[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"argenx\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":559},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,43,68,92,108,137,160,181,202,225,247,268,289,317,339,358,382,398,421,440,461,481,497,519,539],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":38,"leadSponsor":40,"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":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"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",[28,29,30,31],"AChR-Ab Seropositive Generalized Myasthenia Gravis","Myasthenia Gravis (MG)","MG - Myasthenia Gravis","gMG","NOT_YET_RECRUITING","2026-06-23",{"date":35,"type":36},"2026-06-29","ACTUAL",{"date":35,"type":22},{"date":39,"type":22},"2028-04",{"name":41,"class":42},"argenx","INDUSTRY",{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100644715","phase-1-a-study-to-assess-the-absolute-bioavailability-and-how-adimanebart-sc-moves-through-the-body-in-healthy-adult-participants-100644715","NCT07673601","A Study to Assess the Absolute Bioavailability and How Adimanebart SC Moves Through the Body in Healthy Adult Participants","A Phase 1, Open-Label, Randomized, Single Dose, Parallel-Group Study to Assess the Absolute Bioavailability and Evaluate the Effect of Body Weight on the Pharmacokinetics of Adimanebart SC in Healthy Adult Participants","Inclusion Criteria:\n\n* Is at least the local legal age of consent and aged 18 to 65 years, inclusive, when signing the ICF.\n* Has a body weight between 60 and 100 kg and a BMI between 18.5 and 30 kg\u002Fm2, inclusive, at screening and on day -1 for part 1 and part 3, or has a body weight \\\u003C60 kg or between 100 and 130 kg and a BMI between 18.5 and 38.0 kg\u002Fm2, inclusive, at screening and on day -1 for part 2.\n* Discontinues and refrains from using all medications, including nonprescription and prescription medications, for ≥2 weeks before IMP administration, except for hormonal contraceptives and hormone replacement therapy in female participants. The occasional use of acetaminophen or ibuprofen is allowed.\n\nExclusion Criteria:\n\n* Has any current or past clinically meaningful medical or psychiatric condition, including severe hypersensitivity reactions to drugs and\u002For food that, in the investigator's opinion, would confound the study results or put the participant at undue risk.\n* Previously participated in an adimanebart clinical study and received at least 1 dose of IMP.\n* Is currently participating in another interventional clinical study, or has received an IMP in another clinical study within 12 weeks or 5 half-lives (whichever is longer) before screening.",true,"65 Years",{"count":53,"type":22},52,[55],"PHASE1","This study aims to find out how much adimanebart gets into the blood circulation of healthy adults. Researchers will measure the amount of adimanebart in blood over time to learn how it moves through the body. The drug's safety will also be assessed.\n\nThe participants will be assigned to one of 3 parts of the study: part 1 investigates the absolute bioavailability; part 2 investigates the effect of different body weights on adimanebart in blood after subcutaneous (SC) dosing; part 3 investigates formulation adaptations.\n\nParticipants will be in the study for approximately up to 24 weeks.",[58,59],"Healthy Volunteers (HV)","Healthy Volunteer","RECRUITING",{"date":35,"type":36},{"date":63,"type":36},"2026-06-12",{"date":65,"type":22},"2026-12",{"name":41,"class":42},1,{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"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":76,"type":22},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.",[80,81,31,82,83,28],"Myasthenia Gravis","MG","Generalized Myasthenia Gravis","Generalized Myasthenia Gravis (gMG)","2026-06-11",{"date":63,"type":36},{"date":87,"type":36},"2025-12-19",{"date":89,"type":22},"2028-03-07",{"name":41,"class":42},18,{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":23,"phases":100,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":105,"leadSponsor":106,"locationsCount":107},"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":76,"type":22},[25],"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",[28,80,81,31,82,83],{"date":63,"type":36},{"date":87,"type":36},{"date":89,"type":22},{"name":41,"class":42},15,{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":18,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":130,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},"100607922","phase-2-a-study-of-efgartigimod-iv-in-participants-from-12-years-to-less-than-18-years-of-age-with-chronic-immune-thrombocytopenia-itp-100607922","NCT07194850","A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP)","A Multicenter, Randomized, Double-blinded, Parallel-Arm, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Study Followed by an Open-Label Arm to Evaluate Efgartigimod IV in Pediatric Participants From 12 Years to Less Than 18 Years of Age With Chronic ITP","Inclusion Criteria:\n\n* Is aged 12 to less than 18 years when completing the informed consent process\n* Has a documented duration of primary ITP of more than 12 months on the date the informed consent process is complete\n* Has documented prior ITP treatment with at least 1 of the following treatments: corticosteroids, IVIg, anti-D immunoglobulin, thrombopoietin receptor agonist (TPO-RAs), or rituximab.\n* Has documented prior response, defined as 1 platelet count of ≥50 × 10\\^9\u002FL to at least 1 of the following ITP treatments: prednisone, other or nonspecified corticosteroids, IVIg, or anti-D immunoglobulin\n* Has documented insufficient response to a prior ITP treatment with corticosteroids, IVIg, anti-D immunoglobulin, TPO-RAs, rituximab, or splenectomy\n* Has documented mean platelet count of less than 30 x10\\^9\u002FL\n\nExclusion Criteria:\n\n* Secondary ITP according to the following definition by the International Working Group (IWG): all forms of immune-mediated thrombocytopenia except primary ITP\n* Nonimmune thrombocytopenia\n* ITP-associated critical or severe bleeding\n* History of hereditary thrombocytopenia","12 Years","17 Years",{"count":118,"type":22},24,[25,120],"PHASE3","The main purpose of this study is to confirm the correct dose of efgartigimod IV for treating patients aged 12 to younger than 18 years with chronic immune thrombocytopenia (ITP).\n\nThe study consists of a double-blinded treatment period (DBTP) in which the participants will be randomized in a 2:1 ratio to receive either efgartigimod IV or placebo IV. At the end of the treatment period (up to 24 weeks), all participants will receive efgartigimod IV during the first year open-label treatment period (OLTP1). At the end of the first OLTP1, participants may begin a second year (OLTP2). After the OLTP2, the participants will enter a follow-up period (approximately 8 weeks) while off study drug. The participants will be in the study for up to 138 weeks.