[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07673627":3,"trial-entities:NCT07673627":135,"trial-summary:NCT07673627":140},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":47,"secondary_outcomes":51,"sex":78,"minimum_age":79,"maximum_age":15,"healthy_volunteers":80,"eligibility_criteria":81,"std_ages":92,"locations":95,"central_contacts":124,"overall_officials":129,"references":130,"see_also_links":131},"NCT07673627","ARGX-999-2-MG-20002","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","RECRUITING","2028-04","2026-07","2026-07-24","2026-07-10","argenx","INDUSTRY",null,"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\n\nMore information can be found here: https:\u002F\u002Fclinicaltrials.argenx.com\u002Fadaptforward2","Once the master protocol and ISA2 screening periods are completed, eligible participants will be randomized to receive empasiprubart IV or placebo in the double-blinded treatment period (DBTP). All participants will then receive open-label efgartigimod PH20 SC PFS in the safety follow-up period.\n\nThe study duration for each participant is approximately up to 45 weeks.",[19,20,21,22],"AChR-Ab Seropositive Generalized Myasthenia Gravis","Myasthenia Gravis (MG)","MG - Myasthenia Gravis","gMG",[],"INTERVENTIONAL","TREATMENT",[27],"PHASE2",{"count":29,"type":30},40,"ESTIMATED",[32,37,42],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BIOLOGICAL","Empasiprubart IV","Intravenous infusions of empasiprubart",[34],{"type":38,"name":39,"description":40,"armGroupLabels":41},"OTHER","Placebo IV","Intravenous infusions of placebo",[39],{"type":43,"name":44,"description":45,"armGroupLabels":46},"COMBINATION_PRODUCT","Efgartigimod PH20 SC PFS","Subcutaneous administration of efgartigimod PH20 via pre-filled syringe (PFS)",[44],[48],{"measure":49,"timeFrame":50},"Incidence of adverse events and serious adverse events in the DBTP","Up to 12 weeks",[52,55,58,61,63,66,69,72,75],{"measure":53,"description":54,"timeFrame":50},"MG-ADL total score change from baseline at week 12","The Myasthenia Gravis Activities of Daily Living (MG-ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (normal symptoms) to 24 (most severe symptoms)",{"measure":56,"description":57,"timeFrame":50},"QMG total score change from baseline at week 12","The Quantitative myasthenia gravis (QMG) includes 13 items that measure endurance or fatigability and accounts for fluctuations in disease state. The total score ranges from 0 (no disease severity) to 39 (highest disease severity)",{"measure":59,"description":60,"timeFrame":50},"MG-ADL total score change from baseline over time up to week 12","The Myasthenia Gravis Activities of Daily Living (MG- ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (normal symptoms) to 24 (most severe symptoms)",{"measure":62,"description":57,"timeFrame":50},"QMG total score change from baseline over time up to week 12",{"measure":64,"description":65,"timeFrame":50},"Proportion of participants reaching MSE at any point by week 12","MSE: Minimal symptom expression",{"measure":67,"description":68,"timeFrame":50},"Proportion of participants who have ≥3-point reduction in MG-ADL at week 12","The Myasthenia Gravis Activities of Daily Living (MG- ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (normal symptoms) to 24 (most severe symptoms).",{"measure":70,"description":71,"timeFrame":50},"Proportion of participants who have ≥5-point reduction in QMG at week 12","The Quantitative myasthenia gravis (QMG) includes 13 items that measure endurance or fatigability and accounts for fluctuations in disease state. The total score ranges from 0 (no disease severity) to 39 (highest disease severity).",{"measure":73,"description":74,"timeFrame":50},"Proportion of participants who have a positive PASS at week 12","PASS: Patient acceptable symptom state",{"measure":76,"description":77,"timeFrame":50},"Proportion of participants who have a 50% MG-ADL total score improvement at week 12","The Myasthenia Gravis Activities of Daily Living (MG-ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (normal symptoms) to 24 (most severe symptoms).","ALL","18 Years",false,{"inclusion":82,"exclusion":86,"raw_text":91},[83,84,85],"Is seropositive for anti-acetylcholine receptor antibodies (AChR-Ab).","Has confirmed diagnosis of gMG and is Myasthenia Gravis Foundation of America (MGFA) Class II, III, IVa, or IVb.","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.",[87,88,89,90],"Clinical diagnosis of systemic lupus erythematosus (SLE).","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.","Has received an FcRn antagonist, including efgartigimod, within 4 weeks before baseline.","Had prior empasiprubart exposure.","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.",[93,94],"ADULT","OLDER_ADULT",[96,111],{"facility":97,"status":8,"city":98,"state":99,"zip":100,"country":101,"contacts":102,"geoPoint":108},"Visionary Investigators Network","Miami","Florida","33176-2148","United States",[103],{"name":104,"role":105,"phone":106,"email":107},"Andrew Lerman, MD","CONTACT","786-655-8010","alerman@fcneurology.net",{"lat":109,"lon":110},25.77427,-80.19366,{"facility":112,"status":8,"city":113,"state":114,"zip":115,"country":101,"contacts":116,"geoPoint":121},"Erlanger Health System","Chattanooga","Tennessee","37403-2136",[117],{"name":118,"role":105,"phone":119,"email":120},"Joshua Alpers, MD","423-778-3900","Joshua.Alpers@erlanger.org",{"lat":122,"lon":123},35.04563,-85.30968,[125],{"name":126,"role":105,"phone":127,"email":128},"Sabine Coppieters, MD","857-350-4834","clinicaltrials@argenx.com",[],[],[132],{"label":133,"url":134},"Study website","https:\u002F\u002Fclinicaltrials.argenx.com\u002Fadaptforward2",{"nct_id":4,"conditions":136,"biomarkers":138},[137],"Myasthenia Gravis",[139],"AChR-Ab",{"nct_id":4,"found":141,"summary":142,"prompt_version":152},true,{"design":143,"status":144,"heading":145,"summary":146,"follow_up":147,"word_count":148,"commitments":149,"compensation":150,"drugs_mentioned":151},"This is an interventional study that plans to enroll 40 participants. Participants will be randomly assigned to receive either empasiprubart IV or a placebo IV, and later all will receive efgartigimod PH20 SC PFS.","completed","ADAPT Forward 2 - ISA2: Empasiprubart for Generalized Myasthenia Gravis","This study is testing a medicine called empasiprubart given through an IV for people with generalized myasthenia gravis (gMG). This is a condition where your immune system mistakenly attacks your body, causing muscle weakness. You may be able to join if you are 18 or older, have gMG that is confirmed by a specific blood test (AChR-Ab seropositive), and meet certain health criteria. The main goal is to see how safe empasiprubart is by tracking any side effects over about 12 weeks. This study is part of a larger effort to find better treatments for gMG. The current status of recruitment is unclear.","The primary safety endpoints are measured up to 12 weeks after treatment. The total study duration for each participant is approximately up to 45 weeks.",103,"The study duration for each participant is approximately up to 45 weeks. You would receive intravenous infusions of empasiprubart or placebo, and later subcutaneous injections of efgartigimod PH20.","Not stated in the trial record.",[],"v2"]