EUCTR2010-018559-84-DE
Active, not recruiting
Not Applicable
AMBITIOUSAtopic Dermatitis Biomarker Identification Trial in Omalizumab UsageSingle- arm trial to identify potential markers underlying variability in response to Omalizumab (Xolair®) treatment in atopic dermatitis - AMBITIOUS
Medizinische Fakultät der technischen Universität Muenchen0 sites20 target enrollmentMay 20, 2010
ConditionsAMBITIOUS is a trial to identify potential markers underlying variability in response to Omalizumab (Xolair®) treatment in atopic dermatitisAtopische Dermatitis is a common inflammatory skin disease showing chronically relapsing eczema and high association with elevated serum IgE levels.MedDRA version: 14.0Level: LLTClassification code 10029264Term: Neurodermatitis aggravatedSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
DrugsXolair
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- AMBITIOUS is a trial to identify potential markers underlying variability in response to Omalizumab (Xolair®) treatment in atopic dermatitisAtopische Dermatitis is a common inflammatory skin disease showing chronically relapsing eczema and high association with elevated serum IgE levels.
- Sponsor
- Medizinische Fakultät der technischen Universität Muenchen
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 years or above
- •Dermatological diagnosis of AD, SCORAD \>\=20
- •Eligible to receive systemic therapy for AD in accordance to local guidelines
- •Signed informed consent from patient
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
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
- •Previous treatment with Omalizumab
- •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).
Outcomes
Primary Outcomes
Not specified
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