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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Intervention.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis, Eczema. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Other No Intervention
This is non-interventional study.
Primary outcome measures
- Absolute Measures in the Overall Health-related Well-being Index Evaluated Through World Health Organization (WHO-5) Score Throughout the Study Observation Period [Time frame: 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 [Time frame: Baseline up to Week 104]
Secondary outcome measures (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 [Time frame: 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 [Time frame: 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 [Time frame: Baseline up to Week 104]
- Percentage of Participants with 100% Reduction From Baseline in Overall EASI Score (EASI100) Throughout the Study Observation Period [Time frame: Baseline up to Week 104]
- Percentage of Participants With Absolute EASI Score Less than or Equal (<=) to 7 Throughout the Study Observation Period [Time frame: 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 [Time frame: Baseline up to Week 104]
- Absolute Measures in Overall IGA Score Throughout the Study Observation Period [Time frame: Baseline up to Week 104]
- Change from Baseline in Overall IGA Score Throughout the Study Observation Period [Time frame: Baseline up to Week 104]
- Absolute Measures in Patient-Oriented Eczema Measure (POEM) Score Throughout the Study Observation Period [Time frame: Baseline up to Week 104]
- Change From Baseline in POEM Score Throughout the Study Observation Period [Time frame: Baseline up to Week 104]
- Absolute Measures in Pruritus Numerical Rating Scale (NRS) Score Throughout the Study Observation Period [Time frame: Baseline up to Week 104]
- Change From Baseline in Pruritus NRS Score Throughout the Study Observation Period [Time frame: Baseline up to Week 104]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Aarhus University Hospital — Aarhus
Publications
- 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
Identifiers
NCT: NCT06815380 · M-17923-35