Real-world Effectiveness Study of Long-term Treatment With Dupilumab in Participants ≥6 Years With Atopic Dermatitis

RECRUITING

NCT06039241

Sponsor: Sanofi

Summary

This is a Prospective, non-interventional (NIS) observational study in patients (≥6 years) with atopic dermatitis (AD) receiving dupilumab for the prospective evaluation of signs and symptoms, quality of life and disease control. The aim of this NIS is the characterization of the AD patient population in Germany, receiving dupilumab under everyday conditions in terms of their medical history, socio-demographic and disease-related characteristics, associated atopic comorbidities and type 2 inflammation diseases, concomitant therapy as well as previous systemic and ongoing AD treatments. In addition to the therapeutic response rate at Month 6, the long-term efficacy of dupilumab at Month 12 and Month 24 will be assessed by additional outcomes by measuring disease control in AD patients using questionnaires such as Atopic Dermatitis Control Tool (ADCT) and Recap of Atopic Eczema (RECAP). In addition, this NIS aims to assess the dosing pattern of dupilumab for AD, including variations in dosing regimen, reason for dupilumab treatment initiation or discontinuation, or change in therapy and concomitant therapies and duration of treatment. In addition, the effect of dupilumab in adult and pediatric AD patients with associated atopic comorbidities or type-2 inflammation diseases are observed, which corresponds to the clinical care situation. Finally, this NIS aims to collect long-term safety data in adult, adolescent and pediatric AD patients treated with dupilumab. Individual observation period is 2 years or until dupilumab is discontinued. Visits will be scheduled according to standard of care.

Official title: Prospective, Non-interventional, Observational Study for Multi-dimensional Assessment of Signs, Symptoms, Quality of Life and Disease Control of Long-term Treatment With Dupilumab in Patients With Atopic Dermatitis (≥6 Years)

Key Details

Gender

All

Age Range

6 Years - Any

Study Type

OBSERVATIONAL

Enrollment

900

Start Date

2023-03-07

Completion Date

2028-03-08

Last Updated

2026-02-12

Healthy Volunteers

No

Conditions

Atopic Dermatitis

Locations (55)

Investigational Site Number: 061

Aachen, Germany

Investigational Site Number: 092

Ahaus, Germany

Investigational Site Number: 066

Andernach, Germany

Investigational Site Number: 002

Berlin, Germany

Investigational Site Number: 003

Berlin, Germany

Investigational Site Number: 176

Berlin, Germany

Investigational Site Number: 077

Berlin, Germany

Investigational Site Number: 004

Berlin, Germany

Investigational Site Number: 174

Berlin, Germany

Investigational Site Number: 073

Berlin, Germany

Investigational Site Number: 059

Braunschweig, Germany

Investigational Site Number: 057

Buxtehude, Germany

Investigational Site Number: 028

Chemnitz, Germany

Investigational Site Number: 069

Cologne, Germany

Investigational Site Number: 072

Dresden, Germany

Investigational Site Number: 026

Dresden, Germany

Investigational Site Number: 032

Düren, Germany

Investigational Site Number: 043

Erlangen, Germany

Investigational Site Number: 064

Essen, Germany

Investigational Site Number: 184

Friedberg, Germany

Investigational Site Number: 055

Gera, Germany

Investigational Site Number: 007

Giessen, Germany

Investigational Site Number: 031

Gladbeck, Germany

Investigational Site Number: 078

Göttingen, Germany

Investigational Site Number: 087

Hamburg, Germany

Investigational Site Number: 088

Hamburg, Germany

Investigational Site Number: 020

Hamburg, Germany

Investigational Site Number: 086

Hamburg, Germany

Investigational Site Number: 169

Heidelberg, Germany

Investigational Site Number: 053

Heilbad Heiligenstadt, Germany

Investigational Site Number: 063

Jülich, Germany

Investigational Site Number: 186

Karlsruhe, Germany

Investigational Site Number: 016

Kiel, Germany

Investigational Site Number: 017

Kiel, Germany

Investigational Site Number: 183

Landsberg, Germany

Investigational Site Number: 038

Langenau, Germany

Investigational Site Number: 179

Leipzig, Germany

Investigational Site Number: 178

Mainz, Germany

Investigational Site Number: 185

Mainz, Germany

Investigational Site Number: 014

Mainz, Germany

Investigational Site Number: 013

Mannheim, Germany

Investigational Site Number: 018

Mölln, Germany

Investigational Site Number: 035

Mönchengladbach, Germany

Investigational Site Number: 050

München, Germany

Investigational Site Number: 076

Neubrandenburg, Germany

Investigational Site Number: 045

Nuremberg, Germany

Investigational Site Number: 042

Nuremberg, Germany

Investigational Site Number: 024

Oelde, Germany

Investigational Site Number: 082

Potsdam, Germany

Investigational Site Number: 172

Remscheid, Germany

Investigational Site Number: 177

Rostock, Germany

Investigational Site Number: 047

Wasserburg, Germany

Investigational Site Number: 019

Wismar, Germany

Investigational Site Number: 168

Wittlich, Germany

Investigational Site Number: 193

Wuppertal, Germany

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