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LIBERTY-CSU CUPID

Published: 29 July 2021
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Two randomized, double-blind, placebo-controlled, multi‑center, parallel-group studies of dupilumab in patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite the use of H1 antihistamine treatment in patients naïve to omalizumab and in patients who are intolerant or incomplete responders to omalizumab

The purpose of the study is to evaluate how effective dupilumab is and how safe it is in reducing the signs and symptoms in participants with chronic spontaneous urticaria (CSU) who continue to have symptoms despite the use of H1-antihistamines (H1AH). 

The study is a multiple-centre study conducted worldwide which will last approximately 40 weeks and is planned to include approximately 234 participants in total. Out of them:

  • Around 130 participants, including approximately 6 adolescents (≥12 to ≤18 years) and approximately up to 6 children (≥6 to <12 years), have never received medication omalizumab (a monoclonal antibody [a type of protein] that blocks release of substances responsible for allergic reaction) for the treatment of CSU  
  • Around 104 participants, including approximately 5 adolescents, have previously been treated with omalizumab but could not tolerate this treatment or continued to have symptoms despite this treatment.

The study will be divided into 3 periods:

  1.  Screening Period (2 to 4 weeks) with at least 1 site visit to allow the study doctor to confirm if you are eligible to be included in this study.
  2.  Treatment Period (24 weeks) that starts with first study drug injection, with at least 3 site visits to assess treatment effect and safety.
  3.  Follow-up period (12 week) with 1 site visit to provide a safety follow-up of you after the study drug has been stopped.

Participants are expected to attend 5 study visits across the duration of the study. Additional visits may be required if the study doctor considers them necessary for your safety or if you decide you prefer to have the study drug administered by the study team on site. The study doctor will explain differences between study procedures and the usual medical care for your condition.