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
Recruiting · NCT06815380 · Observational (researchers observe without assigning treatment) · Lead sponsor: Almirall, S.A.
View the official record on ClinicalTrials.gov →Interventions studied
No Intervention
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed.
- Aarhus University Hospital - Aarhus, Denmark, Denmark