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

Conditions

• Cold Urticaria

Eligibility Criteria

Sex

ALL

Age

12 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Dupilumab SAR231893 — DRUG
  Pharmaceutical form: Injection solution Route of administration: Subcutaneous
• Placebo — DRUG
  Pharmaceutical form: Injection solution Route of administration: Subcutaneous
• Non sedating H1-antihistamine — DRUG
  Pharmaceutical form: Tablet Route of administration: Oral

Study Details

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

Key Dates

Start date

Dec 10, 2020

Status verified

Sep 2025

Primary completion

Feb 2, 2023

Completion

Apr 20, 2023

Study Design

Enrollment

82 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dupilumab
  Dose regimens, on top of regular or as needed non-sedating H1-antihistamine
• Placebo Comparator: Matched Placebo
  Placebo, on top of regular/as needed non-sedating H1-antihistamine

Primary Outcome Measure

Percentage of Participants With Negative Ice Cube Provocation Test at Week 24 [ Time Frame: Week 24 ]

Locations (5)

Find similar trials in San Diego, CA

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