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

NCT ID: NCT06039241

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-07

Study Completion Date

2028-03-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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AD patients treated with dupilumab

Patients ≥6 years of age in whom dupilumab therapy was initiated to treat their severe AD (6-11 years) or moderate to severe AD (adult and adolescent patients ≥12 years of age) based on the patient's medical requirements and standards of best medical practice.

No interventions assigned to this group

Eligibility Criteria

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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 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.

Exclusion Criteria

\- 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. "The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial."
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences &amp; Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number: 061

Aachen, , Germany

Site Status RECRUITING

Investigational Site Number: 092

Ahaus, , Germany

Site Status RECRUITING

Investigational Site Number: 066

Andernach, , Germany

Site Status RECRUITING

Investigational Site Number: 002

Berlin, , Germany

Site Status RECRUITING

Investigational Site Number: 003

Berlin, , Germany

Site Status RECRUITING

Investigational Site Number: 176

Berlin, , Germany

Site Status RECRUITING

Investigational Site Number: 077

Berlin, , Germany

Site Status RECRUITING

Investigational Site Number: 004

Berlin, , Germany

Site Status RECRUITING

Investigational Site Number: 174

Berlin, , Germany

Site Status RECRUITING

Investigational Site Number: 073

Berlin, , Germany

Site Status RECRUITING

Investigational Site Number: 059

Braunschweig, , Germany

Site Status RECRUITING

Investigational Site Number: 057

Buxtehude, , Germany

Site Status RECRUITING

Investigational Site Number: 028

Chemnitz, , Germany

Site Status RECRUITING

Investigational Site Number: 069

Cologne, , Germany

Site Status RECRUITING

Investigational Site Number: 072

Dresden, , Germany

Site Status RECRUITING

Investigational Site Number: 026

Dresden, , Germany

Site Status RECRUITING

Investigational Site Number: 032

Düren, , Germany

Site Status RECRUITING

Investigational Site Number: 043

Erlangen, , Germany

Site Status RECRUITING

Investigational Site Number: 064

Essen, , Germany

Site Status RECRUITING

Investigational Site Number: 184

Friedberg, , Germany

Site Status RECRUITING

Investigational Site Number: 055

Gera, , Germany

Site Status RECRUITING

Investigational Site Number: 007

Giessen, , Germany

Site Status RECRUITING

Investigational Site Number: 031

Gladbeck, , Germany

Site Status RECRUITING

Investigational Site Number: 078

Göttingen, , Germany

Site Status RECRUITING

Investigational Site Number: 087

Hamburg, , Germany

Site Status RECRUITING

Investigational Site Number: 088

Hamburg, , Germany

Site Status RECRUITING

Investigational Site Number: 020

Hamburg, , Germany

Site Status RECRUITING

Investigational Site Number: 086

Hamburg, , Germany

Site Status RECRUITING

Investigational Site Number: 169

Heidelberg, , Germany

Site Status RECRUITING

Investigational Site Number: 053

Heilbad Heiligenstadt, , Germany

Site Status RECRUITING

Investigational Site Number: 063

Jülich, , Germany

Site Status RECRUITING

Investigational Site Number: 186

Karlsruhe, , Germany

Site Status RECRUITING

Investigational Site Number: 016

Kiel, , Germany

Site Status RECRUITING

Investigational Site Number: 017

Kiel, , Germany

Site Status RECRUITING

Investigational Site Number: 183

Landsberg, , Germany

Site Status RECRUITING

Investigational Site Number: 038

Langenau, , Germany

Site Status RECRUITING

Investigational Site Number: 179

Leipzig, , Germany

Site Status RECRUITING

Investigational Site Number: 178

Mainz, , Germany

Site Status RECRUITING

Investigational Site Number: 185

Mainz, , Germany

Site Status RECRUITING

Investigational Site Number: 014

Mainz, , Germany

Site Status RECRUITING

Investigational Site Number: 013

Mannheim, , Germany

Site Status RECRUITING

Investigational Site Number: 018

Mölln, , Germany

Site Status RECRUITING

Investigational Site Number: 035

Mönchengladbach, , Germany

Site Status RECRUITING

Investigational Site Number: 050

München, , Germany

Site Status RECRUITING

Investigational Site Number: 076

Neubrandenburg, , Germany

Site Status RECRUITING

Investigational Site Number: 045

Nuremberg, , Germany

Site Status RECRUITING

Investigational Site Number: 042

Nuremberg, , Germany

Site Status RECRUITING

Investigational Site Number: 024

Oelde, , Germany

Site Status RECRUITING

Investigational Site Number: 082

Potsdam, , Germany

Site Status RECRUITING

Investigational Site Number: 172

Remscheid, , Germany

Site Status RECRUITING

Investigational Site Number: 177

Rostock, , Germany

Site Status RECRUITING

Investigational Site Number: 047

Wasserburg, , Germany

Site Status RECRUITING

Investigational Site Number: 019

Wismar, , Germany

Site Status RECRUITING

Investigational Site Number: 168

Wittlich, , Germany

Site Status RECRUITING

Investigational Site Number: 193

Wuppertal, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Trial Transparency email recommended (Toll free for US &amp; Canada)

Role: CONTACT

[email protected]
1800633-1610 ext. option 6

Other Identifiers

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U1111-1293-5998

Identifier Type: REGISTRY

Identifier Source: secondary_id

OBS17251

Identifier Type: -

Identifier Source: org_study_id

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