[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"TG Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":240},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,40,63,88,118,140,159,179,200,220],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100645322","phase-2-study-to-evaluate-the-safety-and-efficacy-of-ublituximab-in-participants-with-schizophrenia-100645322",false,"NCT07680946","Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia","Evaluating Safety and Efficacy of Ublituximab in Participants With Schizophrenia","Inclusion Criteria:\n\n1. Primary diagnosis of schizophrenia.\n2. Treatment-resistant.\n3. Requires antipsychotic treatment and is currently receiving \"standard of care\".\n4. PANSS total score between 80 and 120, inclusive at screening and baseline.\n\nExclusion Criteria\n\n1. Any primary Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) disorder other than schizophrenia.\n2. Ongoing clozapine treatment.\n3. Risk for suicidal behavior.\n4. Any severe or uncontrolled medical condition that could affect the participant's ability to participate.\n\nNote: Other protocol-specified Inclusion\u002FExclusion criteria may apply","ALL","18 Years","60 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The main objective of this Phase 2 study is to assess the efficacy of ublituximab as measured by positive and negative syndrome scale (PANSS) total score in participants with schizophrenia.",[27],"Schizophrenia","NOT_YET_RECRUITING","2026-06-26",{"date":31,"type":32},"2026-07-02","ACTUAL",{"date":34,"type":21},"2026-07-06",{"date":36,"type":21},"2029-03-01",{"name":38,"class":39},"TG Therapeutics, Inc.","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"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":48,"type":21},120,[24],"The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod.",[52],"Myasthenia Gravis","RECRUITING","2026-06-22",{"date":56,"type":32},"2026-06-29",{"date":58,"type":21},"2026-07-30",{"date":60,"type":21},"2030-01-01",{"name":38,"class":39},2,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100609874","phase-2-study-to-assess-effects-of-ublituximab-in-pediatric-participants-with-relapsing-forms-of-multiple-sclerosis-100609874","NCT07220252","Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis","Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)","Inclusion Criteria for Part A and Part B:\n\n1. Diagnosis of RMS.\n2. EDSS at screening: 0-5.5, inclusive.\n3. Neurologic stability for ≥ 30 days prior to screening, and between screening and Week 1 Day 1 (W1D1).\n\nInclusion Criteria for Part C:\n\n1\\. Participants must have completed Part A (Week 24 visit) or Part B (Week 96 visit) to be eligible for Part C.\n\nExclusion Criteria for Part A and B:\n\n1. Known presence or suspicion of other neurologic disorders that may mimic MS.\n2. Prior treatments:\n\n   1. Systemic corticosteroids (\\>0.1 milligrams\u002Fkilogram\u002Fday \\[mg\u002Fkg\u002Fday\\], or \\>5 milligrams\u002Fday \\[mg\u002Fday\\] of prednisone equivalent) or adrenocorticotropic hormone (ACTH) within 30 days prior to the screening MRI scan (note: Topical, ophthalmic, or inhaled corticosteroids are permitted).\n   2. High dose intravenous immunoglobulin (IVIG) or subcutaneous IG (SCIG) within 2 months prior to W1D1.\n   3. Treatment with anti-CD20 or other B cell directed treatment at any time.\n   4. Treatment with alemtuzumab, cladribine, cyclophosphamide, mitoxantrone at any time.\n\nAdditional Exclusion Criteria for Part B Only (Relevant to Fingolimod Treatment):\n\n1. Treatment with fingolimod or other sphingosine-1 phosphate-1 (S1P1) modulators at any time.\n2. The following antiarrhythmic drugs at Screening: Class Ia anti-arrhythmics.\n\nExclusion Criteria for Part C:\n\n1\\. If the absolute lymphocyte count (ALC) is outside the specified range the participant will not be eligible to receive ublituximab in Part C.\n\nNote: Other protocol-specified inclusion\u002Fexclusion criteria may apply","10 Years","17 Years",{"count":73,"type":21},240,[24,75],"PHASE3","The primary purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ublituximab in participants ages 10 to less than (\\\u003C)18 years and body weight greater than or equal to (≥)25 kilograms (kg) to less than or equal to (≤)40 kg with RMS (Part A) and to evaluate the non-inferiority of ublituximab compared with fingolimod in pediatric RMS participants with body weight ≥ 25 kg (Part B). The study will further evaluate long-term safety and efficacy of ublituximab in RMS in pediatric participants during its extension period (Part C).",[78],"Relapsing Multiple Sclerosis","2026-06-19",{"date":81,"type":32},"2026-06-23",{"date":83,"type":21},"2026-08-01",{"date":85,"type":21},"2033-06-30",{"name":38,"class":39},1,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":116,"locationsCount":117},"100568347","phase-1-a-study-to-assess-the-safety-and-clinical-activity-of-azer-cel-in-participants-with-b-cell-mediated-autoimmune-disorders-100568347","NCT06680037","A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders","A Phase 1, Open-label Study to Evaluate the Safety and Clinical Activity of Azercabtagene Zapreleucel in Participants With B-cell Mediated Autoimmune Disorders","Inclusion Criteria:\n\nPMS and RMS inclusion criteria:\n\n1. Age 18 years to ≤60 years (inclusive) at screening.