for chronic spontaneous urticaria in children
FDA approved Dupixent (dupilumab) for children aged two to 11 years with chronic spontaneous urticaria who remain symptomatic despite antihistamine treatment.
Chronic spontaneous urticaria is a skin condition causing unpredictable, itchy hives that can last for months or years, often disrupting sleep and daily activities. Dupixent (dupilumab) blocks two key immune signals (IL-4 and IL-13) that drive inflammation and allergy responses. By quieting this overactive immune pathway, Dupixent may reduce hives and itching in children who don't respond to standard antihistamines.
Primary Objective: This study aimed to demonstrate the efficacy of dupilumab in study participants with CSU who remained symptomatic despite the use of H1 antihistamine (Study A and C: omalizumab naïve; Study B: omalizumab intolerant or incomplete responders) Secondary Objectives: This study aimed to demonstrate the efficacy of dupilumab on urticaria activity composite endpoint and itch or hives, separately, at various timepoints This study aimed to demonstrate the efficacy of dupilumab on...
Source: ClinicalTrials.gov