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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014582-51-DE

Enrollment

Registered

2009-10-12

Start date

2010-03-26

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with severe Atopic dermatitis and total IgE-level > 700 IU/ml (potentially associated with bronchial asthma and/or allergic rhinitis) MedDRA version: 12.0 Level: LLT Classification code 10002198 Term: Anaphylactic reaction MedDRA version: 12.0 Level: LLT Classification code 10040400 Term: Serum sickness MedDRA version: 12.0 Level: LLT Classification code 10043554 Term: Thrombocytopenia MedDRA version: 12.0 Level: LLT Classification code 10019211 Term: Headache MedDRA version: 12.0

Interventions

Trade Name: Omalizumab Product Name: Xolair Product Code: Xolair-H-C-606-II-18 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: OMALIZUMAB CAS Number: 242138-07-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 - clinical improvement of atopic dermatitis (SCORAD < 20)	—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026