Real-World Study of Remibrutinib and Dupilumab Treatments in Adults with Chronic Spontaneous Urticaria

What this Trial Is About

Researchers are evaluating the real-world effectiveness and patient-centered outcomes of remibrutinib in adults with chronic spontaneous urticaria CSU, a condition characterized by spontaneous hives and itching. This prospective, non-interventional study compares patients starting remibrutinib treatment to those starting dupilumab, using validated patient reported outcome tools to measure results. The study is based in the United States and sponsored by Novartis Pharmaceuticals. Participants include adult patients diagnosed with CSU who have been prescribed remibrutinib or dupilumab and are expected to start treatment. The study observes two groups one receiving remibrutinib and the other dupilumab. The treatments are not administered by the study but are prescribed by healthcare providers as part of routine care. The study does not involve drug administration or placebo controls, focusing instead on real-world outcomes and patient satisfaction. During the study, participants use electronic devices to complete assessments including the Urticaria Control Test UCT-7 at baseline, week 1, and week 4 to measure symptom control. Treatment satisfaction is measured with the Treatment Satisfaction Questionnaire for Medication TSQM-9 at baseline and week 4. Researchers will monitor changes in these scores to understand treatment impact and patient satisfaction. The study requires participants to be able to read English and provide consent, with ongoing data collection continuing until the study ends in September 2026.

A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients