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

NCT06039241 | Recruiting

• 2 other identifiers: OBS17251U1111-1293-5998
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 55

Brief 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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (3)

• Number of patients who maintain Eczema Area and Severity Index (EASI) ≤ 7 OR peak pruritus Numerical Rating Scale (NRS) ≤ 4 OR Dermatology Life Quality Index (DLQI) ≤ 5

  EASI is a Measure used in clinical practice and clinical trials to assess the severity and extent of Atopic Dermatitis (AD). Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]), higher scores indicated greater severity. DLQI is a questionaire with a score system of 0 to 30 the high score is indicative of poor QoL

  From Month 6 to Month 12

• Mean percent change from baseline in Atopic Dermatitis Control Tools (ADCT) score (≥12 years)

  Atopic dermatitis control tool (ADCT) is a validated, brief and easy scored tool designed to evaluate patient-perceived control of atopic dermatitis, to foster communication between patients and their physicians and help appropriate decision- making. ADCT questionnaire assess patient-self-perceived control of their AD with a total score from 0 to 24; higher scores indicate lower AD control. ADCT is a questionnaire to assess patient-self-perceived control of their AD with a total score from 0 to 24; higher scores indicate lower AD control.

  From baseline to Week 52

• Mean percent change from baseline in Recap of atopic eczema (RECAP) score (6-11 years)

  Recap of atopic eczema (RECAP) is a seven-item questionnaire designed to capture the experience of eczema control in all ages and eczema severities. Patient's who turn 12 years during the course of study will continue to complete RECAP.

  From baseline to Week 52

Secondary Outcomes (46)

• Incidence of treatment emergent adverse events (TEAEs) during the observation period

  From baseline up to 24 months

• Incidence of dupilumab-related TEAEs during the observation period.

  From baseline up to 24 months

• Event rate (per patient year) by type of TEAEs during the observation period.

  From baseline up to 24 months

• Event rate (per patient year) by type of dupilumab related TEAEs during the observational period

  From Baseline up to 24 months

• Treating physician reported effectiveness data: Change from baseline in IGA score after 6, 12, and 24 months dupilumab therapy

  From baseline up to 24 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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) according to the Summary of Product Characteristics. The decision to initiate treatment with dupilumab will be made by the attending physician based on the patient's medical requirements and standards of best medical practice. This decision will be made independent of and prior to data collection in this non-interventional study (NIS).

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (55)

Investigational Site Number: 061

Aachen, 52064, Germany

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Investigational Site Number: 092

Ahaus, 48683, Germany

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Investigational Site Number: 066

Andernach, 56626, Germany

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Investigational Site Number: 002

Berlin, 10117, Germany

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Investigational Site Number: 003

Berlin, 10627, Germany

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Investigational Site Number: 176

Berlin, 10997, Germany

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Investigational Site Number: 077

Berlin, 12353, Germany

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Investigational Site Number: 004

Berlin, 13086, Germany

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Investigational Site Number: 174

Berlin, 13403, Germany

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Investigational Site Number: 073

Berlin, 13507, Germany

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Investigational Site Number: 059

Braunschweig, 38114, Germany

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Investigational Site Number: 057

Buxtehude, 21614, Germany

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Investigational Site Number: 028

Chemnitz, 09113, Germany

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Investigational Site Number: 069

Cologne, 50733, Germany

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Investigational Site Number: 072

Dresden, 01109, Germany

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Investigational Site Number: 026

Dresden, 01277, Germany

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Investigational Site Number: 032

Düren, 52349, Germany

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Investigational Site Number: 043

Erlangen, 91054, Germany

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Investigational Site Number: 064

Essen, 45149, Germany

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Investigational Site Number: 184

Friedberg, 61169, Germany

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Investigational Site Number: 055

Gera, 07545, Germany

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Investigational Site Number: 007

Giessen, 35392, Germany

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Investigational Site Number: 031

Gladbeck, 45964, Germany

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Investigational Site Number: 078

Göttingen, 37075, Germany

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Investigational Site Number: 087

Hamburg, 20249, Germany

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Investigational Site Number: 088

Hamburg, 22159, Germany

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Investigational Site Number: 020

Hamburg, 22303, Germany

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Investigational Site Number: 086

Hamburg, 22549, Germany

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Investigational Site Number: 169

Heidelberg, 69115, Germany

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Investigational Site Number: 053

Heilbad Heiligenstadt, 37308, Germany

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Investigational Site Number: 063

Jülich, 52428, Germany

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Investigational Site Number: 186

Karlsruhe, 76133, Germany

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Investigational Site Number: 016

Kiel, 24103, Germany

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Investigational Site Number: 017

Kiel, 24105, Germany

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Investigational Site Number: 183

Landsberg, 06188, Germany

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Investigational Site Number: 038

Langenau, 89129, Germany

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Investigational Site Number: 179

Leipzig, 04315, Germany

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Investigational Site Number: 178

Mainz, 55116, Germany

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Investigational Site Number: 185

Mainz, 55116, Germany

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Investigational Site Number: 014

Mainz, 55128, Germany

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Investigational Site Number: 013

Mannheim, 68167, Germany

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Investigational Site Number: 018

Mölln, 23879, Germany

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Investigational Site Number: 035

Mönchengladbach, 41061, Germany

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Investigational Site Number: 050

München, 80331, Germany

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Investigational Site Number: 076

Neubrandenburg, 17036, Germany

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Investigational Site Number: 045

Nuremberg, 90402, Germany

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Investigational Site Number: 042

Nuremberg, 90419, Germany

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Investigational Site Number: 024

Oelde, 59302, Germany

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Investigational Site Number: 082

Potsdam, 14469, Germany

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Investigational Site Number: 172

Remscheid, 42897, Germany

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Investigational Site Number: 177

Rostock, 18055, Germany

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Investigational Site Number: 047

Wasserburg, 83512, Germany

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Investigational Site Number: 019

Wismar, 23966, Germany

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Investigational Site Number: 168

Wittlich, 54516, Germany

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Investigational Site Number: 193

Wuppertal, 42349, Germany

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MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

1800633-1610; Contact-US@sanofi.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: September 15, 2023
• Study Start: March 7, 2023
• Primary Completion (Estimated): March 8, 2028
• Study Completion (Estimated): March 8, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

DE (55)