Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Molecular Endotypes of Chronic Idiopathic Urticaria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04774315
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : January 19, 2022
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives
Drug Information available for: Omalizumab

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04774315


Contacts
Layout table for location contacts
Contact: Jenny Stitt, M.D. 303-724-1111 clinicalresearchsupportcenter@ucdenver.edu

Locations
Layout table for location information
United States, Colorado
University of Colorado Anschutz Recruiting
Aurora, Colorado, United States, 80045
Contact: Jenny Stitt    303-724-7205    jenny.stitt@cuanschutz.edu   
Principal Investigator: Jenny Stitt, M.D.         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Layout table for investigator information
Principal Investigator: Jenny Stitt, M.D. University of Colorado, Denver
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04774315    
Other Study ID Numbers: 18-0850
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: January 19, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Urticaria
Chronic Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
 Immune System Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents