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

Recruiting
6 years of age
Both
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

  • Male or female, 6 years or older.
  • Initiating treatment with dupilumab for AD according to French-specific prescribing information (≥ 12 years old: moderate to severe AD versus 6-11 years old: severe AD). The decision of initiation of the treatment is independent to the study's participation.
  • Able to understand and complete study-related questionnaires.
  • Signed informed consent form. For participants <18 years old, Informed consent form signed by the parent/legal guardian and participant's assent obtained.

Exclusion Criteria:

  • Patients who have a contraindication to the drug according to the French-specific prescribing information label.
  • Any condition that, in the opinion of the Investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the patient from adequately completing, as per routine care, the schedule of visits and assessments.
  • Patients currently participating in any interventional clinical trial.
  • Patients previously treated with dupilumab.
  • Patients under tutorship or curatorship; patients under safeguard of justice or deprived of his/her liberty by an administrative or court decision.

Study details

Atopic Dermatitis

NCT06169527

Sanofi

23 June 2024

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