[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655221":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":48,"studyPopulation":36,"armGroups":49,"interventions":62,"overallOfficials":36,"centralContacts":36,"locations":70,"responsibleParty":198,"collaborators":36,"id":200,"slug":201,"hasResults":202,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":36,"eligibilityCriteria":206,"healthyVolunteers":202,"sex":207,"minAge":208,"maxAge":209,"enrollmentInfo":210,"targetDuration":36,"studyType":213,"phases":214,"briefSummary":216,"conditions":217,"keywords":219,"overallStatus":224,"whyStopped":36,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":234},{"fullName":5,"class":6},"Prana Therapies Inc","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)","Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of PRA-216 in patients with moderate to severe atopic dermatitis (AD)","Up to 28 weeks",[14,18,21,24,27,30,33],{"measure":15,"description":16,"timeFrame":17},"Clinical efficacy of PRA-216 compared to placebo in participants with moderate to severe AD","Mean percent change from baseline in Eczema Area and Severity Index (EASI). EASI is a score that will grade atopic dermatitis, with a higher number indicating more severe disease. A score of 0 indicates clear skin, and a score of 72 is severe disease.","Up to 24 weeks",{"measure":19,"description":20,"timeFrame":17},"Clinical efficacy of PRA-216 compared to placebo in participants with moderate to severe AD: EASI-75","Percentage of patients achieving EASI-75. EASI-75 indicates a 75% improvement in severity and spread of skin lesions compared to baseline.",{"measure":22,"description":23,"timeFrame":17},"Clinical efficacy of PRA-216 compared to placebo in participants with moderate to severe AD: EASI-90","Percentage of patients achieving EASI-90. EASI-90 indicates a 90% improvement in severity and spread of skin lesions compared to baseline.",{"measure":25,"description":26,"timeFrame":12},"Pharmacokinetics of PRA-216: Tmax in patients with AD","Time to maximum concentration of drug in plasma",{"measure":28,"description":29,"timeFrame":12},"Pharmacokinetics of PRA-216: AUC in patients with AD","Area under the curve",{"measure":31,"description":32,"timeFrame":12},"Pharmacokinetics of PRA-216: Cmax in patients with AD","Maximum concentration of PRA-216 in plasma",{"measure":34,"description":35,"timeFrame":17},"Immunogenicity of PRA-216: ADA in patients with AD","Incidence of anti-drug antibody following drug administration",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":36,"primaryPurpose":40,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":36,"whoMasked":43},"QUADRUPLE",[44,45,46,47],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy response of PRA-216 in patients with moderate to severe Atopic Dermatitis (AD). Eligible participants will be those with AD who are inadequately controlled by topical corticosteroids (TCS) or had adverse reaction or contraindication to the medication.\n\nThis study will enroll approximately 39 participants at multiple study sites who will be randomized 2:1 to receive either PRA-216 or placebo subcutaneous injections four times throughout the study period.",[50,56],{"label":51,"type":52,"description":53,"interventionNames":54},"Active PRA-216","ACTIVE_COMPARATOR","Participants with moderate to severe AD will be randomized to receive PRA-216",[55],"Drug: Active PRA-216",{"label":57,"type":58,"description":59,"interventionNames":60},"Placebo","PLACEBO_COMPARATOR","Participants with moderate to severe AD will be randomized to receive placebo",[61],"Drug: Placebo",[63,67],{"type":64,"name":51,"description":65,"armGroupLabels":66,"otherNames":36},"DRUG","biologic",[51],{"type":64,"name":57,"description":68,"armGroupLabels":69,"otherNames":36},"matching placebo for PRA-216",[57],[71,92,108,124,139,156,168,183],{"facility":72,"status":36,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Emeritus Sydney","Botany","New South Wales","2019","Australia","AU",{"type":79,"coordinates":80},"Point",[81,82],151.19591,-33.94599,{"lat":82,"lon":81},[85,90],{"name":86,"role":87,"phone":88,"phoneExt":36,"email":89},"Priya Loomba, MD","CONTACT","02 8964 8186","priyaloomba@emeritusresearch.com",{"name":86,"role":91,"phone":36,"phoneExt":36,"email":36},"PRINCIPAL_INVESTIGATOR",{"facility":93,"status":36,"city":94,"state":95,"zip":96,"country":76,"countryCode":77,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Cornerstone Centre for Clinical Research","Coorparoo","Queensland","4151",{"type":79,"coordinates":98},[99,100],153.05826,-27.49325,{"lat":100,"lon":99},[103,107],{"name":104,"role":87,"phone":105,"phoneExt":36,"email":106},"Young