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

Investigating the Effectiveness of an Investigational Medication for Cold-Induced Urticaria

Not Recruiting
12 years - 80 years
All
Phase 3
82 participants needed

Study Overview

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

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cold Urticaria
  • Age: 12 years - 80 years
  • Gender: All

Inclusion Criteria:

  • Participant had to be ≥12 years to 80 years of age inclusive at the time of signing the informed consent
  • Participants who had a diagnosis of primary acquired chronic inducible ColdU defined as recurrence of itchy wheals and/or angioedema due to cold for longer than 6 weeks prior to screening visit (Visit 1)
  • Participants with positive ice cube provocation test, ie, presenting at least a confluent hive/wheal on the exposed skin area, at the screening visit (Visit 1) and randomization visit (Visit 2)
  • Participants meeting at least 1 of the following criteria despite regular/daily or as needed use of H1-antihistamine (AH):
    • Urticaria Control Test (UCT) (4 item) <12 at the screening visit (Visit 1) and randomization visit (Visit 2)
    • Within 6 months prior to the screening visit, documented medical history of cold exposure triggered anaphylaxis or oropharyngeal edema
    • Within 6 months prior to the screening visit, documented medical history of cold exposure triggered urticaria requiring emergency medical care visit or treatment with epinephrine
  • Participants using a study defined H1-antihistamine regularly/daily or as needed for

    primary acquired chronic inducible cold urticaria

  • Body weight ≥30 kg

Exclusion Criteria:

Participants were excluded from the study if any of the following criteria applied:

  • Clearly defined underlying etiology for urticaria other than primary acquired chronic inducible ColdU
  • Presence of skin morbidities other than cold urticaria that may interfere with the assessment of the study outcomes
  • Active atopic dermatitis
  • Severe concomitant illness(es) that, in the investigator's judgment, would have adversely affected the patient's participation in the study
  • Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated.
  • Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection
  • Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit and during the screening period
  • Known or suspected immunodeficiency
  • Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin
  • History of systemic hypersensitivity or anaphylaxis to any other biologic therapy or any of its excipients.
  • Participation in prior dupilumab clinical study, or have been treated with commercially available dupilumab.
        The above information was not intended to contain all considerations relevant to a
        patient's potential participation in a clinical trial.

Updated on 10 Feb 2025. Study ID: NCT04681729

This study investigates the effectiveness of an investigational medication in treating patients with chronic inducible cold urticaria (ColdU), a condition where exposure to cold triggers itchy hives or swelling. The purpose of this study is to see if the investigational medication can help control the symptoms of ColdU in participants who have not improved with standard antihistamine treatments.

Participants will receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will include regular assessments of symptoms such as hives, itching, and pain, as well as tests to determine the impact on quality of life and the need for additional treatments.

  • Who can participate: Participants aged 12 to 80 years with a diagnosis of ColdU for more than 6 weeks can join. They must have a positive ice cube provocation test and be using antihistamines regularly without adequate symptom control.
  • Study details: Participants will receive either the investigational medication or a placebo. They will undergo regular assessments to monitor symptoms and any changes in their condition. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.
  • Study timelines: The study will last 38 to 40 weeks.