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Be Part of Research - Trial Details - Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID)
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Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID)

Completed

Open to: ALL

Age: 6.0 - 80.0

London Manchester

Medical Conditions

Chronic Spontaneous Urticaria

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Primary Objective:

This study aimed to demonstrate the efficacy of dupilumab in study participants with CSU who remained symptomatic despite the use of H1 antihistamine (Study A and C: omalizumab naïve; Study B: omalizumab intolerant or incomplete responders)

Secondary Objectives:

This study aimed to demonstrate the efficacy of dupilumab on urticaria activity composite endpoint and itch or hives, separately, at various timepoints This study aimed to demonstrate the efficacy of dupilumab on angioedema This study aimed to demonstrate the efficacy of dupilumab on urticaria control This study aimed to demonstrate improvement in health-related quality of life and overall disease status and severity This study aimed to evaluate the ability of dupilumab in reducing the proportion of participants who require treatment with oral corticosteroids (OCS) This study aimed to evaluate safety outcome measures This study aimed to evaluate immunogenicity of dupilumab

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2019 Aug 2024

Publications

"Maurer M, Casale TB, Saini SS, Ben-Shoshan M, Laws E, Maloney J, Bauer D, Radin A, Makhija M. Dupilumab Reduces Urticaria Activity, Itch, and Hives in Patients with Chronic Spontaneous Urticaria Regardless of Baseline Serum Immunoglobulin E Levels. Dermatol Ther (Heidelb). 2024 Sep;14(9):2427-2441. doi: 10.1007/s13555-024-01231-y. Epub 2024 Jul 27."; "39066978"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Intervention Arm Group : Study A Dupilumab;Study B Dupilumab;Study C Dupilumab;

Intervention Type : DRUG
Intervention Description : Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Intervention Arm Group : Study A Placebo;Study B Placebo;Study C Placebo;

Intervention Type : DRUG
Intervention Description : Pharmaceutical form:Tablet Route of administration: oral administration

Intervention Arm Group : Study A Dupilumab;Study A Placebo;Study B Dupilumab;Study B Placebo;Study C Dupilumab;Study C Placebo;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Investigational Site Number : 8260002
    London
    London, City of
    E1 1BB
  • Investigational Site Number : 8260001
    Manchester
    M23 9QZ,


The study is sponsored by Sanofi and is in collaboration with Regeneron Pharmaceuticals.



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Read full details for Trial ID: NCT04180488
Last updated 18 August 2025

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