[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mg\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mg":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,61],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100615558","adapt-forward---master-protocol-of-a-platform-study-to-evaluate-the-safety-and-efficacy-of-multiple-regimens-in-participants-with-myasthenia-gravis-100615558",false,"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","ALL","18 Years",{"count":19,"type":20},70,"ESTIMATED","OBSERVATIONAL","ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life.",[24,25,26,27,28,29],"Myasthenia Gravis","MG","gMG","Generalized Myasthenia Gravis","Generalized Myasthenia Gravis (gMG)","AChR-Ab Seropositive Generalized Myasthenia Gravis","RECRUITING","2026-06-11",{"date":33,"type":34},"2026-06-12","ACTUAL",{"date":36,"type":34},"2025-12-19",{"date":38,"type":20},"2028-03-07",{"name":40,"class":41},"argenx","INDUSTRY",18,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":58,"leadSponsor":59,"locationsCount":60},"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":19,"type":20},"INTERVENTIONAL",[53],"PHASE2","This study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life.\n\nThe aim of this 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",[29,24,25,26,27,28],{"date":33,"type":34},{"date":36,"type":34},{"date":38,"type":20},{"name":40,"class":41},15,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":51,"phases":69,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100575717","early-phase-1-clinical-study-on-targeted-cd19bcma-car-t-therapy-for-autoimmune-diseases-100575717","NCT06775912","Clinical Study on Targeted CD19\u002FBCMA CAR-T Therapy for Autoimmune Diseases","Inclusion Criteria:\n\n1. The subjects voluntarily participated in the study and signed the informed consent form.\n2. Age ≥18 years old and ≤70 years old, both sexes.\n3. Organ function and laboratory tests:\n\n   1. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN), total bilirubin (TBIL) ≤2×ULN (except Gilbert's syndrome).\n   2. Renal function: creatinine ≤1.5×ULN or creatinine clearance ≥40 ml\u002Fmin.\n   3. Blood routine: neutrophil count ≥1×109\u002FL, hemoglobin ≥60g\u002FL, platelet count ≥20×109\u002FL, lymphocyte count \\>0.3×109\u002FL.\n   4. Coagulation: international normalized ratio (INR) ≤ 1.5×ULN, or prothrombin time (PT) ≤ 1.5×ULN.\n   5. Oxygen saturation (SpO2) ≥92% at rest in room air.\n   6. Left ventricular ejection fraction (LVEF) ≥50% on echocardiography.\n4. Negative serum or urine pregnancy test results in female subjects of childbearing potential at screening.\n5. Women of childbearing potential must agree to use a highly effective method of contraception for at least 28 days before initiation of elution and up to 12 months after RD06-04 reinfusion. Men of childbearing potential had to agree to the use of an effective barrier method of contraception from the initiation of lymphoidectomy until 12 months after reinfusion of RD06-04 and had to refrain from donating semen or sperm throughout the trial.\n\nSLE Patient Inclusion Criteria:\n\n1. A definitive diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR) \u002F American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria.\n2. Positive antinuclear antibodies (ANA) at screening, and\u002For positive anti-double-stranded DNA (anti-dsDNA) antibodies, and\u002For positive anti-Smith antibodies.\n3. A SLEDAI-2K score \\>6 at screening, and a 'clinical' SLEDAI-2K score ≥4.\n\nSSc Patient Inclusion Criteria:\n\n1. Diagnosed with SSc according to the 2013 ACR\u002FEULAR classification criteria.\n2. Diagnosed with diffuse cutaneous SSc at screening, with a disease duration ≤6 years.\n\nAAV Patient Inclusion Criteria:\n\n1. Meeting the diagnostic criteria for ANCA-associated vasculitis established by the 2022 ACR\u002FEULAR, including Microscopic Polyangiitis (MPA), Granulomatosis with Polyangiitis (GPA), and Eosinophilic Granulomatosis with Polyangiitis (EGPA).\n2. Positive testing for ANCA-associated antibodies 3 months before screening or at screening (specifically, positive anti-myeloperoxidase antibodies, MPO-ANCA, or positive anti-proteinase 3 antibodies, PR3-ANCA).\n\nIIM Patients Inclusion Criteria:\n\n1. Diagnosed with IIM according to the 2017 ACR\u002FEULAR classification criteria (including probable or definite diagnosis, i.e., probability ≥55%), including subtypes such as Dermatomyositis (DM), Anti-Synthetase Syndrome (ASS), and Immune-Mediated Necrotizing Myopathy (IMNM).\n2. Patients in the active phase, defined as those with at least 2 of the following six core set measures being abnormal: decreased muscle strength (MMT-8 \\\u003C142), Physician Global Assessment (PhGA, 10cm VAS) ≥2cm, Patient Global Assessment (PtGA, 10cm VAS) ≥2cm, Extramuscular Disease Activity Total Score (assessed using the MDAAT scoring tool) ≥2cm, Health Assessment Questionnaire (HAQ) ≥0.25, and Creatine Kinase (CK) muscle enzyme levels ≥1.5×ULN\n\nSjögren's Syndrome (SS) Patient Inclusion Criteria:\n\n1. Diagnosed with primary Sjögren's Syndrome according to the 2016 ACR\u002FEULAR classification criteria.\n2. Positive for anti-SSA\u002FRo antibodies detected 3 months before screening or at screening.\n3. A score of ≥5 on the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) at screening.\n\nExclusion Criteria:\n\n1. SLE Patients: Those with uncontrolled lupus crisis within the 8 weeks prior to screening, including rapidly progressive lupus nephritis, severe neuropsychiatric lupus, severe hemolytic anemia, severe immune thrombocytopenia, agranulocytosis, severe cardiac damage, severe lupus pneumonia, severe lupus hepatitis, and severe vasculitis, as assessed by the investigator as unsuitable to participate in this study.\n2. IIM Patients: Presence of severe rhabdomyolysis or CK levels ≥120×ULN at screening.\n3. Patients with severe asthma or Chronic Obstructive Pulmonary Disease (COPD) are eligible. Patients with mild or moderate asthma or COPD who are receiving stable treatment can also be enrolled.\n4. There has been an active infection requiring systemic treatment within 2 weeks prior to the urethral irrigation, such as infectious pneumonia, tuberculosis, etc.\n5. Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive for hepatitis C virus (HCV) antibody with detectable HCV RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis antibody.\n6. Pregnant or breastfeeding women.\n7. Any condition that, in the investigator's opinion, may affect study participation, pose a safety risk to the patient, or potentially confound the interpretation of study results.","70 Years",{"count":42,"type":20},[70],"EARLY_PHASE1","This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with active SLE, SSc, AAV, IIM, NMOSD, MS, MG",[73,74,75,76,77,25,78],"SLE","Systemic Sclerosis","IIM","NMOSD","MS","ANCA Associated Vasculitis (AAV)","2026-01-30",{"date":81,"type":34},"2026-02-02",{"date":83,"type":34},"2025-01-03",{"date":85,"type":20},"2027-06-01",{"name":87,"class":41},"Nanjing Bioheng Biotech Co., Ltd.",1,""]