[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592067":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":41,"studyPopulation":42,"armGroups":43,"interventions":37,"overallOfficials":37,"centralContacts":47,"locations":53,"responsibleParty":1054,"collaborators":37,"id":1056,"slug":37,"hasResults":1057,"nctId":1058,"briefTitle":1059,"officialTitle":1059,"acronym":1060,"eligibilityCriteria":1061,"healthyVolunteers":1057,"sex":1062,"minAge":1063,"maxAge":37,"enrollmentInfo":1064,"targetDuration":37,"studyType":1067,"phases":37,"briefSummary":1068,"conditions":1069,"keywords":37,"overallStatus":70,"whyStopped":37,"lastUpdateSubmitDate":1071,"lastUpdatePostDateStruct":1072,"startDateStruct":1075,"completionDateStruct":1077,"leadSponsor":1079,"locationsCount":1080},{"fullName":5,"class":6},"Galderma R&D","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":37},[9,13],{"measure":10,"description":11,"timeFrame":12},"Investigator Global Assessment (IGA) at Month 6","The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the investigator or trained designee to evaluate the global severity of AD and the clinical response to a treatment.","At Month 6",{"measure":14,"description":15,"timeFrame":12},"Peak Pruritus Numerical Rating Scale (PP NRS) at Month 6","The PP NRS is a single question validated PRO assessment that participants will use to report the maximum intensity of their pruritus (itch). The PP NRS consists of the following question: \"On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?\". Here, a lower score indicates a better outcome.",[17,21,24,26,28,31,34],{"measure":18,"description":19,"timeFrame":20},"Eczema Area and Severity Index (EASI) up to Month 12","The EASI is a validated measure commonly used in clinical trials and clinical practice to assess the severity and the extent of AD signs. The EASI score is a composite score ranging from 0 to 72. The severity of erythema, induration\u002Fpapulation, excoriation, and lichenification will be assessed by the investigator or trained designee on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head\u002Fneck, trunk, upper limbs, and lower limbs, with half points allowed. In addition, the extent of AD involvement in each of the 4 body areas will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. A higher score indicates severe AD.","Up to Month 12",{"measure":22,"description":23,"timeFrame":20},"Scoring Atopic Dermatitis (SCORAD) up to Month 12","The SCORAD is a validated measure commonly used in clinical trials and clinical practice to assess the severity and the extent of AD signs and symptoms. The SCORAD ranges from 0 to 103 and has 3 components: extent, intensity, and patient-reported symptoms of pruritus and sleep loss. The investigator or trained designee will assess the severity of 6 signs of AD (erythema, edema\u002Fpapulation, oozing\u002Fcrust, excoriation, lichenification, and dryness), each on a scale ranging from 0 (absence) to 3 (severe). The investigator or trained designee will also ask the participant to evaluate their symptoms of pruritus and sleep loss (average for the last 3 days\u002Fnights), each evaluated on a visual analogue scale (VAS) from 0 to 10. A higher score indicates severe AD.",{"measure":25,"description":11,"timeFrame":20},"Investigator Global Assessment (IGA) up to Month 12",{"measure":27,"description":15,"timeFrame":20},"Peak Pruritus Numerical Rating Scale (PP NRS) up to Month 12",{"measure":29,"description":30,"timeFrame":20},"Average Pruritus Numerical Rating Scale (AP NRS) up to Month 12","The AP NRS is a single question assessment that participants will use to report the average intensity of their pruritus (itch). The AP NRS consists of the following question: \"On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?\". Here, a lower score indicates a better outcome.",{"measure":32,"description":33,"timeFrame":20},"Sleep Disturbance Numerical Rating Scale (SD NRS) up to Month 12","The SD NRS is a single-item PRO for quantifying sleep disturbance. The SD NRS consists of the following question: \"On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of my skin disease (atopic dermatitis)' and 10 being 'I did not sleep at all due to the symptoms of my skin disease (atopic dermatitis)', how would you rate your sleep last night?\". Here, a lower score indicates a better outcome.",{"measure":35,"description":36,"timeFrame":20},"Pain Numerical Rating Scale (Pain NRS) up to Month 12","The Pain NRS is a single-item assessment with a potential follow-up question that participants will use to report the average intensity of their pain. The Pain NRS consists of the following question: \"Over the past 24 hours, how severe was the pain in your skin?\". If the participant rates their pain from 1 to 10, then the following question will be asked: \"Do you think the pain is part of the itch, from scratching or both?\". Here, a lower score indicates a better outcome.",null,{"allocation":37,"interventionModel":37,"interventionModelDescription":37,"primaryPurpose":37,"observationalModel":39,"timePerspective":40,"maskingInfo":37},"OTHER","PROSPECTIVE","This prospective, multicenter, non-interventional study (NIS) seeks to evaluate treatment with nemolizumab of moderate-to-severe AD in adolescents and adults over an approximately 12-month period using physician assessments in routine clinical practice and PRO measures.\n\nTreatment with nemolizumab will be determined solely by the participant's physician prior to study enrollment. No additional visits, procedures, or laboratory tests are required outside of routine clinical practice. The visit structure is not defined by the study protocol but is determined by routine medical practice. The visit schedule is intended to facilitate a systematic data assessment according to clinical routine. A sub-study will be completed in Germany and the UK at selected sites in which participants will complete the Peak Pruritus (PP) Numerical Rating Scale (NRS), Average Pruritus (AP) NRS, Sleep Disturbance (SD) NRS, and Pain NRS on a daily basis from Day -1 to Day 14. Data collection will occur remotely, and no clinic visits will be required.","The clinical decision for treatment with nemolizumab has to be made by the physicians independently of the participation in this NIS and prior to the informed consent process. Participants greater than or equal to (\\>=) 12 years of age will be eligible for the trial.",[44],{"label":45,"type":37,"description":46,"interventionNames":37},"Nemolizumab","Participants with moderate-to-severe AD who are receiving nemolizumab (Nemluvio®) in routine clinical practice will be observed for approximately 12 months.",[48],{"name":49,"role":50,"phone":51,"phoneExt":37,"email":52},"Galderma Research and 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Dale","20769-9182",{"type":63,"coordinates":327},[328,329],-76.82053,38.98761,{"lat":329,"lon":328},{"facility":332,"status":70,"city":333,"state":315,"zip":334,"country":60,"countryCode":61,"cosmosGeoPoint":335,"geoPoint":339,"contacts":37},"Galderma Investigational Site 7068","Rockville","20850-6243",{"type":63,"coordinates":336},[337,338],-77.15276,39.084,{"lat":338,"lon":337},{"facility":341,"status":70,"city":342,"state":343,"zip":344,"country":60,"countryCode":61,"cosmosGeoPoint":345,"geoPoint":349,"contacts":350},"Galderma Investigational Site 7065","Brighton","Massachusetts","02135",{"type":63,"coordinates":346},[347,348],-71.15644,42.3501,{"lat":348,"lon":347},[351],{"name":177,"role":50,"phone":37,"phoneExt":37,"email":37},{"facility":353,"status":70,"city":354,"state":343,"zip":355,"country":60,"countryCode":61,"cosmosGeoPoint":356,"geoPoint":360,"contacts":37},"Galderma Investigationa Site 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