[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07711418":3,"trial-entities:NCT07711418":153,"trial-summary:NCT07711418":157},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":45,"secondary_outcomes":55,"sex":106,"minimum_age":107,"maximum_age":17,"healthy_volunteers":108,"eligibility_criteria":109,"std_ages":127,"locations":131,"central_contacts":141,"overall_officials":147,"references":151,"see_also_links":152},"NCT07711418","25-358-10","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","RECRUITING","2029-01","2026-07","2026-07-17","2026-08","Nektar Therapeutics","INDUSTRY",true,"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.",null,[19],"Moderate-to-Severe Atopic Dermatitis",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE3",{"count":26,"type":27},510,"ESTIMATED",[29,40],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":38},"DRUG","Rezpegaldesleukin","Pharmaceutical form: Injection solution Route of administration: subcutaneous",[34,35,36,37],"Blinded Induction Period: Rezpegaldesleukin every 2 weeks","Blinded Maintenance Period: Rezpegaldesleukin every 12 weeks","Blinded Maintenance Period: Rezpegaldesleukin every 4 weeks","Open-Label Escape",[39],"NKTR-358",{"type":30,"name":41,"description":32,"armGroupLabels":42},"Placebo",[43,44],"Blinded Induction Period: Placebo","Blinded Maintenance Period: Placebo",[46,50,52],{"measure":47,"description":48,"timeFrame":49},"US only: Number of participants with an Investigator's Global Assessment (IGA) score of 0 or 1 and reduction ≥ 2 points from baseline at Week 24","The IGA scale ranges from 0 to 4, with higher score indicating more severe disease.","Week 0 and Week 24",{"measure":51,"description":48,"timeFrame":49},"Non-US regions only: Number of participants with an Investigator's Global Assessment (IGA) score of 0 or 1 at Week 24",{"measure":53,"description":54,"timeFrame":49},"Non-US regions only: Number of participants with a ≥ 75% reduction in Eczema Area and Severity Index (EASI) score from baseline at Week 24 (EASI-75)","The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.",[56,58,60,64,66,69,71,74,76,79,81,84,86,89,92,94,96,98,100,102,104],{"measure":57,"description":54,"timeFrame":49},"US only: Number of participants with a ≥ 75% reduction in EASI score from baseline at Week 24 (EASI-75)",{"measure":59,"description":54,"timeFrame":49},"Number of participants with a ≥ 90% reduction in EASI score from baseline at Week 24 (EASI-90)",{"measure":61,"description":62,"timeFrame":63},"Number of participants at week 6 achieving a 4-point or greater improvement in Itch numerical rating scale (NRS) in the subset of participants with a 4-point or greater Itch NRS at baseline","The itch NRS goes from 0 to 10, with higher score indicating more severe itch.","Week 0 and Week 6",{"measure":65,"description":62,"timeFrame":49},"Number of participants at week 24 achieving a 4-point or greater improvement in Itch numerical rating scale (NRS) in the subset of participants with a 4-point or greater Itch NRS at baseline",{"measure":67,"description":68,"timeFrame":63},"Number of participants at week 6 achieving a 4-point or greater improvement in Skin Pain numerical rating scale (NRS) in the subset of participants with a 4-point or greater Skin Pain NRS at baseline","The Skin Pain NRS goes from 0 to 10, with higher score indicating more severe pain.",{"measure":70,"description":68,"timeFrame":49},"Number of participants at week 24 achieving a 4-point or greater improvement in Skin Pain numerical rating scale (NRS) in the subset of participants with a 4-point or greater Skin Pain NRS at baseline",{"measure":72,"description":73,"timeFrame":63},"Number of participants at week 6 achieving a 1.25-point or greater improvement in Atopic Dermatitis Sleep Scale Question 1 (ADSS Q1) in the subset of participants with a 1.25-point or greater ADSS Q1 at baseline","The ADSS Q1 goes from 0 to 4, with higher score indicating more difficulty sleeping.",{"measure":75,"description":73,"timeFrame":49},"Number of participants at week 24 achieving a 1.25-point or greater improvement in ADSS Q1 in the subset of participants with a 1.25-point or greater ADSS Q1 at baseline",{"measure":77,"description":78,"timeFrame":49},"Change in Asthma Control Questionnaire-5 (ACQ-5) score from baseline at Week 24 in the subpopulation of patients with a 0.5-point or greater ACQ-5 at baseline","The ACQ-5 goes from 0 to 6, with higher score indicating worse asthma control.",{"measure":80,"description":78,"timeFrame":49},"Number of participants at week 24 achieving a 0.5-point or greater improvement in ACQ-5 in the subset of participants with a 0.5-point or greater ACQ-5 at baseline",{"measure":82,"description":83,"timeFrame":49},"Change