[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypereosinophilia-syndrome-hes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypereosinophilia-syndrome-hes":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100555499","phase-3-a-trial-to-investigate-benralizumab-in-children-with-eosinophilic-diseases-100555499",false,"NCT06512883","A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases","Phase 3, Open-label Trial to Evaluate Safety, Pharmacokinetics, and Efficacy of Benralizumab in Children With Eosinophilic Diseases (CLIPS)","CLIPS","Inclusion Criteria:\n\nAll Cohorts:\n\n* Male or female participants must be aged 6 to \\\u003C 18 years of age at the time of signing the assent form and their caregiver signing the informed consent form.\n* Body weight greater than (\\>=) 15 kilograms (kg).\n\nEGPA Cohort:\n\n* Therapy with corticosteroids: The prescribed dose of oral corticosteroids (OCS) (greater than \\[\\>\\] 0.1 milligrams per kilogram per day (mg\u002Fkg\u002Fday), max dose of 50 milligrams per day (mg\u002Fday) must be stable (that is, no adjustment of the dose) for at least 4 weeks prior to baseline (Visit 2).\n* Immunosuppressive therapy: If receiving immunosuppressive therapy, the dosage must be stable for at least 4 weeks prior to baseline (Visit 2).\n\nHES Cohort:\n\n* Documented HES diagnosis, defined as history of persistent eosinophilia \\>1500 cells\u002FµL without secondary cause on 2 examinations ≥1 month apart and evidence of eosinophil-mediated organ involvement.\n* Symptomatic active HES, or history of a prior flare, or considered eligible based on disease severity per investigator judgement.\n* AEC ≥1000 cells\u002FµL at screening (Visit 1).\n* Documented negative testing for Fip1-like 1 gene fused with the platelet-derived growth factor receptor alpha gene (FIP1L1-PDGFR) fusion tyrosine kinase gene translocation.\n\nExclusion Criteria:\n\nAll Cohorts:\n\n* Any current malignancy or history of malignancy.\n* History of anaphylaxis to any biologic therapy or vaccine.\n* Known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological, respiratory, or any other system abnormalities.\n* Previous receipt of benralizumab in an interventional clinical study.\n\nEGPA Cohort:\n\n* Diagnosed with granulomatosis with polyangiitis (previously known as Wegener'granulomatosis) or microscopic polyangiitis.\n* EGPA relapse: any deterioration in EGPA and\u002For organ-threatening EGPA that per Investigator judgement renders participants unstable in their EGPA within 3 months prior to screening (Visit 1) and through first administration of IP at baseline (Visit 2).\n* Life-threatening EGPA: imminently life-threatening EGPA disease within 3 months prior to screening (Visit 1) and through first administration of IP at baseline (Visit 2), as per Investigator judgement.\n\nHES Cohort:\n\n* Life-threatening HES or HES complications, as judged by the investigator.\n* Hypereosinophilia of unknown significance (HE-US).\n* Diagnosis of systemic mastocytosis.","ALL","6 Years","17 Years",{"count":21,"type":22},14,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab.",[28,29],"Eosinophilic Granulomatosis With Polyangiitis (EGPA)","Hypereosinophilia Syndrome (HES)","RECRUITING","2026-06-29",{"date":33,"type":34},"2026-06-30","ACTUAL",{"date":36,"type":34},"2025-04-17",{"date":38,"type":22},"2029-05-14",{"name":40,"class":41},"AstraZeneca","INDUSTRY",15]