[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647692":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":48,"centralContacts":52,"locations":58,"responsibleParty":73,"collaborators":47,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":47,"enrollmentInfo":85,"targetDuration":47,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":47,"overallStatus":61,"whyStopped":47,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Nektar Therapeutics","INDUSTRY",[8,14,20,24,28,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Blinded Induction Period: Rezpegaldesleukin every 2 weeks","EXPERIMENTAL","Rezpegaldesleukin every 2 weeks during the induction period",[13],"Drug: Rezpegaldesleukin",{"label":15,"type":16,"description":17,"interventionNames":18},"Blinded Induction Period: Placebo","PLACEBO_COMPARATOR","Placebo every 2 weeks during the induction period",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Blinded Maintenance Period: Rezpegaldesleukin every 4 weeks","Rezpegaldesleukin every 4 weeks during the maintenance period",[13],{"label":25,"type":10,"description":26,"interventionNames":27},"Blinded Maintenance Period: Rezpegaldesleukin every 12 weeks","Rezpegaldesleukin every 12 weeks during the maintenance period",[13],{"label":29,"type":16,"description":30,"interventionNames":31},"Blinded Maintenance Period: Placebo","Placebo every 4 weeks during the maintenance period",[19],{"label":33,"type":10,"description":34,"interventionNames":35},"Open-Label Escape","Rezpegaldesleukin at a frequency determined by the investigator during the open-label escape",[13],[37,44],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","Rezpegaldesleukin","Pharmaceutical form: Injection solution Route of administration: subcutaneous",[9,25,21,33],[43],"NKTR-358",{"type":38,"name":45,"description":40,"armGroupLabels":46,"otherNames":47},"Placebo",[15,29],null,[49],{"name":50,"affiliation":5,"role":51},"Study Director","STUDY_DIRECTOR",[53],{"name":54,"role":55,"phone":56,"phoneExt":47,"email":57},"Nektar Recruitment","CONTACT","855-482-8676","StudyInquiry@nektar.com",[59],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":47},"Nektar Investigative Site","RECRUITING","The Bronx","New York","10455","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-73.86641,40.84985,{"lat":71,"lon":70},{"type":74,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100647692","phase-3-a-phase-3-study-of-rezpegaldesleukin-nktr-358-for-patients--12-years-of-age-with-moderate-to-severe-atopic-dermatitis-100647692",false,"NCT07711418","A Phase 3 Study of Rezpegaldesleukin (NKTR-358) for Patients ≥ 12 Years of Age With Moderate-to-Severe Atopic Dermatitis","A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin (NKTR-358) Monotherapy in the Treatment of Patients ≥ 12 Years of Age With Moderate-to- Severe Atopic Dermatitis","ZENITH AD-2","Inclusion Criteria:\n\n* Male or female patients, ≥ 12 years of age on the day of signing the informed consent form and weighing ≥ 40 kg prior to randomization at Baseline\n* Chronic atopic dermatitis (AD) defined as onset of AD signs and symptoms\n\n  ≥ 12 months prior to Screening as determined by the Investigator through patient interview and\u002For review of medical history at the Screening Visit\n* Patients must meet the following AD severity criteria:\n* IGA score ≥ 3 (scale of 0 to 4) at Screening and Baseline\n* ≥ 10.0% of BSA involvement at Screening and Baseline\n* EASI ≥ 16.0 at Screening and Baseline\n* Are candidates for systemic therapy and have history, documented by a physician and\u002For the Investigator, of inadequate response to existing topical medications within 6 months preceding Screening, or history of intolerance to a topical therapy\n* Provide written, informed consent to participate in the study and follow the study procedures, including compliance with the use of highly effective contraceptives\n\nExclusion Criteria:\n\n* Are currently experiencing or have a history of concomitant skin conditions other than AD, including skin infection in the area affected by the patient's AD that requires treatment with systemic antimicrobial therapy\n* Are currently experiencing or have a history of unstable course of AD\n* History of chronic idiopathic urticaria at any time or urticaria from other causes within 4 weeks prior to randomization at the Baseline Visit.\n* Have a history of TCS use suggestive of a high risk for topical corticosteroid (TCS) withdrawal\n* Have received any of the following treatments at any time before Screening: aldesleukin; investigational IL-2 analog; systemic biologic; oral JAKi; or any prior investigational agent for AD\n* Have a current or recent acute, active infection","ALL","12 Years",{"count":86,"type":87},510,"ESTIMATED","INTERVENTIONAL",[90],"PHASE3","This is an interventional, randomized, parallel group, treatment, Phase 3, double blind study to assess the effect of Rezpegaldesleukin in participants 12 years of age or older with moderate to severe atopic dermatitis, as compared to placebo.\n\nThe estimated participant overall duration is approximately 15 months.",[93],"Moderate-to-Severe Atopic Dermatitis","2026-07-14",{"date":96,"type":97},"2026-07-17","ACTUAL",{"date":99,"type":87},"2026-08",{"date":101,"type":87},"2029-01",{"name":5,"class":6},1]