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

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.