Treatment for severe atopic dermatitis using IgE removal

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

This study is testing a new treatment that removes a specific allergy protein from the blood to see if it helps adults with severe atopic dermatitis who haven't found relief from other medications.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Universitaire Ziekenhuizen KU Leuven (Academic / other)
• Drugs / interventions: methotrexate
• Locations: 1 site (Leuven)
• Trial ID: NCT02365246 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to treat adults with severe atopic dermatitis who have not responded adequately to standard immunosuppressive therapies. The approach involves immunoadsorption, where IgE is removed from the blood using a specialized column over a series of treatment sessions. Patients will undergo treatment for four consecutive days in the first week, followed by three consecutive days in the fifth and ninth weeks. The study will evaluate clinical improvement as well as histological and serological changes.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with severe atopic dermatitis that has been persistent and stable for over a year.

Not a fit: Patients with mild or moderate atopic dermatitis or those whose severe condition is improving with standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant relief for patients suffering from severe atopic dermatitis who have limited options due to inadequate responses or side effects from existing therapies.

How similar studies have performed: While this approach is innovative, similar studies exploring IgE removal have shown promise, indicating potential for success.

Eligibility criteria

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

Where this trial is running

Leuven

• UZ Leuven — Leuven, Belgium (Recruiting)

Study contacts

• Principal investigator: Marie-Anne Morren, MD — UZ Leuven
• Study coordinator: Marie-Anne C Morren, MD

Conditions Atopic Dermatitis; atopic dermatitis; immunoadsorption