Extrinsic and Intrinsic Factors in Atopic Dermatitis Upon Systemic Immune Modulation

NCT ID: NCT05098821

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Atopic Dermatitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Dupilumab treated Patients

Patients with atopic dermatitis with indication for dupilumab treatments will be observed

not applicable, observational study

Intervention Type: OTHER

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

Interventions

not applicable, observational study

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

LEO Pharma

INDUSTRY

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Margitta Worm

Prof. Dr. med. Margitta Worm

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dpt of Dermatology and Allergology, Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Facility Contacts

Margitta Worm, Prof. Dr. med.

Role: primary

margitta.worm@charite.de

+49 30 450 518105

Sabine Dölle-Bierke, PhD

Role: backup

sabine.doelle@charite.de

+49 30 450 518367

Other Identifiers

PRI-ADD

Identifier Type: -

Identifier Source: org_study_id