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NCT Number: NCT05098821

Extrinsic and Intrinsic Factors in Atopic Dermatitis Upon Systemic Immune Modulation

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dpt of Dermatology and Allergology, Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location status: Recruiting

Location contact

Margitta Worm, Prof. Dr. med.

CONTACT

[email protected]

+49 30 450 518105

Margitta Worm, Prof. Dr. med.

PRINCIPAL_INVESTIGATOR

Sabine Dölle-Bierke, PhD

CONTACT

[email protected]

+49 30 450 518367

Wojciech Francuzik, Dr. med.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

not applicable, observational study

Other

Patients undergoing systemic therapy according to international accepted guidelines for the therapy of atopic dermatitis, observational study

Primary outcomes

  1. Comparison of T-cell inflammatory markers

    Time frame: 1 year

    Identification of at least one pattern recognition profile showing a strong association with responder status to dupilumab therapy

Secondary outcomes

  1. Different T-cell pattern with dupilumab therapy

    Time frame: 1.5 years

    Time in which the pattern of T-cell modulation after initiation of dupilumab therapy (measured using PRI) shows significant differences from the baseline.

  2. Assign recognition patterns to clinical symptoms

    Time frame: 3 months

    Association of recognition patterns with clinical symptoms of atopic dermatitis (measured using Cramer's V > 0.5) with a specific interest in conjunctivitis, pruritus, asthma and herpes infections.

  3. Connection of molecular profile and phenotype

    Time frame: 3 months

    Classification and clustering of at least two molecular profiles of peripheral blood immune cells in relation to phenotypes of atopic dermatitis (Cramer's V either with association to IgE levels or early/late onset AD).

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • LEO Pharma
  • Sanofi

Registry information

Official study title

Pattern Recognition of Immune Cells in Atopic Dermatitis Patients Receiving Dupilumab

Acronym: AD-Sys

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Oct 28, 2021
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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