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Real-world Effectiveness Study of Long-term Treatment With Dupilumab in Participants ≥6 Years With Atopic Dermatitis
Led by Sanofi · Updated on 2026-02-12
900
Participants Needed
55
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Real-world Effectiveness Study of Long-term Treatment With Dupilumab in Participants ≥6 Years With Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients are at least 6 years of age at the baseline visit.
- Initial treatment with dupilumab was initiated in adults and adolescents 12 years of age and older with moderate to severe AD, or in children 6 to 11 years of age with severe AD according to the Summary of Product Characteristics.
- Patients or their guardians are able to understand and complete the study-related questionnaires.
- Signing a written informed consent form by the patients before the initiation of documentation within the framework of this NIS or informed consent of parents/guardian, if applicable.
You will not qualify if you...
- Patients who have a contraindication for dupilumab based on the current Summary of Product 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 this study or could affect the interpretation of the results.
- Participation in an ongoing interventional or observational study, which, in the opinion of the attending physician, could affect the assessment of the current study.
AI-Screening
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Trial Site Locations
Total: 55 locations
1
Investigational Site Number: 061
Aachen, Germany, 52064
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2
Investigational Site Number: 092
Ahaus, Germany, 48683
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3
Investigational Site Number: 066
Andernach, Germany, 56626
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4
Investigational Site Number: 002
Berlin, Germany, 10117
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5
Investigational Site Number: 003
Berlin, Germany, 10627
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6
Investigational Site Number: 176
Berlin, Germany, 10997
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7
Investigational Site Number: 077
Berlin, Germany, 12353
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8
Investigational Site Number: 004
Berlin, Germany, 13086
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9
Investigational Site Number: 174
Berlin, Germany, 13403
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10
Investigational Site Number: 073
Berlin, Germany, 13507
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11
Investigational Site Number: 059
Braunschweig, Germany, 38114
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12
Investigational Site Number: 057
Buxtehude, Germany, 21614
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13
Investigational Site Number: 028
Chemnitz, Germany, 09113
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14
Investigational Site Number: 069
Cologne, Germany, 50733
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15
Investigational Site Number: 072
Dresden, Germany, 01109
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16
Investigational Site Number: 026
Dresden, Germany, 01277
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17
Investigational Site Number: 032
Düren, Germany, 52349
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18
Investigational Site Number: 043
Erlangen, Germany, 91054
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19
Investigational Site Number: 064
Essen, Germany, 45149
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20
Investigational Site Number: 184
Friedberg, Germany, 61169
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21
Investigational Site Number: 055
Gera, Germany, 07545
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22
Investigational Site Number: 007
Giessen, Germany, 35392
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23
Investigational Site Number: 031
Gladbeck, Germany, 45964
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24
Investigational Site Number: 078
Göttingen, Germany, 37075
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25
Investigational Site Number: 087
Hamburg, Germany, 20249
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26
Investigational Site Number: 088
Hamburg, Germany, 22159
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27
Investigational Site Number: 020
Hamburg, Germany, 22303
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28
Investigational Site Number: 086
Hamburg, Germany, 22549
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29
Investigational Site Number: 169
Heidelberg, Germany, 69115
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30
Investigational Site Number: 053
Heilbad Heiligenstadt, Germany, 37308
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31
Investigational Site Number: 063
Jülich, Germany, 52428
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32
Investigational Site Number: 186
Karlsruhe, Germany, 76133
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33
Investigational Site Number: 016
Kiel, Germany, 24103
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34
Investigational Site Number: 017
Kiel, Germany, 24105
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35
Investigational Site Number: 183
Landsberg, Germany, 06188
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36
Investigational Site Number: 038
Langenau, Germany, 89129
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37
Investigational Site Number: 179
Leipzig, Germany, 04315
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38
Investigational Site Number: 178
Mainz, Germany, 55116
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39
Investigational Site Number: 185
Mainz, Germany, 55116
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40
Investigational Site Number: 014
Mainz, Germany, 55128
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41
Investigational Site Number: 013
Mannheim, Germany, 68167
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42
Investigational Site Number: 018
Mölln, Germany, 23879
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43
Investigational Site Number: 035
Mönchengladbach, Germany, 41061
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44
Investigational Site Number: 050
München, Germany, 80331
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45
Investigational Site Number: 076
Neubrandenburg, Germany, 17036
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46
Investigational Site Number: 045
Nuremberg, Germany, 90402
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47
Investigational Site Number: 042
Nuremberg, Germany, 90419
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48
Investigational Site Number: 024
Oelde, Germany, 59302
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49
Investigational Site Number: 082
Potsdam, Germany, 14469
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50
Investigational Site Number: 172
Remscheid, Germany, 42897
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51
Investigational Site Number: 177
Rostock, Germany, 18055
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52
Investigational Site Number: 047
Wasserburg, Germany, 83512
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53
Investigational Site Number: 019
Wismar, Germany, 23966
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54
Investigational Site Number: 168
Wittlich, Germany, 54516
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55
Investigational Site Number: 193
Wuppertal, Germany, 42349
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Research Team
T
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CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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