[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myasthenia-gravis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myasthenia-gravis":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,60,0,25,[9,44,84,108,128,165,189,205,230,254,285,310,333,354,395,418,457,479,495,514,537,557,582,609,629],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100616326","phase-1-a-study-evaluating-the-safety-and-efficacy-of-kite-363-in-relapsedrefractory-autoimmune-neurologic-diseases-100616326",false,"NCT07304154","A Study Evaluating the Safety and Efficacy of KITE-363 in Relapsed\u002FRefractory Autoimmune Neurologic Diseases","A Phase 1 Open-label, Multiregional, Multicenter, Basket Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19\u002FCD20 CAR T-cell Therapy in Participants With Relapsed\u002FRefractory Autoimmune Neurologic Diseases","Key Inclusion Criteria:\n\n* Reproductive status-related eligibility and contraception requirements:\n\n  * Participants must agree to use protocol-specified method(s) of contraception where applicable\n\nInclusion Criteria for multiple sclerosis (MS):\n\nMS (Relapsing and progressive forms):\n\n* Diagnosed with MS according to the 2017 revision of the McDonald diagnostic criteria\n\nRelapsing forms of MS (relapsing-remitting multiple sclerosis (RRMS), active secondary-progressive multiple sclerosis (aSPMS)):\n\n* Inadequate response to previous therapies is defined as evidence of breakthrough disease activity within 12 months prior to screening while on high efficacy disease-modifying therapy (DMT) OR Inadequate response to previous therapies defined as intolerance to ≥ 2 DMTs due to side effects prohibiting the chronic use of the DMT.\n* Expanded Disability Status Scale (EDSS) 0 to 5.5\n\nProgressive forms of MS (primary-progressive multiple sclerosis (PPMS) and non-active secondary-progressive multiple sclerosis (naSPMS)):\n\n* Inadequate response to previous therapies is defined as evidence of disease progression within 12 months prior to screening despite standard of care therapy for naSPMS or despite ocrelizumab, where available, for PPMS\n* Absence of clinical relapses for at least 24 months\n* No evidence of Gadolinium enhancing (GadE+) on magnetic resonance imaging (MRI) brain at screening or baseline\n* EDSS of 3 to 6.5 who are ambulatory\n\nInclusion Criteria for myasthenia gravis (MG):\n\n* Documentation of autoantibodies against acetylcholine receptor (AChR), muscle-specific kinase (MuSK), or low-density lipoprotein receptor-related protein 4 (LRP4)\n* Diagnosis of MG with generalized weakness meeting criteria as defined by the Myasthenia Gravis Foundation of American (MGFA) classification of II- IV at screening\n* Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥ 6 (\\> 50% of the total score due to non-ocular symptoms)\n* Quantitative Myasthenia Gravis (QMG) score ≥ 10\n* Inadequate response to previous therapies while taking at least 2 classes of immunosuppressants (ie, steroids, azathioprine (AZA), mycophenolate mofetil (MMF), intravenous immunoglobulin (IVIg), biologics (eg, rituximab, anti-neonatal fragment crystallizable (Fc) receptor (FcRN) class, and anti-complement class))\n* Thymectomy allowed if completed ≥ 12 months prior to screening\n\nInclusion Criteria for chronic inflammatory demyelinating polyneuropathy (CIDP):\n\n* Probable or definite CIDP as defined by the 2010 European Federation of Neurological Societies\u002FPeripheral Nerve Society (EFNS\u002FPNS) criteria, relapsing or progressive forms\n* CIDP Disease Activity Status (CDAS) score ≥ 3 at screening\n* Inflammatory neuropathy cause and treatment (INCAT) score ≥ 3\n* Inadequate response to previous therapies despite standard of care therapy (ie, steroids, IVIg, subcutaneous immunoglobulin (SCIg), plasmapheresis exchange (PLEX), rituximab, or anti FcRN) OR Unable to tolerate standard of care due to side effects with ongoing disease activity\n* Except for nodal\u002Fparanodal CIDP, historical documentation of objective improvement in the past 24 months while on IVIg, SCIg, PLEX, or anti-FcRN OR Historical documentation of objective disease worsening in the past 24 months when IVIg, SCIg, PLEX, or anti-FcRN has been reduced or interrupted\n\nKey Exclusion Criteria:\n\n* History or presence of central nervous system (CNS) or peripheral nervous system disorders before enrollment that may impact cognition, strength, or cause weakness\n* History of autologous or allogeneic stem cell transplant and\u002For organ transplant\n\nExclusion Criteria for MS:\n\n* Cohort 1 or 2; inability to complete 9-hole Peg Test (9-HPT) in \\\u003C 240 seconds and Timed 25 foot Walk (T25FW) \\\u003C 150 seconds\n* History of hypersensitivity to parenteral administration of gadolinium-based contrast agents\n* Any renal condition that would preclude the administration of gadolinium (for the relapsing forms of MS and progressive forms of MS)\n* Any contraindication to lumbar puncture (LP) (for the relapsing forms of MS and progressive forms of MS)\n\nExclusion Criteria for MG:\n\n* Current myasthenic crisis not effectively controlled within 2 weeks before enrollment\n* Thymectomy performed within 12 months of baseline\n\nExclusion Criteria for CIDP:\n\n* Pure sensory CIDP and focal CIDP\n* Polyneuropathy of other causes\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years","75 Years",{"count":21,"type":22},52,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study will have two Phases: Phase 1a and Phase 1b. The goals of this clinical study are to learn more about the study drug KITE-363, by evaluating its safety, tolerability and efficacy in participants with relapsed\u002Frefractory autoimmune neurologic diseases.\n\nThe primary objectives of this study are:\n\n* To evaluate the safety and tolerability of KITE-363 in participants with autoimmune neurologic diseases\n* To determine the recommended dose for Phase 1b.\n* To evaluate the preliminary efficacy of KITE-363 in participants with autoimmune neurologic diseases.",[28,29,30],"Chronic Inflammatory Demyelinating Polyneuropathy","Myasthenia Gravis","Multiple Sclerosis","RECRUITING","2026-06-30",{"date":34,"type":35},"2026-07-01","ACTUAL",{"date":37,"type":35},"2026-04-10",{"date":39,"type":22},"2029-06",{"name":41,"class":42},"Kite, A Gilead Company","INDUSTRY",6,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100533006","phase-1-a-study-to-evaluate-the-safety-tolerability-efficacy-and-drug-levels-of-cc-97540-in-participants-with-relapsing-forms-of-multiple-sclerosis-progressive-forms-of-multiple-sclerosis-or-refractory-myasthenia-gravis-mg-breakfree-2-100533006","NCT06220201","A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis or Refractory Myasthenia Gravis (MG) (Breakfree-2)","A Phase 1, Multicenter, Single-arm, Dose-escalation Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, Evaluating Safety and Tolerability in Participants With Autoimmune Neurological Diseases: Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS), or Refractory Myasthenia Gravis (MG).","Inclusion Criteria\n\n\\- Relapsing forms of Multiple Sclerosis (RMS) - Cohort 1.\n\ni) Participants must have an Expanded Disability Status Scale (EDSS) of ≥ 3.0 and ≤ 5.5.\n\nii) Participants must have a diagnosis of Multiple Sclerosis (MS) with relapsed\u002Frefractory MS or conversion to active secondary progressive multiple sclerosis (aSPMS), and worsening of disease within 12 months prior to Screening and while on treatment with a high-efficacy DMT for at least 6 months.\n\n\\- Progressive forms of MS - Cohort 2.\n\ni) Participants must have an EDSS ≥ 3.0 and ≤ 6.0.\n\nii) Participants must have a diagnosis of primary progressive multiple sclerosis (PPMS) that is treatment-resistant or diagnosis of inactive secondary progressive multiple sclerosis (iSPMS).\n\n\\- Myasthenia Gravis - Cohort 3\n\ni)MGFA classification of II-IV at screening\n\nii) Documentation of autoantibodies against AChR or MuSK (historical or at Screening)\n\niii) Refractory disease defined as disease activity on at least 2 immunosuppressants, including steroids, NSIs, or biologics.\n\niv) Has had thymectomy, only if indicated according to current guidelines.\n\nExclusion Criteria\n\n* Cohorts 1 and 2: Participants that cannot complete the 9-Hole Peg Test (9-HPT) in at least 1 hand in \\\u003C240 seconds unless extenuating medical conditions unrelated to MS prohibit this.\n* Participants that cannot perform a Timed 25-Foot Walk Test (T25FWT) in \\\u003C 150 seconds.\n* Presence of other confounding peripheral nervous system disorders or other disorders that may impact muscle strength (eg, myositis) or cause weakness, stroke, chronic inflammatory demyelinating polyradiculoneuropathy, Lambert-Eaton myasthenic syndrome.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","60 Years",{"count":53,"type":22},120,[25],"The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS) or Refractory Myasthenia Gravis (MG).",[30,29],[58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75],"CC-97540","CAR T","CART","NEX T","NEXT","BMS-986353","RMS","PMS","Multiple sclerosis","RRMS","aSPMS","PPMS","iSPMS","MG","gMG","refractory myasthenia gravis","general myasthenia gravis","CD19",{"date":34,"type":35},{"date":78,"type":35},"2024-03-28",{"date":80,"type":22},"2027-07-15",{"name":82,"class":42},"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company",35,{"id":85,"slug":86,"hasResults":12,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":23,"phases":94,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100547974","phase-2-safety-and-efficacy-of-3-dose-levels-of-nmd670-in-adult-patients-with-myasthenia-gravis-100547974","NCT06414954","Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis","A Phase 2b, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 3 Dose Levels of NMD670 Over 21 Days in Adult Patients With AChR\u002FMuSK-Ab+ Myasthenia Gravis","SYNAPSE-MG","Inclusion Criteria:\n\n* Participant must be a male or female being 18 or more, at the time of signing the informed consent\n* Diagnosis of MG, MGFA class II, III or IV\n* Documented positive AChR or MuSK antibody test.