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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01179529
Recruitment Status : Completed
First Posted : August 11, 2010
Last Update Posted : January 10, 2012
Information provided by:
Technische Universität München

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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Atopic Eczema Drug: Omalizumab (Xolair®) Phase 2

Study Type : Interventional  (Clinical Trial)
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: Single- Arm Trial to Identify Potential Markers Underlying Variability in Response to Omalizumab (Xolair®) Treatment in Atopic Dermatitis

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Omalizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Omalizumab Drug: Omalizumab (Xolair®)

Primary Outcome Measures :
  1. To evaluate efficacy of Omalizumab treatment in a sample of adult patients with moderate to severe AD

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01179529

Klinikum rechts der Isar Dermatologie/Biederstein
Munic, Bavaria, Germany, 80802
Sponsors and Collaborators
Technische Universität München
Principal Investigator: Stephan Weidinger, Identifier: NCT01179529     History of Changes
Other Study ID Numbers: AMBITIOUS
First Posted: August 11, 2010    Key Record Dates
Last Update Posted: January 10, 2012
Last Verified: January 2012

Keywords provided by Technische Universität München:
Atopic dermatitis (atopic eczema)

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents