Evaluating the effects of lebrikizumab on well-being in adults 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
This study is testing how the medication lebrikizumab affects the well-being and skin symptoms of adults with moderate-to-severe atopic dermatitis in everyday settings.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Almirall, S.A. Industry-sponsored |
| Drugs / interventions | lebrikizumab |
| Locations | 1 site (Aarhus, Denmark) |
| Trial ID | NCT06815380 on ClinicalTrials.gov |
What this trial studies
This study assesses how lebrikizumab treatment impacts the health-related well-being and skin symptoms of adults suffering from moderate-to-severe atopic dermatitis in real-world clinical settings across Europe. It utilizes the validated WHO-5 Well-being Index to measure overall well-being, treatment satisfaction, and the long-term effects of the medication on various aspects of life, including disease control and quality of life. Participants are adults who have been prescribed lebrikizumab as part of their routine care for atopic dermatitis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with moderate-to-severe atopic dermatitis who are prescribed lebrikizumab.
Not a fit: Patients with hypersensitivity to lebrikizumab or those with pre-existing helminth infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of lebrikizumab's effectiveness in improving the quality of life for patients with atopic dermatitis.
How similar studies have performed: Other studies have shown positive outcomes with similar treatments for atopic dermatitis, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aarhus, Denmark
- Aarhus University Hospital — Aarhus, Denmark, Denmark (Recruiting)
Study contacts
- Study coordinator: Èric Massana
- Email: eric.massana@almirall.com
- Phone: 0034 932 913 986
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.