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 (ADTrust)

Almirall

Status: Enrolling

Conditions: Atopic Dermatitis; Eczema

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT06815380

M-17923-35

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 1 patient group

All Participants

Description:

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.

Treatment:

Other: No Intervention