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 and swelling that can last for months or years. Dupilumab is an injected antibody that blocks two key immune proteins (IL-4 and IL-13) that drive inflammation. By quieting this specific immune pathway, the drug may provide relief from the persistent itching and hives that standard antihistamines cannot control.
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