At a glance
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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
In Brief
A Phase 3 clinical trial evaluating Dupilumab SAR231893, Placebo, and 1 other intervention for Cold Urticaria. Completed, enrolled 82 participants across 33 sites in 5 countries.
Detailed 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
Study Details
Timeline
Interventions
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Pharmaceutical form: Tablet Route of administration: Oral