NCT06815380Recruiting
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
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
Source: ClinicalTrials.gov · Last updated 7 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 4 Feb 2025
- Start date
- 23 Jan 2025
- Primary completion date
- Mar 2029
- Lead sponsor
- Almirall, S.A.
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06815380
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 23 Jan 2025 to the primary completion date, Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant use of live and live attenuated vaccines.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.