Study to Determine the Effect of an Anti-IgE Agent on Inflammatory Cells in the Skin of Atopic Dermatitis Patients

Atopic Dermatitis Clinical Trial

Official title:

An Exploratory 16 Week, Double Blind, Placebo-Controlled Single Center Mechanistic Study to Determine the Effect of Rhumab-E25 on Phenotype and Function of IgE Mediated Antigen Presentation by Dendritic Cells in Subjects With Atopic Dermatitis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822783
• Other study ID #: CIGE025A2412
• Status: Completed
• Phase: Phase 4
• First received: January 13, 2009
• Last updated: January 13, 2009
• Start date: October 2001
• Est. completion date: April 2003

Study information

• Verified date: January 2009
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

Elevated levels of immunoglobuline E in blood are said to promote the occurence of atopic dermatitis; in fact, many patients with atopic dermatitis have high IgE levels. This study tried to explore whether the depletion of IgE from blood and skin might result in a change of immunological parameters and might alter the clinical course of the disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 60 Years

Eligibility

Inclusion Criteria:

• aged between 12 and 60 years

• clinical diagnosis of AD (criteria of Hanifin and Rajka, 1980)

• serum IgE between 30 and 1,300 IU/ml

• at least one significantly positive RAST

• a positive skin prick test of the same specificity as the RAST

• an Investigator`s Global Assessment Score of 2 or more at randomization

• stable AD, as defined as active AD (IGA 2 or more) for > 9 months per year

• signed informed consent.

Exclusion Criteria:

• pregnant or nursing females or women of childbearing potential who did not use a reliable contraceptive method

• treatment with omalizumab within the last 12 months before study treatment

• known hypersensitivity to any ingredients of omalizumab or omalizumab- related drugs

• elevated serum IgE levels for reasons other than atopy

• ongoing immunotherapy

• use of long-acting antihistamine astemizol within 3 months prior to visit1

• use of medium-acting antihistamines (e.g. loratadine, cetirizine) within 5 days prior to visit 1

• use of short-acting antihistamines (e.g. diphenhydramin, terfenadine) within 3 days prior to visit 1

• use of zafirlukast or other leukotriene receptor inhibitors and zileuton or other 5-lipoxygenase enzyme inhibitors within 3 days prior to visit 1

• use of phototherapy or systemic therapy that is known or suspected to have had an effect on AD within 1 month prior to first application of study medication

• treatment with topical therapy (other than hydrocortisone 1%) that is known or suspected to have had an effect on AD within 14 days prior to first application of study medication

• use of systemic steroids (oral, intravenous, including intraarticular and rectal) within one month prior to first application of study medication. (Patients on a stable maintenance dose of inhaled steroids were allowed to participate)

• use of systemic antibiotics within 2 weeks prior to first application of study medication

• use of tranquilizers, hypnotic agents or tricyclic antidepressants within 2 weeks prior to the start of the study

• immunocompromised patients or patients having a history of malignant disease

• concurrent skin diseases

• active bacterial, viral or fungal infections that required treatment with a prohibited medication

• a history of recurrent herpes simplex infection having active lesions at baseline

• tinea corporis / tinea cruris

• clinically significant laboratory abnormalities

• a history of noncompliance to medical regimens and patients who were considered potentially unreliable

• evidence of drug or alcohol abuse or other factors limiting ability to fully cooperate

• any condition or prior/continuing treatment which, in the opinion of the investigator, should have rendered the patient ineligible for the study.

Study Design

N/A

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Omalizumab

• Placebo

Locations

Country	Name	City	State
Austria	Division of Immunology, Allergy and Infectious Diseases, Department of Dermatology, Medical University of Vienna, Austria.	Vienna, Waehringer Guertel 18-20

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (4)

Krathen RA, Hsu S. Failure of omalizumab for treatment of severe adult atopic dermatitis. J Am Acad Dermatol. 2005 Aug;53(2):338-40. — View Citation

Lane JE, Cheyney JM, Lane TN, Kent DE, Cohen DJ. Treatment of recalcitrant atopic dermatitis with omalizumab. J Am Acad Dermatol. 2006 Jan;54(1):68-72. Epub 2005 Nov 28. — View Citation

Maurer D, Ebner C, Reininger B, Fiebiger E, Kraft D, Kinet JP, Stingl G. The high affinity IgE receptor (Fc epsilon RI) mediates IgE-dependent allergen presentation. J Immunol. 1995 Jun 15;154(12):6285-90. — View Citation

Maurer D, Fiebiger E, Reininger B, Ebner C, Petzelbauer P, Shi GP, Chapman HA, Stingl G. Fc epsilon receptor I on dendritic cells delivers IgE-bound multivalent antigens into a cathepsin S-dependent pathway of MHC class II presentation. J Immunol. 1998 Sep 15;161(6):2731-9. — View Citation