[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gmg\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gmg":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,42,70,95,111,132,163],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"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":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"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",[27,28,29,30],"AChR-Ab Seropositive Generalized Myasthenia Gravis","Myasthenia Gravis (MG)","MG - Myasthenia Gravis","gMG","NOT_YET_RECRUITING","2026-06-23",{"date":34,"type":35},"2026-06-29","ACTUAL",{"date":34,"type":21},{"date":38,"type":21},"2028-04",{"name":40,"class":41},"argenx","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100641863","phase-3-efficacy-and-safety-of-ravulizumab-in-chinese-adults-participants-with-generalized-myasthenia-gravis-gmg-100641863","NCT07596784","Efficacy and Safety of Ravulizumab in Chinese Adults Participants With Generalized Myasthenia Gravis (gMG)","An Open-label, Single-arm, Multi-center, Interventional Study to Evaluate the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Ravulizumab in Chinese Adult Patients With Generalized Myasthenia Gravis (gMG)","Inclusion (key)\n\n* Confirmed generalized MG: Diagnosis ≥6 months before screening, anti-AChR antibody positive, and supportive diagnostic evidence (e.g., abnormal SFEMG\u002FRNS or response to anticholinesterase therapy).\n* Disease severity: MGFA Class II-IV at screening.\n* Symptoms threshold: MG-ADL ≥6 at screening and on Day 1.\n* Meningococcal vaccination: Up to date within 3 years or vaccinated before first dose to mitigate risk with complement inhibition.\n* Body weight: ≥40 kg.\n* Vaccinated against meningococcal infections within the 3 years prior to, or at the time of, initiating study drug.\n\nExclusion (key)\n\n* Thymic disease:\n\n  * Untreated thymic malignancy\u002Fcarcinoma\u002Fthymoma excluded.\n  * Prior thymic malignancy allowed only if treatment completed \\>5 years, no recurrence in last 5 years, and clear CT\u002FMRI within 6 months.\n  * Prior benign thymoma allowed if confirmed benign, treatment \\>12 months ago, no recurrence in last 12 months, and clear CT\u002FMRI within 6 months; otherwise follow malignancy rules.\n  * Thymectomy within the last 12 months\n* Infection risk:\n\n  * History of meningococcal disease or unresolved infection, or active systemic infection within 14 days of Day 1 excluded.\n  * Persistent\u002Frecurrent infections in past 12 months that add risk\n  * HIV, active HBV (HBsAg+ or anti-HBc+ with anti-HBs-), or active HCV (unless documented successful treatment\u002FSVR)\n* Safety\u002Fmedical status:\n\n  * Hypersensitivity to study drug components (including murine proteins)\n  * Recent hospitalization ≥24 hours within 28 days of screening\n  * Substance use disorder per DSM within 12 months.\n  * Recent\u002Fother malignancy within 5 years (except as above for thymic).\n* Prior\u002FConcomitant Therapy\n\n  * Complement inhibitor within \\\u003C 5 half-lives before Day 1.\n  * Human neonatal Fc receptor (FcRn) inhibitor within \\\u003C 5 half-lives before Day 1.\n  * Rituximab, ocrelizumab or other B cell-depleting therapy within ≤ 6 months (180 days) before Day 1.\n  * Periodic (chronic) administration of PP\u002FPE, or IVIg as maintenance therapy received or scheduled within ≤ 6 months before Day 1\n* Key labs:\n\n  * ALT \\>2× ULN, direct bilirubin \\>2× ULN.\n  * eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m² or on dialysis.\n  * Any other clinically significant lab abnormality making participation unsafe.\n\nNote: Other protocol-defined criteria may apply and should be verified during full eligibility review.","130 Years",{"count":51,"type":21},20,[53],"PHASE3","The primary purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in Chinese adult participants with Acetylcholine receptor (AChR) + Generalized Myasthenia Gravis (gMG).",[56,30],"Generalized Myasthenia Gravis",[58,30,59],"generalized myasthenia gravis","ravulizumab","2026-06-17",{"date":62,"type":35},"2026-06-22",{"date":64,"type":21},"2026-07-30",{"date":66,"type":21},"2027-08-27",{"name":68,"class":41},"Alexion Pharmaceuticals, Inc.",10,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100615558","adapt-forward---master-protocol-of-a-platform-study-to-evaluate-the-safety-and-efficacy-of-multiple-regimens-in-participants-with-myasthenia-gravis-100615558","NCT07294170","ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis","A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis","Inclusion Criteria:\n\n* Is at least 18 years of age and the local legal age of consent for clinical studies\n* Has been diagnosed with MG with consistent clinical features per the investigator's clinical judgment\n* If receiving MG therapy, including nonsteroidal immunosuppressive drugs (NSIDs), corticosteroids, or