[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578752":3},{"organization":4,"outcomesModule":7,"designInfo":67,"detailedDescription":66,"studyPopulation":70,"armGroups":71,"interventions":77,"overallOfficials":66,"centralContacts":83,"locations":89,"responsibleParty":106,"collaborators":66,"id":108,"slug":66,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":109,"sex":115,"minAge":116,"maxAge":66,"enrollmentInfo":117,"targetDuration":66,"studyType":120,"phases":66,"briefSummary":121,"conditions":122,"keywords":66,"overallStatus":92,"whyStopped":66,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Almirall, S.A.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":66},[9,13],{"measure":10,"description":11,"timeFrame":12},"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",{"measure":14,"description":11,"timeFrame":12},"Change From Baseline in the Overall Health-related Well-being Index Evaluated Through WHO-5 Score Throughout the Study Observation Period",[16,19,22,25,28,31,34,36,38,41,43,46,48,51,53,56,58,61,63],{"measure":17,"description":18,"timeFrame":12},"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\u002Fpapulation, (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.",{"measure":20,"description":21,"timeFrame":12},"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\u002Fpapulation, (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.",{"measure":23,"description":24,"timeFrame":12},"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\u002Fpapulation, (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.",{"measure":26,"description":27,"timeFrame":12},"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\u002Fpapulation, (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.",{"measure":29,"description":30,"timeFrame":12},"Percentage of Participants With Absolute EASI Score Less than or Equal (\u003C=) 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\u002Fpapulation, (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.",{"measure":32,"description":33,"timeFrame":12},"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\u002Fpapulation, lichenification, and oozing\u002Fcrusting.",{"measure":35,"description":33,"timeFrame":12},"Absolute Measures in Overall IGA Score Throughout the Study Observation Period",{"measure":37,"description":33,"timeFrame":12},"Change from Baseline in Overall IGA Score Throughout the Study Observation Period",{"measure":39,"description":40,"timeFrame":12},"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",{"measure":42,"description":40,"timeFrame":12},"Change From Baseline in POEM Score Throughout the Study Observation Period",{"measure":44,"description":45,"timeFrame":12},"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).",{"measure":47,"description":45,"timeFrame":12},"Change From Baseline in Pruritus NRS Score Throughout the Study Observation Period",{"measure":49,"description":50,"timeFrame":12},"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).",{"measure":52,"description":50,"timeFrame":12},"Change From Baseline in Skin Pain NRS Score Throughout the Study Observation Period",{"measure":54,"description":55,"timeFrame":12},"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).",{"measure":57,"description":55,"timeFrame":12},"Change From Baseline in Fatigue NRS Score Throughout the Study Observation Period",{"measure":59,"description":60,"timeFrame":12},"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).",{"measure":62,"description":60,"timeFrame":12},"Change From Baseline in Sleep Quality Scale Throughout the Study Observation Period",{"measure":64,"description":65,"timeFrame":12},"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 \u002F 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.",null,{"allocation":66,"interventionModel":66,"interventionModelDescription":66,"primaryPurpose":66,"observationalModel":68,"timePerspective":69,"maskingInfo":66},"COHORT","PROSPECTIVE","Adult participants with moderate to severe atopic dermatitis treated with lebrikizumab (Ebglyss®) will be included.",[72],{"label":73,"type":66,"description":74,"interventionNames":75},"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.",[76],"Other: No Intervention",[78],{"type":79,"name":80,"description":81,"armGroupLabels":82,"otherNames":66},"OTHER","No Intervention","This is non-interventional study.",[73],[84],{"name":85,"role":86,"phone":87,"phoneExt":66,"email":88},"Èric Massana","CONTACT","0034 932 913 986","eric.massana@almirall.com",[90],{"facility":91,"status":92,"city":93,"state":94,"zip":66,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"Aarhus University Hospital","RECRUITING","Aarhus","Denmark","DK",{"type":97,"coordinates":98},"Point",[99,100],10.21076,56.15674,{"lat":100,"lon":99},[103],{"name":104,"role":105,"phone":66,"phoneExt":66,"email":66},"Dr. Christian Vestergaard","PRINCIPAL_INVESTIGATOR",{"type":107,"investigatorFullName":66,"investigatorTitle":66,"investigatorAffiliation":66,"oldNameTitle":66,"oldOrganization":66},"SPONSOR","100578752",false,"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","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","ADTrust","Inclusion Criteria:\n\n* Adult (greater than or equal to \\[\\>=\\] 18 years) male or female participants with diagnosis of moderate-to-severe Atopic dermatitis.\n* Adult participants prescribed lebrikizumab as part of routine\u002Fusual care to manage their moderate-to severe Atopic dermatitis.\n* Willingness and ability to participate in the study; participants must give their written consent to participate.\n\nExclusion Criteria:\n\n* Hypersensitivity to the active substances or to any of the excipients of lebrikizumab (Ebglyss®).\n* Participants with pre-existing helminth infections. These participants should be treated for helminth infection before starting lebrikizumab therapy.\n* Concomitant use of live and live attenuated vaccines.\n* Pregnant women, except when the potential benefit justifies the potential risk.\n* Participants included in a clinical trial at baseline or at any time during the planned study period.\n* 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.\n* Participants for whom medical chart is inaccessible to physicians to complete baseline data collection.","ALL","18 Years",{"count":118,"type":119},1000,"ESTIMATED","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\u002Fcontrol, fatigue, work impairment, patient's relationship with their skin, and overall QOL among adult participants.",[123,124],"Atopic Dermatitis","Eczema","2025-02-04",{"date":127,"type":128},"2025-02-07","ACTUAL",{"date":130,"type":128},"2025-01-23",{"date":132,"type":119},"2029-03",{"name":5,"class":6},1]