\n* Participant must be able to swallow tablets\n* Body mass index between 18 and 35 kg\u002Fm2, inclusive, at screening, and with a minimum weight of 40 kg\n* Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n* Participant is capable of and has given signed informed consent\n\nExclusion Criteria:\n\n* Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the patient's full participation in the study, pose any additional risk for the patient, or confound the assessment of the patient or outcome of the study\n* Participants with other significant clinical and\u002For laboratory safety findings that may interfere with the conduction or interpretation of the study\n* Participants that received treatment with an investigational medical product within 30 days or 5 half-lives of the medication, whichever is longer prior to Day 1\n* Participants with history of poor compliance with relevant MG therapy\n* Female patients who plan to become pregnant during the study or are currently pregnant or breastfeeding",{"count":93,"type":22},84,[95],"PHASE2","This Phase 2 proof-of-concept, dose range finding study aims to evaluate the safety and efficacy of 3 dose levels of NMD670 vs placebo in adult patients with MG with antibodies against AChR or MuSK, administered twice a day (BID) for 21 days.",[29,98],"Myasthenia Gravis, MuSK","2026-06-29",{"date":34,"type":35},{"date":102,"type":35},"2024-05-16",{"date":104,"type":22},"2026-12",{"name":106,"class":42},"NMD Pharma A\u002FS",40,{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100644671","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-maintenance-ublituximab-following-induction-with-efgartigimod-administration-in-participants-with-myasthenia-gravis-mg-100644671","NCT07673744","A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG)","A Phase 2, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Treatment Following Induction With Efgartigimod Administration in Adults With Myasthenia Gravis","Inclusion Criteria:\n\n1. Documentation of MG diagnosis.\n2. Eligible for treatment with efgartigimod per effective local product label, confirmed by serological testing at screening.\n3. MG-ADL score at the time of screening more than or equal to (≥) 6 and less than or equal to (≤) 10 with more than (\\>) 50 percent (%) of this score attributed to non-ocular items, or an MG-ADL score ≥ 11.\n\nExclusion Criteria:\n\n1. Active chronic (or stable but treated with immune therapy) disease of the immune system other than MG (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency, etc.).\n2. Lack of efficacy or observed safety concerns from prior neonatal Fc receptor (FcRn) treatment.\n3. Prior treatment with B-cell depleting therapy, alemtuzumab, total lymphoid irradiation, bone marrow transplant, T-cell vaccination therapy, or natalizumab at any time prior to screening.\n4. Participants with significantly impaired organ function.\n5. History of life-threatening injection\u002Finfusion related reaction (IRR\u002FISR), hypersensitivity, or anaphylactic reaction with components of efgartigimod or ublituximab solutions, protocol-allowed rescue medications, or protocol required pre-treatment medications.\n6. Unwillingness or inability to comply with study and\u002For follow-up procedures outlined in the protocol.\n\nNote: Other protocol-specified Inclusion\u002FExclusion criteria may apply.",{"count":53,"type":22},[95],"The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod.",[29],"2026-06-22",{"date":99,"type":35},{"date":122,"type":22},"2026-07-30",{"date":124,"type":22},"2030-01-01",{"name":126,"class":42},"TG Therapeutics, Inc.",2,{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":135,"sex":136,"minAge":137,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":142,"conditions":143,"keywords":148,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":164},"100641464","cohort-study-on-neuroimmune-diseases-in-the-reproductive-age-100641464","NCT07653984","Cohort Study on Neuroimmune Diseases in the Reproductive Age","RANID","Inclusion Criteria:\n\n* Patient Group: A total of fifty participants are expected to be enrolled.\n\n  1. Women aged 20-55 years with childbearing potential.\n  2. Voluntary informed consent.\n  3. Availability of complete personal information.\n  4. A confirmed diagnosis of neuromyelitis optica spectrum disorder (NMOSD), multiple sclerosis (MS), autoimmune encephalitis, myasthenia gravis, Guillain-Barré syndrome, or myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).\n\nHealthy Control Group: A total of fifty healthy women are expected to be included.\n\n1. Age- and sex-matched women of childbearing age with plans for pregnancy\n2. Voluntary informed consent.\n3. Availability of complete personal information.\n\nExclusion Criteria:\n\n* Patient Group:\n\n  1. Patients with an undetermined or unconfirmed diagnosis.\n  2. Incomplete personal information that cannot be obtained through follow-up.\n  3. Participants who voluntarily withdrew from the study and revoked informed consent.\n\nHealthy Control Group:\n\n1. Individuals diagnosed with neuroimmune-related disorders.\n2. Incomplete personal information that cannot be obtained through follow-up.\n3. Participants who voluntarily withdrew from the study and revoked informed consent.",true,"FEMALE","20 Years","55 Years",{"count":140,"type":22},100,"OBSERVATIONAL","Neuroimmune diseases are more prevalent among women of reproductive age. Studies have shown that neuroimmune diseases may impact fertility. Therefore, effective management of neuroimmune diseases during pregnancy is particularly important. This study included a follow-up period of up to five years in patients with pregnancy-associated neuroimmune disorders. Data collected included relapse frequency, symptomatology, imaging findings, treatment regimens, peripheral blood profiles, EDSS scores, and MRI results. In addition, maternal drug concentrations, postpartum relapse rates, and neonatal development were monitored after delivery. Following the successful completion of the five-year follow-up, the research team plans to continue the prospective epidemiological study with ten-year follow-up phases. The aim of this study is to generate detailed clinical data on pregnancy-associated autoimmune diseases and to equip clinicians with evidence-based strategies for optimizing disease management during the reproductive age.",[144,30,145,29,146,147],"Neuromyelitis Optica Spectrum Disorders (NMOSD)","Autoimmune Encephalitis","Guillain-Barré Syndrome (GBS)","Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)",[149,30,150,151,146,147,152,153],"Neuromyelitis optica spectrum disorders (NMOSD)","Autoimmune encephalitis","myasthenia gravis","reproductive age","cohort study","2026-06-13",{"date":156,"type":35},"2026-06-17",{"date":158,"type":35},"2024-04-21",{"date":160,"type":22},"2030-04",{"name":162,"class":163},"Third Affiliated Hospital, Sun Yat-Sen University","OTHER",1,{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":188},"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":173,"type":22},70,"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.",[29,71,72,176,177,178],"Generalized Myasthenia Gravis","Generalized Myasthenia Gravis (gMG)","AChR-Ab Seropositive Generalized Myasthenia Gravis","2026-06-11",{"date":181,"type":35},"2026-06-12",{"date":183,"type":35},"2025-12-19",{"date":185,"type":22},"2028-03-07",{"name":187,"class":42},"argenx",18,{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":23,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":202,"leadSponsor":203,"locationsCount":204},"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":173,"type":22},[95],"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",[178,29,71,72,176,177],{"date":181,"type":35},{"date":183,"type":35},{"date":185,"type":22},{"name":187,"class":42},15,{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":213,"enrollmentInfo":214,"targetDuration":4,"studyType":23,"phases":216,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":229},"100609669","phase-3-comparative-efficacy-of-nipocalimab-and-efgartigimod-in-participants-with-generalized-myasthenia-gravis-100609669","NCT07217587","Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis","Efficacy and Safety of Nipocalimab vs Efgartigimod for Patients With Generalized Myasthenia Gravis in a Randomized, Open-label, Phase 3b, Interventional Trial Including Within Class Switching From Efgartigimod to Nipocalimab","EPIC","Inclusion criteria:\n\nFor all arms:\n\n* Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening\n* Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized MG (gMG) as defined by the Myasthenia gravis foundation of America (MGFA) clinical classification class II a\u002Fb, III a\u002Fb, or IV a\u002Fb at screening and positive for acetylcholine receptor (AChR) antibodies\n* Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of greater than or equal to (\\>=) 5 with less than (\\\u003C) 50% of symptoms coming from ocular MG-ADL sub-scores at study screening and baseline (Day 1) visits\n\nCriteria specific to Arms 1 and 2 only:\n\n\\- Has suboptimal response to current stable therapy for gMG according to the investigator or has discontinued corticosteroids and\u002For immunosuppressants\u002Fimmunomodulators including eculizumab or other novel approved immune agents at least 4 weeks prior to baseline due to intolerance or lack of efficacy\n\nCriteria specific to Arm 3:\n\n\\- Treatment with efgartigimod IV or subcutaneous (SC) for \\>=1 cycle, and the final cycle is consistent with product information\n\nExclusion criteria:\n\n* Any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his\u002Fher gMG, or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant\n* Had a thymectomy within 1 year prior to baseline, or thymectomy is planned during the study\n* Currently has a malignancy or has a history of malignancy within 3 years before baseline\n\nCriteria specific to Arms 1 and 2 only:\n\n\\- Has received treatment for MG with an FcRn-targeting therapy\n\nCriteria specific to Arm 3 only:\n\n\\- Is currently taking IgG monoclonal antibody therapeutics, or Fc-conjugated therapeutic agents, including factor or enzyme replacement, with the exception of efgartigimod","74 Years",{"count":215,"type":22},115,[217],"PHASE3","The purpose of this study is to assess how well nipocalimab works when compared to efgartigimod in participants with generalized myasthenia gravis (a condition in which body's immune system mistakenly attacks and damages the connection between nerves and muscles causing muscle weakness).",[29],"2026-06-04",{"date":222,"type":35},"2026-06-05",{"date":224,"type":35},"2026-01-05",{"date":226,"type":22},"2029-07-31",{"name":228,"class":42},"Janssen Research & Development, LLC",14,{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":23,"phases":238,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":253},"100611898","phase-4-phase-4-study-evaluating-efficacy-and-safety-of-rozanolixizumab-in-adult-chinese-participants-with-generalized-myasthenia-gravis-100611898","NCT07246564","Phase 4 Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis","An Open-label, Prospective, Single-arm Study Assessing the Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis","Inclusion Criteria:\n\n* Study participant must be ≥18 years of age at the time of signing the informed consent form (ICF)\n* Study participant has documented diagnosis of generalized myasthenia gravis (gMG) at the Screening Visit based on study participant's history and supported by previous evaluation\n* Study participant has a confirmed positive record of autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) documented in the medical history at the Screening Visit\n* Study participant has Myasthenia Gravis Foundation of America (MGFA) Clinical Classification II to IV at Screening Visit.