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 extension study by Novartis Pharmaceuticals evaluates the long-term efficacy, safety, and tolerability of remibrutinib in Chronic Spontaneous Urticaria (CSU) patients who completed prior Phase 3 trials. It includes a randomized withdrawal phase followed by open-label treatment cycles. The study aims to fulfill Novartis' post-trial access commitment. Participants are assessed based on Urticaria Activity Score over 7 days (UAS7) levels, with relapsed patients re-entering treatment cycles.

STUDY GOALS

The study aims to assess the long-term efficacy, safety, and tolerability of remibrutinib in Chronic Spontaneous Urticaria (CSU) patients who completed prior Phase 3 trials. It seeks to fulfill Novartis' commitment to post-trial access and provide valuable insights into the use of remibrutinib in managing CSU.

LOCATION

El Paso, Texas: Western Sky Medical Research

INCLUSION CRITERIA

  • Participants must provide written informed consent.

  • Male and female adults aged 18 years or older.

  • Participants who successfully completed prior core studies: CLOU064A2301, CLOU064A2302, CLOU064A1301, CLOU064A2304, or CLOU064A2305.

  • Willingness and ability to follow the study protocol and visit schedule.

exclusion criteria

  • Significant bleeding risk or coagulation disorders.

  • History of gastrointestinal bleeding.

  • Requirement for anti-platelet or anticoagulant medication.

  • History or current hepatic disease.

  • Evidence of clinically significant disorders across various body systems that may compromise safety, interfere with study interpretation, or hinder participation or protocol adherence.

For more information, visit ClinicalTrials.gov.