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Molecular Endotypes of Chronic Idiopathic Urticaria

Primary Purpose

Chronic Urticaria, Idiopathic

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Omalizumab
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Urticaria, Idiopathic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Colorado AnschutzRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omalizumab

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 16, 2021
Last Updated
March 23, 2022
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT04774315
Brief Title
Molecular Endotypes of Chronic Idiopathic Urticaria
Official Title
Molecular Endotypes of Chronic Idiopathic Urticaria
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Urticaria, Idiopathic

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Omalizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Omalizumab
Intervention Description
omalizumab 300mg SQ every 4 weeks as part of standard of care
Primary Outcome Measure Information:
Title
Responders
Description
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.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Baseline expression of innate immune markers
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenny Stitt, M.D.
Phone
303-724-1111
Email
clinicalresearchsupportcenter@ucdenver.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenny Stitt, M.D.
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenny Stitt
Phone
303-724-7205
Email
jenny.stitt@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Jenny Stitt, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Molecular Endotypes of Chronic Idiopathic Urticaria

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