Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria

NCT01701583 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 12-0780
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study looks at changes in cell proteins in people with chronic hives treated with omalizumab.

Conditions

Chronic Urticaria

Keywords

Chronic Idiopathic Urticaria; CIU; Urticaria; Chronic Hives; Xolair

Outcome Measures

Primary Outcomes (1)

• Change in the Basophil Proteome

  In patients with chronic urticaria who respond clinically to omalizumab, the proteome of blood basophils will be measured at baseline (pre-treatment) and at weeks 6 and 13 (post-treatment). The number of participants with a change observed in basophil proteome out of the total number of participants, stratified by responders and non-responders, is reported.

  Baseline through week 13

Secondary Outcomes (1)

• Change in Basophil Proteome in Responders to Omalizumab Compared to Non-responders to Omalizumab.

  Baseline through week 13

Study Arms (1)

Omalizumab

EXPERIMENTAL

Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.

Drug: Omalizumab

Interventions

Omalizumab DRUG

Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.

Also known as: Xolair

Omalizumab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic urticaria (hives) for more than 6 weeks.
• No improvement with standard doses of antihistamines (loratadine 10 mg daily, desloratadine 5 mg daily, fexofenadine 180 mg daily, cetirizine 10 mg daily, or levocetirizine 5 mg daily)

You may not qualify if:

• Taken any oral steroids for 1 month prior to beginning the study.
• Taken any other immunomodulatory drugs (sulfasalazine, hydroxychloroquine, cyclosporine, methotrexate) for 1 month prior to beginning the study.
• Physical urticaria as a primary diagnosis.
• Known allergic precipitant of urticaria such as foods.
• Urticarial Vasculitis.
• Anemia.
• Asthma.
• Serum Immunoglobulin E (IgE) \>700 IU/ml.
• Women of childbearing potential not using contraception method(s), as well as women who are pregnant and/or breastfeeding.
• Known sensitivity to omalizumab or this class of drug.
• Use of any other investigational agent in the last 1 month.
• Untreated intercurrent illness.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of Colorado Hospital

Denver, Colorado, 80045, United States

Location

Related Publications (1)

• Stitt JM, Dzieciatkowska M, Edwards MG, Hansen K, Hedlund G, Dreskin SC. The basophil proteome in chronic spontaneous urticaria distinguishes responders to omalizumab from non-responders. Clin Exp Allergy. 2018 Jul;48(7):898-901. doi: 10.1111/cea.13149. Epub 2018 May 20. No abstract available.

  PMID: 29671921 RESULT

MeSH Terms

Conditions

Chronic Urticaria; Urticaria

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Limitations and Caveats

Unable to assess primary or secondary outcome due to insufficient data at weeks 6 and 13.

Results Point of Contact

• Title: Jenny Stitt
• Organization: University of Colorado

jenny.stitt@ucdenver.edu

303-724-7205

Study Officials

• Stephen Dreskin, M.D., Ph.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2012
• First Posted: October 5, 2012
• Study Start: April 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: October 1, 2017
• Last Updated: December 4, 2020
• Results First Posted: December 4, 2020

Record last verified: 2020-11

Locations

US (1)