A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU) (LIBERTY-CSU CUPIDKids)

Inclusion Criteria

• Participant must be ≥ 2 years to 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.

Exclusion Criteria

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.