[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555499":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":29,"responsibleParty":176,"collaborators":22,"id":178,"slug":179,"hasResults":180,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":180,"sex":186,"minAge":187,"maxAge":188,"enrollmentInfo":189,"targetDuration":22,"studyType":192,"phases":193,"briefSummary":195,"conditions":196,"keywords":22,"overallStatus":32,"whyStopped":22,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":208},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EGPA\u002FHES Cohort: Benralizumab","EXPERIMENTAL","Participants with greater than or equal to (\\>=) 35 kg weight will receive benralizumab dose-1 and participants with less than (\\\u003C) 35 kg weight will receive benralizumab dose-2 as SC injection Q4W during the 52-week treatment period. All participants who complete the 52-week treatment period will be offered the opportunity to continue into an extension period.",[13],"Drug: Benralizumab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Benralizumab","Benralizumab will be administered as SC injection on Q4W.",[9],[21],"FASENRA",null,[24],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[30,44,54,62,72,83,93,101,111,121,131,141,151,159,168],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":22},"Research Site","RECRUITING","Aurora","Colorado","80045","United 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(Türkiye)",{"type":39,"coordinates":164},[165,166],37.70324,37.09145,{"lat":166,"lon":165},{"facility":31,"status":32,"city":169,"state":22,"zip":170,"country":162,"countryCode":22,"cosmosGeoPoint":171,"geoPoint":175,"contacts":22},"Istanbul","34093",{"type":39,"coordinates":172},[173,174],28.94966,41.01384,{"lat":174,"lon":173},{"type":177,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","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":190,"type":191},14,"ESTIMATED","INTERVENTIONAL",[194],"PHASE3","The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab.",[197,198],"Eosinophilic Granulomatosis With Polyangiitis (EGPA)","Hypereosinophilia Syndrome (HES)","2026-06-29",{"date":201,"type":202},"2026-06-30","ACTUAL",{"date":204,"type":202},"2025-04-17",{"date":206,"type":191},"2029-05-14",{"name":5,"class":6},15]