- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04774315
Molecular Endotypes of Chronic Idiopathic Urticaria
March 23, 2022 updated by: University of Colorado, Denver
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jenny Stitt, M.D.
- Phone Number: 303-724-1111
- Email: clinicalresearchsupportcenter@ucdenver.edu
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- University of Colorado Anschutz
-
Contact:
- Jenny Stitt
- Phone Number: 303-724-7205
- Email: jenny.stitt@cuanschutz.edu
-
Principal Investigator:
- Jenny Stitt, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Omalizumab
|
omalizumab 300mg SQ every 4 weeks as part of standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Responders
Time Frame: 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.
|
Week 16
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline expression of innate immune markers
Time Frame: 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.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jenny Stitt, M.D., University of Colorado, Denver
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Anticipated)
March 1, 2025
Study Completion (Anticipated)
March 1, 2025
Study Registration Dates
First Submitted
February 16, 2021
First Submitted That Met QC Criteria
February 26, 2021
First Posted (Actual)
March 1, 2021
Study Record Updates
Last Update Posted (Actual)
March 25, 2022
Last Update Submitted That Met QC Criteria
March 23, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-0850
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Urticaria, Idiopathic
-
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-
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