Pilot study - sequential combination therapy using selective immunoglobulin apheresis and omalizumab in patients with severe atopic dermatitis and elevated total IgE levels

• Conditions: Patients with severe Atopic dermatitis and total IgE-level > 700 IU/ml (potentially associated with bronchial asthma and/or allergic rhinitis); MedDRA version: 12.0Level: LLTClassification code 10002198Term: Anaphylactic reaction; MedDRA version: 12.0Level: LLTClassification code 10040400Term: Serum sickness; MedDRA version: 12.0Level: LLTClassification code 10043554Term: Thrombocytopenia; MedDRA version: 12.0Level: LLTClassification code 10019211Term: Headache; MedDRA version: 12.0Level: LLTClassification code 10028810Term: Nasopharyngitis; MedDRA version: 12.0Level: LLTClassification code 10040753Term: Sinusitis; MedDRA version: 12.0Level: LLTClassification code 10022000Term: Influenza; MedDRA version: 12.0Level: LLTClassification code 10006451Term: Bronchitis; MedDRA version: 12.0Level: LLTClassification code 10017888Term: Gastroenteritis

• Registration Number: EUCTR2009-014582-51-DE
• Lead Sponsor: Faculty of Medicine, Technische Universität München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Diagnosis of severe atopic dermatitis (potentially associated with bronchial asthma and/or allergic rhinitis)
- Total serum IgE level > 700 IU/ml
- SCORAD > 50 within the last 12 months
- resistance or relapse to/after at least 2 systemic treatment modalities for atopic dermatitis
- No parallel systemic therapies during the omalizumab treatment period
- Adults > 18 years of age
- Both parents of Caucasian heritage
- Residence in the greater Munich area
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

- other chronic dieseases such as diabetes, hematological disorders etc.
- autoimmune diseases
- Cardiopulmonary/cardiovascular diseases
- Allergies against any of the used material or IMP
- Systemic infections (such as HIV-infection etc)
- Systemic medication other than contraceptives
- Pregnancy
- Breast feeding (nursing)
- Parasitic infections
- Planed or recent travel to regions endemic for parasitic infections

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Is it possible to reduce abnormal IgE levels to the normal range in atopic dermatitis patients by sequential application of immunoglobulin apheresis and omalizumab treatment?;Secondary Objective: Is there a correlation with the clinical score of atopic dermatitis?;Primary end point(s): - total IgE level < 100 IU/ml<br>- clinical improvement of atopic dermatitis (SCORAD < 20)