acetylcholinesterase (AChE) inhibitors either in combination or alone, the participant should receive a stable dosage before master protocol screening\n\nExclusion Criteria:\n\n* Known autoimmune disease or any medical condition other than the indication under study that would interfere with an accurate assessment of clinical symptoms of MG or puts the participant at undue risk\n* Is MGFA (Myasthenia Gravis Foundation of America) Class V",{"count":78,"type":21},70,"OBSERVATIONAL","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.",[82,83,30,56,84,27],"Myasthenia Gravis","MG","Generalized Myasthenia Gravis (gMG)","RECRUITING","2026-06-11",{"date":88,"type":35},"2026-06-12",{"date":90,"type":35},"2025-12-19",{"date":92,"type":21},"2028-03-07",{"name":40,"class":41},18,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":108,"leadSponsor":109,"locationsCount":110},"100614809","phase-2-adapt-forward-1---isa1---a-study-to-evaluate-empasiprubart-iv-as-add-on-therapy-to-efgartigimod-iv-in-participants-with-achr-ab-seropositive-generalized-myasthenia-gravis-with-a-partial-clinical-response-to-efgartigimod-100614809","NCT07284420","ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod","An ISA to Master Protocol ARGX-999-2-MG-2000 for an Exploratory, Phase 2a, Proof-of-Concept Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV as Add-On Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod","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 of ISA screening or is willing to receive immunization at least 14 days before the first study drug administration\n\nExclusion Criteria:\n\n* Clinical diagnosis of systemic lupus erythematosus (SLE)\n* Any known complement deficiency\n* Current administration of a complement inhibitor or received zilucoplan or eculizumab \\\u003C2 months or ravulizumab \\\u003C6 months before the first study drug administration\n* Patients proven to be refractory to efgartigimod (ie, not achieving a clinically meaningful improvement in total Myasthenia Gravis Activities of Daily Living (MG-ADL) score defined as an improvement of ≥2 points)",{"count":78,"type":21},[24],"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 ISA1 is to evaluate the safety and therapeutic relevance of empasiprubart as add-on therapy to efgartigimod in participants with AChR-Ab seropositive generalized myasthenia gravis.\n\nThe ADAPT Forward master protocol is registered on https:\u002F\u002Fclinicaltrials.gov\u002Fstudy\u002FNCT07294170",[27,82,83,30,56,84],{"date":88,"type":35},{"date":90,"type":35},{"date":92,"type":21},{"name":40,"class":41},15,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},"100639176","a-study-to-evaluate-the-impact-of-efgartigimod-on-overall-disease-experience-of-people-suffering-from-generalized-myasthenia-gravis-gmg-in-italy-100639176","NCT07595653","A Study to Evaluate the Impact of Efgartigimod on Overall Disease Experience of People Suffering From Generalized Myasthenia Gravis (gMG) in Italy","Non-interventional, Longitudinal Hybrid Data Sources Study to Evaluate the Impact of Efgartigimod on Overall Disease Experience of People Suffering From Generalized Myasthenia Gravis (gMG) in Italy","POEMA","Inclusion Criteria:\n\n* At least 18 years old at signing of informed Consent Form (ICF) and privacy form (PF)\n* Documented diagnosis of gMG\n* AChR-antibody positive\n* The treating physician has decided to initiate efgartigimod alfa as part of routine clinical care and in accordance with product labelling, independently from the study\n\nExclusion Criteria:\n\n* Hypersensitivity to the active substance or to any of the excipients listed: sodium dihydrogen phosphate, monohydrate; disodium hydrogen phosphate, anhydrous; arginine hydrochloride; polysorbate 80, hyaluronidase, histidine, histidine hydrochloride monohydrate, methionine, polysorbate 20, sucrose.\n* Current or planned participation in an interventional clinical trial.",{"count":120,"type":21},100,"This study aims to generate real world evidence (RWE) from Italian clinical practice on the impact of efgartigimod alfa in gMG patients encompassing clinical outcomes and patient reported experiences.\n\nThe study population will consist in adult patients with a documented diagnosis of gMG who are AChR-antibody positive and for whom the decision of treatment with efgartigimod alfa for gMG has been made independently of study participation as part of routine clinical care.