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
NCT ID: NCT06192563
Last Updated: 2024-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2023-11-30
2026-01-31
Brief Summary
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This is an Italian multicenter, 52-week observational (non-interventional) study which will collect data on the characteristics of adolescent (aged 12 to 17 years) participants who suffer from severe AD with EASI score less than (\<) 16, eligible for systemic dupilumab treatment according to Italian reimbursement criteria. It will study the real-world effectiveness and safety of dupilumab in this population, the effect of dupilumab on itching (pruritus), sleep, quality of life and related outcomes, localized AD in sensitive/visible areas, and on coexisting atopic conditions in adolescent participants who receive dupilumab for AD. It will also document dupilumab treatment satisfaction and dupilumab discontinuation in the study participants.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adolescents with AD
Adolescent (aged 12 to 17 years) participants who suffer from severe AD with EASI score \< 16, eligible for systemic dupilumab treatment according to Italian reimbursement criteria.
Dupilumab
Subcutaneous injection, standard of care as prescribed by treating physician (no investigational drug provided)
Interventions
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Dupilumab
Subcutaneous injection, standard of care as prescribed by treating physician (no investigational drug provided)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
1. Children's Dermatology Life Quality Index (CDLQI) ≥ 10 or
2. Peak Pruritus Numerical Rating Scale (PP-NRS) ≥ 7 or
3. 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 Criteria
* 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.
12 Years
17 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number: 002
Bologna, , Italy
Investigational Site Number: 006
Brescia, , Italy
Investigational Site Number: 004
Florence, , Italy
Investigational Site Number: 001
Milan, , Italy
Investigational Site Number: 010
Napoli, , Italy
Investigational Site Number: 011
Napoli, , Italy
Investigational Site Number: 005
Roma, , Italy
Investigational Site Number: 009
Roma, , Italy
Investigational Site Number: 014
Verona, , Italy
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Other Identifiers
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U1111-1290-5921
Identifier Type: REGISTRY
Identifier Source: secondary_id
OBS18015
Identifier Type: -
Identifier Source: org_study_id
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