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 signingthe informed consent

• Participants who had a diagnosis of primary acquired chronic inducible ColdU definedas recurrence of itchy wheals and/or angioedema due to cold for longer than 6 weeksprior to screening visit (Visit 1)

• Participants with positive ice cube provocation test, ie, presenting at least aconfluent hive/wheal on the exposed skin area, at the screening visit (Visit 1) andrandomization visit (Visit 2)

• Participants meeting at least 1 of the following criteria despite regular/daily oras needed use of H1-antihistamine (AH):

• Urticaria Control Test (UCT) (4 item) <12 at the screening visit (Visit 1) andrandomization visit (Visit 2)

• Within 6 months prior to the screening visit, documented medical history ofcold exposure triggered anaphylaxis or oropharyngeal edema

• Within 6 months prior to the screening visit, documented medical history ofcold exposure triggered urticaria requiring emergency medical care visit ortreatment with epinephrine

• Participants using a study defined H1-antihistamine regularly/daily or as needed forprimary 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 acquiredchronic inducible ColdU

• Presence of skin morbidities other than cold urticaria that may interfere with theassessment of the study outcomes

• Active atopic dermatitis

• Severe concomitant illness(es) that, in the investigator's judgment, would haveadversely affected the patient's participation in the study

• Active tuberculosis or non-tuberculous mycobacterial infection, or a history ofincompletely treated tuberculosis unless documented adequately treated.

• Diagnosed active endoparasitic infections; suspected or high risk of endoparasiticinfection

• Active chronic or acute infection requiring treatment with systemic antibiotics,antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visitand 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 andresolved non-metastatic squamous or basal cell carcinoma of the skin

• History of systemic hypersensitivity or anaphylaxis to any other biologic therapy orany of its excipients.

• Participation in prior dupilumab clinical study, or have been treated withcommercially available dupilumab.

The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.