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

STUDY GOALS

Primary Aim: Assess the long-term efficacy, safety, and tolerability of remibrutinib in CSU patients who completed prior Phase 3 trials.

Secondary Goals: Provide insights into the management of CSU with remibrutinib and fulfill Novartis' post-trial access commitment.

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.

  • Successful completion of 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.