\n* Study participant with a myasthenia gravis-activities of daily living (MG-ADL) score of at least 3 points from non-ocular symptoms and a quantitative myasthenia gravis (QMG) score of at least 11 at the Screening and Baseline visits in the first Treatment Cycle.\n* Study participant is considered for additional treatment by the investigator\n* Body weight ≥35kg at the Screening Visit\n\nExclusion Criteria:\n\n* Study participant has a known hypersensitivity to any components of the study drug or any other anti-neonatal Fc receptor (anti-FcRn) medications\n* Study participant has a clinically important active infection including unresolved or not adequately treated infection in the opinion of the investigator\n* Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current\u002Fhistory of nontuberculous mycobacterial infection (NTMBI)\n* Study participant has previously received rozanolixizumab drug product\n* Study participant has received any vaccine in the 4 weeks prior to the initiation of rozanolixizumab treatment or intends to receive any vaccine within 2 weeks after the last infusion of rozanolixizumab. Note: For participants that are on rozanolixizumab treatment, vaccination with live or live-attenuated vaccines is not recommended. During the whole study period, all other vaccines should take place at least 2 weeks after the last infusion of a Treatment Cycle and 4 weeks before initiating the next cycle\n* Study participant has been treated with prohibited immunosuppressants, biologics, and other therapies within the timeframe shorter than the treatment-free period\n* Study participant with severe (defined as Grade 3 on the MG-ADL scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis. Note: Impending Crisis is defined as bulbar or respiratory symptoms of a patient who significantly worsens in a short time (≤2 weeks) and meet MGFA IVb or score 3 in one QMG bulbar muscle item, or score 2 in respiratory muscle item, or bulbar+respiratory items score ≥4",{"count":107,"type":22},[239],"PHASE4","The purpose of the study is to assess the clinical efficacy of rozanolixizumab in adult Chinese participants with generalized myasthenia gravis (gMG) in the first Treatment Cycle.",[29],[243],"Rozanolixizumabg, gMG","2026-05-21",{"date":246,"type":35},"2026-05-22",{"date":248,"type":35},"2025-12-01",{"date":250,"type":22},"2027-10-15",{"name":252,"class":42},"UCB Biopharma SRL",12,{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":261,"targetDuration":4,"studyType":23,"phases":263,"briefSummary":264,"conditions":265,"keywords":266,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":284},"100530984","phase-2-kysa-6-a-study-of-anti-cd19-chimeric-antigen-receptor-t-cell-therapy-in-patients-with-generalized-myasthenia-gravis-100530984","NCT06193889","KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis","KYSA-6: A Phase 2\u002F3, Open-Label, Randomized, Controlled, Multicenter Study of KYV-101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T-cell (CD19 CAR T) Therapy, Versus Ongoing Standard-Of-Care Immunosuppressive Therapy in Patients With Generalized Myasthenia Gravis","Key Inclusion Criteria\n\n1. Presence of autoantibodies to AChR or MuSK\n2. Myasthenia Gravis Foundation of America (MGFA) Class II-IV\n3. MG-Activities of Daily Living (MG-ADL) total score of ≥6 at screening and confirmed at baseline visit\n4. QMG total score of ≥11 at screening an confirmed at baseline visit\n5. Failed treatment with 2 or more immunosuppressive\u002Fimmunomodulatory therapies, or failed at least 1 immunosuppressive therapy and required chronic plasmapheresis, or IVIG (or subcutaneous or intramuscular Ig) to control symptoms\n6. On a stable dose of glucocorticoids and\u002For other immunotherapies for ≥1 month prior to screening. For patients treated with azathioprine, a stable dose for ≥2 months prior to screening is required\n7. No change in dose of acetylcholinesterase inhibitors for ≥2 weeks prior to screening\n8. No use of intravenous immune globulin (IVIG) or plasmapheresis (PLEX) within 4 weeks of screening or pre-dose baseline (unless this is part of their SOC treatment regimen)\n9. No use of rituximab (or any other anti-CD20 or CD19 monoclonal antibody) within 12 weeks prior to screening\n10. Able and willing to attend the necessary visits to the study site\n\nKey Exclusion Criteria\n\n1. Unable to washout or interrupt autoimmune disease therapy prior to apheresis and\u002For baseline if required\n2. Co-occurring neurological autoimmune disease (ie, Lambert-Eaton Myasthenic Syndrome) or any disease affecting the neuromuscular junction or muscle causing weakness (eg, myositis, myopathy, motor neuropathy)\n3. History of stroke (with residual sequalae and\u002For risk for recurrence), seizure (even if well controlled on antiepileptics), neurodegenerative disease, altered mental status (unexplained and\u002For recent\u002Fcurrent), or uncontrolled\u002Fsevere psychiatric disease\n4. Any serious and\u002For uncontrolled medical condition that, in the investigator's judgment, would cause unacceptable safety risk, interfere with study procedures or results, or compromise compliance with the protocol, including but not limited to, clinically significant cardiac or pulmonary disease\n5. History of primary immunodeficiency, organ or allogeneic bone marrow transplant, or splenectomy\n6. Active, uncontrolled, viral, bacterial, or systemic fungal infection or recent history of repeated infections\n7. Thymectomy \\\u003C12 months of screening or planned during the study\n8. Prior treatment with gene therapy product or cellular immunotherapy (eg, CAR T) requiring vector integration and directed at any target\n9. Patients requiring chronic anticoagulation therapy that cannot be discontinued for medical procedures",{"count":262,"type":22},66,[95,217],"A Study of the Anti-CD 19 Chimeric Antigen Receptor T Cell Therapy for Patients with Myasthenia Gravis",[29,176],[267,151,268,269,270,71,271,272,273,274],"KYV-101","autoimmune disease","anti-CD19 CAR-T Therapy","cellular therapy","KYSA-6","KYV101-006","mivocabtagene autoleucel","miv-cel","2026-05-13",{"date":277,"type":35},"2026-05-15",{"date":279,"type":35},"2024-08-28",{"date":281,"type":22},"2028-09",{"name":283,"class":42},"Kyverna Therapeutics",17,{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":289,"acronym":290,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":294,"conditions":295,"keywords":297,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":164},"100582695","evaluating-dyspnea-in-autoimmune-myasthenia-gravis-why-am-i-short-of-breath-100582695","NCT06866652","Evaluating Dyspnea in Autoimmune Myasthenia Gravis \"Why am I Short of Breath?\"","MyaRESP","Inclusion Criteria:\n\n* Age ≥18\n* Confirmed diagnosis of autoimmune MG\n* Shortness of breath in daily life: score 1 or 2 on the respiration item on the MG- activities of daily living score\n* Signed consent form\n* Affiliated to or beneficiary of a social security scheme\n\nExclusion Criteria:\n\n* Known Pregnancy\n* Known respiratory disorder (other than MG)\n* Recent (within past 4 weeks) respiratory infection\n* Current MG crisis or exacerbation (necessitating increase in MG medication \\&\u002For hospital admission)\n* No dyspnea - score 0 or 3 on the respiration item on the MG- activities of daily living score\n* Severe cognitive impairment\u002Fguardianship",{"count":293,"type":22},50,"Individuals with MG (IwMG) experience shortness of breath that may be activity-related, occur at rest and even happen during sleep. Dyspnea is a complex, multidimensional and multifactorial symptom involving sensory perception, cognition and emotion. Identifying the cause(s) of dyspnea in MG may assist in finding therapeutic strategies, reducing discomfort, improving QoL and potentially limiting respiratory deterioration and incidence of MG crisis.",[29,296],"Dyspnea",[298,299,300],"dyspnea","breathlessness","respiratory","2026-05-04",{"date":303,"type":35},"2026-05-08",{"date":305,"type":35},"2026-04-08",{"date":307,"type":22},"2028-06",{"name":309,"class":163},"Institut de Myologie, France",{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":135,"sex":17,"minAge":137,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":23,"phases":318,"briefSummary":320,"conditions":321,"keywords":322,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":164},"100574033","tcm-tongue-diagnosis-and-syndrome-differentiation-in-myasthenia-gravis-compared-to-healthy-controls-100574033","NCT06754020","TCM Tongue Diagnosis and Syndrome Differentiation in Myasthenia Gravis Compared to Healthy Controls","Application of Artificial Intelligence for Precision Medicine in TCM Tongue Diagnosis and Syndrome Differentiation in Myasthenia Gravis Compared to Healthy Controls","Inclusion Criteria:\n\n1. Diagnosed with myasthenia gravis by a physician.\n2. Able to understand and communicate in Mandarin and Taiwanese.\n3. Cognitively alert and without a diagnosis of psychiatric disorders.\n4. Willing to undergo tongue imaging and instrument measurements.\n\nExclusion Criteria:\n\n1. Patients with severe organ diseases.\n2. Hearing loss patients who are unable to complete the questionnaire.\n3. Patients with aphasia who are unable to complete the questionnaire.