Treatment of AD With IgE Specific Immunoadsorption (IGEIAAD)

Atopic Dermatitis Clinical Trial

— IGEIAAD  

Official title:

Interventional Trial With IgE-specific Immunoadsorption in Severe Atopic Dermatitis. Interventional Trial With IgE-specific Immunoadsorption in Severe Atopic Dermatitis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02365246
• Other study ID #: B322201421152
• Status: Recruiting
• Phase: Phase 2
• First received: August 22, 2014
• Last updated: February 17, 2015
• Start date: August 2014
• Est. completion date: June 2017

Study information

• Verified date: May 2014
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Marie-Anne C Morren, MD
• Phone: 0032/16337009
• Email: Marie-anne.morren[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Side effects of immunoadsorption	All side effects that appear during immunoadsorption or during the observation period after the last immunoadsorption will be recorded.	one year	Yes
Primary	clinical improvement (The improvement of Atopic dermatitis will be evaluated with different scales including SCORAD, EASI, LIS, DLQI)	The improvement of Atopic dermatitis will be evaluated with different scales including SCORAD, EASI, LIS, DLQI	one year	No
Secondary	histological improvement and IgE tissue levels	we will evaluate the reduction of IgE and Fc epsilon RI expression in skin and total IgE in blood	one year	No
Secondary	Correlation between the therapeutic response and serum markers of disease activity .	we will evaluate serum levels and biomarkers such as TARC , MDC and TSLP during the course of the treatment	one year	No
Secondary	Effect of the treatment on positivity of skin prick tests.	we will evaluate skin prick reaction to dilution series of a previously positive allergen before and after treatment )	one year	No
Secondary	Evaluation of length of improvement	we will evaluate the duration of improvement after the last immunoadsorption and investigate if there is a correlation with drop in total IgE and / or biomarkers. The/ usefulness of supplemental adsorptionsessions will be investigated if there is an indication.	one year	No