Master protocol of two randomized, double-blind, placebo controlled, multi center, parallel-group studies of dupilumab in patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite the use of H1 antihistamine treatment in patients naïve to omalizumab and in patients who are intolerant or incomplete responders to omalizumab - CUPID

Sanofi-aventis Recherche & Développement0 sites230 target enrollmentStarted: February 6, 2020Last updated: June 15, 2020

Overview

No summary available.

•\- Must be 12 to 80 years of age, at the time of signing the informed consent
•\- Participants who have a diagnosis of CSU refractory to H1 antihistamines (H1\-AH) at the 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 screening visit 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:
•In\-clinic UAS\> 4 prior to randomization
•Study A: omalizumab naïve, Study B; intolerant or incomplete responder to omalizumab
•\- Participants must be willing and able to complete a daily symptom eDiary for the duration of the study
•Are the trial subjects under 18? yes

•Participants are excluded from any of the studies if any of the following criteria apply:
•\- Weight is less than 30 kg
•\- Clearly defined 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
•\- Active atopic dermatitis
•\- Severe concomitant illness(es) that, in the investigator’s judgment, would adversely affect the patient’s participation in the study
•\- Active tuberculosis or non\-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis
•\- 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
•\- Known or suspected immunodeficiency

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