NCT05916937

Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Simon Francis Thomsen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Newly referred patients with CSU who are well-treated (UCT score ≥ 12) 12 weeks after initiating standard treatment with omalizumab 300 mg every four weeks, are randomized into two treatment arms.The first arm will continue standard treatment with omalizumab 300 mg every four weeks for 24 weeks. The second arm will receive treatment in an extended interval of omalizumab 300 mg every six weeks for 24 weeks.

Conditions

• Chronic Spontaneous Urticaria
• Chronic Urticaria, Idiopathic

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2024-01-12
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-06-23
• Last updated: 2025-09-19

Locations

1 site across 1 country: Denmark