\n\nMore information can be found here: https:\u002F\u002Fclinicaltrials.argenx.com\u002Fadvancejunior",[123,124,125,126,127,128,129],"Immune Thrombocytopenia (ITP)","ITP - Immune Thrombocytopenia","ITP","Immune Thrombocytopenic Purpura","Immune Thrombocytopenic Purpura ( ITP )","Idiopathic Thrombocytopenic Purpura","Idiopathic Thrombocytopenic Purpura (ITP)",{"date":63,"type":36},{"date":132,"type":36},"2025-10-20",{"date":134,"type":22},"2030-10",{"name":41,"class":42},10,{"id":138,"slug":139,"hasResults":12,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":23,"phases":147,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},"100599987","phase-3-a-study-to-assess-the-efficacy-and-safety-of-empasiprubart-in-adults-with-cidp-100599987","NCT07091630","A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP","A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy","emnergize","Inclusion Criteria:\n\n* Meets criteria for CIDP based on EAN\u002FPNS Task Force CIDP guidelines, second revision (2021)\n* Has either typical CIDP or 1 of the following CIDP variants: motor CIDP (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP\n* Has residual disability and active disease\n* Has not received previous treatment for CIDP; or has stopped receiving CIDP treatment; or is receiving CIDP treatment (pulsed or oral corticosteroids, immunoglobulins, PLEX, or FcRn inhibitors)\n* Participants already receiving CIDP treatment will have to discontinue their CIDP treatment before first IMP administration and must be willing to switch to the study IMP\n\nExclusion Criteria:\n\n* Meets the criteria for possible CIDP based on EAN\u002FPNS Task Force CIDP guidelines, second revision (2021)\n* Sensory CIDP (including sensory-predominant CIDP)\n* Polyneuropathy of other causes\n* Clinical diagnosis of systemic lupus erythematosus (SLE)\n* Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation",{"count":146,"type":22},160,[120],"The main purpose of this study is to demonstrate the efficacy and safety of empasiprubart in adults with CIDP. The study consists of a part A where participants will either receive empasiprubart or placebo for 24 weeks (6 months). Following part A, participants will enter part B in which all participants will receive empasiprubart for 96 weeks (24 months).\n\nMore information can be found here: https:\u002F\u002Fclinicaltrials.argenx.com\u002Femnergize",[150,151,152],"Chronic Inflammatory Demyelinating Polyneuropathy","CIDP","Chronic Inflammatory Demyelinating Polyradiculoneuropathy",{"date":63,"type":36},{"date":155,"type":36},"2025-09-16",{"date":157,"type":22},"2031-01-23",{"name":41,"class":42},61,{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":23,"phases":170,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},"100586793","phase-3-a-study-to-assess-efficacy-and-safety-of-empasiprubart-versus-ivig-in-adults-with-cidp-100586793","NCT06920004","A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP","A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Intravenous Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy","emvigorate","Inclusion Criteria:\n\n* Meets criteria for CIDP based on EAN\u002FPNS Task Force CIDP guidelines, second revision (2021)\n* Has either typical CIDP or 1 of the following CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP\n* Has responded to IVIg in the past 5 years\n* Receiving treatment with IVIg within a standard optimal maintenance dosing regimen, with a minimum weekly IVIg dose of at least 0.125 g\u002Fkg\n* Has residual disability and active disease\n\nExclusion Criteria:\n\n* Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP or puts the participant at undue risk, including polyneuropathy of other causes\n* Meets the criteria for possible or sensory CIDP based on EAN\u002FPNS Task Force CIDP guidelines, second revision (2021)\n* Use of other long-acting immunomodulatory treatment",{"count":169,"type":22},218,[120],"The main purpose of this study is to compare empasiprubart and IVIg for treating people with CIDP. This study consists of a Part A where participants will either receive empasiprubart and a placebo resembling IVIg, or IVIg and a placebo resembling empasiprubart for 24 weeks (6 months). Following Part A, participants will enter Part B in which all participants will receive empasiprubart for 96 weeks (24 months).\n\nMore information can be found here: https:\u002F\u002Fclinicaltrials.argenx.com\u002Femvigorate",[150,151,173],"CIDP - Chronic Inflammatory Demyelinating Polyneuropathy",{"date":63,"type":36},{"date":176,"type":36},"2025-08-22",{"date":178,"type":22},"2030-09",{"name":41,"class":42},75,{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":18,"minAge":188,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},"100522125","a-natural-history-study-in-participants-with-congenital-myasthenic-syndromes-cms-due-to-mutations-in-dok7-musk-agrn-or-lrp4-100522125","NCT06078553","A Natural History Study in Participants With Congenital Myasthenic Syndromes (CMS) Due to Mutations in DOK7, MUSK, AGRN, or LRP4","Multicenter, Multinational, Natural History Study in Participants With Congenital Myasthenic Syndromes Due to Mutations in DOK7, MUSK, AGRN, or LRP4","Inclusion Criteria:\n\n* Can understand the requirements of the study and can provide written informed consent\u002Fassent, and willingness and ability to comply with the study protocol procedures\n* Is male or female and aged ≥2 years at the time of providing informed consent\u002Fassent\n* Has a diagnosis of CMS due to biallelic pathogenic mutations in DOK7 or any pathogenic mutations in MUSK, AGRN, or LRP4\n* Has a total Quantitative Myasthenia Gravis (QMG) score of ≥3 (applies only to participants aged ≥6 years)\n* For participants taking oral beta agonists (eg, albuterol, salbutamol, ephedrine), participant must have been receiving the medication for ≥3 months before screening\u002Fbaseline\n\nExclusion Criteria:\n\n* Known medical condition that would interfere with an accurate assessment of CMS, in the investigator's opinion\n* Is currently participating in any interventional clinical study with a study drug at the time of providing informed consent\u002Fassent\n* Diagnosis of CMS due to mutation of any gene other than DOK7, MUSK, AGRN, or LRP4","2 Years",{"count":190,"type":22},100,"Participants will attend up to 4 study visits to collect clinical assessments. The assessments will evaluate participants' symptoms and quality of life to understand disease activity in patients with CMS due to mutations in DOK7, MUSK, AGRN, or LRP4.\n\nMore information can be found here: https:\u002F\u002Fclinicaltrials.argenx.com\u002Fcms",[193],"Congenital Myasthenic Syndrome",{"date":195,"type":36},"2026-06-15",{"date":197,"type":36},"2024-02-13",{"date":199,"type":22},"2027-06",{"name":41,"class":42},31,{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":12,"sex":18,"minAge":115,"maxAge":116,"enrollmentInfo":210,"targetDuration":4,"studyType":23,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":4},"100643609","phase-2-a-study-to-assess-the-correct-dose-safety-and-efficacy-of-empasiprubart-in-adolescent-participants-aged-12-to-less-than-18-years-with-chronic-inflammatory-demyelinating-polyradiculoneuropathy-100643609","NCT07638566","A Study to Assess the Correct Dose, Safety and Efficacy of Empasiprubart in Adolescent Participants Aged 12 to Less Than 18 Years With Chronic Inflammatory Demyelinating Polyradiculoneuropathy","An Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Empasiprubart in Adolescent Participants Aged 12 to Less Than 18 Years With Chronic Inflammatory Demyelinating Polyradiculoneuropathy","emlight","Inclusion Criteria:\n\n* Is aged 12 to \\\u003C18 years.