-week cycles of observation or open-label retreatment with remibrutinib, based on participants' Urticaria Activity Score (UAS7) levels.

STUDY GOALS

The goal of this extension study is to assess the long-term efficacy, safety, and tolerability of remibrutinib in adults with Chronic Spontaneous Urticaria (CSU) who completed preceding Phase 3 studies, while also providing post-trial access as per Novartis commitment.

LOCATION

El Paso, Texas: Western Sky Medical Research

INCLUSION CRITERIA

  • Obtain written informed consent before assessments.

  • Adults aged 18 and above.

  • Successfully completed previous core studies: CLOU064A2301, CLOU064A2302, CLOU064A1301, CLOU064A2304, or CLOU064A2305.

  • Willing and able to follow the study protocol and visit schedule.

exclusion criteria

  • Significant bleeding risk or coagulation disorders.

  • History of gastrointestinal bleeding.

  • Need for anti-platelet medication.

  • Need for anticoagulant medication.

  • History or current hepatic disease.

  • Evidence of clinically significant conditions, as determined by the investigator, that could compromise safety, interfere with study interpretation, or hinder protocol adherence.

For more information, visit ClinicalTrials.gov.