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Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria
Sponsor: Simon Francis Thomsen
Summary
This study is a multicentre, randomized, open-label, non-inferiority clinical trial. The purpose and aim of this study is to investigate if patients with well controlled (UCT score score ≥ 12) chronic spontaneous urticaria (CSU) on omalizumab 300 mg every four weeks can extend treatment intervals and maintain disease control.
Official title: Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria (EXOTIC Trial): a Multicentre, Randomized, Open-label, Non-inferiority Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-01-12
Completion Date
2025-12-31
Last Updated
2025-09-19
Healthy Volunteers
No
Interventions
omalizumab 300 mg every four weeks
Continue standard treatment with omalizumab 300 mg every four weeks from week 12 to week 36. Both arms are treated with omalizumab 300 mg from week 0 to week 12.
omalizumab 300 mg every six weeks
Treatment in an extended interval of omalizumab 300 mg every six weeks from week 12 to week 36. Both arms are treated with omalizumab 300 mg from week 0 to week 12.
Locations (1)
Department of Dermatology, Bispebjerg Hospital
Copenhagen, Copenhagen N, Denmark