\n* Meets criteria for CIDP based on EAN\u002FPNS Task Force CIDP guidelines, second revision (2021).\n* Has a diagnosis of either typical CIDP or 1 of the following CIDP variants: motor CIDP (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP.\n\nExclusion Criteria:\n\n* Possible CIDP based on EAN\u002FPNS Task Force CIDP guidelines, second revision (2021).\n* Sensory CIDP (including sensory-predominant CIDP).\n* Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP, or that puts the participant at undue risk.\n* Prior use of other long-acting immunomodulatory treatment.",{"count":211,"type":22},6,[25,120],"The main purpose of the study is to determine the correct dose of empasiprubart in adolescent participants. It also aims to evaluate if empasiprubart may work and how safe it is for the use in children living with CIDP.\n\nThe study consists of an open label treatment phase where participants will receive empasiprubart for up to 27 months approximately. After the final dose of empasiprubart, participants will enter a safety follow-up period for up to 14 months approximately.\n\nThe overall study duration for each participant is up to 43 months.\n\nMore information can be found here: clinicaltrials.argenx.com\u002Femlight",[152,215,151,216],"CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)","Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)","2026-06-05",{"date":219,"type":36},"2026-06-10",{"date":221,"type":22},"2026-09",{"date":223,"type":22},"2031-08",{"name":41,"class":42},{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":18,"minAge":188,"maxAge":116,"enrollmentInfo":233,"targetDuration":4,"studyType":23,"phases":235,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":246},"100546242","phase-2-a-study-of-efgartigimod-ph20-sc-in-children-between-2-and-less-than-18-years-of-age-with-generalized-myasthenia-gravis-100546242","NCT06392386","A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis","An Open-label, Uncontrolled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod PH20 SC in Participants From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis","ADAPT Jr SC","Inclusion Criteria:\n\n* The participant (and\u002For their legally authorized representative) understands the requirements of the study and is capable of providing written informed consent\u002Fassent and complying with protocol requirements\n* The participant is aged 2 to \\\u003C18 years at the time of informed consent\u002Fassent\n* The participant has been diagnosed with generalised Myasthenia Gravis that is supported by a physical examination and confirmed seropositivity for anti-acetylcholine receptor antibodies\n* The participant has had an unsatisfactory response to immunosuppressants, corticosteroids, or acetylcholinesterase inhibitors but is on stable concomitant MG therapy. If receiving corticosteroids and\u002For immunosuppressants, must be on a stable dose for ≥1 month before screening\n* The participant agrees to use birth control consistent with local regulations and people of child-bearing potential must have a negative blood pregnancy test at screening and a negative urine pregnancy test before receiving the study drug\n\nExclusion Criteria:\n\n* Is a female adolescent of child-bearing potential who is pregnant and\u002For lactating or intends to become pregnant during their participation in the study\n* Has worsening muscle weakness secondary to a concurrent infection or as a result of a medication\n* Has a documented lack of clinical response to plasma exchange (PLEX)\n* Received a live or live-attenuated vaccine within \\\u003C4 weeks before screening\n* Received a thymectomy within 3 months before screening or is planning to get a thymectomy during their participation in the study\n* Has a known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of generalised Myasthenia Gravis or puts the participant at undue risk\n* History of malignancy, cancer, unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histological findings of prostate cancer\n* Clinically significant active infection that is not sufficiently resolved in the investigator's opinion or positive serum test at screening for active infection with any of the following: Hepatitis B virus (HBV), Hepatitis C virus (HCV), HIV\n* Has a positive PCR test for SARS-CoV-2 at screening\n* Has\u002Fhad a clinically significant disease, had recent major surgery (within 3 months of screening) or intends to have major surgery during the study, or has\u002Fhad any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk\n* Has received a different study drug in another clinical study within \\\u003C12 before screening\n* Is currently participating in another interventional clinical study\n* Has previously participated in an efgartigimod clinical study and received at least one dose of study drug\n* Has a known hypersensitivity to study drug or any of its excipients\n* Has a history of or current episode of alcohol, drug, or medication abuse as assessed by the investigator\n* Use of some medications before screening (more information is found in the protocol)\n\nThe complete list of exclusion criteria can be found in the protocol.",{"count":234,"type":22},12,[25,120],"The purpose of this study is to measure the pharmacokinetics (PK), pharmacodynamics (PD), safety, tolerability, and immunogenicity of efgartigimod PH20 SC in pediatric participants with gMG aged 2 to \\\u003C18 years. The primary goal is to confirm an appropriate dose of efgartigimod PH20 SC for pediatric patients using PK and PD results from this study. Participants will receive injections of efgartigimod PH20 SC and will be monitored for safety until the end of the study. At the end of the follow-up period, eligible participants may roll over to an open-label extension (OLE) study.\n\nThe participants will be in the study for up to 14 weeks.",[82],"2026-06-02",{"date":240,"type":36},"2026-06-04",{"date":242,"type":36},"2024-06-28",{"date":244,"type":22},"2026-09-30",{"name":41,"class":42},20,{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":50,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":254,"targetDuration":4,"studyType":23,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":67},"100637796","phase-1-a-study-to-assess-the-absolute-bioavailability-of-empasiprubart-sc-administered-with-an-autoinjector-and-the-pharmacokinetic-noninferiority-of-empasiprubart-sc-versus-intravenous-iv-in-healthy-adult-participants-100637796","NCT07612020","A Study to Assess the Absolute Bioavailability of Empasiprubart SC Administered With an Autoinjector and the Pharmacokinetic Noninferiority of Empasiprubart SC Versus Intravenous (IV) in Healthy Adult Participants","A Phase 1, Randomized, Open-Label Study to Assess the Absolute Bioavailability of Empasiprubart SC Administered With an Autoinjector (Part A) and the Pharmacokinetic Noninferiority of Empasiprubart SC Versus IV (Part B) in Healthy Adult Participants","Inclusion Criteria:\n\n* Is at least the local legal age of consent and aged 18 to 65 years, inclusive, when signing the ICF.