Vanderbilt Clinical Trials

• Participant must be ≥ 2 years to <12 years of age, at the time of signing the informed consent. - Participants who had history of a diagnosis of CSU prior to screening (Visit 1) or symptoms consistent with a diagnosis of CSU for at least 3 months in the Investigator's opinion. - Participants with CSU (characterized by recurrent itchy wheals with or without angioedema for >6 weeks) who remain symptomatic at the time of screening despite regular H1-antihistamine treatment. - Body weight within ≥5 kg to <60 kg. - Participant/parent(s)/caregiver(s)/participant's legally authorized representative, as appropriate, willing and able to comply with study visits and related procedures.

Participants were excluded from the study if any of the following criteria apply: - Underlying etiology for chronic urticarias other than CSU. - Presence of skin morbidities other than CSU that may interfere with the assessment of the study outcomes. - Participants with a diagnosis of chronic inducible cold urticaria. - Participants with active AD. - Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study. - Participants with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated. - Diagnosed with, suspected of, or at high risk of endoparasitic infection. - Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the screening visit or during the screening period. - Known or suspected immunodeficiency. - Active malignancy or history of malignancy within 5 years before the baseline visit. - History of systemic hypersensitivity or anaphylaxis to dupilumab including any excipient. - 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.