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

This study has been completed.
Sponsor:
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01179529
First received: August 2, 2010
Last updated: January 9, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Atopic Dermatitis
Atopic Eczema
Drug: Omalizumab (Xolair®)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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 NLM:


Further study details as provided by Technische Universität München:

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

Arms Assigned Interventions
Experimental: Omalizumab Drug: Omalizumab (Xolair®)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179529

Locations
Germany
Klinikum rechts der Isar Dermatologie/Biederstein
Munic, Bavaria, Germany, 80802
Sponsors and Collaborators
Technische Universität München
Investigators
Principal Investigator: Stephan Weidinger, Prof.Dr.med.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01179529     History of Changes
Other Study ID Numbers: AMBITIOUS
Study First Received: August 2, 2010
Last Updated: January 9, 2012
Health Authority: Germany: Regierung von Oberbayern

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

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 22, 2014