\n* Has a body weight between 50 and 120 kg and a BMI between 18 and 35 kg\u002Fm2, inclusive.\n\nExclusion Criteria:\n\n* Has any current or past clinically meaningful medical or psychiatric condition that, in the investigator's opinion, would confound the study results or put the participant at undue risk.\n* Clinical diagnosis of SLE. For participants with an antinuclear antibody titer of ≥1:80 and a positive anti-double-stranded DNA and\u002For positive anti-Smith result at screening, an SLE diagnosis must be ruled out before the first IMP administration.\n* Previously participated in an empasiprubart clinical study and received at least 1 dose of IMP.",{"count":255,"type":22},130,[55],"This study aims to see how the body reacts to empasiprubart, administered using an autoinjector (AI). The study will also look at other effects of empasiprubart, how it works in the body, and if it is safe.\n\nThe study consists of 2 parts: parts A and B. In part A, eligible participants will be randomized to receive empasiprubart SC AI via abdomen, empasiprubart SC AI via thigh, or empasiprubart IV (intravenously). In part B, eligible participants will be randomized to receive empasiprubart SC AI via abdomen or empasiprubart IV.\n\nParticipants from part A will be in the study for approximately up to 37 weeks . Participants from part B will be in the study for up to approximately 43 weeks.",[259],"Healthy Volunteers","2026-05-21",{"date":262,"type":36},"2026-05-28",{"date":264,"type":36},"2026-03-16",{"date":266,"type":22},"2027-10",{"name":41,"class":42},{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":23,"phases":278,"briefSummary":279,"conditions":280,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":4},"100639608","phase-1-a-study-to-assess-the-effect-of-empasiprubart-on-nerve-morphology-by-ultrasound-in-adults-with-multifocal-motor-neuropathy-100639608","NCT07610564","A Study to Assess the Effect of Empasiprubart on Nerve Morphology by Ultrasound in Adults With Multifocal Motor Neuropathy","An Open-Label, Single-Arm, Phase 1b Study to Evaluate the Effect of Empasiprubart on Nerve Morphology by Ultrasound in Adults With Multifocal Motor Neuropathy","EmpaSound","Inclusion Criteria:\n\n* Is at least 18 years old\n* Diagnosed with MMN\n* Has an MMN-RODS centile score of ≤90\n* Has confirmed nerve thickening in at least 1 nerve per ultrasound measurement\n\nExclusion Criteria:\n\n* Besides the indication under study, known autoimmune disease or any medical condition that, in the investigator's opinion, would interfere with an accurate assessment of clinical symptoms of MMN or puts the participant at undue risk.",{"count":277,"type":22},60,[55],"The main purpose of the study is to evaluate empasiprubart use in adults living with Multifocal Motor Neuropathy (MMN). The researchers will evaluate the effect of empasiprubart on the thickness of the nerves, muscle strength, movement, and on the potential improvement of grip strength of the participants in handling objects.\n\nThe study consists of an open-label treatment period where all participants will receive empasiprubart intravenously (IV). After the last dose of empasiprubart participants will enter a safety follow-up period for up to 15 months.\n\nThe total study duration for each participant will be approximately 29 months.\n\nMore information can be found here: clinicaltrials.argenx.com\u002Fempasound",[281],"Multifocal Motor Neuropathy (MMN)","2026-05-20",{"date":262,"type":36},{"date":285,"type":22},"2026-06-30",{"date":287,"type":22},"2030-04-01",{"name":41,"class":42},{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":18,"minAge":297,"maxAge":116,"enrollmentInfo":298,"targetDuration":4,"studyType":23,"phases":299,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":313,"leadSponsor":315,"locationsCount":316},"100615082","phase-2-a-study-to-assess-the-safety-tolerability-efficacy-pharmacokinetics-and-immunogenicity-of-intravenous-administration-of-argx-119-in-pediatric-participants-aged-5-to-less-than-18-years-with-spinal-muscular-atrophy-100615082","NCT07287982","A Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Intravenous Administration of ARGX-119 in Pediatric Participants Aged 5 to Less Than 18 Years With Spinal Muscular Atrophy","A Phase 2 Double-Blinded, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Intravenous Administration of ARGX-119 in Pediatric Participants Aged 5 to Less Than 18 Years With Spinal Muscular Atrophy","Sparkle","Inclusion Criteria:\n\n* Is aged ≥5 to \\\u003C18 years when completing the informed consent process, defined as providing informed assent according to local regulations and having a parent or guardian sign the ICF, and can comply with protocol\n* requirements.\n* Has documented historical genetic diagnosis of 5q-SMA.\n* Currently receiving a stable SMA treatment regimen (nusinersen or risdiplam) and\u002For have a history of onasemnogene abeparvovec treatment\n* Must be able to walk at least 50 meters without walking aids in the 6MWT at screening\n\nExclusion Criteria:\n\n* Known medical condition that would interfere with an accurate assessment of SMA, confound the results of the study, or put the participant at undue risk, as assessed by the investigator\n* Recent major surgery, except spinal fusion, within 3 months of screening or intends to have major surgery during the study\n* Current or previous administration of antimyostatin therapies in the past 6 months\n* Severe scoliosis (defined as curvature \\>40°) and\u002For contractures at screening. o History of spinal fusion within 6 months before screening or planned during the study\n* Respiratory insufficiency, defined by the medical necessity for invasive or noninvasive ventilation for daytime treatment while awake. Ventilation used overnight or during daytime naps is acceptable.","5 Years",{"count":277,"type":22},[25],"This study aims to find the correct dose of ARGX-119 for children with SMA. The study will also look at how safe the study drug is, how well it works, how it moves through the body, and how the immune system responds to it. The study consists of a double-blinded treatment period (DBTP) where participants will either receive ARGX-119 IV or placebo IV, in addition to disease-modifying therapy (DMT) for 24 weeks. Participants who complete the DBTP will enter the open-label active-treatment extension period (ATEP) during which all participants will receive ARGX-119 IV up to 100 weeks (approximately 2 years).",[302],"Spinal Muscular Atrophy (SMA)",[304,305,306,307,308,309],"Spinal Muscular Atrophy","Pediatric","Muscle Function","Fatigability","SMA","ambulant",{"date":311,"type":36},"2026-05-22",{"date":87,"type":36},{"date":314,"type":22},"2029-05-28",{"name":41,"class":42},17,{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":323,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":23,"phases":327,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":4},"100640696","phase-3-a-study-to-assess-efficacy-and-safety-of-efgartigimod-ph20-sc-pfs-in-adult-participants-with-graves-disease-100640696","NCT07596849","A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.","A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease Inadequately Controlled With Antithyroid Drugs","VitaliThy","Inclusion Criteria:\n\n* Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF.\n* Has a documented diagnosis of GD with TRAb (anti-thyrotropin receptor antibody) levels \\>=ULN (upper limit of normal) at screening\n* Has active hyperthyroidism due to GD with TSH (thyroid-stimulating hormone) \\\u003C0.1 mIU\u002FL at screening\n* Has been treated with MMI (methimazole) or CBZ (carbimazole) for at least 3 months before screening\n\nExclusion Criteria:\n\n* History of hyperthyroidism not caused by GD (eg, toxic adenoma or toxic multinodular goiter)\n* History of RAI (radioactive iodine) therapy or received a total thyroidectomy\n* T3- or T4-containing medication or supplement (eg, levothyroxine, liothyronine, desiccated thyroid preparations, or thyroid-support supplements) received \\\u003C6 weeks before screening\n* Any complication of hyperthyroidism or underlying medical condition that would put the participant at undue risk. This includes arrhythmia or tachyarrhythmia related to GD, such as atrial fibrillation or atrial flutter not sufficiently controlled with medications.\n* Graves' orbitopathy\u002FThyroid Eye Disease (GO\u002FTED) requiring systemic therapy (eg, corticosteroids), orbital injections, orbital surgery, or orbital radiation, or expected immediate surgical intervention and\u002For planned corrective surgery\u002Firradiation or medical therapy during the study",{"count":326,"type":22},230,[120],"The main purpose of this study is to look at how efgartigimod affects thyroid function in adults with Graves' Disease (GD). The study will also check whether efgartigimod is safe and well tolerated. It will look at how efgartigimod is distributed and eliminated in the body, how it changes antibody levels, and how the immune system responds to it.\n\nThe study consists of a part A double-blinded treatment period, a part B treatment\u002Fobservation period and a part C open-label treatment\u002Fobservation period. During the part A and part B treatment periods, participants will receive efgartigimod PH20 SC via Prefilled Syringe (PFS) or placebo. During the part C open-label treatment period, participants will receive efgartigimod PH20 SC PFS. Participation in the different parts of the study will depend on the participant's response to treatment.\n\nThe total study duration for participants ranges from 63 to 135 weeks, depending on the response to treatment.",[330],"Graves Disease","2026-05-13",{"date":333,"type":36},"2026-05-19",{"date":335,"type":22},"2026-06",{"date":337,"type":22},"2030-05",{"name":41,"class":42},{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":348,"conditions":349,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":357},"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":190,"type":22},"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",[83,31],"2026-05-12",{"date":333,"type":36},{"date":353,"type":36},"2026-02-25",{"date":355,"type":22},"2028-07",{"name":41,"class":42},30,{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":18,"minAge":115,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":23,"phases":368,"briefSummary":369,"conditions":370,"keywords":372,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":4},"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","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.",{"count":367,"type":22},170,[25],"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",[371],"Autoimmune Encephalitis (AE)",[373,374],"Autoimmune Encephalitis (AIE)","Adolescents","2026-05-07",{"date":331,"type":36},{"date":378,"type":22},"2026-07-13",{"date":380,"type":22},"2031-07-26",{"name":41,"class":42},{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":322,"acronym":323,"eligibilityCriteria":387,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":388,"targetDuration":4,"studyType":23,"phases":389,"briefSummary":328,"conditions":390,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":396,"leadSponsor":397,"locationsCount":4},"100636794","phase-3-a-study-to-assess-efficacy-and-safety-of-efgartigimod-ph20-sc-pfs-in-adult-participants-with-graves-disease-100636794","NCT07570316","A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease","Inclusion Criteria:\n\n* Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF.\n* Has a documented diagnosis of GD with TRAb (anti-thyrotropin receptor antibody) levels \\>=ULN (upper limit of normal) at screening.\n* Has active hyperthyroidism due to GD with TSH (thyroid-stimulating hormone) \\\u003C0.1 mIU\u002FL at screening.\n* Has been treated with MMI (methimazole) or CBZ (carbimazole) for at least 3 months before screening.\n\nExclusion Criteria:\n\n* History of hyperthyroidism not caused by GD (eg, toxic adenoma or toxic multinodular goiter).\n* History of RAI (radioactive iodine) therapy or received a total thyroidectomy.\n* T3- or T4-containing medication or supplement (eg, levothyroxine, liothyronine, desiccated thyroid preparations, or thyroid-support supplements) received \\\u003C6 weeks before screening.\n* Any complication of hyperthyroidism or underlying medical condition that would put the participant at undue risk. This includes arrhythmia or tachyarrhythmia related to GD, such as atrial fibrillation or atrial flutter not sufficiently controlled with medications.\n* Graves' orbitopathy\u002FThyroid Eye Disease (GO\u002FTED) requiring systemic therapy (eg, corticosteroids), orbital injections, orbital surgery, or orbital radiation, or expected immediate surgical intervention and\u002For planned corrective surgery\u002Firradiation or medical therapy during the study.",{"count":326,"type":22},[120],[391,330],"Graves' Disease","2026-04-30",{"date":394,"type":36},"2026-05-06",{"date":335,"type":22},{"date":337,"type":22},{"name":41,"class":42},{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":406,"targetDuration":4,"studyType":23,"phases":408,"briefSummary":409,"conditions":410,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":420},"100557929","phase-3-a-study-to-assess-the-efficacy-and-safety-of-efgartigimod-iv-in-adult-participants-with-primary-immune-thrombocytopenia-100557929","NCT06544499","A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia","A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Arm Study Followed by an Open-Label Arm to Evaluate the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia","advance NEXT","Inclusion Criteria:\n\n* Is at least 18 years of age and the local legal age of consent for clinical studies when signing the informed consent form (ICF).