Clinical trial NCT00822783: Study to Determine the Effect of an Anti-IgE Agent on Inflammatory Cells in the Skin of Atopic Dermatitis Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Keywords: Serum IgE levels
inflammatory cells in the skin
inflammatory cells in the blood
IgE
IgE depletion
atopic dermatitis
atopic eczema
Omalizumab
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-01-14
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna, Waehringer Guertel 18-20
country: Austria
facility: Division of Immunology, Allergy and Infectious Diseases, Department of Dermatology, Medical University of Vienna, Austria.
Study officials:
References:
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. doi: 10.1016/j.jaad.2005.09.030. Epub 2005 Nov 28.
citation: Krathen RA, Hsu S. Failure of omalizumab for treatment of severe adult atopic dermatitis. J Am Acad Dermatol. 2005 Aug;53(2):338-40. doi: 10.1016/j.jaad.2005.02.014.
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.
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.