NCT04180488

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)

Master Protocol of Three 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 397 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 6 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The duration of study for each participant included 2-4 weeks of screening period, 24 weeks of treatment period and 12 weeks of post treatment period.

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
DRUG	Dupilumab SAR231893	Pharmaceutical form:Injection solution Route of administration: Subcutaneous
DRUG	Placebo	Pharmaceutical form:Injection solution Route of administration: Subcutaneous
DRUG	non sedating H1-antihistamine	Pharmaceutical form:Tablet Route of administration: oral administration

Timeline

• Start date: 2019-12-11
• Primary completion: 2024-08-01
• Completion: 2024-10-25
• First posted: 2019-11-27
• Last updated: 2025-08-20
• Results posted: 2025-08-20

Locations

98 sites across 11 countries: United States, Argentina, Canada, China, France, Germany, Hungary, Japan, Russia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study