Status:
RECRUITING
Real-world Effectiveness Study of Long-term Treatment With Dupilumab in Participants ≥6 Years With Atopic Dermatitis
Lead Sponsor:
Sanofi
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
6+ years
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...
Eligibility Criteria
Inclusion
- \- 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
- \- 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."
Key Trial Info
Start Date :
March 7 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 8 2028
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT06039241
Start Date
March 7 2023
End Date
March 8 2028
Last Update
July 3 2025
Active Locations (55)
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1
Investigational Site Number: 061
Aachen, Germany, 52064
2
Investigational Site Number: 092
Ahaus, Germany, 48683
3
Investigational Site Number: 066
Andernach, Germany, 56626
4
Investigational Site Number: 002
Berlin, Germany, 10117