Molecular Endotypes of Chronic Idiopathic Urticaria

Phase 4

Active, not recruiting

• Conditions: Chronic Urticaria, Idiopathic
• Interventions: Drug: Omalizumab

• Registration Number: NCT04774315
• Lead Sponsor: University of Colorado, Denver

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-01
• Study Start: 2022-01-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Omalizumab	Omalizumab	-

Primary Outcome Measures

Name	Time	Method
Responders	Week 16	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.

Secondary Outcome Measures

Name	Time	Method
Baseline expression of innate immune markers	Baseline	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.

Trial Locations

Locations (1)

University of Colorado Anschutz; 🇺🇸 Aurora, Colorado, United States