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

Last updated: February 10, 2026
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dermatitis, Atopic

Eczema (Atopic Dermatitis)

Allergy

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 with dupilumab was initiated in adults and adolescents 12 years ofage and older with moderate to severe AD, or in children 6 to 11 years of age withsevere AD according to the Summary of Product Characteristics.

  • Patients or their guardians are able to understand and complete the study-relatedquestionnaires.

  • Signing a written informed consent form by the patients before the initiation ofdocumentation within the framework of this NIS or informed consent ofparents/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 for more than 7 days.

  • Any acute or chronic diseases, which, in the opinion of the attending physician,would impair the patient's ability to complete questionnaires or participate in thisstudy 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 relevant to 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

    Site Not Available

  • Investigational Site Number: 061

    Aachen 3247449, 52064
    Germany

    Active - Recruiting

  • Investigational Site Number: 092

    Ahaus, 48683
    Germany

    Site Not Available

  • Investigational Site Number: 092

    Ahaus 2959279, 48683
    Germany

    Active - Recruiting

  • Investigational Site Number: 066

    Andernach, 56626
    Germany

    Site Not Available

  • Investigational Site Number: 066

    Andernach 2956206, 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

    Site Not Available

  • Investigational Site Number: 002

    Berlin 2950159, 10117
    Germany

    Active - Recruiting

  • Investigational Site Number: 003

    Berlin 2950159, 10627
    Germany

    Active - Recruiting

  • Investigational Site Number: 004

    Berlin 2950159, 13086
    Germany

    Active - Recruiting

  • Investigational Site Number: 073

    Berlin 2950159, 13507
    Germany

    Active - Recruiting

  • Investigational Site Number: 077

    Berlin 2950159, 12353
    Germany

    Active - Recruiting

  • Investigational Site Number: 174

    Berlin 2950159, 13403
    Germany

    Active - Recruiting

  • Investigational Site Number: 176

    Berlin 2950159, 10997
    Germany

    Active - Recruiting

  • Investigational Site Number: 059

    Braunschweig, 38114
    Germany

    Site Not Available

  • Investigational Site Number: 059

    Braunschweig 2945024, 38114
    Germany

    Active - Recruiting

  • Investigational Site Number: 057

    Buxtehude, 21614
    Germany

    Site Not Available

  • Investigational Site Number: 057

    Buxtehude 2940451, 21614
    Germany

    Active - Recruiting

  • Investigational Site Number: 028

    Chemnitz, 09113
    Germany

    Site Not Available

  • Investigational Site Number: 028

    Chemnitz 2940132, 09113
    Germany

    Active - Recruiting

  • Investigational Site Number: 069

    Cologne 2886242, 50733
    Germany

    Active - Recruiting

  • Investigational Site Number: 026

    Dresden, 01277
    Germany

    Site Not Available

  • Investigational Site Number: 072

    Dresden, 01109
    Germany

    Active - Recruiting

  • Investigational Site Number: 026

    Dresden 2935022, 01277
    Germany

    Active - Recruiting

  • Investigational Site Number: 072

    Dresden 2935022, 01109
    Germany

    Active - Recruiting

  • Investigational Site Number: 032

    Düren, 52349
    Germany

    Site Not Available

  • Investigational Site Number: 032

    Düren 2934486, 52349
    Germany

    Active - Recruiting

  • Investigational Site Number: 043

    Erlangen, 91054
    Germany

    Site Not Available

  • Investigational Site Number: 043

    Erlangen 2929567, 91054
    Germany

    Active - Recruiting

  • Investigational Site Number: 064

    Essen, 45149
    Germany

    Site Not Available

  • Investigational Site Number: 064

    Essen 2928810, 45149
    Germany

    Active - Recruiting

  • Investigational Site Number: 184

    Friedberg, 61169
    Germany

    Site Not Available

  • Investigational Site Number: 184

    Friedberg 2924803, 61169
    Germany

    Active - Recruiting

  • Investigational Site Number: 055

    Gera, 07545
    Germany

    Site Not Available

  • Investigational Site Number: 055

    Gera 2921232, 07545
    Germany

    Active - Recruiting

  • Investigational Site Number: 007

    Giessen 2920512, 35392
    Germany

    Active - Recruiting

  • Investigational Site Number: 007

    Gießen, 35392
    Germany

    Site Not Available

  • Investigational Site Number: 031

    Gladbeck, 45964
    Germany

    Site Not Available

  • Investigational Site Number: 031

    Gladbeck 2920236, 45964
    Germany

    Active - Recruiting

  • Investigational Site Number: 078

    Göttingen, 37075
    Germany

    Site Not Available

  • Investigational Site Number: 078

    Göttingen 2918632, 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

    Site Not Available

  • Investigational Site Number: 088

    Hamburg, 22159
    Germany

    Active - Recruiting

  • Investigational Site Number: 020

    Hamburg 2911298, 22303
    Germany

    Active - Recruiting

  • Investigational Site Number: 086

    Hamburg 2911298, 22549
    Germany

    Active - Recruiting

  • Investigational Site Number: 087

    Hamburg 2911298, 20249
    Germany

    Active - Recruiting

  • Investigational Site Number: 088

    Hamburg 2911298, 22159
    Germany

