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

Last updated: July 2, 2025
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

N/A

Condition

Scalp Disorders

Atopic Dermatitis

Hives (Urticaria)

Treatment

N/A

Clinical Study ID

NCT06039241
OBS17251
U1111-1293-5998
  • Ages > 6
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients are at least 6 years of age at the baseline visit. - Initial treatment withdupilumab was initiated in adults and adolescents 12 years of age and older withmoderate to severe AD, or in children 6 to 11 years of age with severe AD accordingto the Summary of Product Characteristics. - Patients or their guardians are able tounderstand and complete the study-related questionnaires. - Signing a writteninformed consent form by the patients before the initiation of documentation withinthe framework of this NIS or informed consent of parents/guardian, if applicable.

Exclusion

Exclusion Criteria:

  • Patients who have a contraindication for dupilumab based on the current Summary ofProduct Characteristics. - Patients who have already been treated with dupilumab formore than 7 days. - Any acute or chronic diseases, which, in the opinion of theattending physician, would impair the patient's ability to complete questionnairesor participate in this study or could affect the interpretation of the results. -Participation in an ongoing interventional or observational study, which, in theopinion of the attending physician, could affect the assessment of the currentstudy. "The above information is not intended to contain all considerations relevantto a potential participation in a clinical trial."

Study Design

Total Participants: 900
Study Start date:
March 07, 2023
Estimated Completion Date:
March 08, 2028

Connect with a study center

  • Investigational Site Number: 061

    Aachen, 52064
    Germany

    Active - Recruiting

  • Investigational Site Number: 092

    Ahaus, 48683
    Germany

    Active - Recruiting

  • Investigational Site Number: 066

    Andernach, 56626
    Germany

    Active - Recruiting

  • Investigational Site Number :

    Berlin, 10117
    Germany

    Active - Recruiting

  • Investigational Site Number: 002

    Berlin, 10117
    Germany

    Active - Recruiting

  • Investigational Site Number: 003

    Berlin, 10627
    Germany

    Active - Recruiting

  • Investigational Site Number: 004

    Berlin, 13086
    Germany

    Active - Recruiting

  • Investigational Site Number: 073

    Berlin, 13507
    Germany

    Active - Recruiting

  • Investigational Site Number: 077

    Berlin, 12353
    Germany

    Active - Recruiting

  • Investigational Site Number: 174

    Berlin, 13403
    Germany

    Active - Recruiting

  • Investigational Site Number: 176

    Berlin, 10997
    Germany

    Active - Recruiting

  • Investigational Site Number: 059

    Braunschweig, 38114
    Germany

    Active - Recruiting

  • Investigational Site Number: 057

    Buxtehude, 21614
    Germany

    Active - Recruiting

  • Investigational Site Number: 028

    Chemnitz, 09113
    Germany

    Active - Recruiting

  • Investigational Site Number: 026

    Dresden, 01277
    Germany

    Active - Recruiting

  • Investigational Site Number: 072

    Dresden, 01109
    Germany

    Active - Recruiting

  • Investigational Site Number: 032

    Düren, 52349
    Germany

    Active - Recruiting

  • Investigational Site Number: 043

    Erlangen, 91054
    Germany

    Active - Recruiting

  • Investigational Site Number: 064

    Essen, 45149
    Germany

    Active - Recruiting

  • Investigational Site Number: 184

    Friedberg, 61169
    Germany

    Active - Recruiting

  • Investigational Site Number: 055

    Gera, 07545
    Germany

    Active - Recruiting

  • Investigational Site Number: 007

    Gießen, 35392
    Germany

    Active - Recruiting

  • Investigational Site Number: 031

    Gladbeck, 45964
    Germany

    Active - Recruiting

  • Investigational Site Number: 078

    Göttingen, 37075
    Germany

    Active - Recruiting

  • Investigational Site Number: 020

    Hamburg, 22303
    Germany

    Active - Recruiting

  • Investigational Site Number: 086

    Hamburg, 22549
    Germany

    Active - Recruiting

  • Investigational Site Number: 087

    Hamburg, 20249
    Germany

    Active - Recruiting

  • Investigational Site Number: 088

    Hamburg, 22159
    Germany

    Active - Recruiting

  • Investigational Site Number: 169

    Heidelberg, 69115
    Germany

    Active - Recruiting

  • Investigational Site Number: 053

    Heilbad Heiligenstadt, 37308
    Germany

    Active - Recruiting

  • Investigational Site Number: 063

    Jülich, 52428
    Germany

    Active - Recruiting

  • Investigational Site Number: 186

    Karlsruhe, 76133
    Germany

    Active - Recruiting

  • Investigational Site Number: 016

    Kiel, 24103
    Germany

    Active - Recruiting

  • Investigational Site Number: 017

    Kiel, 24105
    Germany

    Active - Recruiting

  • Investigational Site Number: 069

    Köln, 50733
    Germany

    Active - Recruiting

  • Investigational Site Number: 183

    Landsberg, 06188
    Germany

    Active - Recruiting

  • Investigational Site Number: 038

    Langenau, 89129
    Germany

    Active - Recruiting

  • Investigational Site Number: 179

    Leipzig, 04315
    Germany

    Active - Recruiting

  • Investigational Site Number: 014

    Mainz, 55128
    Germany

    Active - Recruiting

  • Investigational Site Number: 178

    Mainz, 55116
    Germany

    Active - Recruiting

  • Investigational Site Number: 185

    Mainz, 55116
    Germany

    Active - Recruiting

  • Investigational Site Number: 013

    Mannheim, 68167
    Germany

    Active - Recruiting

  • Investigational Site Number: 018

    Mölln, 23879
    Germany

    Active - Recruiting

  • Investigational Site Number: 035

    Mönchengladbach, 41061
    Germany

    Active - Recruiting

  • Investigational Site Number: 050

    München, 80331
    Germany

    Active - Recruiting

  • Investigational Site Number: 076

    Neubrandenburg, 17036
    Germany

    Active - Recruiting

  • Investigational Site Number: 042

    Nürnberg, 90419
    Germany

    Active - Recruiting

  • Investigational Site Number: 045

    Nürnberg, 90402
    Germany

    Active - Recruiting

  • Investigational Site Number: 024

    Oelde, 59302
    Germany

    Active - Recruiting

  • Investigational Site Number: 082

    Potsdam, 14469
    Germany

    Active - Recruiting

  • Investigational Site Number: 172

    Remscheid, 42897
    Germany

    Active - Recruiting

  • Investigational Site Number: 177

    Rostock, 18055
    Germany

    Active - Recruiting

  • Investigational Site Number: 047

    Wasserburg, 83512
    Germany

    Active - Recruiting

  • Investigational Site Number: 019

    Wismar, 23966
    Germany

    Active - Recruiting

  • Investigational Site Number: 168

    Wittlich, 54516
    Germany

    Active - Recruiting

  • Investigational Site Number: 193

    Wuppertal, 42349
    Germany

    Active - Recruiting

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