Last updated: April 12, 2024
Sponsor: Sanofi
Overall Status: Active - Recruiting
Phase
N/A
Condition
Dermatitis, Atopic
Allergy
Rash
Treatment
Dupilumab
Clinical Study ID
NCT06192563
OBS18015
U1111-1290-5921
Ages 12-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 delFarmaco (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 representativeconsent and patient assent where applicable
Exclusion
Exclusion Criteria:
- Prior use of dupilumab within 6 months prior the study entry
- Patients currently participating in any interventional clinical trial which modifiespatient care
- Any condition that, in the opinion of the Investigator, may interfere with patient'sability to participate in the study (e.g., substance abuse) The above information is not intended to contain all considerations relevant to a potentialparticipation in a clinical trial.
Study Design
Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Dupilumab
Phase:
Study Start date:
November 30, 2023
Estimated Completion Date:
January 31, 2026
Study Description
Connect with a study center
Investigational Site Number: 002
Bologna, 40138
ItalyActive - Recruiting
Investigational Site Number: 006
Brescia, 25123
ItalyActive - Recruiting
Investigational Site Number: 004
Firenze, 50139
ItalyActive - Recruiting
Investigational Site Number: 001
Milano, 20122
ItalyActive - Recruiting
Investigational Site Number : 010
Napoli, 80131
ItalyActive - Recruiting
Investigational Site Number: 010
Napoli, 80131
ItalyActive - Recruiting
Investigational Site Number: 011
Napoli, 80138
ItalyActive - Recruiting
Investigational Site Number: 005
Roma, 00133
ItalyActive - Recruiting
Investigational Site Number: 009
Roma, 00168
ItalyActive - Recruiting
Investigational Site Number: 014
Verona, 37134
ItalyActive - Recruiting
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