    Active - Recruiting

  • Investigational Site Number: 169

    Heidelberg, 69115
    Germany

    Site Not Available

  • Investigational Site Number: 169

    Heidelberg 2907911, 69115
    Germany

    Active - Recruiting

  • Investigational Site Number: 053

    Heilbad Heiligenstadt, 37308
    Germany

    Site Not Available

  • Investigational Site Number: 053

    Heilbad Heiligenstadt 2907545, 37308
    Germany

    Active - Recruiting

  • Investigational Site Number: 063

    Jülich, 52428
    Germany

    Site Not Available

  • Investigational Site Number: 063

    Jülich 2894553, 52428
    Germany

    Active - Recruiting

  • Investigational Site Number: 186

    Karlsruhe, 76133
    Germany

    Site Not Available

  • Investigational Site Number: 186

    Karlsruhe 2892794, 76133
    Germany

    Active - Recruiting

  • Investigational Site Number: 016

    Kiel, 24103
    Germany

    Active - Recruiting

  • Investigational Site Number: 017

    Kiel, 24105
    Germany

    Site Not Available

  • Investigational Site Number: 016

    Kiel 2891122, 24103
    Germany

    Active - Recruiting

  • Investigational Site Number: 017

    Kiel 2891122, 24105
    Germany

    Active - Recruiting

  • Investigational Site Number: 069

    Köln, 50733
    Germany

    Site Not Available

  • Investigational Site Number: 183

    Landsberg, 06188
    Germany

    Site Not Available

  • Investigational Site Number: 183

    Landsberg 2881508, 06188
    Germany

    Active - Recruiting

  • Investigational Site Number: 038

    Langenau, 89129
    Germany

    Site Not Available

  • Investigational Site Number: 038

    Langenau 2881259, 89129
    Germany

    Active - Recruiting

  • Investigational Site Number: 179

    Leipzig, 04315
    Germany

    Site Not Available

  • Investigational Site Number: 179

    Leipzig 2879139, 04315
    Germany

    Active - Recruiting

  • Investigational Site Number: 014

    Mainz, 55128
    Germany

    Active - Recruiting

  • Investigational Site Number: 178

    Mainz, 55116
    Germany

    Site Not Available

  • Investigational Site Number: 185

    Mainz, 55116
    Germany

    Active - Recruiting

  • Investigational Site Number: 014

    Mainz 2874225, 55128
    Germany

    Active - Recruiting

  • Investigational Site Number: 178

    Mainz 2874225, 55116
    Germany

    Active - Recruiting

  • Investigational Site Number: 185

    Mainz 2874225, 55116
    Germany

    Active - Recruiting

  • Investigational Site Number: 013

    Mannheim, 68167
    Germany

    Site Not Available

  • Investigational Site Number: 013

    Mannheim 2873891, 68167
    Germany

    Active - Recruiting

  • Investigational Site Number: 018

    Mölln, 23879
    Germany

    Site Not Available

  • Investigational Site Number: 018

    Mölln 2869994, 23879
    Germany

    Active - Recruiting

  • Investigational Site Number: 035

    Mönchengladbach, 41061
    Germany

    Site Not Available

  • Investigational Site Number: 035

    Mönchengladbach 2869894, 41061
    Germany

    Active - Recruiting

  • Investigational Site Number: 050

    München, 80331
    Germany

    Site Not Available

  • Investigational Site Number: 050

    München 2867711, 80331
    Germany

    Active - Recruiting

  • Investigational Site Number: 076

    Neubrandenburg, 17036
    Germany

    Site Not Available

  • Investigational Site Number: 076

    Neubrandenburg 2866135, 17036
    Germany

    Active - Recruiting

  • Investigational Site Number: 042

    Nuremberg 2861650, 90419
    Germany

    Active - Recruiting

  • Investigational Site Number: 045

    Nuremberg 2861650, 90402
    Germany

    Active - Recruiting

  • Investigational Site Number: 042

    Nürnberg, 90419
    Germany

    Active - Recruiting

  • Investigational Site Number: 045

    Nürnberg, 90402
    Germany

    Site Not Available

  • Investigational Site Number: 024

    Oelde, 59302
    Germany

    Site Not Available

  • Investigational Site Number: 024

    Oelde 2857943, 59302
    Germany

    Active - Recruiting

  • Investigational Site Number: 082

    Potsdam, 14469
    Germany

    Site Not Available

  • Investigational Site Number: 082

    Potsdam 2852458, 14469
    Germany

    Active - Recruiting

  • Investigational Site Number: 172

    Remscheid, 42897
    Germany

    Site Not Available

  • Investigational Site Number: 172

    Remscheid 2848273, 42897
    Germany

    Active - Recruiting

  • Investigational Site Number: 177

    Rostock, 18055
    Germany

    Site Not Available

  • Investigational Site Number: 177

    Rostock 2844588, 18055
    Germany

    Active - Recruiting

  • Investigational Site Number: 047

    Wasserburg, 83512
    Germany

    Site Not Available

  • Investigational Site Number: 047

    Wasserburg 2813756, 83512
    Germany

    Active - Recruiting

  • Investigational Site Number: 019

    Wismar, 23966
    Germany

    Site Not Available

  • Investigational Site Number: 019

    Wismar 2807465, 23966
    Germany

    Active - Recruiting

  • Investigational Site Number: 168

    Wittlich, 54516
    Germany

    Site Not Available

  • Investigational Site Number: 168

    Wittlich 2807240, 54516
    Germany

    Active - Recruiting

  • Investigational Site Number: 193

    Wuppertal, 42349
    Germany

    Site Not Available

  • Investigational Site Number: 193

    Wuppertal 2805753, 42349
    Germany

    Active - Recruiting

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