[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610190":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":11,"studyPopulation":11,"armGroups":45,"interventions":58,"overallOfficials":67,"centralContacts":71,"locations":77,"responsibleParty":132,"collaborators":11,"id":134,"slug":11,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":11,"eligibilityCriteria":139,"healthyVolunteers":135,"sex":140,"minAge":141,"maxAge":11,"enrollmentInfo":142,"targetDuration":11,"studyType":145,"phases":146,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":80,"whyStopped":11,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"CSL Behring","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":11},[9,13,15,18,21,23],{"measure":10,"description":11,"timeFrame":12},"Number of participants with Treatment Emergent Adverse Events (TEAEs), Overall and by severity, seriousness and relationship to Investigational Product (IP)",null,"From baseline up to Week 75",{"measure":14,"description":11,"timeFrame":12},"Percentage of participants with TEAEs Overall and by severity, seriousness and relationship to IP",{"measure":16,"description":17,"timeFrame":12},"Number of participants with Adverse Events of Special Interest (AESI)","The following AEs are to be reported as AESI: neutropenia (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade 3 or 4), severe infection and neutropenic fever.",{"measure":19,"description":20,"timeFrame":12},"Percentage of participants with AESI","The following AEs are to be reported as AESI: neutropenia (CTCAE Grade 3 or 4), severe infection and neutropenic fever.",{"measure":22,"description":11,"timeFrame":12},"Number of participants with clinically relevant changes from baseline in laboratory assessments and vital signs",{"measure":24,"description":11,"timeFrame":12},"Percentage of participants with clinically relevant changes from baseline in laboratory assessments and vital signs",[26,29],{"measure":27,"description":11,"timeFrame":28},"Serum concentration of Anumigilimab","From the first dose of anumigilimab to Week 65",{"measure":30,"description":31,"timeFrame":32},"Annualized rate of Vaso-occlusive crisis (VOC) (medical facility)","VOC (medical facility) is defined as VOC that results in a visit to a medical facility and treatment with parenteral opioids or a parenteral nonsteroidal anti-inflammatory drug.","During the maintenance period from Week 13 to Week 65",{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":11,"timePerspective":11,"maskingInfo":38},"RANDOMIZED","PARALLEL","This is a double blind, placebo controlled study.","TREATMENT",{"masking":39,"maskingDescription":11,"whoMasked":40},"QUADRUPLE",[41,42,43,44],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[46,52],{"label":47,"type":48,"description":49,"interventionNames":50},"Anumigilimab","EXPERIMENTAL","Safety of Anumigilimab (CSL324) in Adults with Sickle Cell Disease (SCD)",[51],"Biological: Anumigilimab",{"label":53,"type":54,"description":55,"interventionNames":56},"Placebo","PLACEBO_COMPARATOR","Participants will receive matching volume of placebo.",[57],"Drug: Placebo",[59,63],{"type":60,"name":47,"description":61,"armGroupLabels":62,"otherNames":11},"BIOLOGICAL","Participants will receive anumigilimab, escalated to a maximum dose guided by absolute neutrophil count (ANC) and safety concerns.",[47],{"type":64,"name":53,"description":65,"armGroupLabels":66,"otherNames":11},"DRUG","Volume matched saline will be administered SC.",[53],[68],{"name":69,"affiliation":5,"role":70},"Study Director","STUDY_DIRECTOR",[72],{"name":73,"role":74,"phone":75,"phoneExt":11,"email":76},"Trial Registration Coordinator","CONTACT","+1 610-878-4697","clinicaltrials@cslbehring.com",[78,92,102,112,122],{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":11},"UAMS Medical Center","RECRUITING","Little Rock","Arkansas","72202","United States","US",{"type":87,"coordinates":88},"Point",[89,90],-92.28959,34.74648,{"lat":90,"lon":89},{"facility":93,"status":80,"city":94,"state":95,"zip":96,"country":84,"countryCode":85,"cosmosGeoPoint":97,"geoPoint":101,"contacts":11},"The Foundation for Sickle Cell Disease","Hollywood","Florida","33023-6703",{"type":87,"coordinates":98},[99,100],-80.14949,26.0112,{"lat":100,"lon":99},{"facility":103,"status":80,"city":104,"state":105,"zip":106,"country":84,"countryCode":85,"cosmosGeoPoint":107,"geoPoint":111,"contacts":11},"Center for Cancer and Blood Disorders","Bethesda","Maryland","20817",{"type":87,"coordinates":108},[109,110],-77.10026,38.98067,{"lat":110,"lon":109},{"facility":113,"status":80,"city":114,"state":115,"zip":116,"country":84,"countryCode":85,"cosmosGeoPoint":117,"geoPoint":121,"contacts":11},"Southern Specialty Research","Flowood","Mississippi","39232",{"type":87,"coordinates":118},[119,120],-90.13898,32.30959,{"lat":120,"lon":119},{"facility":123,"status":80,"city":124,"state":125,"zip":126,"country":84,"countryCode":85,"cosmosGeoPoint":127,"geoPoint":131,"contacts":11},"Jacobi Medical Center","The Bronx","New York","10461",{"type":87,"coordinates":128},[129,130],-73.86641,40.84985,{"lat":130,"lon":129},{"type":133,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100610190",false,"NCT07224360","Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)","Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease","Inclusion Criteria:\n\n* • Adults aged greater than or equal to (\\>=) 18 years on the day of signing the informed consent form.\n* • Confirmed diagnosis of SCD of any genotype.\n* • Experienced 1 to 12 VOCs requiring a visit to a medical facility and treatment with parenteral opioids or a parenteral nonsteroidal anti-inflammatory drug within the 12 months before Screening.\n* • HU Regimen:\n* a. On stable and well-tolerated Hydroxyurea (HU) regimen for at least 30 days before Screening.\n* or\n* b. HU was discontinued or refused (eg, due to concern of side effects or lack of effect).\n\nExclusion Criteria:\n\n* • Absolute neutrophil count less than (\\\u003C) 2.5 ×10\\^9 cells\u002FLitre at Screening or Baseline (Week 1 Day 1).\n* • If on SCD preventive medication, dose is not stable in the 30 days before Screening.","ALL","18 Years",{"count":143,"type":144},63,"ESTIMATED","INTERVENTIONAL",[147],"PHASE2","This is a phase 2a, global, multicenter, randomized, double-blind, placebo-controlled study investigating the safety of anumigilimab administered subcutaneously (SC) at the maximum tolerated dose (MTD) in adult participants with SCD.\n\nThe primary aim of the study is to assess the safety of anumigilimab in participants with SCD. Participants will be treated for 64 weeks: for 12 weeks in the dose escalation period, where the dose will be escalated to each participant's individual MTD; and for 52 weeks at the MTD in the maintenance period.",[150],"Sickle Cell Disease",[152,153,154],"Anemia","Genetic Disorder","Vaso-occlusive Crises","2026-05-11",{"date":157,"type":158},"2026-05-12","ACTUAL",{"date":160,"type":158},"2026-02-02",{"date":162,"type":144},"2028-06-29",{"name":5,"class":6},5]