Back to results

Molecular Endotypes of Chronic Idiopathic Urticaria

Primary Purpose

Chronic Urticaria, Idiopathic

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Omalizumab

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

NCT ID

NCT04774315

First Posted

February 16, 2021

Last Updated

March 23, 2022

Sponsor

University of Colorado, Denver

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

Product Manufactured in and Exported from the U.S.

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

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

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

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

jenny.stitt@cuanschutz.edu

First Name & Middle Initial & Last Name & Degree

Jenny Stitt, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Molecular Endotypes of Chronic Idiopathic Urticaria

We'll reach out to this number within 24 hrs