Status:
ACTIVE_NOT_RECRUITING
A Long-term Data Collection Study of Participants in France Aged 6 Years Old or More With Atopic Dermatitis Receiving Dupilumab
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
6+ years
Brief Summary
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 Derm...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 28 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 10 2028
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT06169527
Start Date
November 28 2023
End Date
May 10 2028
Last Update
July 14 2025
Active Locations (42)
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1
Investigational Site Number: 2500041
Amiens, France, 80054
2
Investigational Site Number: 2500037
Angers, France, 49000
3
Investigational Site Number: 2500021
Argenteuil, France, 95107
4
Investigational Site Number: 2500044
Armentières, France, 59280