NCT04681729

Dupilumab for the Treatment of Chronic Inducible Cold Urticaria in Patients Who Remain Symptomatic Despite the Use of H1-antihistamine (LIBERTY-CINDU CUrIADS)

A Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel-group Study of Dupilumab in Patients With Chronic Inducible Cold Urticaria Who Remain Symptomatic Despite the Use of H1-antihistamine Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 12 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To demonstrate the efficacy of dupilumab in adult and adolescent participants with primary acquired chronic inducible cold urticaria (ColdU) who remain symptomatic despite the use of an H1-antihistamine Secondary Objectives: To demonstrate the efficacy of dupilumab on primary acquired chronic inducible ColdU disease control To demonstrate the efficacy of dupilumab on primary acquired chronic inducible ColdU local signs and symptoms (hives/wheals, itch, burning sensation and pain) after provocation test To demonstrate the efficacy of dupilumab on primary acquired chronic inducible ColdU disease activity To demonstrate improvement in health-related quality-of-life and overall disease status and severity To evaluate the ability of dupilumab in reducing the proportion of participants who require rescue therapy To evaluate the proportion of participants with cold exposure triggered urticaria To evaluate safety outcome measures 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

• Cold 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

Timeline

• Start date: 2020-12-10
• Primary completion: 2023-02-02
• Completion: 2023-04-20
• First posted: 2020-12-23
• Last updated: 2025-09-10
• Results posted: 2024-02-21

Locations

33 sites across 5 countries: United States, Argentina, Canada, Germany, Japan

Regulatory

• FDA-regulated drug study