CLOU064F12301 Enrolling

Chronic Spontaneous Urticaria Research Trial – (28 Weeks)


Age: 12 Years



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Chile

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The following information is from ClinicalTrials.gov

Last Update Posted: July 16, 2024

Official Title

A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy, Pharmacokinetics and Safety of Remibrutinib (LOU064) for 24 Weeks in Adolescents From 12 to Less Than 18 Years of Age With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Followed by an Optional Open-label Extension for up to Another 3 Years and an Optional Safety Long-term Treatment-free Follow-up Period for up to an Additional 3 Years

ClinicalTrials.gov ID

NCT05677451

Sponsor

Novartis Pharmaceuticals

Study Description

  • Brief Summary:

    The purpose of this trial is: 1. to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to \< 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by H1-antihistamines 2. to collect long-term efficacy, safety and tolerability data on remibrutinib in adolescents after having completed 24 weeks of treatment 3. to collect safety data in this population for up to three years after the last dose of study treatment

  • Condition or Disease:

    Chronic Spontaneous Urticaria

  • Intervention/Treatment:

    Drug: LOU064 (blinded) Drug: placebo
  • Phase:

    PHASE3

  • Ages Eligible for Study:

    12 Years and 17 Years (CHILD)

  • 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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