Atopic Dermatitis Biomarker Identification Trial in Omalizumab Usage
AMB-WEI-1052-I
Single- Arm Trial to Identify Potential Markers Underlying Variability in Response to Omalizumab (Xolair®) Treatment in Atopic Dermatitis
1 other identifier
interventional
N/A
1 country
1
Brief Summary
This study aims at evaluating the therapeutic potential of omalizumab in atopic dermatitis, and to work out biomarkers predictive of treatment response.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2010
CompletedFirst Posted
Study publicly available on registry
August 11, 2010
CompletedJanuary 10, 2012
January 1, 2012
August 2, 2010
January 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate efficacy of Omalizumab treatment in a sample of adult patients with moderate to severe AD
Study Arms (1)
Omalizumab
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinikum rechts der Isar Dermatologie/Biederstein
Munich, Bavaria, 80802, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephan Weidinger, Prof.Dr.med.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 2, 2010
First Posted
August 11, 2010
Last Updated
January 10, 2012
Record last verified: 2012-01