Jin Kim, MD","+61 7 2102 5054","drkim@cornerstonederm.com.au",{"name":104,"role":91,"phone":36,"phoneExt":36,"email":36},{"facility":109,"status":36,"city":110,"state":111,"zip":112,"country":76,"countryCode":77,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Emeritus Melbourne","Camberwell","Victoria","3124",{"type":79,"coordinates":114},[115,116],145.0694,-37.84205,{"lat":116,"lon":115},[119,123],{"name":120,"role":87,"phone":121,"phoneExt":36,"email":122},"Raf Malik, MD","03 9509 6166","rafikmalik@emeritusresearch.com",{"name":120,"role":91,"phone":36,"phoneExt":36,"email":36},{"facility":125,"status":36,"city":126,"state":111,"zip":127,"country":76,"countryCode":77,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Momentum Sunshine","Melbourne","3021",{"type":79,"coordinates":129},[130,131],144.96332,-37.814,{"lat":131,"lon":130},[134,138],{"name":135,"role":87,"phone":136,"phoneExt":36,"email":137},"King Cheung, MD","03 9125 0799","King.Cheung@momentumclinicalresearch.com.au",{"name":135,"role":91,"phone":36,"phoneExt":36,"email":36},{"facility":140,"status":36,"city":141,"state":36,"zip":142,"country":143,"countryCode":144,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Optimal Clinical Trials (North)","Auckland","0627","New Zealand","NZ",{"type":79,"coordinates":146},[147,148],174.76349,-36.84853,{"lat":148,"lon":147},[151,155],{"name":152,"role":87,"phone":153,"phoneExt":36,"email":154},"Claudette Lionnet, MD","+64 9 303 4987","Claudette@optimalclinicaltrials.com",{"name":152,"role":91,"phone":36,"phoneExt":36,"email":36},{"facility":157,"status":36,"city":141,"state":36,"zip":158,"country":143,"countryCode":144,"cosmosGeoPoint":159,"geoPoint":161,"contacts":162},"Aotearoa Clinical Trials","2025",{"type":79,"coordinates":160},[147,148],{"lat":148,"lon":147},[163,167],{"name":164,"role":87,"phone":165,"phoneExt":36,"email":166},"Cheng Huang, MD","+64 9 276 0000","cheng.huang@TeWhatuOra.govt.nz",{"name":164,"role":91,"phone":36,"phoneExt":36,"email":36},{"facility":169,"status":36,"city":170,"state":36,"zip":171,"country":143,"countryCode":144,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Momentum Christchurch","Christchurch","8013",{"type":79,"coordinates":173},[174,175],172.63333,-43.53333,{"lat":175,"lon":174},[178,182],{"name":179,"role":87,"phone":180,"phoneExt":36,"email":181},"Ben Image, MD","64 3 337 1976","benimage@pcrn.co.nz",{"name":179,"role":91,"phone":36,"phoneExt":36,"email":36},{"facility":184,"status":36,"city":185,"state":36,"zip":186,"country":143,"countryCode":144,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"Clinical Trials New Zealand","Hamilton","3204",{"type":79,"coordinates":188},[189,190],175.28333,-37.78333,{"lat":190,"lon":189},[193,197],{"name":194,"role":87,"phone":195,"phoneExt":36,"email":196},"Amy Stanway, MD","+64 7 843 0105","amystanway@yahoo.co.nz",{"name":194,"role":91,"phone":36,"phoneExt":36,"email":36},{"type":199,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100655221","phase-2-pra-216-atopic-dermatitis-safety-and-efficacy-study-100655221",false,"NCT07810777","PRA-216 Atopic Dermatitis Safety and Efficacy Study","A Phase 2 Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Safety and Efficacy of PRA-216 in Participants With Moderate to Severe Atopic Dermatitis","Inclusion Criteria:\n\n* Must be in good health with no significant medical history\n* Willing and able to attend all study visits, comply with study requirements.\n* Able and willing to provide written informed consent\n* Documented AD diagnosis prior for at least 6 months prior to enrollment.\n* History of inadequate response to topical medications for AD\n\nExclusion Criteria:\n\n* Evidence of clinically significant skin condition or disease other than AD\n* Any physical or psychological condition that prohibits study completion\n* Known history of illicit drug use or alcoholism within 12 months prior to the first dose of study agent\n* History of severe allergic reactions or hypersensitivity\n* Receipt of antibody therapy within 4 months or 5 half-lives\n* Other investigational agent(s) within 30 days or 5 half-lives","ALL","18 Years","70 Years",{"count":211,"type":212},39,"ESTIMATED","INTERVENTIONAL",[215],"PHASE2","This study will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 compared to placebo in patients with moderate to severe Atopic Dermatitis (AD)",[218],"Atopic Dermatitis (AD)",[220,221,222,223],"Inflammatory response","pharmacokinetics","pharmacodynamics","immunogenicity","NOT_YET_RECRUITING","2026-09-03",{"date":227,"type":228},"2026-09-09","ACTUAL",{"date":230,"type":212},"2026-09-01",{"date":232,"type":212},"2027-10-01",{"name":5,"class":6},8]