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Treatment of AD With IgE Specific Immunoadsorption (IGEIAAD) (IGEIAAD)

Primary Purpose

Atopic Dermatitis

Status
Unknown status
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
immunoadsorptions with an IgE-specific adsorption column
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis, immunoadsorption

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UZ LeuvenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

immunoadsorption group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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 )
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.

Full Information

First Posted
August 22, 2014
Last Updated
February 17, 2015
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT02365246
Brief Title
Treatment of AD With IgE Specific Immunoadsorption (IGEIAAD)
Acronym
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

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
atopic dermatitis, immunoadsorption

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
immunoadsorption group
Arm Type
Experimental
Arm Description
All patients will be treated with 10 immunoadsorptions with an IgE-specific adsorption column :
Intervention Type
Device
Intervention Name(s)
immunoadsorptions with an IgE-specific adsorption column
Intervention Description
immunoadsorptions
Primary Outcome Measure Information:
Title
clinical improvement (The improvement of Atopic dermatitis will be evaluated with different scales including SCORAD, EASI, LIS, DLQI)
Description
The improvement of Atopic dermatitis will be evaluated with different scales including SCORAD, EASI, LIS, DLQI
Time Frame
one year
Secondary Outcome Measure Information:
Title
histological improvement and IgE tissue levels
Description
we will evaluate the reduction of IgE and Fc epsilon RI expression in skin and total IgE in blood
Time Frame
one year
Title
Correlation between the therapeutic response and serum markers of disease activity .
Description
we will evaluate serum levels and biomarkers such as TARC , MDC and TSLP during the course of the treatment
Time Frame
one year
Title
Effect of the treatment on positivity of skin prick tests.
Description
we will evaluate skin prick reaction to dilution series of a previously positive allergen before and after treatment )
Time Frame
one year
Title
Evaluation of length of improvement
Description
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.
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
Side effects of immunoadsorption
Description
All side effects that appear during immunoadsorption or during the observation period after the last immunoadsorption will be recorded.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Adults (> 18 year) with severe atopic dermatitis (objective SCORAD > 40) Who's AD is persistent and stable since more than 1 year Who signed the informed consent Who are not pregnant or do not plan to become pregnant, during the immunoadsorption treatment 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: Patients who did not give an informed consent. Patients with mild or moderate AD. 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 Pregnant women and female patients willing to become pregnant during the planned period of treatment or immediately after. 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. Having a malignant disease not under remission
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Anne C Morren, MD
Phone
0032/16337009
Email
Marie-anne.morren@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Björn Meijers, PhD
Phone
003216344580
Email
Bjorn.meijers@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Anne Morren, MD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-anne Morren, MD
Phone
0032/16337009
Email
marie-anne.morren@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Bjorn Meijers, MD, PhD
Phone
003216342409
Email
Björn.meijers@uzleuven.be

12. IPD Sharing Statement

Citations:
PubMed Identifier
20970174
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.
Results Reference
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Treatment of AD With IgE Specific Immunoadsorption (IGEIAAD)

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