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

  • STATUS
    Recruiting
  • End date
    May 9, 2023
  • participants needed
    78
  • sponsor
    Sanofi
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Updated on 29 July 2022
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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

Description

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

Details
Condition Cold Urticaria
Treatment Placebo, Dupilumab SAR231893, non sedating H1-antihistamine
Clinical Study IdentifierNCT04681729
SponsorSanofi
Last Modified on29 July 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Participant must be ≥12 years to 80 years of age inclusive at the time of signing the informed consent
Participants who have 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

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 adversely affect 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 omalizumab or any biologic therapy, including any excipients
Participation in prior dupilumab clinical study, or have been treated with commercially available dupilumab
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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