Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria (EXOTIC Trial): a Multicentre, Randomized, Open-label, Non-inferiority Trial

What this Trial Is About

Researchers are evaluating whether patients with well-controlled chronic spontaneous urticaria (CSU) who are receiving omalizumab 300 mg every four weeks can safely extend their treatment intervals while maintaining disease control. This open-label, randomized, non-inferiority trial focuses on people with CSU who have a Urticaria Control Test (UCT) score of 12 or higher, indicating well-controlled symptoms. The study is designed to compare two dosing schedules to better understand the optimal treatment frequency for maintaining control of CSU. Participants initially receive omalizumab 300 mg every four weeks for 12 weeks. After this period, those who meet the criteria are randomly assigned to one of two groups: one continues with the standard treatment of omalizumab 300 mg every four weeks for an additional 24 weeks, while the other receives omalizumab 300 mg every six weeks for 24 weeks. Both treatment schedules aim to assess if extending the interval affects disease control. Throughout the study, participants undergo regular assessments including UCT scoring at weeks 24 and 36 to measure urticaria control. Researchers also monitor weekly urticaria activity scores, quality of life indexes, the occurrence of symptom flares, and any adverse events. The primary outcome is the difference in average UCT scores at week 36. The total participation lasts about 36 weeks, during which safety and efficacy of the extended dosing interval are closely observed.

Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria