Last updated on June 2019

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


Brief description of study

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.

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.

Clinical Study Identifier: NCT03580356

Find a site near you

Start Over

Novartis Investigative Site

Birmingham, AL United States
  Connect »

Novartis Investigative Site

Los Angeles, CA United States
  Connect »

Novartis Investigative Site

Sarasota, FL United States
  Connect »

Novartis Investigative Site

Wheaton, MD United States
  Connect »

Novartis Investigative Site

White Marsh, MD United States
  Connect »

Novartis Investigative Site

Brighton, MA United States
  Connect »

Novartis Investigative Site

Rochester, MN United States
  Connect »

Novartis Investigative Site

Saint Louis, MO United States
  Connect »

Novartis Investigative Site

Missoula, MT United States
  Connect »

Novartis Investigative Site

Papillion, NE United States
  Connect »

Novartis Investigative Site

Clackamas, OR United States
  Connect »

Novartis Investigative Site

Blue Bell, PA United States
  Connect »

Novartis Investigative Site

North Charleston, SC United States
  Connect »

Novartis Investigative Site

Bellaire, TX United States
  Connect »

Novartis Investigative Site

El Paso, TX United States
  Connect »

Novartis Investigative Site

Fort Worth, TX United States
  Connect »

Novartis Investigative Site

Houston, TX United States
  Connect »

Novartis Investigative Site

San Antonio, TX United States
  Connect »

Novartis Investigative Site

Bellingham, WA United States
  Connect »

Novartis Investigative Site

East Melbourne, Australia
  Connect »

Novartis Investigative Site

Clermont Ferrand cedex 1, France
  Connect »

Novartis Investigative Site

Bergen op Zoom, Netherlands
  Connect »

Novartis Investigative Site

Chelyabinsk, Russian Federation
  Connect »

Novartis Investigative Site

Kazan, Russian Federation
  Connect »

Novartis Investigative Site

Moscow, Russian Federation
  Connect »

Novartis Investigative Site

Saint Petersburg, Russian Federation
  Connect »

Novartis Investigative Site

St Petersburg, Russian Federation
  Connect »

Novartis Investigative Site

St.-Petersburg, Russian Federation
  Connect »

Novartis Investigative Site

Stavropol, Russian Federation
  Connect »

Novartis Investigative Site

Povazska Bystrica, Slovakia
  Connect »

Novartis Investigative Site

Pozuelo de Alarcon, Spain
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.