Effect of Anti-IgE in Chronic Urticaria

NCT00130234 | Completed Phase 2

• 1 other identifier: NA_00000804
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to find out if a drug called Xolair (omalizumab), an anti-IgE antibody, is safe and effective for people with chronic urticaria (hives) with persistent symptoms in spite of taking antihistamines.

Conditions

Urticaria

Keywords

urticaria; hives; Xolair

Interventions

Xolair® (Omalizumab) DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and non-pregnant, non-breastfeeding females
• Chronic urticaria defined as symptoms \>50% of the days or 3 days per week for more than 12 weeks
• History of angioedema
• Chronic daily therapy with anti-histamines and stable doses of antihistamines for at least 4 weeks.
• High baseline score for pruritis (at least 2 on a 3 point scale)
• No other etiology identified for chronic urticaria such as drug-related or physical urticaria as determined by history, physical examination and laboratory studies

You may not qualify if:

• Concomitant use of systemic corticosteroids for 1 month prior to enrollment. Topical steroid use will not be permitted, but inhaled topical steroids are allowed.
• Current use of immunosuppressive medication (cyclosporine, IVIg, methotrexate, cyclophosphamide). Any such medication will be discontinued for at least 6 weeks before screening.
• Treatment with any investigational agent within 30 days of screening
• Previous treatment with omalizumab
• Recent history of drug or alcohol abuse (within 3 years prior to study)
• Active atopic dermatitis requiring the use of topical steroid agents
• Clinically relevant cardiovascular, hepatic, neurologic, psychiatric, endocrine, or other major systemic disease making the protocol or interpretation of the study results difficult.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, 21224-6821, United States

Location

Related Publications (11)

• Beck LA, Marcotte GV, MacGlashan D, Togias A, Saini S. Omalizumab-induced reductions in mast cell Fce psilon RI expression and function. J Allergy Clin Immunol. 2004 Sep;114(3):527-30. doi: 10.1016/j.jaci.2004.06.032.

  PMID: 15356552 BACKGROUND

• Sabroe RA, Francis DM, Barr RM, Black AK, Greaves MW. Anti-Fc(episilon)RI auto antibodies and basophil histamine releasability in chronic idiopathic urticaria. J Allergy Clin Immunol. 1998 Oct;102(4 Pt 1):651-8. doi: 10.1016/s0091-6749(98)70283-0.

  PMID: 9802375 BACKGROUND

• Sabroe RA, Fiebiger E, Francis DM, Maurer D, Seed PT, Grattan CE, Black AK, Stingl G, Greaves MW, Barr RM. Classification of anti-FcepsilonRI and anti-IgE autoantibodies in chronic idiopathic urticaria and correlation with disease severity. J Allergy Clin Immunol. 2002 Sep;110(3):492-9. doi: 10.1067/mai.2002.126782.

  PMID: 12209101 BACKGROUND

• Saini SS, MacGlashan DW Jr, Sterbinsky SA, Togias A, Adelman DC, Lichtenstein LM, Bochner BS. Down-regulation of human basophil IgE and FC epsilon RI alpha surface densities and mediator release by anti-IgE-infusions is reversible in vitro and in vivo. J Immunol. 1999 May 1;162(9):5624-30.

  PMID: 10228046 BACKGROUND

• Zweiman B, Valenzano M, Atkins PC, Tanus T, Getsy JA. Characteristics of histamine-releasing activity in the sera of patients with chronic idiopathic urticaria. J Allergy Clin Immunol. 1996 Jul;98(1):89-98. doi: 10.1016/s0091-6749(96)70230-0.

  PMID: 8765822 BACKGROUND

• Baiardini I, Giardini A, Pasquali M, Dignetti P, Guerra L, Specchia C, Braido F, Majani G, Canonica GW. Quality of life and patients' satisfaction in chronic urticaria and respiratory allergy. Allergy. 2003 Jul;58(7):621-3. doi: 10.1034/j.1398-9995.2003.00091.x.

  PMID: 12823121 BACKGROUND

• Soter NA. Acute and chronic urticaria and angioedema. J Am Acad Dermatol. 1991 Jul;25(1 Pt 2):146-54. doi: 10.1016/0190-9622(91)70180-a.

  PMID: 1869689 BACKGROUND

• Kaplan AP. Clinical practice. Chronic urticaria and angioedema. N Engl J Med. 2002 Jan 17;346(3):175-9. doi: 10.1056/NEJMcp011186. No abstract available.

  PMID: 11796852 BACKGROUND

• Grattan CE. Basophils in chronic urticaria. J Investig Dermatol Symp Proc. 2001 Nov;6(2):139-40. doi: 10.1046/j.0022-202x.2001.00027.x.

  PMID: 11764301 BACKGROUND

• Kern F, Lichtenstein LM. Defective histamine release in chronic urticaria. J Clin Invest. 1976 May;57(5):1369-77. doi: 10.1172/JCI108405.

  PMID: 57121 BACKGROUND

• Saini S, Rosen KE, Hsieh HJ, Wong DA, Conner E, Kaplan A, Spector S, Maurer M. A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine-refractory chronic idiopathic urticaria. J Allergy Clin Immunol. 2011 Sep;128(3):567-73.e1. doi: 10.1016/j.jaci.2011.06.010. Epub 2011 Jul 18.

  PMID: 21762974 DERIVED

MeSH Terms

Conditions

Urticaria

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

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

Study Officials

• Sarbjit Saini, M.D.

  Johns Hopkins Asthma and Allergy Center, Division of Allergy and Clinical Immunology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 12, 2005
• First Posted: August 15, 2005
• Study Start: November 1, 2004
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: May 7, 2008

Record last verified: 2008-05

Locations

US (1)