Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID)

Inclusion Criteria:

• Study A and C: Participant must be ≥6 years to 80 years of age at the time ofsigning the informed consent.

• Study B: Participant must be ≥12 years (or the minimum legal age for adolescents inthe country of the investigational site) to 80 years of age at the time of signingthe informed consent

• Participants who have a diagnosis of CSU refractory to H1 antihistamines (H1-AH) atthe time of randomization defined by

• Diagnosis of CSU>6 months prior to screening visit

• Presence of itch and hives for >6 consecutive weeks at any time prior to screeningvisit despite the use of H1-AH during this time period

• Using a study defined H1-antihistamine for CSU treatment

• During the 7 days before randomization:

UAS7≥16 ISS7≥ 8

• Study A and C: omalizumab naïve, Study B; intolerant or incomplete responder toomalizumab

• Participants must be willing and able to complete a daily symptom e-Diary for theduration of the study

Exclusion Criteria:

Participants are excluded from any of the studies if any of the following criteria apply:

• Weight is less than 30 kg in adults and adolescents and 15 kg in children aged 6to<12years

• Clearly defined underlying etiology for chronic urticarias other than CSU

• Presence of skin morbidities other than CSU that may interfere with the assessmentof the study outcomes

• Active atopic dermatitis

• Severe concomitant illness(es) that, in the investigator's judgment, would adverselyaffect 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 omalizumab or any biologictherapy, including any excipients

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

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