Actively Recruiting
Led by Almirall, S.A. · Updated on 2025-02-07
1000
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the impact of lebrikizumab treatment on the overall well-being of adults with moderate-to-severe atopic dermatitis in real-world clinical settings across Europe. The study aims to measure health-related well-being using the World Health Organization Well-being Index (WHO-5) and to assess lebrikizumab's effectiveness, safety, treatment satisfaction, and long-term effects on symptoms, fatigue, work impairment, skin relationships, and overall quality of life. Participants prescribed lebrikizumab as part of their usual care will be observed for 104 weeks. This is a non-interventional, observational study where data on participants receiving lebrikizumab will be collected according to routine clinical practice without altering their treatment. The study focuses on tracking health and symptom control over this two-year period. During the study, participants will undergo regular assessments of their well-being, eczema severity, itch and skin pain intensity, fatigue, sleep quality, and adverse events. Researchers will use validated scales including WHO-5, Eczema Area and Severity Index (EASI), Investigator Global Assessment (IGA), Patient-Oriented Eczema Measure (POEM), and Numerical Rating Scales for pruritus, skin pain, and fatigue. Safety and treatment satisfaction will also be monitored throughout the 104 weeks of observation.
CONDITIONS
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
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 104 weeks
Participants who are treated with lebrikizumab as part of routine care are observed and data are collected to assess health-related well-being and skin condition over time.
Visits occurring throughout the 104-week observation period as per routine clinical practice
Total: 1 location
1
Aarhus University Hospital
Aarhus, Denmark, Denmark
Actively Recruiting
È
Èric Massana
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Matthias Augustin, Anthony Bewley, Marie-Charlotte Brüggen...
https://pubmed.ncbi.nlm.nih.gov/40645621