An observational study in Atopic Dermatitis and Eczema, sponsored by Almirall, S.A.. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by Almirall, S.A. · Observational
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.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 150 across 282 observational studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Almirall, S.A. is the lead sponsor of 66 studies on the registry; 9 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult participants with moderate to severe atopic dermatitis treated with lebrikizumab (Ebglyss®) will be included.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
This is non-interventional study.
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
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
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
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
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
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
Percentage of Participants With Absolute EASI Score Less than or Equal (<=) to 7 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.
Time frame: Baseline up to Week 104
Percentage of Participants with Overall Investigator Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) Throughout the Study Observation Period
The IGA is an instrument used to globally rate the severity of the participants AD. It is based on a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (severe), and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point. The score is based on an overall assessment of the degree of erythema, induration/papulation, lichenification, and oozing/crusting.
Time frame: Baseline up to Week 104
Absolute Measures in Overall IGA Score Throughout the Study Observation Period
The IGA is an instrument used to globally rate the severity of the participants AD. It is based on a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (severe), and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point. The score is based on an overall assessment of the degree of erythema, induration/papulation, lichenification, and oozing/crusting.
Time frame: Baseline up to Week 104
Change from Baseline in Overall IGA Score Throughout the Study Observation Period
The IGA is an instrument used to globally rate the severity of the participants AD. It is based on a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (severe), and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point. The score is based on an overall assessment of the degree of erythema, induration/papulation, lichenification, and oozing/crusting.
Time frame: Baseline up to Week 104
Absolute Measures in Patient-Oriented Eczema Measure (POEM) Score Throughout the Study Observation Period
The POEM is a 7-item, validated, questionnaire used by the participants to assess disease symptoms over the last week. The participants will be asked to respond to 7 questions on skin dryness, itching, flaking, cracking, sleep disturbance, bleeding and weeping. All 7 answers carry equal weight with a total possible score from 0 to 28 (answers scored as: No days=0; 1- 2 days = 1; 3-4 days = 2; 5-6 days = 3; everyday = 4). A high score is indicative of severe atopic dermatitis
Time frame: Baseline up to Week 104
Change From Baseline in POEM Score Throughout the Study Observation Period
The POEM is a 7-item, validated, questionnaire used by the participants to assess disease symptoms over the last week. The participants will be asked to respond to 7 questions on skin dryness, itching, flaking, cracking, sleep disturbance, bleeding and weeping. All 7 answers carry equal weight with a total possible score from 0 to 28 (answers scored as: No days=0; 1- 2 days = 1; 3-4 days = 2; 5-6 days = 3; everyday = 4). A high score is indicative of severe atopic dermatitis
Time frame: Baseline up to Week 104
Absolute Measures in Pruritus Numerical Rating Scale (NRS) Score Throughout the Study Observation Period
Pruritus NRS is a self-administered scale to assess participants worst level of itching on the skin (in the last 24 hours) experienced due to atopic dermatitis. The scale has a single-item that describes the worst level of itching on the skin due to atopic dermatitis in the last 24 hours on an 11-point scale anchored at 0 (no itching) and 10 (worst itching imaginable).
Time frame: Baseline up to Week 104
Change From Baseline in Pruritus NRS Score Throughout the Study Observation Period
Pruritus NRS is a self-administered scale to assess participants worst level of itching on the skin (in the last 24 hours) experienced due to atopic dermatitis. The scale has a single-item that describes the worst level of itching on the skin due to atopic dermatitis in the last 24 hours on an 11-point scale anchored at 0 (no itching) and 10 (worst itching imaginable).
Time frame: Baseline up to Week 104
Absolute Measures in Skin Pain NRS Score Throughout the Study Observation Period
Skin pain NRS is a self-administered scale to assess participants worst level of skin pain (in the last 24 hours) experienced due to atopic dermatitis. The scale has a single-item that describes the worst level of skin pain due to atopic dermatitis in the last 24 hours on an 11-point scale anchored at 0 (no skin pain) and 10 (worst skin pain imaginable).
Time frame: Baseline up to Week 104
Change From Baseline in Skin Pain NRS Score Throughout the Study Observation Period
Skin pain NRS is a self-administered scale to assess participants worst level of skin pain (in the last 24 hours) experienced due to atopic dermatitis. The scale has a single-item that describes the worst level of skin pain due to atopic dermatitis in the last 24 hours on an 11-point scale anchored at 0 (no skin pain) and 10 (worst skin pain imaginable).
Time frame: Baseline up to Week 104
Absolute Measures in Fatigue NRS Score Throughout the Study Observation Period
Fatigue NRS is a self-administered scale to assess participants worst level fatigue (in the last 24 hours) experienced due to atopic dermatitis. The scale has a single-item that describes the worst level of fatigue due to atopic dermatitis in the last 24 hours on an 11-point scale anchored at 0 (no fatigue) and 10 (worst fatigue imaginable).
Time frame: Baseline up to Week 104
Change From Baseline in Fatigue NRS Score Throughout the Study Observation Period
Fatigue NRS is a self-administered scale to assess participants worst level fatigue (in the last 24 hours) experienced due to atopic dermatitis. The scale has a single-item that describes the worst level of fatigue due to atopic dermatitis in the last 24 hours on an 11-point scale anchored at 0 (no fatigue) and 10 (worst fatigue imaginable).
Time frame: Baseline up to Week 104
Absolute Measures in Sleep Quality Scale Throughout the Study Observation Period
Sleep quality scale is a self-administered scale to assess participants overall sleep quality, in terms of the extent to which itching interfered with their sleep last night. The scale has a single-item that describes the interference of itching on sleep last night on an 11-point scale anchored at 0 (no interference) and 10 (unable to sleep at all).
Time frame: Baseline up to Week 104
Change From Baseline in Sleep Quality Scale Throughout the Study Observation Period
Sleep quality scale is a self-administered scale to assess participants overall sleep quality, in terms of the extent to which itching interfered with their sleep last night. The scale has a single-item that describes the interference of itching on sleep last night on an 11-point scale anchored at 0 (no interference) and 10 (unable to sleep at all).
Time frame: Baseline up to Week 104
Number of Participants With Adverse Events (AEs), Serious AEs, Adverse Drug Reactions (ADRs) and Serious ADRs Throughout the Study Observation Period
An AE is any untoward medical occurrence in a study participant who has been administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. An ADR is defined as a response to a medicinal product which is noxious and unintended. Response in this context means that there is a reasonable suspected causal relationship between the medicinal product and the adverse event. An AE or ADR is serious (SAE / SADR) as per following categories: death, is life-threatening, requires in-patient hospitalization or prolongs existing hospitalization, results in persistent or significant disability or incapacity, congenital anomaly or birth defect, or any other medically important event.
Time frame: Baseline up to Week 104
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.