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

Официальное название

A Prospective Observational Study of Adolescent Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions (Eczema Area and Severity Index Score < 16) Receiving Dupilumab

Обзор

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 with Eczema Area and Severity Index (EASI) score greater than or equal to (≥) 16 were enrolled, and effectiveness on sensitive/visible areas was not specifically evaluated. Further data about the effectiveness of dupilumab in adolescent participants with moderate to mild EASI score and severe itching and/or localized AD are therefore necessary to better understand the potential clinical benefits of dupilumab in these populations. 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.

Подробное описание

The individual observational period is planned to be up to 52 weeks.

Вмешательства

• Препарат Dupilumab
  Subcutaneous injection, standard of care as prescribed by treating physician (no investigational drug provided)

Первичные конечные точки

• Physician assessment: Percentage (%) change from baseline in Eczema Area and Severity Index (EASI) score at Week 4, Week 16 and Week 52 [Срок оценки: Baseline, Weeks 4, 16 and 52]
• Physician assessment: Percentage (%) of participants with EASI-50 at 4, 16, 52 weeks [Срок оценки: Weeks 4, 16, 52]
• Physician assessment: Percentage (%) of participants with EASI-75 at 4, 16, 52 weeks [Срок оценки: Weeks 4, 16, 52]
• Physician assessment: Percentage (%) of participants with EASI-90 at 4, 16, 52 weeks [Срок оценки: Weeks 4, 16, 52]
• Participant assessment: Change from baseline in Patient Oriented Eczema Measure (POEM) score at 4, 16, 52 weeks [Срок оценки: Baseline, Weeks 4, 16, 52]
• Participant assessment: Percentage (%) of participants with a ≥ 6-point improvement from baseline in POEM score at 4, 16, 52 weeks [Срок оценки: Baseline, Weeks 4, 16, 52]
• Percentage (%) of participants with adverse events [Срок оценки: Baseline to Week 52]
• Participant assessment: Percentage (%) change from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) at 4, 16, 52 weeks [Срок оценки: Baseline, Weeks 4, 16 and 52]
• Participant assessment: Percentage (%) of participants with a ≥4-point improvement from baseline in PP-NRS at 4, 16, 52 weeks [Срок оценки: Baseline, Weeks 4, 16 and 52]
• Participant assessment: Percentage (%) of participants with a PP-NRS score of 0, 1 to 3, and 4 to 6 at 4, 16, 52 weeks (only patients with baseline PP-NRS ≥ 7 [Срок оценки: Weeks 4, 16 and 52]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 9 центров

• Investigational Site Number: 002 — Bologna
• Investigational Site Number: 006 — Brescia
• Investigational Site Number: 004 — Florence
• Investigational Site Number: 001 — Milan
• Investigational Site Number: 010 — Naples
• Investigational Site Number: 011 — Naples
• Investigational Site Number: 005 — Roma
• Investigational Site Number: 009 — Roma
• … и ещё 1 центр

Идентификаторы

NCT: NCT06192563 · OBS18015 · U1111-1290-5921

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