Clinical trial 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
Official title: A European, Multicenter, 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Eczema
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2025-02-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with moderate to severe atopic dermatitis treated with lebrikizumab (Ebglyss®) will be included.

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.

Primary outcomes:
measure: Absolute Measures in the Overall Health-related Well-being Index Evaluated Through World Health Organization (WHO-5) Score Throughout the Study Observation Period
timeFrame: Baseline up to Week 104
measure: Change From Baseline in the Overall Health-related Well-being Index Evaluated Through WHO-5 Score Throughout the Study Observation Period
timeFrame: Baseline up to Week 104
Secondary outcomes:
measure: 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
timeFrame: Baseline up to Week 104
measure: Percentage of Participants with 75% or Greater Reduction From Baseline in Overall EASI Score (EASI75) Throughout the Study Observation Period
timeFrame: Baseline up to Week 104
measure: Percentage of Participants with 90% or Greater Reduction From Baseline in Overall EASI Score (EASI90) Throughout the Study Observation Period
timeFrame: Baseline up to Week 104
measure: Percentage of Participants with 100% Reduction From Baseline in Overall EASI Score (EASI100) Throughout the Study Observation Period
timeFrame: Baseline up to Week 104
measure: Percentage of Participants With Absolute EASI Score Less than or Equal (<=) to 7 Throughout the Study Observation Period
timeFrame: Baseline up to Week 104
measure: Percentage of Participants with Overall Investigator Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) Throughout the Study Observation Period
timeFrame: Baseline up to Week 104
measure: Absolute Measures in Overall IGA Score Throughout the Study Observation Period
timeFrame: Baseline up to Week 104
measure: Change from Baseline in Overall IGA Score Throughout the Study Observation Period
timeFrame: Baseline up to Week 104
measure: Absolute Measures in Patient-Oriented Eczema Measure (POEM) Score Throughout the Study Observation Period
timeFrame: Baseline up to Week 104
measure: Change From Baseline in POEM Score Throughout the Study Observation Period
timeFrame: Baseline up to Week 104
measure: Absolute Measures in Pruritus Numerical Rating Scale (NRS) Score Throughout the Study Observation Period
timeFrame: Baseline up to Week 104
measure: Change From Baseline in Pruritus NRS Score Throughout the Study Observation Period
timeFrame: Baseline up to Week 104
measure: Absolute Measures in Skin Pain NRS Score Throughout the Study Observation Period
timeFrame: Baseline up to Week 104
measure: Change From Baseline in Skin Pain NRS Score Throughout the Study Observation Period
timeFrame: Baseline up to Week 104
measure: Absolute Measures in Fatigue NRS Score Throughout the Study Observation Period
timeFrame: Baseline up to Week 104
measure: Change From Baseline in Fatigue NRS Score Throughout the Study Observation Period
timeFrame: Baseline up to Week 104
measure: Absolute Measures in Sleep Quality Scale Throughout the Study Observation Period
timeFrame: Baseline up to Week 104
measure: Change From Baseline in Sleep Quality Scale Throughout the Study Observation Period
timeFrame: Baseline up to Week 104
measure: Number of Participants With Adverse Events (AEs), Serious AEs, Adverse Drug Reactions (ADRs) and Serious ADRs Throughout the Study Observation Period
timeFrame: Baseline up to Week 104
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References: