Molecular Endotypes of Chronic Idiopathic Urticaria

Last updated: August 13, 2024
Sponsor: University of Colorado, Denver
Overall Status: Active - Not Recruiting

Phase

4

Condition

Urticaria

Hives (Urticaria)

Treatment

Omalizumab

Clinical Study ID

NCT04774315
18-0850
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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 omalizumab as part of standard of care, to see if there are differences in their blood and skin that can predict who responds to treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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, orlevocetirizine 5mg daily)

  • Planned initiation of treatment with omalizumab (Xolair) as part of standard of carefor antihistamine-refractory urticaria

Exclusion

Exclusion Criteria:

  • 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

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: Omalizumab
Phase: 4
Study Start date:
January 01, 2022
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • University of Colorado Anschutz

    Aurora, Colorado 80045
    United States

    Site Not Available

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