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NCT Number: NCT02365246

Treatment of AD With IgE Specific Immunoadsorption (IGEIAAD)

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

immunoadsorptions with an IgE-specific adsorption column

Device

immunoadsorptions

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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 )

  4. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Björn Meijers, PhD

CONTACT

[email protected]

003216344580

Marie-Anne C Morren, MD

CONTACT

[email protected]

0032/16337009

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: IGEIAAD

Important dates

Study start
2014
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2015
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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