Status:
ACTIVE_NOT_RECRUITING
Molecular Endotypes of Chronic Idiopathic Urticaria
Lead Sponsor:
University of Colorado, Denver
Conditions:
Chronic Urticaria, Idiopathic
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This study plans to learn more about why some people with Chronic Idiopathic Urticaria (CIU) respond to treatment with omalizumab (Xolair). It will test people before they receive treatment with omali...
Eligibility Criteria
Inclusion
- CIU as defined as frequent urticarial lesions for ≥ 6 weeks
- Symptoms not controlled with standard dose antihistamines (loratadine 10mg daily, desloratadine 5mg daily, fexofenadine 180mg daily, cetirizine 10mg daily, or levocetirizine 5mg daily)
- Planned initiation of treatment with omalizumab (Xolair) as part of standard of care for antihistamine-refractory urticaria
Exclusion
- Use of immunomodulatory drugs in the past 1 month prior to beginning the study
- Use of systemic steroids in the past 1 month prior to beginning the study
- Use of omalizumab in the past 3 months prior to beginning the study
- Use of any investigational agent in the past 30 days
- Untreated intercurrent illness
- Severe Asthma
- Primary diagnosis of flushing
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04774315
Start Date
January 1 2022
End Date
March 1 2025
Last Update
August 15 2024
Active Locations (1)
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1
University of Colorado Anschutz
Aurora, Colorado, United States, 80045