\n4. Have eaten food or drinks that can easily contaminate tongue coating within 2 hours.",{"count":140,"type":22},[319],"NA","Myasthenia gravis primarily results from neuromuscular junction dysfunction and damage, leading to chronic muscle weakness. While combined traditional and Western medicine treatments are now common, TCM tongue diagnosis remains a simple and practical clinical method. However, results can vary among different practitioners. Therefore, you are interested in using scientific methods to compare TCM tongue diagnosis images between patients with myasthenia gravis and healthy individuals to aid in diagnosis.",[29],[29,323],"traditional Chinese medicine","2026-04-07",{"date":326,"type":35},"2026-04-13",{"date":328,"type":35},"2023-01-17",{"date":330,"type":22},"2027-12-31",{"name":332,"class":163},"Yi Ting Yeh",{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":340,"enrollmentInfo":341,"targetDuration":4,"studyType":23,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":352,"locationsCount":164},"100553834","light-vs-moderate-intensity-exercise-in-individuals-with-myasthenia-gravis-100553834","NCT06491238","Light vs. Moderate Intensity Exercise in Individuals With Myasthenia Gravis","MG-Ex","Inclusion Criteria:\n\n* Ability to provide and provision of signed and dated informed consent form.\n* Age 18-80\n* Diagnosis of generalized MG.\n* On a stable MG prescription medication regimen for the last 3 months.\n\nExclusion Criteria:\n\n* Non-English speaking\n* Regular exercise participation within the month prior to study enrollment or any outside exercise participation during the study intervention period.\n* Significant cognitive impairment of any etiology that would impact study participation.\n* History of heart failure, chronic lung disease, angina or any other condition that causes unreasonable shortness of breath on exertion.\n* History of any serious neurological, psychiatric, or substance use disorders that would impact study participation.\n* Women who are currently pregnant or planning to become pregnant during the study.\n* Any other medical conditions that could affect their ability to participate in exercise for the study duration (as determined by study investigators).\n* Active participation or past participation ≤3 months in any other interventional research study.\n* Unwilling to participate in all study related activities.","80 Years",{"count":342,"type":22},20,[319],"The overall purpose of this pilot study is to examine the feasibility, acceptability, and tolerability of light and moderate intensity exercise in adults with MGeffect of light vs. moderate intensity exercise on health outcomes. Participants will be enrolled into the NeuroWell exercise program, which is geared toward individuals with neurological disorders or injuries and led by Certified Exercise Physiologists (CEPs) at the HealthPartners Neuroscience Center. A total of 20 people with MG will be enrolled in this study and participate in a small group exercise program 3 times a week for 12 weeks. Participants will be randomized into two exercise groups: 1) Light intensity or 2) Moderate intensity. We hypothesize that light and moderate intensity exercise will be feasible, acceptable, and tolerable in adults with MG and that individuals in the light intensity exercise group will be able to achieve the same improvement in health outcomes as the moderate intensity group.",[29],"2026-03-20",{"date":348,"type":35},"2026-03-23",{"date":350,"type":35},"2024-09-16",{"date":104,"type":22},{"name":353,"class":163},"HealthPartners Institute",{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":23,"phases":362,"briefSummary":363,"conditions":364,"keywords":381,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":164},"100629707","effects-of-whole-body-electrical-muscle-stimulation-exercise-on-adults-with-neuromuscular-disease-100629707","NCT07478172","Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease","Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults withNeuromuscular Disease","Inclusion Criteria:\n\n* Age 18 or older\n* Diagnosed with one or more of the following neuromuscular conditions: Amyotrophic lateral sclerosis, primary lateral sclerosis, progressive muscle atrophy, spinal muscular atrophy, postpolio syndrome, inclusion body myositis, pompedisease, fascioscapulohumeral muscular dystrophy, charcot marie tooth disease, chronic inflammatory demyelinating polyneuropathy, hereditary spastic paraplegia, myasthenia gravis, lambert-eaton myasthenic syndrome, postural orthostatic tachycardia syndrome, mitochondrial myopathy, nemaline myopathy, centronuclear myopathy, lumbar radiculopathy, non-specific low back pain.\n* Ability to stand for approximately 15 minutes continuously with or without an assistive device (i.e. the length of time to stand to take a shower, complete meal preparation, wait in line at the bank, etc.)\n* At least some anti-gravity strength in major muscle groups as assessed by manual muscle testing (i.e. 2+\u002F5 strength or better)\n* Medical clearance to participate in an exercise program\n* Ability to provide informed consent\n* Ability to conform to the requirements of the study (i.e. attendance at assessment and intervention visits, maintain current level of non-study physical activity for the duration of the study, no intention to relocate mid-study)\n\nExclusion Criteria:\n\n* Diagnosed with one of the following neuromuscular conditions: Becker's muscular dystrophy, Duchenne muscular dystrophy, limb-girdle muscular dystrophy, myotonic dystrophy type 1 or 2, Freidrich's ataxia, any other NMD with known or suspected cardiac involvement or muscle fiber structural integrity defects.\n* Concurrent participation in another interventional research study\n* Unable to tolerate 15 minutes of continuous standing with or without an assistive device\n* Presence of a pacemaker, metal implants, or other implanted medical devices that could impact participant safety during WB-EMS intervention\n* Presence of cochlear implant, cortical stimulator, deep brain stimulator, ventriculoperitoneal shunt, recent skull defect, seizure in the past 12 months while taking anti-epilepsy medication, or previous serious adverse event with TMS, which could impact participant safety during TMS testing\n* Presence of unstable acute or chronic disease (i.e. renal failure, rheumatologic disease, cardia arrhythmia, neoplasm, uncontrolled hypertension)\n* Known pregnancy at time of screening; verbal screening will occur throughout the study.\n* Presence of a terminal disease (i.e. receiving hospice services)\n* Current or previous use of any drugs known to influence muscle mass or performance within 6 months; these may include but are not limited to anabolic steroids, IGF01, growth hormone, replacement androgen therapy, anti-androgen therapy\n* Presence of an additional neurologic conditions affecting somatosensory or motor function\u002Fcontrol (i.e. Parkinson's disease, Multiple Sclerosis, h\u002Fo stroke, TBI, SCI, ataxia, apraxia, hemiplegia, etc.)\n* Musculoskeletal condition or surgery in the past year that would confound results of exercise interventions (i.e. TKA, THA, RTC repair, spinal fusion)\n* Other medical conditions, signs, or symptoms that would interfere with study conductor interpretation of results as determined by an investigator",{"count":293,"type":22},[319],"This single-arm pilot study evaluates the effects of whole-body electrical muscle stimulation (WB-EMS) exercise on neuromuscular and physical function in adults with neuromuscular disease (NMD). Due to motor unit impairments, NMD patients often cannot tolerate traditional exercise. WB-EMS bypasses voluntary activation limits by directly stimulating muscle contractions. Up to 50 adults with conditions like ALS, SMA, and MG will undergo 20-minute supervised WB-EMS sessions (1-2 times weekly for 4-8 weeks) using the Katalyst system. Outcomes include neural excitability (TMS), motor unit behavior (EMG, NCS), functional tests (walk, balance, strength), and patient-reported fatigue, pain, and quality of life. Strict safety monitoring and exclusion criteria are in place. This study will provide preliminary data on WB-EMS as a potential exercise modality for NMD.",[365,366,29,367,368,369,370,371,372,373,374,375,376,377,28,378,379,380],"Neuromuscular Diseases (NMD)","Amyotrophic Lateral Sclerosis","Lambert-eaton Myasthenic Syndrome","Primary Lateral Sclerosis","Spinal Muscular Atrophy","Charcot Marie Tooth Disease (CMT)","Fascioscapulohumeral Muscular Dystrophy","Inclusion Body Myositis","Mitochondrial Myopathy","Nemaline Myopathy","Centronuclear Myopathy","Postpolio Syndrome","Pompe Disease (Late-onset)","Hereditary Spastic Paraplegia","Postural Orthostatic Tachycardia Syndrome (POTS)","Progressive Muscular Atrophy",[382,383,384,385],"Neuromuscular Disease","Electrical Stimulation","Whole Body stimulation","Exercise intervention","2026-03-12",{"date":388,"type":35},"2026-03-17",{"date":390,"type":35},"2026-03-10",{"date":392,"type":22},"2031-01-07",{"name":394,"class":163},"University of Missouri-Columbia",{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":17,"minAge":402,"maxAge":403,"enrollmentInfo":404,"targetDuration":4,"studyType":23,"phases":405,"briefSummary":406,"conditions":407,"keywords":408,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":417},"100459642","phase-2-a-study-of-nipocalimab-in-children-aged-2-to-less-than-18-years-with-generalized-myasthenia-gravis-100459642","NCT05265273","A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis","An Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis","Key Inclusion Criteria:\n\n* Age: For US sites only: 8 to \\\u003C 18 years\n* Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized myasthenia gravis (gMG) as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class IIa\u002Fb, IIIa\u002Fb, or IVa\u002Fb at screening\n* Has a positive serologic test for acetylcholine receptor (anti-AChR) antibodies or muscle-specific tyrosine kinase (anti-MuSK) antibodies at screening\n* A participant using herbal, naturopathic, traditional Chinese remedies, ayurvedic or nutritional supplements, or medical marijuana (with a doctor's prescription) is eligible if the use of these medications is acceptable to the Investigator. These remedies must remain at a stable dose and regimen throughout the study\n* Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol\n* Participants should have a body weight and body mass index between 5th and 95th percentile for age and sex. Obese participants greater than 95th percentile and underweight participants below 5th percentile may participate following medical clearance\n* A female of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \\[beta-hCG\\]) at Screening and a negative urine pregnancy test at Day 1 prior