[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643299":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":37,"locations":23,"responsibleParty":47,"collaborators":23,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":23,"enrollmentInfo":59,"targetDuration":23,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":71,"whyStopped":23,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":23},{"fullName":5,"class":6},"Incyte Corporation","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"INCA033989","EXPERIMENTAL","Administered intravenous (IV) in accordance with the protocol-defined requirements.",[13],"Drug: INCA033989",{"label":15,"type":10,"description":16,"interventionNames":17},"Best Available Therapy (BAT)","Best Available Therapy (BAT) will be selected by the investigator.",[18],"Drug: Best Available Treatment",[20,24],{"type":21,"name":9,"description":11,"armGroupLabels":22,"otherNames":23},"DRUG",[9],null,{"type":21,"name":25,"description":16,"armGroupLabels":26,"otherNames":27},"Best Available Treatment",[15],[28,29,30,31,32],"BAT could include:","• HU","• ANA","• PEG interferon alfa-2a","• Ropeginterferon alfa-2b",[34],{"name":35,"affiliation":5,"role":36},"Incyte Medical Monitor","STUDY_DIRECTOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":23,"email":42},"Incyte Corporation Call Center (US)","CONTACT","1.855.463.3463","medinfo@incyte.com",{"name":44,"role":40,"phone":45,"phoneExt":23,"email":46},"Incyte Corporation Call Center (ex-US)","+800 00027423","eumedinfo@incyte.com",{"type":48,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100643299","phase-3-a-phase-3-study-of-inca033989-versus-best-available-therapy-in-participants-with-essential-thrombocythemia-100643299",false,"NCT07623200","A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia","A Phase 3, Randomized, Open-Label Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia and a CALR Mutation Previously Treated With Cytoreductive Therapy (EXCALIBUR-ET2)","EXCALIBUR-ET2","Inclusion Criteria:\n\n* Confirmed diagnosis of high-risk ET.\n* Presence of mutCALR.\n* Prior treatment with at least 1 cytoreductive therapy.\n\nExclusion Criteria:\n\n* Presence of any hematologic malignancy other than ET.\n* Major bleeding or thrombosis within the last 3 months prior to study enrollment.\n* Any prior allogenic or autologous stem-cell transplantation.\n* Unresolved toxicity ≥ Grade 2 from previous therapy except for stable chronic toxicities (Grade 2) not expected to resolve, such as stable Grade 2 peripheral neuropathy.\n* Prior nonhematologic malignancy except for the following: Malignancy treated with curative intent and with no evidence of active disease for more than 2 years before screening. Adequately treated carcinoma in situ without current evidence of disease.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria apply.","ALL","18 Years",{"count":60,"type":61},426,"ESTIMATED","INTERVENTIONAL",[64],"PHASE3","This study is being conducted to evaluate INCA033989 versus best available therapy in participants with essential thrombocythemia and a CALR mutation previously treated with cytoreductive therapy.",[67],"Essential Thrombocythemia",[69,70],"calreticulin (CALR)","mutCALR","NOT_YET_RECRUITING","2026-06-05",{"date":74,"type":75},"2026-06-09","ACTUAL",{"date":77,"type":61},"2026-07-31",{"date":79,"type":61},"2030-11-01",{"name":5,"class":6}]