A first randomized controlled trial, EXOTIC, is examining whether extending the dosing interval of omalizumab from 4 to 6 weeks can maintain disease control in chronic spontaneous urticaria. The trial aims to assess the impact of omalizumab administered every 6 weeks in comparison to the standard 4-week dosing regimen on disease control and cost-effectiveness.
The trial has enrolled 11 out of 39 patients and aims to complete recruitment by August 2025. The primary endpoint is the difference in Urticaria Control Test scores at week 36, with secondary outcomes including quality-of-life measures and the proportion of patients maintaining disease control.