Molecular Endotypes of Chronic Idiopathic Urticaria

Chronic Urticaria, Idiopathic Clinical Trial

Official title:

Molecular Endotypes of Chronic Idiopathic Urticaria

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04774315
• Other study ID #: 18-0850
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2022
• Est. completion date: March 2025

Study information

• Verified date: March 2022
• Source: University of Colorado, Denver
• Contact: Jenny Stitt, M.D.
• Phone: 303-724-1111
• Email: clinicalresearchsupportcenter[@]ucdenver.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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, or levocetirizine 5mg daily)

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

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

Related Conditions & MeSH terms

• Chronic Urticaria
• Chronic Urticaria, Idiopathic
• Urticaria

Intervention

Drug:
• Omalizumab
omalizumab 300mg SQ every 4 weeks as part of standard of care

Locations

Country	Name	City	State
United States	University of Colorado Anschutz	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responders	The number of participants who meet the definition of "Responder" to omalizumab. "Responders" are defined as having a UAS7 of 6 or less after 16 weeks of treatment.	Week 16
Secondary	Baseline expression of innate immune markers	Baseline expression of innate immune markers in peripheral blood between eventual responders and nonresponders to omalizumab. 5 significant markers will be reported. Results will be stratified between groups determined by the pre-specified arms and by the classification of participants as responders versus non-responders to omalizumab.	Baseline