Treatment of AD With IgE Specific Immunoadsorption (IGEIAAD)

Phase 2

Recruiting

• Conditions: Atopic Dermatitis
• Interventions: Device: immunoadsorptions with an IgE-specific adsorption column

• Registration Number: NCT02365246
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-22
• Study First Submitted QC: 2015-02-17
• Study First Posted: 2015-02-18
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-15
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
immunoadsorption group	immunoadsorptions with an IgE-specific adsorption column	All patients will be treated with 10 immunoadsorptions with an IgE-specific adsorption column :

Primary Outcome Measures

Name	Time	Method
clinical improvement (The improvement of Atopic dermatitis will be evaluated with different scales including SCORAD, EASI, LIS, DLQI)	one year	The improvement of Atopic dermatitis will be evaluated with different scales including SCORAD, EASI, LIS, DLQI

Secondary Outcome Measures

Name	Time	Method
Evaluation of length of improvement	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.
histological improvement and IgE tissue levels	one year	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 .	one year	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.	one year	we will evaluate skin prick reaction to dilution series of a previously positive allergen before and after treatment )

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium