Atopic DermatitisPhase 2IGEIAADNCT02365246
Treatment of AD With IgE Specific Immunoadsorption (IGEIAAD)
A Phase 2 study testing immunoadsorptions with an IgE-specific adsorption column in people with Atopic Dermatitis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- immunoadsorptions with an IgE-specific adsorption column
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2014to Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 sufficiently helpful, had unacceptable side effects or are contraindicated
Who cannot join
- 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.
Show all 11Show fewer
- Severe cardiovascular diseases.
- Severe bleeding during anticoagulation .
- Treated with ACE-inhibitors.
- Patients younger than18 years.
- Having a malignant disease not under remission
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Marie-anne Morren, MD, 0032/16337009, marie-anne.morren@uzleuven.be
Bjorn Meijers, MD, PhD, 003216342409, Björn.meijers@uzleuven.be
About this study
Official title: Interventional Trial With IgE-specific Immunoadsorption in Severe Atopic Dermatitis. Interventional Trial With IgE-specific Immunoadsorption in Severe Atopic Dermatitis.
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- immunoadsorptions with an IgE-specific adsorption column
- Keywords
- atopic dermatitis, immunoadsorption
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunoadsorptions with an IgE-specific adsorption columnDevice
immunoadsorptions
| Study group | Role | What they receive |
|---|---|---|
| immunoadsorption group | Experimental | All patients will be treated with 10 immunoadsorptions with an IgE-specific adsorption column : Receives: Device: immunoadsorptions with an IgE-specific adsorption column |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (4)
histological improvement and IgE tissue levels
we will evaluate the reduction of IgE and Fc epsilon RI expression in skin and total IgE in blood
Measured: one year
Correlation between the therapeutic response and serum markers of disease activity .
we will evaluate serum levels and biomarkers such as TARC , MDC and TSLP during the course of the treatment
Measured: one year
Effect of the treatment on positivity of skin prick tests.
we will evaluate skin prick reaction to dilution series of a previously positive allergen before and after treatment )
Measured: one year
Evaluation of length of improvement
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startAug 2014
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Anne Morren, MD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365246
- Sponsor's protocol ID
- B322201421152
- Acronym
- IGEIAAD
- Status last verified
- Jul 2024
- First submitted
- 22 Aug 2014
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20970174
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Trial With IgE-specific Immunoadsorption in Severe Atopic Dermatitis. Interventional Trial With IgE-specific Immunoadsorption in Severe Atopic Dermatitis.
- ClinicalTrials.gov ID
- NCT02365246
- Acronym / sponsor ID
- IGEIAAD / B322201421152
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, immunoadsorption
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| immunoadsorption group | Experimental | Device: immunoadsorptions with an IgE-specific adsorption columnAll patients will be treated with 10 immunoadsorptions with an IgE-specific adsorption column : |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunoadsorptions with an IgE-specific adsorption columnimmunoadsorptions | Device | immunoadsorption group |
Primary outcome
clinical improvement (The improvement of Atopic dermatitis will be evaluated with different scales including SCORAD, EASI, LIS, DLQI)
Time frame: one year
The improvement of Atopic dermatitis will be evaluated with different scales including SCORAD, EASI, LIS, DLQI
4 secondary outcomes
histological improvement and IgE tissue levels
Time frame: one year
Correlation between the therapeutic response and serum markers of disease activity .
Time frame: one year
Effect of the treatment on positivity of skin prick tests.
Time frame: one year
Evaluation of length of improvement
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Results publication: PubMed 20970174Kasperkiewicz 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.
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Anne Morren, MD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing immunoadsorptions with an IgE-specific adsorption column in people with Atopic Dermatitis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Anne C Morren, MD (0032/16337009, Marie-anne.morren@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical improvement (The improvement of Atopic dermatitis will be evaluated with different scales including SCORAD, EASI, LIS, DLQI) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02365246, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.