A Study to Assess the Impact of Lebrikizumab on Health-Related Well-Being and Control of Skin Manifestations in Participants With Moderate-to-Severe Atopic Dermatitis

Официальное название

A European, Multicenter, Prospective Observational Phase IV Clinical Study to Assess the Impact of Lebrikizumab on Health-Related Well-Being and Control of Skin Manifestations in Patients With Moderate-to-Severe Atopic Dermatitis

Обзор

The main purpose of this study is to evaluate the impact of lebrikizumab treatment on the overall well-being of adult participants with moderate-to-severe AD in real-world clinical practice settings across Europe, as measured using validated 5-item World Health Organization Well-being Index (WHO-5) and to investigate effectiveness and safety of lebrikizumab, treatment satisfaction, and long-term effect of lebrikizumab treatment on participants in terms of disease symptomatology/control, fatigue, work impairment, patient's relationship with their skin, and overall QOL among adult participants.

Вмешательства

• Другое No Intervention
  This is non-interventional study.

Первичные конечные точки

• Absolute Measures in the Overall Health-related Well-being Index Evaluated Through World Health Organization (WHO-5) Score Throughout the Study Observation Period [Срок оценки: Baseline up to Week 104]
• Change From Baseline in the Overall Health-related Well-being Index Evaluated Through WHO-5 Score Throughout the Study Observation Period [Срок оценки: Baseline up to Week 104]

Вторичные конечные точки (12)

• Percentage of Participants with 50 Percent (%) or Greater Reduction From Baseline in Overall Eczema Area and Severity Index (EASI) Score (EASI50) Throughout the Study Observation Period [Срок оценки: Baseline up to Week 104]
• Percentage of Participants with 75% or Greater Reduction From Baseline in Overall EASI Score (EASI75) Throughout the Study Observation Period [Срок оценки: Baseline up to Week 104]
• Percentage of Participants with 90% or Greater Reduction From Baseline in Overall EASI Score (EASI90) Throughout the Study Observation Period [Срок оценки: Baseline up to Week 104]
• Percentage of Participants with 100% Reduction From Baseline in Overall EASI Score (EASI100) Throughout the Study Observation Period [Срок оценки: Baseline up to Week 104]
• Percentage of Participants With Absolute EASI Score Less than or Equal (<=) to 7 Throughout the Study Observation Period [Срок оценки: Baseline up to Week 104]
• Percentage of Participants with Overall Investigator Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) Throughout the Study Observation Period [Срок оценки: Baseline up to Week 104]
• Absolute Measures in Overall IGA Score Throughout the Study Observation Period [Срок оценки: Baseline up to Week 104]
• Change from Baseline in Overall IGA Score Throughout the Study Observation Period [Срок оценки: Baseline up to Week 104]
• Absolute Measures in Patient-Oriented Eczema Measure (POEM) Score Throughout the Study Observation Period [Срок оценки: Baseline up to Week 104]
• Change From Baseline in POEM Score Throughout the Study Observation Period [Срок оценки: Baseline up to Week 104]
• Absolute Measures in Pruritus Numerical Rating Scale (NRS) Score Throughout the Study Observation Period [Срок оценки: Baseline up to Week 104]
• Change From Baseline in Pruritus NRS Score Throughout the Study Observation Period [Срок оценки: Baseline up to Week 104]

Критерии участия

Критерии включения

• Adult (greater than or equal to \[>=\] 18 years) male or female participants with diagnosis of moderate-to-severe Atopic dermatitis.
• Adult participants prescribed lebrikizumab as part of routine/usual care to manage their moderate-to severe Atopic dermatitis.
• Willingness and ability to participate in the study; participants must give their written consent to participate.

Критерии исключения

• Hypersensitivity to the active substances or to any of the excipients of lebrikizumab (Ebglyss®).
• Participants with pre-existing helminth infections. These participants should be treated for helminth infection before starting lebrikizumab therapy.
• Concomitant use of live and live attenuated vaccines.
• Pregnant women, except when the potential benefit justifies the potential risk.
• Participants included in a clinical trial at baseline or at any time during the planned study period.
• Participants unable to comply with the requirements of the study or who, in the opinion of the study physician, should not participate in the study.
• Participants for whom medical chart is inaccessible to physicians to complete baseline data collection.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Дания · 1 центр

• Aarhus University Hospital — Aarhus

Публикации

• Augustin M, Bewley A, Bruggen MC, de Bruin-Weller MS, Ezzedine K, Ferrucci SM, Gkalpakiotis S, Herranz P, Johansson EK, Kampe T, Lapeere H, Legat FJ, Rehbinder EM, Szepietowski JC, Torres T, Vestergaard C, Werfel T, Domenech A, Massana E, Koscielny V, Narayanan S, Kasujee I, Gutermuth J. European, multicentre, prospective observational phase IV clinical study to assess the impact of lebrikizumab o PMID 40645621

Идентификаторы

NCT: NCT06815380 · M-17923-35

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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