to administration of study intervention\n\nKey Exclusion Criteria:\n\n* Has a history of severe and\u002For uncontrolled hepatic (example, viral\u002Falcoholic\u002F autoimmune hepatitis\u002F cirrhosis\u002F and\u002For metabolic liver disease), gastrointestinal, renal, pulmonary, cardiovascular (including congenital heart diseases), psychiatric, neurological musculoskeletal disorder, any other medical disorder(s) (example, diabetes mellitus), risk factors for thrombosis events (example, a history of venous thromboembolism \\[VTE\\] or antiphospholipid syndrome, or a personal or family history of heritable coagulation disorder such as factor V leiden, protein S or protein C deficiency, atrial fibrillation\u002Fflutter, major orthopedic surgery or significant trauma that may increase the risk of VTE, is expected to be immobilized for prolonged periods of time), or has clinically significant abnormalities in screening laboratory, that might interfere with participant's full participation in the study, and\u002F or might jeopardize the safety of the participant or the validity of the study results\n* Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his\u002Fher generalized myasthenia gravis (gMG), or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant\n* Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the Active treatment Phase of the study\n* Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis to therapeutic proteins (example, monoclonal antibodies)\n* Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening","2 Years","17 Years",{"count":253,"type":22},[95,217],"The purpose of this study is to determine the effect of nipocalimab on total serum immunoglobulin G (IgG) in pediatric participants 2 to less than (\\\u003C) 18 years of age (globally) and 8 to \\\u003C18 years of age (for Unites Stated (US) sites only), the safety and tolerability of treatment with nipocalimab in children and adolescents and to evaluate the pharmacokinetics (PK) of nipocalimab in children and adolescents with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing, stable standard-of-care therapy.",[29],[409],"Pediatric",{"date":411,"type":35},"2026-03-13",{"date":413,"type":35},"2022-07-20",{"date":415,"type":22},"2029-07-02",{"name":228,"class":42},19,{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":23,"phases":426,"briefSummary":427,"conditions":428,"keywords":435,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":456},"100564264","phase-1-a-phase-1-study-of-anitocabtagene-autoleucel-for-the-treatment-of-subjects-with-non-oncology-plasma-cell-related-diseases-100564264","NCT06626919","A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases","Inclusion Criteria:\n\n* Subject must be 18 years of age or older\n* Must have MGFA clinical classification Grades 2-4A at time of screening\n* Subject must have clinically active disease and requiring ongoing therapy for GMG\n* MG-ADL score 6 and QMG score \\>10 at screening\n* GMG specific autoantibodies must be above the reference laboratory ULN\n\nExclusion Criteria:\n\n* Subject is pregnant or breastfeeding\n* Treatment with Anti-CD20 agents, calcineurin inhibitors, FcRN inhibitors, azathioprine, mycophenolate mofetil, methotrexate, or cyclophosphamide within the specified time frame prior to leukapheresis or prior to anito-cel infusion\n* Previous treatment with any gene therapy, chimeric antigen receptor therapy or T cell engager\n* Previous thymectomy within 6 months of screening\n* Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator",{"count":425,"type":22},30,[25],"A Phase 1 dose-escalation study designed to evaluate the safety, tolerability, and preliminary efficacy of anito-cel in subjects with generalized myasthenia gravis (GMG). Anitocabtagene autoleucel (anito-cel) is a BCMA-directed CAR-T cell therapy.",[429,430,431,432,433,29,434],"Muscular Diseases","Neuromuscular Manifestations","Autoimmune","Autoimmune Diseases","Autoimmune Diseases of the Nervous System","Muscle Weakness",[436,60,437,438,439,176,72,71,29,440,441,442,443,444,445,446],"ARC-311","CAR-T","BCMA","Anito-cel","non-oncology plasma cell","autoimmune","auto-antibody","chimeric antigen receptor","D-Domain chimeric antigen receptor","B-cell maturation antigen (BCMA)","anitocabtagene autoleucel","2026-02-24",{"date":449,"type":35},"2026-02-25",{"date":451,"type":35},"2025-04-30",{"date":453,"type":22},"2028-04",{"name":455,"class":42},"Arcellx, Inc.",13,{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":136,"minAge":4,"maxAge":4,"enrollmentInfo":464,"targetDuration":466,"studyType":141,"phases":4,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":478},"100539123","a-worldwide-pregnancy-safety-study-to-assess-maternal-fetal-and-infant-outcomes-following-exposure-to-efgartigimod-during-pregnancy-andor-breastfeeding-100539123","NCT06299748","A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and\u002For Breastfeeding.","A Worldwide Pregnancy Safety Study To Assess Maternal, Fetal, And Infant Outcomes Following Exposure To Efgartigimod During Pregnancy And\u002FOr Breastfeeding","Inclusion Criteria:\n\n* Women with exposure to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy, or women with exposure to efgartigimod or efgartigimod PH20 SC during breastfeeding. The timeframe of 25 days prior to conception is calculated based on five times the efgartigimod half-life, which is 3 to 5 days.\n* Written\u002Fverbal informed consent or eConsent (depending on country regulations) (for adolescents under the age of majority, written\u002Fverbal informed assent or eConsent by the pregnant minor (where applicable) and written\u002Fverbal informed consent or eConsent by the parent\u002Flegal guardian).\n\nExclusion Criteria:\n\n* None",{"count":465,"type":22},279,"1 Year","This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy. Women exposed to efgartigimod or efgartigimod PH20 SC only during breastfeeding will also be eligible to enroll. Background rates of major congenital malformations (MCMs) will be obtained from populations within the same countries\u002Fregions as the countries\u002Fregions in which the efgartigimod or efgartigimod PH20 SC exposed pregnancies were reported.",[29,469],"CIDP - Chronic Inflammatory Demyelinating Polyneuropathy","2026-02-13",{"date":472,"type":35},"2026-02-17",{"date":474,"type":35},"2023-11-30",{"date":476,"type":22},"2033-12",{"name":187,"class":42},4,{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":489,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":83},"100539032","a-non-interventional-post-authorisation-safety-study-of-patients-treated-with-efgartigimod-alfa-100539032","NCT06298565","A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa","Inclusion Criteria:\n\n* Patients diagnosed with gMG who are expected to start commercial efgartigimod at enrolment or who are within their first cycle of efgartigimod at enrolment or Patients diagnosed with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment\n* Have provided appropriate written informed consent\n\nExclusion Criteria:\n\n* None",{"count":486,"type":22},680,"This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment will be eligible to enroll into the non-efgartigimod cohort.",[29],{"date":472,"type":35},{"date":491,"type":35},"2024-11-04",{"date":493,"type":22},"2034-06",{"name":187,"class":42},{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":501,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":504,"conditions":505,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":164},"100624617","evaluation-of-the-condition-of-patients-receiving-early-ravulizumab-and-admitted-in-icu-for-gmg-crisis-100624617","NCT07411963","Evaluation of the Condition of Patients Receiving EARLY Ravulizumab and Admitted in ICU for gMG Crisis","Evaluation of the Condition of Patients Receiving EARLY Treatment With Ravulizumab and Admitted in ICU for Generalized Myasthenia Gravis (gMG) Crisis : an Observational Prospective Multicentric Study in France","EARLY-MG","Inclusion Criteria:\n\n* Male or female aged ≥18 years.\n* Diagnosed with gMG with confirmed documentation and supported by a physical exam and confirmed seropositivity for AChR-Abs.\n* Patients having received more than 1 cycle of PLEX or IVIg 1-2 g\u002Fkg (max 50g\u002Fday), according to clinical practice.\n* Meets the clinical criteria as defined by the Myasthenia Gravis Foundation of America (MFGA) for generalized MG class V - IV, at ICU admission.\n* Patients treated with at least one standard MG-targeted therapy.\n* Patients receiving Ravulizumab following PLEX of IVIg during their stay in the ICU, as per local label and reimbursement conditions. The prescription must be validated by experts from the French Health Care Network for rare neuromuscular diseases FILNEMUS.\n* Patients capable of understanding written informed consent and providing signed, dated, and witnessed written informed consent. If unable to sign the consent due to muscular weakness, a dedicated informed consent can be signed by a trusted witness.\n* Patients willing and able to comply with scheduled visits, treatment plan, study restrictions and other study procedures.\n* Patients affiliated to a European social security system.\n* Patients agree to comply with the prevention of meningococcal infections by vaccination and\u002For antibiotic prophylaxis in accordance with the current local vaccination\u002Fantibiotic prophylaxis recommendations.\n* Patients with no contraindication to anti-C5 treatment.\n* Patients with no contraindication to antibiotic therapy.\n\nExclusion Criteria:\n\n* Active infection or other disorders causing weakness, known immunoglobulin A deficiency, active renal or hepatic disease, clinically significant cardiac disease, known hyperviscosity, or hypercoagulable state.\n* Any active malignancy.\n* Presence of antibodies other than anti-AChR-Ab+ (anti-titin-Ab+ were permitted as these are considered complementary markers to anti-AChR-Ab+).\n* Patient with a diagnosed thymoma.\n* Patient with a pathology judged by the investigator to interfere with the proper conduct of the study.\n* Positive pregnancy test. A urine pregnancy test will be carried out for women of childbearing age.\n* Any current mental condition (psychiatric disorder, senility, or dementia) that, in the opinion of the investigator, may affect study compliance or prevent understanding of the aims, investigational procedures, or possible consequences of the study.\n* Vaccination with live or live-attenuated vaccines within the 6 weeks.