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
Last Updated: 2025-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2025-01-23
2029-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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All Participants
Participants with atopic dermatitis and treated with lebrikizumab (Ebglyss®) according to Summary of Product Characteristics (SmPC) in routine clinical practice, data will be collected and observed for 104 weeks.
No Intervention
This is non-interventional study.
Interventions
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No Intervention
This is non-interventional study.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Almirall, S.A.
INDUSTRY
Responsible Party
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Locations
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Aarhus University Hospital
Aarhus, Denmark, Denmark
Countries
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Central Contacts
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References
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Augustin M, Bewley A, Bruggen MC, de Bruin-Weller MS, Ezzedine K, Ferrucci SM, Gkalpakiotis S, Herranz P, Johansson EK, Kampe T, Lapeere H, Legat FJ, Rehbinder EM, Szepietowski JC, Torres T, Vestergaard C, Werfel T, Domenech A, Massana E, Koscielny V, Narayanan S, Kasujee I, Gutermuth J. European, multicentre, 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 (ADTrust): study protocol. BMJ Open. 2025 Jul 11;15(7):e102155. doi: 10.1136/bmjopen-2025-102155.
Other Identifiers
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M-17923-35
Identifier Type: -
Identifier Source: org_study_id
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