Atopic Dermatitis Biomarker Identification Trial in Omalizumab Usage (AMB-WEI-1052-I)

January 9, 2012 updated by: Technical University of Munich

Single- Arm Trial to Identify Potential Markers Underlying Variability in Response to Omalizumab (Xolair®) Treatment in Atopic Dermatitis

This study aims at evaluating the therapeutic potential of omalizumab in atopic dermatitis, and to work out biomarkers predictive of treatment response.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

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

  • Germany
    • Bavaria
      • Munic, Bavaria, Germany, 80802
        • Klinikum rechts der Isar Dermatologie/Biederstein

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

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18-70 years of age, body weight ≥ 20 kg and ≤ 150 kg
  • Dermatological diagnosis of AD, SCORAD >=20
  • A positive RAST (≥CAP1) result for at least one aeroallergen specific IgE and total IgE >=100kU/l at screening (or within the previous 12 months)
  • Eligible to receive systemic therapy for AD in accordance to local guidelines
  • Signed informed consent from patient

Exclusion Criteria:

  • Evidence of skin disease other than AD (e.g. psoriasis) at the inclusion time
  • Treatment with systemic AD medications or any investigational drug within a 30-day washout period
  • Concomitant treatment with substances interfering with the immune system
  • Permanent severe diseases, especially those affecting the immune system, except asthma
  • Pregnancy or breast feeding
  • History of food or drug related severe anaphylactoid or anaphylactic reaction(s)
  • History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
  • History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy
  • Elevated serum IgE levels for reasons other than allergy and/or urticaria (e.g.: parasite infections, hyperimmunoglobulin E syndrome, Wiskott - Aldrich syndrome or clinical allergic bronchopulmonary aspergillosis)
  • Evidence of severe renal dysfunction or significant hepatic disease
  • Evidence for active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy
  • History of malignancy of any organ system, treated or untreated, whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
  • Clinically significant laboratory abnormalities (not associated with AD) at Visit 1
  • Known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study medication or drugs related to Omalizumab (e.g.: monoclonal antibodies, polyclonal gammaglobulin)
  • Patients who are considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits
  • Patients with serious psychiatric and/or psychological disturbances
  • Patients with a history of drug or alcohol abuse
  • Patients who are unable to complete a patient diary or complete questionnaires on paper
  • Patients with any other condition or prior/current treatment, which in the opinion of the investigator renders the patient ineligible for the study schedule

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?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omalizumab
Drug: Omalizumab (Xolair®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate efficacy of Omalizumab treatment in a sample of adult patients with moderate to severe AD

Collaborators and Investigators

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

Sponsor

Technical University of Munich

Investigators

  • Principal Investigator: Stephan Weidinger, Prof.Dr.med.

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 Registration Dates

First Submitted

August 2, 2010

First Submitted That Met QC Criteria

August 9, 2010

First Posted (Estimate)

August 11, 2010

Study Record Updates

Last Update Posted (Estimate)

January 10, 2012

Last Update Submitted That Met QC Criteria

January 9, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMBITIOUS

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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