[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644739":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":31,"centralContacts":39,"locations":31,"responsibleParty":45,"collaborators":31,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":31,"enrollmentInfo":57,"targetDuration":31,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":31,"overallStatus":69,"whyStopped":31,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":75,"leadSponsor":77,"locationsCount":31},{"fullName":5,"class":6},"argenx","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Empasiprubart IV","EXPERIMENTAL","Participants receive empasiprubart IV in the DBTP",[13],"Biological: Empasiprubart IV",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo IV","PLACEBO_COMPARATOR","Participants receive placebo IV in the DBTP",[19],"Other: Placebo IV",{"label":21,"type":22,"description":23,"interventionNames":24},"Efgartigimod PH20 SC PFS","OTHER","Participants receive open-label efgartigimod PH20 SC PFS in the safety follow-up period",[25],"Combination Product: Efgartigimod PH20 SC PFS",[27,32,35],{"type":28,"name":9,"description":29,"armGroupLabels":30,"otherNames":31},"BIOLOGICAL","Intravenous infusions of empasiprubart",[9],null,{"type":22,"name":15,"description":33,"armGroupLabels":34,"otherNames":31},"Intravenous infusions of placebo",[15],{"type":36,"name":21,"description":37,"armGroupLabels":38,"otherNames":31},"COMBINATION_PRODUCT","Subcutaneous administration of efgartigimod PH20 via pre-filled syringe (PFS)",[21],[40],{"name":41,"role":42,"phone":43,"phoneExt":31,"email":44},"Sabine Coppieters, MD","CONTACT","857-350-4834","clinicaltrials@argenx.com",{"type":46,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100644739","phase-2-adapt-forward-2---isa2---a-study-to-evaluate-the-safety-tolerability-and-efficacy-of-empasiprubart-iv-monotherapy-in-participants-with-achr-ab-seropositive-generalized-myasthenia-gravis-100644739",false,"NCT07673627","ADAPT Forward 2 - ISA2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis","ISA2 to Master Protocol ARGX-999-2-MG-2000 - an Exploratory, Phase 2a, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis","ADAPT Forward2","Inclusion Criteria:\n\n* Is seropositive for anti-acetylcholine receptor antibodies (AChR-Ab).\n* Has confirmed diagnosis of gMG and is Myasthenia Gravis Foundation of America (MGFA) Class II, III, IVa, or IVb.\n* Has documented immunization against encapsulated bacterial pathogens (Neisseria meningitidis and Streptococcus pneumoniae) within 5 years before ISA screening or will complete immunization at least 14 days before the first IMP administration.\n\nExclusion Criteria:\n\n* Clinical diagnosis of systemic lupus erythematosus (SLE).\n* Is receiving concurrent complement inhibitors (eg, eculizumab, zilucoplan, ravulizumab, or others). Participants who received zilucoplan or eculizumab \\>2 months or ravulizumab \\>6 months before baseline are allowed to participate.\n* Has received an FcRn antagonist, including efgartigimod, within 4 weeks before baseline.\n* Had prior empasiprubart exposure.","ALL","18 Years",{"count":58,"type":59},40,"ESTIMATED","INTERVENTIONAL",[62],"PHASE2","This study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life.\n\nThe aim of this ISA2 is to investigate the effects of empasiprubart in participants with AChR-Ab seropositive generalized myasthenia gravis (gMG).\n\nThe ADAPT Forward master protocol is registered on https:\u002F\u002Fclinicaltrials.gov\u002Fstudy\u002FNCT07294170",[65,66,67,68],"AChR-Ab Seropositive Generalized Myasthenia Gravis","Myasthenia Gravis (MG)","MG - Myasthenia Gravis","gMG","NOT_YET_RECRUITING","2026-06-23",{"date":72,"type":73},"2026-06-29","ACTUAL",{"date":72,"type":59},{"date":76,"type":59},"2028-04",{"name":5,"class":6}]