NCT02365246

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

11.3 years

First QC Date

August 22, 2014

Last Update Submit

July 12, 2024

Conditions

Atopic Dermatitis

Keywords

atopic dermatitisimmunoadsorption

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • histological improvement and IgE tissue levels

    one year

  • Correlation between the therapeutic response and serum markers of disease activity .

    one year

  • Effect of the treatment on positivity of skin prick tests.

    one year

  • Evaluation of length of improvement

    one year

Other Outcomes (1)

  • Side effects of immunoadsorption

    one year

Study Arms (1)

immunoadsorption group

EXPERIMENTAL

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

Device: immunoadsorptions with an IgE-specific adsorption column

Interventions

immunoadsorptions with an IgE-specific adsorption columnDEVICE

immunoadsorptions

immunoadsorption group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Related 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.e1-6. doi: 10.1016/j.jaci.2010.07.042. Epub 2010 Oct 20. No abstract available.

    PMID: 20970174RESULT

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Marie-Anne Morren, MD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Anne C Morren, MD

CONTACT

0032/16337009Marie-anne.morren@uzleuven.be

Björn Meijers, PhD

CONTACT

003216344580Bjorn.meijers@uzleuven.be

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2014

First Posted

February 18, 2015

Study Start

August 1, 2014

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

July 15, 2024

Record last verified: 2024-07

Locations

BE(1)