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

January 13, 2009 updated by: Medical University of Vienna

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Waehringer Guertel 18-20, Austria, 1090 Vienna
        • Division of Immunology, Allergy and Infectious Diseases, Department of Dermatology, Medical University of Vienna, Austria.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
ACTIVE_COMPARATOR: Omalizumab
Drug: Omalizumab

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Study Completion

April 1, 2003

Study Registration Dates

First Submitted

January 13, 2009

First Submitted That Met QC Criteria

January 13, 2009

First Posted (ESTIMATE)

January 14, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2009

Last Update Submitted That Met QC Criteria

January 13, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIGE025A2412

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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