CLOU064A2303B Enrolling

Chronic Spontaneous Urticaria Research Study – (24 Weeks)


Age: 18 Years



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The following information is from ClinicalTrials.gov

Last Update Posted: July 16, 2024

Official Title

A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal and Open-label Extension Study Followed by Long-term Open-label Treatment Cycles to Assess the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Chronic Spontaneous Urticaria Patients Who Completed the Preceding Remibrutinib Phase 3 Studies

ClinicalTrials.gov ID

NCT05513001

Sponsor

Novartis Pharmaceuticals

Study Description

  • Brief Summary:

    The purpose of this extension study is to collect long-term efficacy, safety and tolerability data on remibrutinib in a selected group of participants with Chronic Spontaneous Urticaria (CSU) who previously completed the treatment phase of remibrutinib preceding Phase 3 studies. This study will also fulfill the Novartis commitment to provide post-trial access to participants who have completed the preceding Phase 3 studies, where applicable.

  • Condition or Disease:

    Chronic Spontaneous Urticaria

  • Intervention/Treatment:

    Drug: LOU064 (blinded),Drug: LOU064 (open label) Drug: Placebo,Drug: LOU064 (open label) Drug: LOU064 (open label)
  • Phase:

    PHASE3

  • Ages Eligible for Study:

    18 Years and older (ADULT,OLDER_ADULT)

  • Sexes Eligible for Study:

    ALL


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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