Molecular Endotypes of Chronic Idiopathic Urticaria

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04774315
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 37.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Urticaria, Idiopathic	Drug: Omalizumab	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Molecular Endotypes of Chronic Idiopathic Urticaria
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Mar 1, 2025
• Anticipated Study Completion Date: Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Omalizumab	Drug: Omalizumab; omalizumab 300mg SQ every 4 weeks as part of standard of care

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Anschutz	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver

Investigators

• Principal Investigator: Jenny Stitt, M.D., University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT04774315
• Other Study ID Numbers: 18-0850
• First Posted: Mar 1, 2021
• Last Update Posted: Mar 25, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Urticaria; Chronic Urticaria; Omalizumab

Study Results

No Results Posted as of Mar 25, 2022