\n* Refusal of the subject to participate in the study.\n* Patient protected by law, under guardianship or curator ship, or not able to participate in a clinical study according to the article L.1121-16 of the French Public Health Code.\n* Known hypersensitivity to the active substance or to any of the excipients.",{"count":425,"type":22},"Myasthenia Gravis (MG) is a rare autoimmune disease that causes muscle weakness and fatigue. It occurs when the immune system produces antibodies that block communication between nerves and muscles. In some patients, the disease can suddenly worsen and cause severe breathing problems. This life-threatening situation is called a myasthenic crisis and requires immediate treatment in an intensive care unit (ICU). During such crises, patients may need to receive respiratory assistance through a ventilator. These episodes are often long and can lead to complications such as infections or heart problems.\n\nTo manage a myasthenic crisis, doctors usually use treatments that remove or neutralize the harmful antibodies: plasma exchange (PLEX) or intravenous immunoglobulin (IVIg). Although both are effective, recovery can be slow, and many patients remain in the ICU for several weeks.\n\nRavulizumab (Ultomiris®) is a new medicine that targets a specific part of the immune system called the complement system, which contributes to muscle damage in MG. It is already approved for adults with generalized MG who have anti-acetylcholine receptor (AChR) antibodies. Ravulizumab is given by intravenous infusion every eight weeks. Clinical studies have shown that it can improve symptoms within one week of starting treatment.\n\nSome doctors have started using ravulizumab early, after PLEX or IVIg, for patients hospitalized in the ICU for a myasthenic crisis. Early use of this treatment could help reduce the duration and severity of the crisis, leading to faster recovery and shorter hospital stays. However, there is currently no national study that systematically collects data on this approach.\n\nThe EARLY-MG study aims to describe the condition and recovery of patients who receive ravulizumab early during a myasthenic crisis requiring ICU admission. The study will not test an experimental treatment or change medical care. It is an observational study.\n\nThe main hypothesis of the study is that early administration of ravulizumab, after PLEX or IVIg, may help patients recover faster, improve muscle strength, and reduce complications and hospital stay.\n\nAround 30 adult patients with generalized MG and anti-AChR antibodies will be enrolled in 10 centers across France.\n\nEach patient will be followed for 26 weeks (about six months). Assessments will be performed at the start of the study and at weeks 2, 4, 10, 18, and 26. Investigators will collect information such as:\n\n* Duration of stay in the ICU and in the hospital after receiving ravulizumab\n* Duration of mechanical ventilation, if needed\n* Clinical improvement using standard evaluation scales (Myasthenia Gravis Activities of Daily Living, MG Foundation of America classification, and Garches' score)\n* Occurrence of any complications or additional treatments The study will last about 18 months in total, including one year for patient inclusion and six months of follow-up per patient. The results may help guide future recommendations and improve patient care in France and worldwide.",[29],"2026-02-09",{"date":472,"type":35},{"date":509,"type":35},"2025-11-26",{"date":511,"type":22},"2027-06-01",{"name":513,"class":163},"Centre Hospitalier Universitaire de Nice",{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":520,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":213,"enrollmentInfo":522,"targetDuration":4,"studyType":23,"phases":524,"briefSummary":525,"conditions":526,"keywords":527,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":535,"locationsCount":7},"100612220","phase-1-a-phase-1b2-study-of-im-101-in-adult-participants-with-generalized-myasthenia-gravis-and-ocular-myasthenia-gravis-100612220","NCT07250750","A Phase 1b\u002F2 Study of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis","A Phase 1b\u002F2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate A) the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of IM-101 in Adult Participants With Generalized Myasthenia Gravis, and B) the Efficacy and Safety of Treatment of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis","Synergy-MG","Inclusion Criteria:\n\n1. Able and willing to provide signed informed consent\n2. Willingness to consent to screening for genetic muscular diseases\n3. Male or female aged ≥ 18 years and \\\u003C 75 years\n4. Diagnosed with MG\n5. On a stable dose of background therapy for the treatment of MG\n6. Body weight ≥ 40 kg at screening\n7. Vaccinated against meningococcal infection (Neisseria meningitidis), streptococcus pneumoniae, and haemophilus influenzae type B\n\nExclusion Criteria:\n\n1. Previous exposure to IM-101\n2. Anti-MuSK antibody Positive\n3. History of malignant thymoma, or history of cancer within the past 5 years of screening\n4. History of N. meningitidis infection\n5. Has been treated with any complement inhibitor, but failed due to intolerability or lack of efficacy\n\nFull eligibility criteria is available in the study protocol.",{"count":523,"type":22},96,[25,95],"The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and potential efficacy of IM-101 in adult participants with AChR antibody-positive gMG. Subsequently, the safety and efficacy of the selected IM-101 dose-regimen will be tested in participants with AChR antibody-negative gMG and participants with AChR antibody-positive or AChR antibody-negative oMG.",[29],[528,29,529],"IM-101","C5 inhibitor",{"date":531,"type":35},"2026-02-11",{"date":533,"type":35},"2026-02-05",{"date":307,"type":22},{"name":536,"class":42},"ImmunAbs Inc.",{"id":538,"slug":539,"hasResults":135,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":544,"targetDuration":4,"studyType":23,"phases":546,"briefSummary":547,"conditions":548,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":556},"100435546","phase-3-a-study-of-nipocalimab-administered-to-adults-with-generalized-myasthenia-gravis-100435546","NCT04951622","A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis","Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis","Inclusion Criteria:\n\n* Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized myasthenia gravis (gMG) as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II a\u002Fb, III a\u002Fb, or IVa\u002Fb at screening\n* Myasthenia Gravis - Activities of Daily Living (MG-ADL) score of greater than or equal to (\\>=) 6 at screening and baseline\n* Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol\n* A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \\[beta-hCG\\]) at screening and a negative urine pregnancy test at Day 1 prior to administration of study intervention\n* A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last administration of study intervention\n* For the SC Substudy (Cohort 1 and Cohort 2): Has reasonable abdominal skin area for SC administration\n* For the SC Substudy (Cohort 1 and Cohort 2): Participants must be willing to comply with maintaining their stable dose of corticosteroids and\u002For immunosuppressants for the initial 8 weeks of the SC substudy, that is, through the SC Week 8 visit\n\nExclusion Criteria:\n\n* Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his\u002Fher gMG, or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant\n* Has MGFA Class I disease or presence of MG crisis (MGFA Class V) at screening, history of MG crisis within 1 month of screening, or fixed weakness (and\u002For 'burnt out' MG)\n* Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the study\n* Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients\n* Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening\n* For the SC Substudy (Cohort 1): Participants who have undergone a recent tapering of their concomitant MG medication in the OLE\n* For the SC Substudy (Cohort 1): Participants deteriorating during the OLE in the month prior to SC Dose 1 of the SC substudy such that they meet the criteria for clinical deterioration\n* For the SC Substudy (Cohort 2): History of an unprovoked pulmonary embolism within 1 year prior to screening or history of recurrent deep vein thrombosis (DVT)",{"count":545,"type":22},199,[217],"The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG). The purpose of the subcutaneous substudy is to evaluate how well it works in the body (pharmacodynamic \\[PD\\]) when given as an injection under the skin (subcutaneous) compared to when given through a vein (intravenous) in participants with gMG.",[29],{"date":550,"type":35},"2026-03-03",{"date":552,"type":35},"2021-07-15",{"date":554,"type":22},"2029-03-30",{"name":228,"class":42},112,{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":4,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":564,"targetDuration":4,"studyType":23,"phases":565,"briefSummary":567,"conditions":568,"keywords":570,"overallStatus":573,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":164},"100623122","early-phase-1-universal-chimeric-antigen-receptor-t-cell-ucar-t-cell-therapy-targeting-cd19-bcmaqt-019c-in-patients-with-r-r-neurological-autoimmune-diseases-100623122","NCT07392528","Universal Chimeric Antigen Receptor T-Cell （UCAR T-cell） Therapy Targeting CD19\u002F BCMA（QT-019C） in Patients With r\u002F r Neurological Autoimmune Diseases","A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA（QT-019C） in Patients With Relapsed \u002F Refractory Neurological Autoimmune Diseases","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Subjects with relapsed or refractory neurological autoimmune diseases, Including neuromyelitis optica spectrum disorders(NMOSD), myasthenia gravis(MG), multiple sclerosis(MS)，Autoimmune encephalitis(AE) and chronic inflammatory demyelinating Polyradiculoneuropathy(CIDP).\n* Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating.\n* Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* Subjects with a history of severe drug allergies or allergic tendencies.\n* History of malignancy within five years. The following conditions are excluded: non-melanoma skin cancer, stage I tumors that have a low recurrence probability after complete resection, clinically localized prostate cancer after treatment, cervical carcinoma in situ confirmed by biopsy or squamous intraepithelial lesion shown on smear, stable papillary thyroid carcinoma or follicular thyroid carcinoma.