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

NCT06815380 | Recruiting

• 1 other identifier: M-17923-35
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Eczema

Outcome Measures

Primary Outcomes (2)

• Absolute Measures in the Overall Health-related Well-being Index Evaluated Through World Health Organization (WHO-5) Score Throughout the Study Observation Period

  The WHO-5 item well-being index is a generic global rating scale measuring subjective well-being and contains positively phrased items. The respondent is asked to rate how well each of the 5 items applies to him or her when considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). The raw score therefore theoretically ranges from 0 (absence of well-being) to 25 (maximal well-being). To standardize the score on a scale from 0 (absent) to 100 (maximal), it is recommended to multiply the raw score by 4.

  Baseline up to Week 104

• Change From Baseline in the Overall Health-related Well-being Index Evaluated Through WHO-5 Score Throughout the Study Observation Period

  The WHO-5 item well-being index is a generic global rating scale measuring subjective well-being and contains positively phrased items. The respondent is asked to rate how well each of the 5 items applies to him or her when considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). The raw score therefore theoretically ranges from 0 (absence of well-being) to 25 (maximal well-being). To standardize the score on a scale from 0 (absent) to 100 (maximal), it is recommended to multiply the raw score by 4.

  Baseline up to Week 104

Secondary Outcomes (19)

• Percentage of Participants with 50 Percent (%) or Greater Reduction From Baseline in Overall Eczema Area and Severity Index (EASI) Score (EASI50) Throughout the Study Observation Period

  Baseline up to Week 104

• Percentage of Participants with 75% or Greater Reduction From Baseline in Overall EASI Score (EASI75) Throughout the Study Observation Period

  Baseline up to Week 104

• Percentage of Participants with 90% or Greater Reduction From Baseline in Overall EASI Score (EASI90) Throughout the Study Observation Period

  Baseline up to Week 104

• Percentage of Participants with 100% Reduction From Baseline in Overall EASI Score (EASI100) Throughout the Study Observation Period

  Baseline up to Week 104

• Percentage of Participants With Absolute EASI Score Less than or Equal (<=) to 7 Throughout the Study Observation Period

  Baseline up to Week 104

Study Arms (1)

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.

Other: No Intervention

Interventions

No Intervention OTHER

This is non-interventional study.

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with moderate to severe atopic dermatitis treated with lebrikizumab (Ebglyss®) will be included.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, Denmark, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 40645621 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Èric Massana

CONTACT

0034 932 913 986; eric.massana@almirall.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 7, 2025
• Study Start: January 23, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)