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

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-23

Study Completion Date

2029-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atopic Dermatitis Eczema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

This is non-interventional study.

Interventions

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No Intervention

This is non-interventional study.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Almirall, S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aarhus University Hospital

Aarhus, Denmark, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Èric Massana

Role: CONTACT

0034 932 913 986

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.

Reference Type DERIVED
PMID: 40645621 (View on PubMed)

Other Identifiers

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M-17923-35

Identifier Type: -

Identifier Source: org_study_id

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