Recruiting PHASE2 Atopic Dermatitis

New treatment option for Atopic Dermatitis

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

ClinicalTrials.gov ID: NCT02365246

What this study is testing

What it's testing
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.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 70

You may be able to join 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...

You likely can't join 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...
  • 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.
See the full eligibility criteria
Who can join
  • 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...
What rules you out
  • 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...
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Leuven, Belgium

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.