\n* Subjects with insufficient cardiac function.\n* Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \\>the upper limit of detection; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing.\n* Pregnant women or women planning to conceive.",{"count":204,"type":22},[566],"EARLY_PHASE1","This is an open label, single-site, dose-escalation study in up to 15 participants with relapsed or refractory Neurological Autoimmune Diseases. This study aims to evaluate the safety and efficacy of the treatment with universal CD19\u002FBCMA CAR T-cells（QT-019C）.",[569,30,29],"Neuromyelitis Optica Spectrum Disorders",[571,572],"Universal Allogeneic CAR T-cells","QT-019C","NOT_YET_RECRUITING","2026-02-08",{"date":531,"type":35},{"date":577,"type":22},"2026-03",{"date":579,"type":22},"2028-12",{"name":581,"class":163},"Tianjin Huanhu Hospital",{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":340,"enrollmentInfo":589,"targetDuration":591,"studyType":141,"phases":4,"briefSummary":592,"conditions":593,"keywords":4,"overallStatus":573,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":603,"completionDateStruct":605,"leadSponsor":607,"locationsCount":164},"100618559","tongji-nads-cohort-100618559","NCT07333196","Tongji NADs Cohort","Tongji NADs Cohort: A Real-world Observation of Neurological Autoimmune Disorders","Inclusion Criteria:\n\n* Participants must meet the following eligibility criteria at the time of screening to participate in this study.\n\n1.1. The subject is able to understand the purpose and risks of the study, provide informed consent and authorize the use of confidential health information in accordance with national and local privacy regulations.\n\n1.2. Open to both men and women, aged 18-80 years (inclusive) at the time of informed consent.\n\n1.3. Must be diagnosed with one of the following conditions:\n\n1.3.1. This study adhered to the 2017 McDonald criteria for diagnosing multiple sclerosis:\n\n1. ≥2 clinical episodes with ≥2 objective clinical evidences of lesions.\n2. ≥2 clinical episodes with one clear historical evidence of the lesion involving specific anatomical site.\n3. ≥2 clinical episodes with objective clinical evidence of one lesion, and spatial multiplicity confirmed by clinical episodes in different CNS sites or MRI findings.\n4. A single episode with ≥2 objective clinical evidences, confirmed by additional clinical episodes or MRI showing temporal multiple lesions or OCB positivity.\n5. A single episode with one objective clinical manifestation, confirmed by clinical seizures or MRI scans across multiple CNS regions to demonstrate spatial multiplicity, and further supported by additional clinical episodes or MRI findings to confirm temporal multiplicity or OCB positivity.\n6. Indication for the progressive multifocal sclerosis (PPMS) phase: Disease progression at 1 year (confirmed retrospectively or prospectively), with two of the following three criteria: \\[1\\] Spatially multifocal evidence of brain lesions: ≥1 T2-weighted lesion in characteristic MS regions (periventricular, corticoprotuberant, or subarachnoid) \\[2\\] Spatially multifocal evidence of spinal lesions: ≥2 T2-weighted lesions in the spinal cord \\[3\\] OCB positivity.\n\n1.3.2. This study adhered to the 2015 IPND diagnostic criteria for adult neuromyelitis optica spectrum disorders:\n\n1. NMOSD diagnosis with AQP4-IgG positivity: meeting ≥1 core clinical feature, confirmed by reliable AQP4-IgG detection (CBA method recommended), and excluding other diagnoses.\n2. Diagnostic criteria for NMOSD with AQP4-lgG negative or undetermined status: In at least one clinical episode, the presence of ≥2 core clinical features meeting all of the following criteria: ①≥1 core clinical feature is ON, acute LETM, or bulbar syndrome; ②≥2 distinct core clinical features; ③MRI supplementary criteria are satisfied. AQP4-lgG should be reliably detected as negative or undetected, and other diagnoses must be excluded.\n\nNote: Core clinical features include six cardinal signs: optic neuritis (ON), acute myelitis (LETM), and the final area syndrome (unexplained paroxysmal hiccups, nausea, and vomiting); other brainstem syndromes; symptomatic narcolepsy\u002Fhypothalamic syndrome with characteristic hypothalamic MRI lesions; and brain syndrome with characteristic cerebral MRI lesions.\n\nMRI diagnostic criteria: Acute optic neuritis (ON) requires MRI demonstrating one of the following: ① Normal brain MRI or non-specific white matter lesions; ② Long T-weighted signal or T-weighted enhancement exceeding 1\u002F2 of optic nerve length, or optic chiasm involvement; ③ Acute myelitis (LETM) requires three or more consecutive vertebral segments with spinal cord lesions, or spinal cord atrophy exceeding three consecutive vertebral segments in patients with myelitis history; ④ Final region syndrome: lesions in the dorsal medulla or final region. Acute brainstem syndrome: periventricular lesions in the brainstem.\n\n1.3.3. This study adhered to the MOGAD diagnostic criteria established by the International Parkinson's Disease and Movement Disorders (IPMD) in 2023:\n\n1. A diagnosis of MOGAD can be confirmed when: (a) fixed or live-cell CBA detects strong positivity of MOG-IgG in serum with ≥1 core clinical manifestation, and (b) other diagnoses (e.g., MS, NMOSD) are excluded;\n2. If the CBA shows weak positivity of MOG-IgG in serum, or MOG-IgG positivity without titer, or negative serum MOG-IgG with strong positivity in cerebrospinal fluid (CSF), the diagnosis requires: 1) ≥1 core clinical manifestation, 2) ≥1 supporting clinical or imaging feature, 3) negative serum AQP4-IgG, and 4) exclusion of other diagnoses (e.g., MS, NMOSD).\n\nNote: The core clinical features include six main signs: optic neuritis, myelitis, acute disseminated encephalomyelitis, monofocal or multifocal cerebral dysfunction, brainstem or cerebellar functional deficits, and cerebral cortex inflammation with epilepsy.\n\nTypical MRI imaging features: ① Optic Neuropathy (ON): Bilateral optic nerve involvement with long-segment optic nerve damage (\\>50% optic nerve length), optic nerve sheath enhancement, and papilledema. ② Myelitis: Long-segment transverse myelitis with central spinal cord damage or \"H\" sign, and conus medullaris damage. ③ Cerebral, brainstem, or cerebral cortex symptoms: Multifocal ill-defined T2 hyperintense lesions in supratentorial and infratentorial white matter, deep gray matter involvement, ill-defined T2 hyperintense lesions in pons, cerebellar midfoot, or medulla oblongata, and cortical lesions with or without focal enhancement and local dural enhancement.\n\nThe strong positive result of serum and cerebrospinal fluid MOG-IgG was defined as the value of the live CBA was more than 2 times the detection limit or the fixed CBA titer was ≥1:100. The weak positive result was defined as the value of the live CBA was in the lower range or the fixed CBA titer was ≥1:10 but less than 1:100.\n\n1.3.4. This study followed the expert consensus on the diagnosis and treatment of autoimmune encephalitis in China (2022 edition)\n\n1. Possible AE: meeting the following three diagnostic criteria A, B, and D; confirmed AE: meeting the four diagnostic criteria A, B, C, and D.\n2. Diagnostic criteria:\n\nA. Clinical presentation: Acute or subacute onset (\\\u003C3 months) with ≥1 of the following neurological or psychiatric symptoms or clinical syndromes: limbic system symptoms, encephalitis syndrome, lymphocytic inflammation in cerebrospinal fluid cytology, and positive specific oligoclonal bands.\n\nB. Neuroimaging or electrophysiological abnormalities: T2 or FLAIR abnormal signals in the limbic system (unilateral or bilateral), or T2\u002FFLAIR abnormalities in other regions (excluding nonspecific white matter changes and stroke); or PET findings of high metabolism in the limbic system, or multiple high metabolic areas in the cortex and\u002For basal ganglia; or EEG abnormalities such as focal epilepsy or epileptiform discharges (in the temporal lobe or outside it), or diffuse or multifocal slow-wave rhythms.\n\nC. Diagnostic test: Positive for anti-neuronal antibodies. D. Reasonably rule out other possible causes.\n\n1.3.5. This study adhered to the diagnostic criteria for AIDP, CIDP, and autoimmune Ranvier node disease:\n\n1. AIDP: Essential features include: ① Progressive weakness in the upper and\u002For lower limbs, ranging from mild bilateral lower limb weakness to complete paralysis of all limbs (including trunk, medullary muscles, and facial muscles) and oculomotor muscle paralysis; ② Weakened or absent deep tendon reflexes in the affected limbs; ③ Symptom progression ≤4 weeks. Supporting features include: ① Symptom progression from days to 4 weeks; ② Relatively symmetrical bilateral symptoms; ③ Trunk or limb pain; ④ Cranial nerve symptoms or signs; ⑤ Autonomic dysfunction; ⑥ Respiratory insufficiency; ⑦ Mild or absent sensory dysfunction; ⑧ History of prodromal systemic infection in approximately 70% of cases; ⑨ No fever at symptom onset; ⑩ Elevated cerebrospinal fluid protein with normal or mildly elevated white blood cell count (\\\u003C5 mm³); ⑪ Electrophysiological examination showing abnormalities consistent with Guillain-Barré syndrome (GBS); ⑫ Recovery begins 2-4 weeks after symptom stabilization.\n2. CIDP: CIDP develops in 2%-5% of patients initially diagnosed with AIDP, with the following clinical features: ① Progressive or recurrent disease progression lasting over 8 weeks; ② Only approximately 30% of patients experience prodromal events; ③ Additional supporting features include: ≥3 acute relapses or exacerbations occurring ≥8 weeks after symptom onset, milder symptoms, preserved independent walking ability throughout the disease course, and absence of cranial nerve involvement or frequent respiratory system involvement.\n3. Autoimmune Ranvier node disease:\n\n   * Clinical manifestations: a. Acute, subacute or chronic course, with persistent progression after 8 weeks of onset; b. Clinical features consistent with polyneuropathy; c. May be accompanied by significant ataxia, tremor or neuropathic pain; d. May be associated with nephrotic syndrome.\n   * Electrophysiological findings: a. Motor nerve conduction tests reveal prolonged distal motor latency, slowed conduction velocity, abnormal waveform dispersion, and conduction block, with decreased F-wave conduction velocity, consistent with myelination abnormalities; b. Both motor and sensory nerve conduction show markedly reduced amplitude. Electromyography (EMG) at needle electrodes demonstrates abnormal spontaneous potentials and decreased recruitment, indicating early axonal damage.