Observes how lebrikizumab affects well-being in adults with atopic dermatitis
Follows adults with moderate-to-severe atopic dermatitis treated with lebrikizumab in routine care.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Aarhus, DenmarkSee the site
Where in Denmark
- Aarhus University HospitalAarhus, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Almirall, S.A.
- Trial code
- NCT06815380
- Record updated
- 7 February 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Concomitant use of live and live attenuated vaccines; 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; 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.