Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Absolute difference in average Urticaria Control Test (UCT) score at week 36 — Through study completion, an average of 36 weeks
  The Urticaria Control Test (UCT) is a retrospective questionnaire that gathers information regarding the past 4 weeks. It consists of four questions, each with four possible answer options. A score ranging from 0 to 4 is assigned to each answer option. Consequently, the UCT score ranges from 0 to 16, with higher scores indicating lower control of the disease. A UCT score of 12 or higher suggests well-controlled urticaria, while a score of 16 indicates complete control.

Trial sites (1)

Other trials for the same condition