NCT02365246 Treatment of AD With IgE Specific Immunoadsorption (IGEIAAD)
| NCT ID | NCT02365246 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Atopic Dermatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2014-08 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 15 participants in total. It began in 2014-08 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Marie-Anne Morren, MD
PRINCIPAL INVESTIGATOR
UZ Leuven
Frequently Asked Questions
Who can join the NCT02365246 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Atopic Dermatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02365246 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT02365246 currently recruiting?
Yes, NCT02365246 is actively recruiting participants. Contact the research team at Marie-anne.morren@uzleuven.be for enrollment information.
Where is the NCT02365246 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT02365246 clinical trial?
NCT02365246 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Marie-Anne Morren, MD at UZ Leuven. The trial plans to enroll 15 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.