[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614194":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":24,"studyPopulation":33,"armGroups":24,"interventions":34,"overallOfficials":24,"centralContacts":41,"locations":47,"responsibleParty":62,"collaborators":66,"id":70,"slug":24,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":24,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":24,"enrollmentInfo":78,"targetDuration":81,"studyType":82,"phases":24,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":50,"whyStopped":24,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"UMC Utrecht","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":24},[9,13,16,19,22,26,28],{"measure":10,"description":11,"timeFrame":12},"Peak Pruritus NRS (PP-NRS)","Peak pruritus NRS of the past 24 hours","From enrollment to 52 weeks of treatment",{"measure":14,"description":15,"timeFrame":12},"Investigator Global Assessment scale of Prurigo Nodularis stage (IGA-PN)","Investigator Global Assessment scale of Prurigo Nodularis stage",{"measure":17,"description":18,"timeFrame":12},"Drug survival","Duration of dupilumab treatment, reasons for discontinuation",{"measure":20,"description":21,"timeFrame":12},"Adverse events","Data on the incidence, severity, relation to dupilumab and clinical consequences of adverse events",{"measure":23,"description":24,"timeFrame":25},"Skin homing T cell subtypes",null,"Up to 52 weeks of treatment",{"measure":27,"description":24,"timeFrame":25},"Serum levels of relevant proteins",{"measure":29,"description":24,"timeFrame":25},"Systemic epigenetic changes",{"allocation":24,"interventionModel":24,"interventionModelDescription":24,"primaryPurpose":24,"observationalModel":31,"timePerspective":32,"maskingInfo":24},"COHORT","PROSPECTIVE","Secondary and tertiary care clinics",[35],{"type":36,"name":37,"description":38,"armGroupLabels":24,"otherNames":39},"DRUG","Dupilumab","In the Netherlands, the standard care for patients with moderate-to-severe prurigo nodularis who have failed or are contraindicated to conventional systemic immunosuppressive treatments consists of 300 mg of dupilumab administered subcutaneously every two weeks, following a loading dose of 600 mg administered subcutaneously.",[40],"Dupixent",[42],{"name":43,"role":44,"phone":45,"phoneExt":24,"email":46},"Marjolein de Bruin-Weller, Professor","CONTACT","000","m.s.debruin-weller@umcutrecht.nl",[48],{"facility":49,"status":50,"city":51,"state":51,"zip":24,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"University Medical Center Utrecht","RECRUITING","Utrecht","Netherlands","NL",{"type":55,"coordinates":56},"Point",[57,58],5.12222,52.09083,{"lat":58,"lon":57},[61],{"name":43,"role":44,"phone":45,"phoneExt":24,"email":46},{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Dr M.S. de Bruin-Weller","Professor",[67],{"name":68,"class":69},"Sanofi","INDUSTRY","100614194",false,"NCT07276425","Early and Long-Term Efficacy and Immune Changes With Dupilumab in Prurigo Nodularis","Early and Long-term Clinical Efficacy and Local Tissue and Peripheral Immune Changes Following Dupilumab Treatment in Prurigo Nodularis Patients","Inclusion Criteria:\n\n* Adult patients with moderate-to-severe prurigo nodularis starting dupilumab treatment\n\nExclusion Criteria:\n\n* Unwilling to participate in the BioDay registry\n* (For translational endpoints only) Unwilling to participate in UMC Utrecht Biobank","ALL","18 Years",{"count":79,"type":80},40,"ESTIMATED","52 Weeks","OBSERVATIONAL","With the arrival of dupilumab as the first available targeted therapy for PN, there is an unmet need for real-world data and translational research on the working mechanism of dupilumab on PN, to optimize individualized targeted treatment.",[85],"Prurigo Nodularis (PN)",[87,88],"prurigo nodularis","dupilumab","2025-12-11",{"date":91,"type":92},"2025-12-18","ACTUAL",{"date":94,"type":92},"2025-06-01",{"date":96,"type":80},"2028-06-01",{"name":5,"class":6},1]