NCT06815380 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
| NCT ID | NCT06815380 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Almirall, S.A. |
| Condition | Atopic Dermatitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-01-23 |
| Primary Completion | 2029-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2025-01-23 with a primary completion date of 2029-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06815380 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atopic Dermatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06815380 currently recruiting?
Yes, NCT06815380 is actively recruiting participants. Contact the research team at eric.massana@almirall.com for enrollment information.
Where is the NCT06815380 trial being conducted?
This trial is being conducted at Aarhus, Denmark.
Who is sponsoring the NCT06815380 clinical trial?
NCT06815380 is sponsored by Almirall, S.A.. The trial plans to enroll 1,000 participants.
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