\n* Has documented baseline mean platelet count of \\\u003C30 x 10\\^9\u002FL before randomization\n* Has a documented duration of primary immune thrombocytopenia (ITP) of more than 12 months on the date of informed consent form (ICF) signature.\n* Has documented prior ITP treatment with at least 1 of the following treatments: corticosteroids, intravenous immunoglobulin (IVIg), anti-D immunoglobulin, thrombopoietin receptor agonist (TPO-RAs), or rituximab.\n* Has documented insufficient response to a prior ITP treatment (the specific criteria can be found in the protocol).\n* Has documented prior response defined as 1 platelet count of ≥50 × 109\u002FL to at least 1 of the following ITP treatments in the 3 years before the date of ICF signature: prednisone, dexamethasone, other or nonspecified corticosteroids, IVIg, or anti-D immunoglobulin\n\nExclusion Criteria:\n\n* Other than the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of ITP, confound the results of the study or put the participant at undue risk.\n* Secondary ITP\n* Nonimmune thrombocytopenia\n* Autoimmune hemolytic anemia\n* ITP-associated critical or severe bleeding The complete list of criteria can be found in the protocol.",{"count":407,"type":22},69,[120],"The main purpose of this study is to look at the effect (efficacy) and safety of efgartigimod IV in participants with primary immune thrombocytopenia (ITP). After an up to 2 weeks screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod IV or placebo IV, respectively during the double-blinded treatment period (DBTP). At the end of the treatment period (up to 24 weeks), all participants will receive efgartigimod IV during the first 52-week open-label treatment period (OLTP1). At the end of the first OLTP1, participants may begin a second 52-week OLTP2. After the OLTP2, the participants will enter a follow-up period (approximately 8 weeks) while off study drug. The participants will be in the study for up to 138 weeks.\n\nMore information can be found here: https:\u002F\u002Fclinicaltrials.argenx.com\u002Fadvancenext",[411],"Primary Immune Thrombocytopenia (ITP)","2026-04-29",{"date":414,"type":36},"2026-05-01",{"date":416,"type":36},"2024-10-18",{"date":418,"type":22},"2028-06",{"name":41,"class":42},94,{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":427,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":429,"conditions":430,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":439},"100613272","real-world-efgartigimod-effectiveness-in-cidp-a-prospective-study-100613272","NCT07264426","Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study","Inclusion Criteria:\n\n* Aged ≥18 years at time of providing informed consent\n* Diagnosed with CIDP\n* Planned to be receiving efgartigimod treatment within the CIDP treatment label of efgartigimod in the participant's respective country\n* Efgartigimod treatment-naïve at time of screening\n\nExclusion Criteria:\n\n* Polyradiculoneuropathy due to any other cause(s)\n* Current participation in any interventional clinical study at time of screening, or planned participation before initiation of efgartigimod",{"count":428,"type":22},200,"The aims of this study are to assess the real-world effectiveness of efgartigimod in treating chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), describe the \"treatment journey\" of participants with CIDP, and assess the utilization of health care services among adult participants with CIDP who initiate treatment with efgartigimod.\n\nAs this is a noninterventional study, treatment choices and decisions will be left to the discretion of participants and their physicians, according to the standard of care.\n\nEach participant will be prospectively followed for up to 2 years from the date of initial administration of efgartigimod.",[152,151,215],"2026-04-22",{"date":433,"type":36},"2026-04-23",{"date":435,"type":36},"2025-08-11",{"date":437,"type":22},"2029-10",{"name":41,"class":42},23,{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":446,"eligibilityCriteria":447,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":23,"phases":450,"briefSummary":451,"conditions":452,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":454,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":460},"100566436","phase-2-a-study-to-assess-the-efficacy-and-safety-of-efgartigimod-ph20-sc-in-adults-with-systemic-sclerosis-100566436","NCT06655155","A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis","A Randomized, Double-Blinded, Placebo-Controlled, Phase 2, Parallel-Group Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Adult Participants With Systemic Sclerosis","eSScape","Inclusion Criteria:\n\n* Is aged ≥18 years and the local legal age of consent for clinical studies\n* Has diffuse or limited SSc diagnosis and fulfills the 2013 ACR\u002FEULAR classification criteria\n* Has a positive antinuclear antibodies (ANA) test result at the central laboratory with titer of at least 1:160\n* Has a Health Assessment Questionnaire-Disability Index (HAQ-DI) score of at least 0.5 OR a Patient Global Assessment (PGA) score of at least 3\n* Has a modified Rodnan Skin Score (mRSS) score between 15 and 35\n* The participant is anti-RNA polymerase III autoantibody negative at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 5 years before screening or the participant is anti-RNA polymerase III autoantibody positive at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 2 years before screening\n* Has uninvolved or mildly thickened skin area in at least 1 injection site\n\nExclusion Criteria:\n\n* Isolated anticentromere antibodies (ACA) seropositivity at the central laboratory\n* Significant Pulmonary Arterial Hypertension\n* Severe digital vasculopathy within the past 3 months\n* Skin thickening due to scleroderma mimics or localized scleroderma\n* Scleroderma renal crisis within the past 6 months of participating to the study\n* Another rheumatic autoimmune disease, except for secondary Sjögren's syndrome or fibromyalgia",{"count":449,"type":22},81,[25],"The main purpose of this study is to evaluate the effect and safety of efgartigimod PH20 SC compared to placebo in adults with systemic sclerosis. The study consists of a screening period, a treatment period of up to 48 weeks and a safety follow-up period. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod PH20 SC or placebo. The total study duration can be up to approximately 15 months.\n\nMore information can be found on: https:\u002F\u002Fclinicaltrials.argenx.com\u002Fesscape",[453],"Systemic Sclerosis (SSc)",{"date":433,"type":36},{"date":456,"type":36},"2024-11-11",{"date":458,"type":22},"2027-09",{"name":41,"class":42},74,{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":23,"phases":470,"briefSummary":471,"conditions":472,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":474,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":480},"100549646","phase-1-a-phase-1b-study-to-investigate-safety-and-tolerability-of-argx-119-in-adult-participants-with-dok7-congenital-myasthenic-syndromes-cms-100549646","NCT06436742","A Phase 1b Study to Investigate Safety and Tolerability of ARGX-119 in Adult Participants With DOK7-Congenital Myasthenic Syndromes (CMS)","A Phase 1b, Double-Blinded, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Efficacy of ARGX-119 in Adult Participants With DOK7-Congenital Myasthenic Syndromes","Inclusion Criteria:\n\n* At least 18 years of age.