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

Official title

Prospective, Non-interventional, Observational Study for Multi-dimensional Assessment of Signs, Symptoms, Quality of Life and Disease Control of Long-term Treatment With Dupilumab in Patients With Atopic Dermatitis (≥6 Years)

Overview

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.

Primary outcome measures

• 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 [Time frame: From Month 6 to Month 12]
• Mean percent change from baseline in Atopic Dermatitis Control Tools (ADCT) score (≥12 years) [Time frame: From baseline to Week 52]
• Mean percent change from baseline in Recap of atopic eczema (RECAP) score (6-11 years) [Time frame: From baseline to Week 52]

Secondary outcome measures (12)

• Incidence of treatment emergent adverse events (TEAEs) during the observation period [Time frame: From baseline up to 24 months]
• Incidence of dupilumab-related TEAEs during the observation period. [Time frame: From baseline up to 24 months]
• Event rate (per patient year) by type of TEAEs during the observation period. [Time frame: From baseline up to 24 months]
• Event rate (per patient year) by type of dupilumab related TEAEs during the observational period [Time frame: 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 [Time frame: From baseline up to 24 months]
• Treating physician reported effectiveness data.: Number of patients achieving EASI-75 (improvement in EASI score from baseline of ≥ 75%) after 6, 12 and 24 months of dupilumab therapy [Time frame: From baseline up to 24 months]
• Treating physician reported effectiveness data: Absolute change from baseline in EASI score after 6, 12 and 24 months of dupilumab therapy [Time frame: From baseline up to 24 months]
• Treating physician reported effectiveness data: Percentage change from baseline in EASI score after 6, 12, and 24 months of dupilumab therapy [Time frame: From baseline up to 24 months]
• Treating physician reported effectiveness data: Absolute change from baseline in IGA score after 6, 12, and 24 months of dupilumab therapy [Time frame: From baseline up to 24 months]
• Treating physician reported effectiveness data: Change from baseline in body surface area (BSA) after 6, 12, and 24 months of dupilumab therapy [Time frame: From baseline up to 24 months]
• Patient reported effectiveness and impact on quality of life (QoL) data: Mean absolute change from baseline in Atopic Dermatitis Control Test (ADCT) score after 3, 6, 9, 15, 18, and 24 months of dupilumab therapy [Time frame: From baseline up to 24 months]
• Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in ADCT score after 3, 6, 9, 15, 18, and 24 months of dupilumab therapy [Time frame: From baseline up to 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Other

Study locations

Germany · 55 centers

• Investigational Site Number: 061 — Aachen
• Investigational Site Number: 092 — Ahaus
• Investigational Site Number: 066 — Andernach
• Investigational Site Number: 002 — Berlin
• Investigational Site Number: 003 — Berlin
• Investigational Site Number: 176 — Berlin
• Investigational Site Number: 077 — Berlin
• Investigational Site Number: 004 — Berlin
• … and 47 more centers

Identifiers

NCT: NCT06039241 · OBS17251 · U1111-1293-5998

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