Extrinsic and Intrinsic Factors in Atopic Dermatitis Upon Systemic Immune Modulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: not applicable, observational study.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pattern Recognition of Immune Cells in Atopic Dermatitis Patients Receiving Dupilumab
Overview
Currently, patients with moderate to severe atopic dermatitis are treated with dupilumab if unresponsive to topical treatment. However, not all patients who suffer from atopic dermatitis respond similarly to this treatment. Pattern recognition of immune cells (PRI) is an efficient method to screen patients to allow a more personalized therapy. The main aim of this scientific explorative study is to unravel the changes in peripheral blood immune cell compositions in patients with atopic eczema undergoing dupilumab treatment. This allows the identification of phenotypes of treatment responders and non-responders and possible approaches of treatment modifications for non-responders.
Detailed description
A better understanding of the pathology of atopic dermatitis could lead to the development of new therapeutic strategies for this disease and contribute to better and more targeted disease management - an advantage for all patients with atopic dermatitis.
The PRI is a new bioinformatic analysis strategy that allows in-depth data analysis from flow cytometry with multiple variables. This facilitates the identification of meaningful T cell subpopulations, which are differentially abundant between two groups to predict responders and non-responders prior to dupilumab treatment.
Peripheral blood will be collected before, 4 weeks, 8 weeks, and 16 weeks after initiating the systemic treatment with dupilumab to identify recognition patterns/markers on the T cells. Therefore, a predefined multicolor flow cytometry panel was developed to analyse lineage, differentiation and activation markers.
Patients will receive a systemic therapy (dupilumab 600 mg loading dose, followed by 300 mg in two weeks intervals). Follow up visits will be performed every 3 months starting from the second visit (2nd visit will take place 4 weeks after initiating Dupilumab treatment).
The blood samples that are taken as part of this scientific study are pseudonymized in the research laboratories and stored for a period of 5 years after the end of this study or the publication of the results and destroyed.
Interventions
- Other not applicable, observational study
Patients undergoing systemic therapy according to international accepted guidelines for the therapy of atopic dermatitis, observational study
Primary outcome measures
- Comparison of T-cell inflammatory markers [Time frame: 1 year]
Secondary outcome measures (3)
- Different T-cell pattern with dupilumab therapy [Time frame: 1.5 years]
- Assign recognition patterns to clinical symptoms [Time frame: 3 months]
- Connection of molecular profile and phenotype [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- Age 18 and above
- Diagnosis of atopic dermatitis for ≥1 year
- Inadequate response to treatment with topical medications
- Confirmed dupilumab treatment
Exclusion criteria
- Age below 18
- Known or suspected allergy or reaction to any component of the dupilumab formulation
- Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of the severity of AD
- Severe conjunctivitis or blepharitis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Germany · 1 center
- Dpt of Dermatology and Allergology, Charité - Universitätsmedizin Berlin — Berlin
Identifiers
NCT: NCT05098821 · PRI-ADD