A Long-term Data Collection Study of Participants in France Aged 6 Years Old or More With Atopic Dermatitis Receiving Dupilumab

Sponsor
Sanofi
Study ID
NCT06169527
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a long-term study to collect data over 3 years in order to find out what is likely to happen in the future regarding participants 6 years of age and older who receive dupilumab for Atopic Dermatitis (AD) commonly known as Eczema, and to characterize real-world effectiveness, safety and use patterns of dupilumab in real world setting in France. Patients will be invited to participate if initiating treatment with dupilumab for AD according to French-specific prescribing information. The decision of initiation of the treatment is independent to the study's participation. The study will be conducted in approximately 50 centers in France to evaluate a representative sample of patients treated in France. At each participating site, all AD participants who receive an initial prescription for dupilumab will be invited to participate in this study, until the enrollment goal is achieved.

Key Dates

Start date
Nov 28, 2023
Status verified
Jul 2025
Primary completion
May 10, 2028
Completion
May 10, 2028

Study Design

Enrollment
303 participants (actual)

Arms

  • Arm: Participants with AD treated with dupilumab
    Patients ≥6 years of age in whom dupilumab therapy was initiated to treat their AD according to French-specific prescribing information.

Primary Outcome Measure

Demographic characteristics of participants who receive dupilumab for AD [ Time Frame: At baseline ]

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