\n* Has genetically confirmed congenital myasthenic syndromes due to mutation of downstream of kinase 7 (DOK7-CMS).\n* Participants taking oral beta agonists (eg, albuterol, salbutamol, ephedrine) must have been receiving the medication for more than 3 months and agree to remain on a same stable dosing regimen of the same medication until the end of the study.\n\nExclusion Criteria:\n\n* Diagnosis of CMS due to mutation of any gene other than DOK7.\n* Known medical condition that would interfere with an accurate assessment of CMS, confound the results of the study, or put the patient at undue risk, as assessed by the investigator.\n* History of malignancy, cancer, unless considered cured by adequate treatment with no evidence of recurrence for more than 5 years. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histological findings of prostate cancer.\n* Pregnant or lactating state or intention to become pregnant during the study.",{"count":469,"type":22},16,[55],"The purpose of this study is to assess the safety and tolerability of ARGX-119 in adult participants with DOK7- Congenital Myasthenic Syndromes. The study will also assess how ARGX-119 is processed by the body (pharmacokinetics), how the immune system reacts to it (immunogenicity), and how it may improve the way patients feel and function.\n\nAfter the screening period, eligible participants will be randomized in a 4:1 ratio to receive intravenous infusions of ARGX-119 or placebo during the double-blinded treatment period. Participants will then enter the follow-up period. After the follow-up period, participants may enrol in the active-treatment period, where they will receive open-label ARGX-119.\n\nThe full duration of the study is approximately 38 months.",[193,473],"CMS",{"date":433,"type":36},{"date":476,"type":36},"2024-09-24",{"date":478,"type":22},"2028-01-24",{"name":41,"class":42},9,{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":488,"phases":4,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":492,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":496,"locationsCount":4},"100422200","pre-approval-access-for-efgartigimod-ph20-sc-in-adults-with-chronic-inflammatory-demyelinating-polyneuropathy-cidp-100422200","NCT04777734","Pre-Approval Access for Efgartigimod PH20 SC in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","Pre-Approval Access for Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","Inclusion Criteria:\n\n* Cannot be included in an ongoing clinical study and cannot be satisfactorily treated with a product that has regulatory approval\n* Is ≥18 years of age at the time of signing the informed consent form\n* Patient has a diagnosis of CIDP according to the 2021 EAN\u002FPNS CIDP guidelines\n* Patient has progressive or relapsing active disease after prior treatment with corticosteroids or immunoglobulins\n\nExclusion Criteria:\n\n* Known autoimmune disease or any medical condition that, in the opinion of the treating physician, would interfere with an accurate assessment of clinical symptoms of CIDP or that puts the patient at undue risk\n* Is currently being treated or plans to start treatment with monoclonal antibodies or treatments that contain the human Fc domain of the IgG subclass\n* Pregnant or lactating state or intention to become pregnant during the program","EXPANDED_ACCESS","The aim of the Pre-Approval Access program is to provide efgartigimod PH20 SC treatment to patients with CIDP who are ineligible to participate in a clinical study and have unmet medical need despite available treatment options. The program will continue until the patient discontinues treatment or until the reimbursement process for CIDP concludes, whichever comes first.",[491,151],"Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","AVAILABLE","2026-03-20",{"date":495,"type":36},"2026-03-24",{"name":41,"class":42},{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":503,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":505,"targetDuration":4,"studyType":23,"phases":506,"briefSummary":508,"conditions":509,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":91},"100585964","phase-4-a-study-to-evaluate-the-clinical-outcomes-of-efgartigimod-ph20-sc-in-adults-with-new-onset-generalized-myasthenia-gravis-gmg-100585964","NCT06909214","A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)","A Phase 4, Open-Label, Prospective, Single-Group, Multicenter Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adult Participants With New-Onset Generalized Myasthenia Gravis","ADAPT-EARLY","Inclusion Criteria:\n\n* Is at least 18 years when signing the ICF\n* Has been diagnosed with gMG of MGFA class II, III, or IV\n* Is seropositive for AChR-Ab\n* Is treatment-naive for gMG or has been administered AChEI for the treatment of gMG\n* Had onset of generalized MG signs and\u002For symptoms within 12 months before screening; candidates who also had onset of ocular MG signs and\u002For symptoms within 24 months before screening may be enrolled in the study\n* Has an MG-ADL score ≥5\n\nExclusion Criteria:\n\n* gMG diagnosis of MGFA class I or V\n* Underwent a thymectomy prior to screening, except thymectomy for treatment of nonmalignant thymoma prior to the gMG diagnosis\n* Prior or current use of any of any systemic corticosteroid therapy or nonsteroidal immunosuppressive therapy for the treatment of gMG",{"count":357,"type":22},[507],"PHASE4","The main purpose of this study is to measure how well adults with new-onset gMG (which means they've had generalized disease signs and\u002For symptoms for less than 1 year) respond to treatment with efgartigimod PH20 SC. The study consists of a treatment period of 51 weeks. The study duration for each participant will be approximately 58 weeks.",[510],"New Onset Generalized Myasthenia Gravis (gMG)","2026-03-09",{"date":513,"type":36},"2026-03-10",{"date":515,"type":36},"2025-04-17",{"date":517,"type":22},"2027-05",{"name":41,"class":42},{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":50,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":526,"targetDuration":4,"studyType":23,"phases":528,"briefSummary":529,"conditions":530,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":67},"100621959","phase-1-a-study-to-assess-the-safety-of-argx-124-in-healthy-volunteers-100621959","NCT07377396","A Study to Assess the Safety of ARGX-124 in Healthy Volunteers","A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-124 in Healthy Adult Participants","Inclusion Criteria:\n\n* Is at least the local legal age of consent and aged 18 to 65 years, inclusive, when signing the ICF.\n* Is a female of Nonchildbearing Potential (postmenopausal or surgically sterilized) or a male.\n* Has a body weight between 50 and 120 kg and a BMI between 18 and 30.5 kg\u002Fm2, inclusive.