A Phase III Study of Efficacy and Safety of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines

  • STATUS
    Recruiting
  • End date
    Jun 16, 2022
  • participants needed
    1050
  • sponsor
    Novartis Pharmaceuticals
Updated on 9 June 2021
Investigator
Novartis Pharmaceuticals
Primary Contact
Novartis Investigative Site (8.7 mi away) Contact
+165 other location
antihistamines
omalizumab
urticaria
a 12
ligelizumab

Summary

The purpose of this study is to establish efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo.

The study population will consist of approximately 1050 male and female subjects aged 12 years who have been diagnosed with CSU and who remain symptomatic despite the use of H1-antihistamines. Of these, approximately 1000 adults and 50 adolescents are planned for inclusion in the study.

This is a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There is a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.

Details
Condition Chronic Idiopathic Urticaria, Chronic Spontaneous Urticaria
Treatment Placebo, omalizumab, Ligelizumab
Clinical Study IdentifierNCT03580369
SponsorNovartis Pharmaceuticals
Last Modified on9 June 2021

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