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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAlmirall, S.A.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No Intervention

    Other intervention

    This is non-interventional study.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: All Participants1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline up to Week 104
2

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.

Time frame
Baseline up to Week 104

Secondary outcomes

1

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

The EASI is used to assess the severity and extent of AD; The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranging from 0 to 72 where 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe, with higher values indicating more severe and or extensive disease. EASI 50 is defined as 50% or greater reduction from baseline in the EASI score.

Time frame
Baseline up to Week 104
2

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

The EASI is used to assess the severity and extent of AD; The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranging from 0 to 72 where 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe, with higher values indicating more severe and or extensive disease. EASI75 is defined as 75% or greater reduction from baseline in the EASI score.

Time frame
Baseline up to Week 104
3

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

The EASI is used to assess the severity and extent of AD; The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranging from 0 to 72 where 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe, with higher values indicating more severe and or extensive disease. EASI 90 is defined as 90% or greater reduction from baseline in the EASI score.

Time frame
Baseline up to Week 104
4

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

The EASI is used to assess the severity and extent of AD; The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranging from 0 to 72 where 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe, with higher values indicating more severe and or extensive disease. EASI100 is defined as 100% reduction from baseline in the EASI score.

Time frame
Baseline up to Week 104

Other outcomes

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