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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Omalizumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omalizumab<br> | Drug: Omalizumab<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Serum IgE levels, inflammatory cells in the skin, inflammatory cells in the blood, IgE, IgE depletion, atopic dermatitis, atopic eczema, Omalizumab