European Observational Study on Lebrikizumab Impact for Adults with Moderate-to-Severe Atopic Dermatitis
Assessing Well-Being and Skin Symptom Control Over Two Years
Led by Almirall, S.A. · Updated on 2025-02-07
1000
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
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 lebrikizumabs 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
Brief Title
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
Research Team
È
Èric Massana
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Adult (18 years or older) male or female participants with a diagnosis of moderate-to-severe atopic dermatitis.
Adult participants prescribed lebrikizumab as part of routine care for moderate-to-severe atopic dermatitis.
Willing and able to participate in the study and provide written consent.
You will not qualify if you...
Allergy or hypersensitivity to lebrikizumab or any of its ingredients.
Presence of pre-existing helminth infections without prior treatment.
Use of live or live attenuated vaccines during the study period.
Pregnant women unless potential benefits outweigh risks.
Participation in another clinical trial at baseline or during the study.
Inability to comply with study requirements or deemed unsuitable by the study physician.
Lack of access to medical records needed for baseline data collection.
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Long-term Monitoring
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
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
European, multicentre, 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 (ADTrust): study protocol.
Matthias Augustin, Anthony Bewley, Marie-Charlotte Brüggen...