Clinical trial NCT02365246: Treatment of AD With IgE Specific Immunoadsorption (IGEIAAD)
Official title: Interventional Trial With IgE-specific Immunoadsorption in Severe Atopic Dermatitis. Interventional Trial With IgE-specific Immunoadsorption in Severe Atopic Dermatitis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
immunoadsorption
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-02-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: clinical improvement (The improvement of Atopic dermatitis will be evaluated with different scales including SCORAD, EASI, LIS, DLQI)
timeFrame: one year
Secondary outcomes:
measure: histological improvement and IgE tissue levels
timeFrame: one year
measure: Correlation between the therapeutic response and serum markers of disease activity .
timeFrame: one year
measure: Effect of the treatment on positivity of skin prick tests.
timeFrame: one year
measure: Evaluation of length of improvement
timeFrame: one year
Other outcomes:
measure: Side effects of immunoadsorption
timeFrame: one year
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Marie-Anne Morren, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kasperkiewicz M, Schmidt E, Frambach Y, Rose C, Meier M, Nitschke M, Falk TM, Reich K, Ludwig RJ, Zillikens D. Improvement of treatment-refractory atopic dermatitis by immunoadsorption: a pilot study. J Allergy Clin Immunol. 2011 Jan;127(1):267-70, 270.e1-6. doi: 10.1016/j.jaci.2010.07.042. Epub 2010 Oct 20. No abstract available.