\n\nExclusion Criteria:\n\n* Has any current or past clinically meaningful medical or psychiatric condition that, in the investigator's opinion, would confound the study results or put the participant at undue risk.\n* Has IgG levels \\\u003C6.0 g\u002FL at screening.\n* Has a history of an immunosuppressive disease or an immunosuppressive condition at screening.\n* Previously participated in an ARGX-124, ARGX-213, or efgartigimod clinical study and received at least 1 dose of the study drug.",{"count":527,"type":22},104,[55],"This study aims to assess the safety of ARGX-124 in healthy adults. Another aim is to measure the amount of ARGX-124 in the blood over time to learn how it acts and moves in the body and how the immune system responds to it. Participants will remain in the study for up to approximately 23 weeks.",[259],"2026-03-04",{"date":533,"type":36},"2026-03-06",{"date":535,"type":36},"2026-01-26",{"date":537,"type":22},"2026-12-31",{"name":41,"class":42},{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":18,"minAge":188,"maxAge":19,"enrollmentInfo":547,"targetDuration":4,"studyType":23,"phases":548,"briefSummary":549,"conditions":550,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":7},"100426506","phase-2-evaluating-the-pharmacokinetics-pharmacodynamics-and-safety-of-efgartigimod-administered-intravenously-in-children-with-generalized-myasthenia-gravis-100426506","NCT04833894","Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis","Open-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis","ADAPT Jr","Inclusion Criteria:\n\n1. Ability of the participant and\u002For his\u002Fher legally authorized representative to understand the requirements of the trial and provide written informed consent\u002Fassent, if applicable (including consent\u002Fassent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including attending the required trial visits).\n2. Male or female participants between 2 to less than 18 years of age at the time of providing informed consent\u002Fassent. Age groups are enrolled in a staggered fashion respectively: 6 participants in the 12 to less than 18 years of age group followed by 6 participants in the 2 to less than 12 years of age group at the time of providing informed consent\u002Fassent.\n3. Diagnosed with Generalized Myasthenia Gravis (gMG) with confirmed documentation\n4. Meeting the clinical criteria as defined by the Myasthenia Gravis Foundation of America (MGFA) class II, III, and IVa.\n5. Eligible participants should have an unsatisfactory response (efficacy and\u002For safety) to immunosuppressants, steroids or acetylcholinesterase (AChE) inhibitors and should be on stable concomitant gMG therapy of adequate duration before screening.\n6. Positive serologic test for acetylcholine receptor (anti-AChR) antibodies at screening (for younger participants (\\\u003C15kg) historical values can be used).\n7. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials. A subject is of childbearing potential if, in the opinion of the investigator, he\u002Fshe is biologically capable of having children and is sexually active.\n\n   1. Male participants: Male participants must agree to not donate sperm from of providing informed consent\u002Fassent until they have completed the trial.\n   2. Female participants: Female adolescents of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before investigational medicinal product (IMP) can be administered.\n\nExclusion Criteria:\n\n1. Participants with MGFA class I, IVb, and V.\n2. Female adolescents of childbearing potential: Pregnancy or lactation, or the participant intends to become pregnant during the trial or within 90 days after the last dose of IMP.\n3. Has any of the following medical conditions:\n\n   1. Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection at screening.\n   2. Any other known autoimmune disease that, in the opinion of the investigator, would interfere with an accurate assessment of clinical symptoms of myasthenia gravis or put the participant at undue risk.\n   3. History of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of IMP. Participants with the following cancers can be included at any time: Adequately treated basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological findings of prostate cancer\n   4. Clinical evidence of other significant serious diseases, or have had a recent major surgery, or who have any other condition that, in the opinion of the investigator, could confound the results of the trial or put the participant at undue risk\n4. Worsening muscle weakness secondary to concurrent infections or medications (aminoglycosides, fluoro-quinolones, beta-blockers, etc).\n5. A documented lack of clinical response to plasma exchange (PLEX).\n6. Received a live or live-attenuated vaccine fewer than 28 days before screening. Receiving an inactivated, subunit, polysaccharide, or conjugate vaccine any time before screening is not exclusionary.\n7. Received a thymectomy \\\u003C3 months before screening or 1 is planned to be performed during the trial period.\n8. The following results from these diagnostic assessments will be considered exclusionary:\n\n   a. Positive serum test at screening for an active viral infection with any of the following conditions: Hepatitis B virus (HBV) that is indicative of an acute or chronic infection; Hepatitis C virus (HCV) based on HCV antibody assay; Positive HIV serology at screening; Positive nasopharyngeal swab polymerase chain reaction (PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening.\n9. Using the following prior or concomitant therapies: Use of an investigational product within 3 months or 5 half-lives (whichever is longer) before the first dose of IMP, Use of any monoclonal antibody within the 6 months before the first dose of IMP, Use of intravenous immunoglobulin (IVIg), administered subcutaneously or intramuscularly, or PLEX within 4 weeks before screening.\n10. Total immunoglobulin (IgG) levels \\\u003C6 g\u002FL below the lower limit of normal (LLN) according to the reference ranges of the central laboratory for participant by sex and age at screening.\n11. A known hypersensitivity reaction to efgartigimod or any of its excipients.\n12. Current participation in another interventional clinical trial or previous participation in an efgartigimod trial with at least 1 dose of IMP received.\n13. History (within 12 months of screening) of current alcohol, drug, or medication abuse as assessed by the investigator.",{"count":234,"type":22},[25,120],"The purpose of this trial is to investigate the PK, PD, safety, and activity of efgartigimod IV in children and adolescents aged from 2 to less than 18 years of age with gMG.\n\nTrial details include:\n\n* The maximum trial duration for each individual participant will be approximately 28 weeks\n* The treatment duration will be 8 weeks for the dose-confirmatory part (Part A) and 18 weeks for the treatment response-confirmatory part (Part B)",[82],"2026-02-16",{"date":553,"type":36},"2026-02-18",{"date":555,"type":36},"2021-10-26",{"date":557,"type":22},"2027-03",{"name":41,"class":42},""]