\n\nThe total study duration will be up to 23 months",[84,30],"2026-05-12",{"date":125,"type":35},"2026-05-19",{"date":127,"type":35},"2026-02-25",{"date":129,"type":21},"2028-07",{"name":40,"class":41},30,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":144,"conditions":145,"keywords":146,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":161,"locationsCount":162},"100609996","phase-4-a-study-to-investigate-ocs-tapering-in-adult-participants-with-generalized-myasthenia-gravis-treated-with-ravulizumab-100609996","NCT07221838","A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab","OCTAGON: A Phase 4, Single Arm Study to Investigate Oral Corticosteroid Tapering in Adult Patients With Generalized Myasthenia Gravis Treated With Ravulizumab","OCTAGON","Inclusion Criteria:\n\n* Aged greater than 18 years and male or female\n* Clinical diagnosis of gMG\n* Receiving ravulizumab treatment prior to enrollment\n* Receipt of OCS therapy equivalent to a daily dose ≥ 7.5 mg of prednisone\u002Fprednisolone for ≥ 4 continuous weeks directly preceding enrollment\n* A participant of childbearing potential must have a negative highly sensitive pregnancy test (serum or urine, as required by local regulations) taken at Screening before OCS tapering begins.\n* Willing to sign informed consent\n\nExclusion Criteria:\n\n* Concurrent participation in an interventional clinical trial.\n* History of chronic hypoadrenalism (ie, Addison's disease).\n* Use of concomitant OCS for comorbid conditions other than gMG\n* Receipt of a biologic for gMG (e.g., efgartigimod, rozanolixizumab, inebilizumab, rituximab, intravenous immunoglobulin) within 5 half-lives of enrollment\n* Pregnant, breastfeeding, or intending to conceive during the course of the study",{"count":141,"type":21},75,[143],"PHASE4","This is a prospective, multicenter single arm study designed to evaluate the effectiveness and safety of a predefined oral corticosteroids (OCS) tapering schedule to reduce OCS use in adult participants with acetylcholine receptor positive (AChR+) generalized myasthenia gravis (gMG) being treated with intravenous ravulizumab.",[56,30],[147,30,148,149,150,151,59,152,153,154],"Generalized myasthenia gravis","Glucocorticoid toxicity","Complement C5 inhibitor","Prednisone reduction","Cortisol monitoring","corticosteroids","adrenal insufficiency","steroid sparing","2026-04-06",{"date":157,"type":35},"2026-04-09",{"date":159,"type":35},"2026-03-04",{"date":66,"type":21},{"name":68,"class":41},12,{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":17,"minAge":170,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":174,"conditions":175,"keywords":176,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},"100562781","phase-3-pk-pd-safety-and-efficacy-study-of-gefurulimab-in-pediatric-patients-with-achr-generalized-myasthenia-gravis-100562781","NCT06607627","PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis","An Open-Label, Single-arm Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), Safety, and Efficacy of Gefurulimab in Pediatric Patients (6 to \u003C 18 Years of Age) With Generalized Myasthenia Gravis (gMG) Who Express Acetylcholine Receptor Antibodies (AChR+)","Inclusion Criteria:\n\nUnited States of America (USA) specific inclusion criterion:\n\n* Participant must be 12 to \\\u003C 18 years of age at the time of signing the informed consent\u002Fassent.\n* All participants must be vaccinated against meningococcal infection from serogroups A, B, C, W, and Y within 3 years and at least 2 weeks prior to the first dose of study intervention administration.\n\nRest of World (ROW) specific inclusion criteria:\n\n* Participant must be 6 to \\\u003C 18 years of age at the time of signing the informed consent\u002Fassent.\n* All participants must be vaccinated against meningococcal infection from serogroups A, C, W, Y (and B where available) within 3 years prior to study intervention on Day 1. If vaccination occurs \\\u003C 2 weeks prior to Day 1, the participants will receive prophylactic antibiotics for at least 2 weeks after initial meningococcal vaccination for serogroups A,C,W,Y (and B, where available)\n\nGlobal inclusion criteria:\n\n* Diagnosis of MG with generalized muscle weakness meeting the clinical criteria defined by Myasthenia Gravis Foundation of America (MGFA) Class II, III or IV\n* Positive serological test for autoantibodies against AChR\n\nExclusion Criteria:\n\n* History of thymectomy, or any other thymic surgery within 12 months prior to Screening\n* Untreated thymic malignancy, carcinoma, or thymoma\n* History of Neisseria meningitidis infection\n* Pregnancy, breastfeeding, or intention to conceive during the course of the study","6 Years","17 Years",{"count":162,"type":21},[53],"The primary objective of this study is to assess the pharmacokinetics and pharmacodynamics of gefurulimab in pediatric participants with AChR+ gMG for the duration of the study.",[56,30],[177,178,56,30,179,180,181,182,183,83,184,185,186,187],"Acetylcholine Receptor antibodies","AChR+","ALXN1720","anti-acetylcholine receptor antibody-positive","acetylcholine receptor","AChR","myasthenia gravis","complement component 5","C5","VHH antibody","pediatric","2026-03-31",{"date":190,"type":35},"2026-04-01",{"date":192,"type":35},"2024-11-13",{"date":194,"type":21},"2029-01-23",{"name":68,"class":41},13]