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

July 12, 2024 updated by: Universitaire Ziekenhuizen KU Leuven

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: immunoadsorption group
All patients will be treated with 10 immunoadsorptions with an IgE-specific adsorption column :
Device: immunoadsorptions with an IgE-specific adsorption column
immunoadsorptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical improvement (The improvement of Atopic dermatitis will be evaluated with different scales including SCORAD, EASI, LIS, DLQI)
Time Frame: one year
The improvement of Atopic dermatitis will be evaluated with different scales including SCORAD, EASI, LIS, DLQI
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
histological improvement and IgE tissue levels
Time Frame: one year
we will evaluate the reduction of IgE and Fc epsilon RI expression in skin and total IgE in blood
one year
Correlation between the therapeutic response and serum markers of disease activity .
Time Frame: one year
we will evaluate serum levels and biomarkers such as TARC , MDC and TSLP during the course of the treatment
one year
Effect of the treatment on positivity of skin prick tests.
Time Frame: one year
we will evaluate skin prick reaction to dilution series of a previously positive allergen before and after treatment )
one year
Evaluation of length of improvement
Time Frame: one year
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects of immunoadsorption
Time Frame: one year
All side effects that appear during immunoadsorption or during the observation period after the last immunoadsorption will be recorded.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Marie-Anne Morren, MD, UZ Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 22, 2014

First Submitted That Met QC Criteria

February 17, 2015

First Posted (Estimated)

February 18, 2015

Study Record Updates

Last Update Posted (Actual)

July 15, 2024

Last Update Submitted That Met QC Criteria

July 12, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B322201421152

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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