\n   * Antibody detection: serum anti-Langfei junction antibody was positive, especially serum anti-NF155, anti-CNTN1, anti-Casp1 and anti-NF140\u002F186 antibody.\n   * Cerebrospinal fluid (CSF) analysis: Protein-cell dissociation is observed, with CSF protein levels typically showing significant elevation.\n\n1.3.6. This study adheres to the diagnostic criteria of the 2024 China Expert Consensus on the Diagnosis and Treatment of Refractory Systemic Myasthenia Gravis\n\n1. Basic conditions\n\n   ① Meet the diagnostic criteria in the China Guidelines for the Diagnosis and Treatment of Myasthenia Gravis (2025 edition).\n\n   ② The patient's Myasthenia Gravis Activities of Daily Living (MG-ADL) score was ≥6, and the ocular muscle score was less than 50% of the total score.\n2. Diagnostic criteria:\n\n   * After adequate duration of treatment with at least two conventional immunotherapeutic agents (including both corticosteroids and non-corticosteroid immunosuppressants), the post-intervention status (PIS) remains unchanged or worsens.\n   * After adequate doses and duration of at least two conventional immunotherapeutic drugs, the PIS showed improvement, but the MG-ADL score remained ≥6 points for at least six months.\n   * After adequate duration of treatment with at least two conventional immunotherapeutic agents, the PIS was remitted or improved, but during the regular tapering of immunotherapy, disease symptoms worsened ≥2 times per year (MG-ADL score ≥6).\n   * Patients who, after a crisis, received multiple immunotherapies including intravenous immunoglobulin (IVIG), plasma exchange, and high-dose intravenous methylprednisolone (IVMP), along with active infection control, still remained unable to wean off mechanical ventilation for more than 14 days due to MG-induced respiratory muscle weakness.\n\nDiagnostic criteria: meeting all the above basic conditions plus 1 of the 4 diagnostic conditions.\n\n1.3.7. This study adheres to the 2017 diagnostic criteria for idiopathic inflammatory myopathy (IIM) established by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR), following the EULAR\u002FACR classification system. Patients with a probability score ≥55% in the table below are considered suspected IIM cases. Suspected IIM patients can be diagnosed with dermatomyositis in adults if they meet the following criteria: ① Age ≥18 years at first onset of IIM-related symptoms; ② Presence of Heliotrope sign, Gottron papules, or Gottron sign; ③ Objective proximal symmetrical arm weakness (confirmed by manual muscle strength testing or other strength assessment methods), typically progressive, or objective proximal symmetrical leg weakness, typically progressive, or more pronounced neck flexor weakness than neck extensor weakness, or more pronounced proximal leg weakness than distal leg weakness. If patients meet criteria ① and ② but not ③, they may be diagnosed with non-myopathic dermatomyositis. Compared to previous standards, this criterion demonstrates higher sensitivity and specificity. In this standard, patients with typical clinical manifestations (such as characteristic rashes) do not require further tests (e.g., muscle biopsy), while some patients without typical rashes may be missed.\n\nExclusion Criteria:\n\n* This is an observational study with no specific exclusion criteria.\n* The investigators identified other unexplained factors that may have disqualified participants from enrollment.",{"count":590,"type":22},1550,"10 Years","Neurological Autoimmune Diseases (NADs) are disorders caused by abnormal immune system attacks on neural tissues, affecting multiple systems including the central nervous system, peripheral nervous system, and neuromuscular junctions. This study examines clinically significant NADs such as multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD), myelin oligodendrocyte glycoprotein G antibody-related diseases (MOGAD), autoimmune encephalitis (AE), immune-mediated peripheral neuropathy (PN), myasthenia gravis (MG), and idiopathic inflammatory myopathy (IIM). While sharing the core pathogenesis of autoimmune response, these diseases exhibit significant heterogeneity in epidemiological patterns, clinical manifestations, therapeutic approaches, and disease progression. This heterogeneity stems from multiple factors: (1) Differences in immune targets: MS primarily involves T-cell-mediated myelin attack, NMOSD is mainly driven by astrocyte damage caused by anti-AQP4 antibodies, MOGAD results from myelin surface loss mediated by antibodies against myelin oligodendrocyte glycoprotein immunoglobulin G, while AE involves synaptic dysfunction due to antibodies against neuronal surface proteins (e.g., anti-NMDA-R antibodies); (2) Genetic-environmental interactions: MS is more prevalent in European and American populations, whereas NMOSD is more aggressive in Asian populations; (3) Variability in treatment response: Some diseases respond well to immunomodulatory therapy, but most still face challenges such as high relapse rates, progressive disability accumulation, and irreversible neurological damage.\n\nWhile randomized controlled trials (RCTs) provide high-quality core evidence for drug registration, their strict inclusion\u002Fexclusion criteria, relatively homogeneous patient populations, and short-term observation designs often fail to fully capture the complex disease progression and treatment response patterns in real-world clinical settings. Additionally, long-term RCTs are frequently constrained by economic factors and sustainability challenges. Therefore, conducting comprehensive real-world observational studies (RWS) on NADs-integrating multi-disease cohorts, long-term follow-up data, and diverse clinical practices-holds significant scientific and clinical value for optimizing treatment strategies and improving long-term patient outcomes.",[30,594,145,595,596,597,598,29,599],"NMO Spectrum Disorder","Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease","Autoimmune Nodopathy","Acute Inflammatory Demyelinating Polyradiculoneuropathy","Chronic Inflammatory Demyelinating Polyradiculoneuropathy","Idiopathic Inflammatory Myopathies","2026-01-17",{"date":602,"type":35},"2026-01-21",{"date":604,"type":22},"2026-03-01",{"date":606,"type":22},"2037-03-01",{"name":608,"class":163},"Tongji Hospital",{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":4,"eligibilityCriteria":615,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":616,"targetDuration":4,"studyType":23,"phases":617,"briefSummary":618,"conditions":619,"keywords":620,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":164},"100588266","early-phase-1-universal-chimeric-antigen-receptor-t-cell-ucar-t-cell-therapy-targeting-cd19b-cell-maturation-antigen-cd19bcma-in-patients-with-rr-neurological-autoimmune-diseases-100588266","NCT06939166","Universal Chimeric Antigen Receptor T-Cell （UCAR T-cell） Therapy Targeting CD19\u002FB Cell Maturation Antigen （CD19\u002FBCMA） in Patients With r\u002Fr Neurological Autoimmune Diseases","A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapsed \u002F Refractory Neurological Autoimmune Diseases","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Flow cytometry detected positive B cell CD19 or BCMA in the patient's peripheral blood.\n* Subjects with relapsed or refractory neurological autoimmune diseases, Including neuromyelitis optica spectrum disorders(NMOSD), myasthenia gravis(MG), multiple sclerosis(MS)，Autoimmune encephalitis(AE) and chronic inflammatory demyelinating Polyradiculoneuropathy(CIDP).\n* Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating.\n* Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* Subjects with a history of severe drug allergies or allergic tendencies.\n* History of malignancy within five years.\n* Subjects with insufficient cardiac function.\n* Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \\>the upper limit of detection; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing.\n* Pregnant women or women planning to conceive.",{"count":253,"type":22},[566],"This is an open label, single-site, dose-escalation study in up to 12 participants with relapsed or refractory Neurological Autoimmune Diseases. This study aims to evaluate the safety and efficacy of the treatment with universal CD19\u002FBCMA CAR T-cells.",[569,29,30,598,145],[571],"2025-12-11",{"date":623,"type":35},"2025-12-15",{"date":625,"type":35},"2025-06-17",{"date":627,"type":22},"2027-10",{"name":581,"class":163},{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":4,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":636,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":638,"conditions":639,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":646,"locationsCount":164},"100578733","effectiveness-and-safety-of-zilucoplan-treatment-for-french-patients-with-myasthenia-gravis-over-3-months-100578733","NCT06815133","Effectiveness and Safety of Zilucoplan Treatment for French Patients With Myasthenia Gravis Over 3 Months","Multicenter Retrospective Study on the Short- and Medium-Term Efficacy and Tolerance of Zilucoplan Therapy in a Cohort of French Patients With Anti-AChR Myasthenia Gravis","Inclusion Criteria:\n\n\\- Confirmed diagnosis of myasthenia gravis with anti-AChR antibodies in patients treated with Zilucoplan\n\nExclusion Criteria:\n\n* None",{"count":637,"type":22},55,"This study called \"Multicenter Retrospective Study on the Short- and Medium-Term Efficacy and Tolerance of Zilucoplan Therapy in a Cohort of French Patients with Anti-AChR Myasthenia Gravis\", is investigating the effects of a new treatment called Zilucoplan (generic name: ZILBRYSQ) on patients in France with a condition known as myasthenia gravis. Myasthenia gravis is an autoimmune disease that causes muscle weakness that worsens throughout the day with activity and impacts the ability to work and perform daily activities. The study aims to see if Zilucoplan can improve muscle strength and quality of life over three months, while also assessing its tolerance and safety by monitoring side effects. Researchers hope this treatment will offer significant benefits for people with this challenging condition.",[29],"2025-11-25",{"date":642,"type":35},"2025-12-03",{"date":644,"type":35},"2025-03-01",{"date":550,"type":22},{"name":513,"class":163}]