Treatment of AD With IgE Specific Immunoadsorption (IGEIAAD)

Universitaire Ziekenhuizen KU Leuven

Status and phase: Enrolling; Phase 2

Conditions: Atopic Dermatitis

Treatments: Device: immunoadsorptions with an IgE-specific adsorption column

Study type: Interventional

Funder types: Other

Identifiers

NCT02365246

B322201421152

Details and patient eligibility

About

Removal of IgE through adsorption of IgE on a specially designed column after apheresis of blood has the potential to improve the severity of atopic dermatitis.

In this study the investigators will treat patients with a severe form of Atopic dermatitis not responding or having to much side effects to systemic imunosuppressive treatment with this modality.

Full description

Patients will be treated with immunoadsorption on 4 consecutive days week 1 and three consecutive days week 5 and week 9.

The clinical improvement and histological and serological tests will be evaluated.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Adults (> 18 year) with severe atopic dermatitis (objective SCORAD > 40)
2. Who's AD is persistent and stable since more than 1 year
3. Who signed the informed consent
4. Who are not pregnant or do not plan to become pregnant, during the immunoadsorption treatment
5. Who were treated in the recent past with phototherapy or immunosuppressive therapy ( one or more : cyclosporin A, methotrexate , azathioprine , mycophenolate , systemic corticosteroids ) and where this therapy was not sufficiently helpful, had unacceptable side effects or are contraindicated

Exclusion Criteria:

1. Patients who did not give an informed consent.

2. Patients with mild or moderate AD.

3. Patients with severe AD improving with, and tolerating, standard therapy (including phototherapy, short periods of corticosteroids, the above mentioned immunosuppressive therapies ) and having no contra-indications for these therapies

4. Pregnant women and female patients willing to become pregnant during the planned period of treatment or immediately after.

5. Having contra-indications for immunoadsorption:

   • Patients with a known allergy for the material used during immunoadsorption.
   • Severe cardiovascular diseases.
   • Severe bleeding during anticoagulation .
   • Treated with ACE-inhibitors.
   • Patients younger than18 years.

6. Having a malignant disease not under remission

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

immunoadsorption group

Experimental group

Description:

All patients will be treated with 10 immunoadsorptions with an IgE-specific adsorption column :

Treatment:

Device: immunoadsorptions with an IgE-specific adsorption column