Status:
RECRUITING
A Study to Observe How Adolescent Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions (Eczema Area and Severity Index Score < 16) Respond to Dupilumab Treatment
Lead Sponsor:
Sanofi
Conditions:
Dermatitis Atopic
Eligibility:
All Genders
12-17 years
Brief Summary
In adolescents treated with dupilumab, clinical trials showed significant improvement of atopic dermatitis (AD) signs and symptoms, with a good safety profile. In these clinical trials, only patients ...
Detailed Description
The individual observational period is planned to be up to 52 weeks.
Eligibility Criteria
Inclusion
- Male or female, aged between 12 and 17 years at the baseline visit
- Patients with AD who have been prescribed dupilumab according to Agenzia Italiana del Farmaco (AIFA) reimbursement criteria and fulfilling the following criteria:
- Patients with EASI\<16 and
- Children's Dermatology Life Quality Index (CDLQI) ≥ 10 or
- Peak Pruritus Numerical Rating Scale (PP-NRS) ≥ 7 or
- localization in visible or sensitive areas (head/neck/hands or genitals)
- Patients able to understand and complete study-related questionnaires
- Provided signed informed consent or parental/legally acceptable representative consent and patient assent where applicable
Exclusion
- Prior use of dupilumab within 6 months prior the study entry
- Patients currently participating in any interventional clinical trial which modifies patient care
- Any condition that, in the opinion of the Investigator, may interfere with patient's ability to participate in the study (e.g., substance abuse)
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Key Trial Info
Start Date :
November 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06192563
Start Date
November 30 2023
End Date
January 31 2026
Last Update
April 15 2024
Active Locations (9)
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1
Investigational Site Number: 002
Bologna, Italy, 40138
2
Investigational Site Number: 006
Brescia, Italy, 25123
3
Investigational Site Number: 004
Florence, Italy, 50139
4
Investigational Site Number: 001
Milan, Italy, 20122