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

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.

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.

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.