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Naveed",{"type":1206,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100464951","phase-3-depemokimab-in-participants-with-hypereosinophilic-syndrome-efficacy-and-safety-trial-100464951",false,"NCT05334368","Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial","A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Depemokimab in Adults With Hypereosinophilic Syndrome (HES)","DESTINY","Inclusion Criteria:\n\n* Participants who are greater than or equal (\\>=) 40 kilogram (kg) at Screening Visit 1.\n* Participants who have a documented diagnosis of HES prior to Visit 2.\n* A history of 2 or more HES flares within the past 12 months prior to Visit 1.\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: a) woman of non-childbearing potential (WONCBP) Or b) woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\\\u003C) 1 percentage (%).\n* Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n* Participants with HES disease manifestations which in the opinion of the investigator may put the participant at unacceptable risk from study participation or confound interpretation of efficacy or safety data.\n* Participants with chronic or ongoing active infections requiring systemic treatment or a pre-existing parasitic infestation within 6 months prior to Visit 1.\n* Participants with a known immunodeficiency (e.g., Human Immunodeficiency Virus \\[HIV\\]), other than that explained by the use of OCS or other therapy taken for HES.\n* Participants with a history of or current lymphoma.\n* Participants with current malignancy or previous history of cancer in remission for less than 5 years prior to Visit 1. Participants that had localized carcinoma (i.e., basal or squamous cell) of the skin which was resected for cure will not be excluded.\n* Participants with a haematologic malignancy with hypereosinophilia in which HES is not the primary diagnosis, e.g., chronic myeloid leukaemia, myelodysplastic syndrome, chronic eosinophilic leukaemia-not otherwise specified.\n* Cirrhosis or current unstable liver or biliary disease per investigator assessment.\n* Participants who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment.\n* Participants with current diagnosis of vasculitis.\n* Hypereosinophila with no clinical symptoms and\u002For proof of organ dysfunction.\n* Clinical diagnosis of Eosinophilic granulomatosis with polyangiitis (EGPA).\n* Participants with an allergy\u002F intolerance to a monoclonal antibody or biologic, or any of the excipients of the investigational product.\n* Participants who have a previous documented failure with anti-interleukin (IL)-5\u002F5R therapy.\n* Participants who have received monoclonal antibodies (mAb) within 30 days or 5 half-lives, whichever is longer, prior to Visit 1.\n* Participants who test positive for the FIP1L1-PDGFRα fusion gene.\n* QT interval corrected for heart rate according to Fridericia's formula (QTcF) ≥450 milliseconds (msec) or QTcF ≥480 msec for participants with Bundle Branch Block at Screening Visit 1.\n* Participants who are not responsive to OCS based on clinical response or blood eosinophil counts in the opinion of the Investigator.\n* Participants who are pregnant or breastfeeding.","ALL","18 Years",{"count":1218,"type":1219},123,"ESTIMATED","INTERVENTIONAL",[1222],"PHASE3","This is a 52-week, randomized, placebo-controlled, double-blind, parallel group, multicenter study of depemokimab in adults with uncontrolled HES receiving standard of care (SoC) therapy.\n\nThe study will recruit patients with a confirmed diagnosis of HES and who are on stable HES therapy for at least 4 weeks prior to randomization (Visit 2). Eligible participants must have uncontrolled HES with a history of repeated flare (≥2 flares in the previous 12 months) and blood eosinophil count of ≥1,000 cells\u002F microliter (μL) during Screening. Historical HES flares are defined as documented HES-related worsening of clinical symptoms or blood eosinophil counts requiring an escalation in therapy.\n\nParticipants who meet the inclusion and exclusion criteria will be randomized in a 2:1 ratio to receive either depemokimab or placebo while continuing their SoC HES therapy.",[1225],"Hypereosinophilic Syndrome",[9,1225,1213,1227,1228],"Monoclonal antibody","Anti-interleukin -5","2025-11-24",{"date":1231,"type":1232},"2025-11-25","ACTUAL",{"date":1234,"type":1232},"2022-09-06",{"date":1236,"type":1219},"2028-12-19",{"name":5,"class":6},91]