Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria (EXOTIC Trial): a Multicentre, Randomized, Open-label, Non-inferiority Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• A diagnosis of CSU according to the EAACI/GA2LEN/EDF/WAO guidelines.
• Age ≥ 18 years.
• Omalizumab-naïve prior to initiating treatment with omalizumab.
• Background treatment with four antihistamines daily.
• Candidate for omalizumab treatment according to Danish guidelines.
Locations
Other Locations
Denmark
Department of Dermatology, Bispebjerg Hospital
RECRUITING
Copenhagen
Contact Information
Primary
Simon F Thomsen, MD, DMSc
simon.francis.thomsen.02@regionh.dk
+4526139838
Backup
Ditte G Zhang, MD
DZHA0006@regionh.dk
+4520994864
Time Frame
Start Date: 2024-01-12
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 40
Treatments
Active_comparator: omalizumab 300 mg every six weeks
20 subjects are randomized to receive omalizumab 300 mg every six weeks from week 12 to week 36.
Active_comparator: omalizumab 300 mg every four weeks
20 subjects are randomized to receive omalizumab 300 mg every four weeks from week 12 to week 36.
Related Therapeutic Areas
Sponsors
Leads: Simon Francis Thomsen
Collaborators: Aarhus University Hospital