[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638736":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":34,"centralContacts":40,"locations":34,"responsibleParty":46,"collaborators":34,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":34,"enrollmentInfo":58,"targetDuration":34,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":70,"whyStopped":34,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":34},{"fullName":5,"class":6},"argenx","INDUSTRY",[8,14,18,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A (Open-Label Lead-in Period): Efgartigimod PH20 SC","EXPERIMENTAL","All participants will receive efgartigimod PH20 SC open label for 8 weeks",[13],"Biological: Efgartigimod PH20 (ARGX-113) SC",{"label":15,"type":10,"description":16,"interventionNames":17},"Part B (Double-blinded treatment period): Efgartigimod PH20 SC","Participants will receive efgartigimod PH20 SC for 24 weeks",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Part B (Maintenance double-blinded treatment period): Placebo PH20 SC","PLACEBO_COMPARATOR","Participants will receive placebo for 24 weeks",[23],"Other: Placebo PH20 SC",{"label":25,"type":10,"description":26,"interventionNames":27},"Part C (Open-Label Extension Period): Efgartigimod PH20 SC","Participants who complete Part B will receive efgartigimod PH20 SC for 24 weeks",[13],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"BIOLOGICAL","Efgartigimod PH20 (ARGX-113) SC","subcutaneous administrations of efgartigimod PH20 SC given by prefilled syringe (PFS). For participants aged 12 to \\\u003C18 years with body weight ≤50 kg, the study drug will be administered by vial and syringe.",[9,15,25],null,{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":34},"OTHER","Placebo PH20 SC","subcutaneous administrations of placebo PH20 SC given by prefilled syringe (PFS). For participants aged 12 to \\\u003C18 years with body weight\n\n≤50 kg, the study drug will be administered by vial and syringe",[19],[41],{"name":42,"role":43,"phone":44,"phoneExt":34,"email":45},"Sabine Coppieters, MD","CONTACT","857-350-4834","Clinicaltrials@argenx.com",{"type":47,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100638736","phase-2-a-study-to-learn-about-how-well-the-medicine-efgartigimod-works-to-treat-autoimmune-encephalitis-in-children-12-years-or-older-and-adults-100638736",false,"NCT07583641","A Study to Learn About How Well the Medicine Efgartigimod Works to Treat Autoimmune Encephalitis In Children 12 Years or Older and Adults","A Global, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult and Adolescent Participants With Autoimmune Encephalitis","Polaris","Inclusion Criteria:\n\n* Is at least 12 years of age.\n* Meeting at least the criteria for possible AIE according to the Graus criteria.\n* Part A:\n\nMust not have received prior treatment for AIE with PLEX or Ig (participants may have received glucocorticoids); and must not have received PLEX or Ig for any other medical condition in the last 3 months\n\n\\- Part B: Either completing Part A, or If directly entering Part B, must have received first-line treatment for AIE (i.e. corticosteroids, PLEX, and\u002For Ig) and have a CASE score of 3 or higher, or a score of 2 or higher in a single sub-item\n\nExclusion Criteria:\n\n* Known anti-myelin oligodendrocyte glycoprotein (anti-MOG) antibody positivity.\n* Any medical condition that would interfere with an accurate assessment of clinical symptoms of AIE.\n* Recent major surgery (within 3 months of screening) or intention to have major surgery during the study, except for surgeries for AIE-related teratomas and thymomas.\n* History (within 12 months before screening) of current alcohol, drug (including recreational or prescribed cannabinoids), or medication abuse.\n* Psychiatric or cognitive impairment unrelated to AIE.","ALL","12 Years",{"count":59,"type":60},170,"ESTIMATED","INTERVENTIONAL",[63],"PHASE2","The POLARIS study is designed to evaluate how well efgartigimod PH20 SC may work (called \"efficacy\") and how safe it is for people diagnosed with Autoimmune Encephalitis (AIE). The study consists of 4 parts: in part A participants will receive efgartigimod SC; in part B, participants will be randomized to receive either efgartigimod SC or placebo; in part C, participants who completed part B will receive efgartigimod SC; in part D, participants who completed part C will be observed after their last dose of efgartigimod SC. If AIE symptoms return, efgartigimod SC treatment may be restarted during this time.\n\nThe maximum overall study duration for participants is up to 3 years. More information can be found in clinicaltrials.argenx.com\u002Fpolaris",[66],"Autoimmune Encephalitis (AE)",[68,69],"Autoimmune Encephalitis (AIE)","Adolescents","NOT_YET_RECRUITING","2026-05-07",{"date":73,"type":74},"2026-05-13","ACTUAL",{"date":76,"type":60},"2026-07-13",{"date":78,"type":60},"2031-07-26",{"name":5,"class":6}]