ADTrust Study
Research type
Research Study
Full 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 (ADTrust)
IRAS ID
351874
Contact name
Siva Narayanan
Contact email
Sponsor organisation
Almirall, S.A.
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
4 years, 7 months, 31 days
Research summary
This is a European, prospective, observational, multicentre study in patients with moderate to severe atopic dermatitis treated with lebrikizumab (Ebglyss®) under real-life conditions. The primary objective of the study is to assess the long-term effect of treatment with lebrikizumab on the overall well-being in these patients using the WHO-5 questionnaire.
A total of 1000 adult patients with moderate -to-sever atopic dermatitis will be included from these countries: Countries: Austria, Belgium, Czech Republic, Denmark, France, Germany, Italy, Ireland, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, United Kingdom (UK). Sites (up to 150 sites) will be hospitals or outpatient offices where AD patients are usually managed. The participating physicians will be dermatologists or general practitioners with extended roles (specialised in dermatology).
Lebrikizumab will be prescribed according to Summary of Product Characteristics (SmPC). The visit schedule is not defined by the study protocol but is driven by routine clinical practice according to SmPC. Data will be collected at study inclusion (Baseline Visit) and approximately 16 weeks after baseline, and at weeks 24, 52, 78, and 104 respectively after baseline. Information regarding any unscheduled visit within the observation period due to early disease control, worsening of disease or tolerability problems will be collected at the time of the next closest planned follow-up visit. Duration of the study will be approximately six (6) years across the studied countries. Individual patient study observation period will be up to 24 months.
The study is based on primary data collection directly from healthcare professionals (Investigators), patients and their partners. Investigators will collect data using electronic Case Report Form (eCRFs) that are specifically designed for this study. Patients will be separately asked to complete the study questionnaires in electronic format using a tablet (at scheduled visits) and mobile app (for a brief voluntary diary completed every 4 weeks).
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
25/EM/0088
Date of REC Opinion
27 May 2025
REC opinion
Further Information Favourable Opinion