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

NCT ID: NCT00822783

Last Updated: 2009-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31
• Study Completion Date: 2003-04-30

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.

Conditions

Atopic Dermatitis

Study Groups

Omalizumab

Group Type: ACTIVE_COMPARATOR

Omalizumab

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Omalizumab

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Locations

Division of Immunology, Allergy and Infectious Diseases, Department of Dermatology, Medical University of Vienna, Austria.

Vienna, Waehringer Guertel 18-20, , Austria

Countries

Austria

References

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.

Reference Type: BACKGROUND

PMID: 16384758 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16021135 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7759866 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9743330 (View on PubMed)

Other Identifiers

CIGE025A2412

Identifier Type: -

Identifier Source: org_study_id