in Sino-Nasal Outcome Test (SNOT-22) score from baseline at Week 24 in the subpopulation of patients with an 8.9-point or greater SNOT-22 at baseline","The SNOT-22 scores range from 0 to 110, with a higher score indicating more severe symptoms",{"measure":85,"description":83,"timeFrame":49},"Number of participants at Week 24 achieving a 8.9-point or greater reduction from baseline in SNOT-22 in the subpopulation of patients with an 8.9-point or greater SNOT-22 at baseline",{"measure":87,"description":88,"timeFrame":49},"Number of participants at week 24 achieving an Adapted Investigator's Global Assessment (aIGA) response of 0 or 1","The aIGA scale ranges from 0 to 1, with a lower score indicating improvement in atopic dermatitis.",{"measure":90,"timeFrame":91},"Number of participants with treatment emergent adverse events (TEAEs)","Through participant study completion, approximately Week 56",{"measure":93,"timeFrame":91},"Number of participants with treatment emergent serious adverse events",{"measure":95,"timeFrame":91},"Number of participants with treatment related serious adverse events",{"measure":97,"timeFrame":91},"Number of participants with treatment emergent adverse events of special interest",{"measure":99,"timeFrame":91},"Number of participants with treatment related adverse events of special interest",{"measure":101,"timeFrame":91},"Number of participants with TEAEs leading to treatment discontinuation",{"measure":103,"timeFrame":91},"Number of participants with TEAEs leading to dose hold",{"measure":105,"timeFrame":91},"Number of participants with TEAEs leading to dose modifications","ALL","12 Years",false,{"inclusion":110,"exclusion":119,"raw_text":126},[111,112,113,114,115,116,117,118],"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","Chronic atopic dermatitis (AD) defined as onset of AD signs and symptoms","Patients must meet the following AD severity criteria:","IGA score ≥ 3 (scale of 0 to 4) at Screening and Baseline","≥ 10.0% of BSA involvement at Screening and Baseline","EASI ≥ 16.0 at Screening and Baseline","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","Provide written, informed consent to participate in the study and follow the study procedures, including compliance with the use of highly effective contraceptives",[120,121,122,123,124,125],"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","Are currently experiencing or have a history of unstable course of AD","History of chronic idiopathic urticaria at any time or urticaria from other causes within 4 weeks prior to randomization at the Baseline Visit.","Have a history of TCS use suggestive of a high risk for topical corticosteroid (TCS) withdrawal","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","Have a current or recent acute, active infection","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",[128,129,130],"CHILD","ADULT","OLDER_ADULT",[132],{"facility":133,"status":8,"city":134,"state":135,"zip":136,"country":137,"geoPoint":138},"Nektar Investigative Site","The Bronx","New York","10455","United States",{"lat":139,"lon":140},40.84985,-73.86641,[142],{"name":143,"role":144,"phone":145,"email":146},"Nektar Recruitment","CONTACT","855-482-8676","StudyInquiry@nektar.com",[148],{"name":149,"affiliation":13,"role":150},"Study Director","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":154,"biomarkers":156},[155],"Atopic Dermatitis",[],{"nct_id":4,"found":15,"summary":158,"prompt_version":168},{"design":159,"status":160,"heading":161,"summary":162,"follow_up":163,"word_count":164,"commitments":165,"compensation":166,"drugs_mentioned":167},"This is a Phase 3, randomized, double-blind study comparing Rezpegaldesleukin to a placebo in approximately 510 participants.","completed","Phase 3 Study of Rezpegaldesleukin for Moderate-to-Severe Atopic Dermatitis","This Phase 3 study is testing an investigational medicine called Rezpegaldesleukin for people aged 12 and older who have moderate-to-severe atopic dermatitis (eczema). You would receive either Rezpegaldesleukin or a placebo (an inactive substance) through an injection under the skin. Researchers want to see if Rezpegaldesleukin can improve your eczema symptoms, specifically looking at how clear your skin becomes and how much your Eczema Area and Severity Index (EASI) score improves by Week 24. The study aims to enroll 510 participants, but the current recruitment status is unclear.","The primary endpoints are measured at Week 24, but the overall study duration is approximately 15 months.",88,"Your participation in this study is expected to last about 15 months. You will have assessments at Week 0 and Week 24 to measure your eczema symptoms.","Not stated in the trial record.",[31,41],"v2"]