\n2. Expanded Disability Status Scale (EDSS) score 3.0 - 6.5 (inclusive) at screening.\n3. Diagnosis of primary progressive multiple sclerosis (PPMS), secondary progressive multiple sclerosis (non-active or active), or Relapsing MS (RMS).\n4. Documented evidence of disability progression independent of relapse (PIRA) at any point over the 12 months prior to the screening visit.\n\nNMOSD inclusion criteria:\n\n1. Between age 18 and 65 years, inclusive at the time of signing the informed consent.\n2. EDSS score between 2.0 and 7.0 at screening, inclusive (for higher EDSS, the Investigator must assess that the participant is reasonably able to participate in the study).\n3. Diagnosis of anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive at screening (verified by the allocated central laboratory) and Neuromyelitis Optica Spectrum Disorder (NMOSD).\n4. Must meet the appropriate NMOSD treatment washout criteria prior to receiving lymphodepletion.\n\nMG Inclusion criteria:\n\n1. Age ≥18 and ≤70 years of age at the time of signing the informed consent.\n2. Diagnosed with gMG at least 1 year prior to the date of signing the informed consent.\n3. Confirmation of MG Diagnosis:\n\n   1. Positive serologic test for anti-acetylcholine receptor (AChR) antibodies or anti-muscle-specific kinase (MuSK) antibodies confirmed at screening AND\n   2. One of the following (either historical or during screening):\n\n      * Abnormal neuromuscular transmission test demonstrated by single-fiber electromyography or repetitive nerve stimulation.\n      * Positive anticholinesterase test (e.g., edrophonium chloride test).\n      * Demonstrated improvement in MG signs on oral cholinesterase inhibitors, as assessed by the treating physician.\n4. MG activities of daily living (MG-ADL) score ≥6 at screening.\n\nCIDP Inclusion criteria\n\n1. Age ≥18 and ≤70 years of age at the time of signing the informed consent.\n2. Participant must have either typical CIDP, or one of the following two CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome).\n3. CIDP Disease Activity Status (CDAS): CDAS score ≥3 at screening.\n4. INCAT Disability Score: INCAT disability score ≥4 to ≤9 score at screening.\n\nGeneral Exclusion Criteria:\n\n1. History of malignancy that has not been in remission for at least 2 years.\n2. Viral Screening\n\n   1. Evidence of chronic active or history of hepatitis B virus (HBV).\n   2. Seropositive for human immunodeficiency virus (HIV) antibody.\n3. History of bone marrow\u002Fhematopoietic stem cell or solid organ transplantation.\n4. Prior treatment with adoptive T-cell therapy or any gene therapy product directed at any target (e.g. CAR T-cell therapy).\n\nNote: Other protocol-specified Inclusion\u002FExclusion criteria may apply.",{"count":96,"type":21},100,[98],"PHASE1","The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).",[101],"B-cell Mediated Autoimmune Disorders",[103,104,105,106,107,108,109],"Progressive forms of multiple sclerosis (PMS)","Primary Progressive MS (PPMS)","Secondary Progressive MS (SPMS)","Multiple Sclerosis (MS)","Neuromyelitis optica spectrum disorder (MNOSD)","Myasthenia Gravis (MG)","Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","2026-06-17",{"date":112,"type":32},"2026-06-18",{"date":114,"type":32},"2025-05-06",{"date":60,"type":21},{"name":38,"class":39},8,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":125,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":134,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":87},"100549419","a-study-evaluating-the-effect-of-briumvi-ublituximab-on-pregnancy-and-infant-outcomes-in-participants-with-multiple-sclerosis-ms-100549419","NCT06433765","A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)","BRIUMVI® Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated With BRIUMVI®","Inclusion Criteria:\n\n1. For exposed cohort: Participant exposed to at least 1 dose of BRIUMVI®.\n2. For unexposed cohort: Participants not exposed to BRIUMVI® at any time during the pregnancy.\n3. Diagnosis of MS.\n4. Currently or recently (within 1 year of pregnancy outcome) pregnant.\n5. Authorization from healthcare provider to provide data to registry.\n\nExclusion Criteria:\n\n1. Prior to enrollment, participant has exposure to anti-CD20 monoclonal antibodies at any time during pregnancy.\n2. Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled).\n3. Exposure to known teratogens and\u002For investigational medications during pregnancy.","FEMALE","15 Years","50 Years",{"count":129,"type":21},728,"OBSERVATIONAL","The primary objective of the study is to compare the prevalence rate of major congenital malformations (MCM) between 2 cohorts of pregnant participants with MS who are exposed to BRIUMVI® and who are unexposed to BRIUMVI®.",[133],"Multiple Sclerosis",{"date":112,"type":32},{"date":136,"type":32},"2024-06-01",{"date":138,"type":21},"2035-03-31",{"name":38,"class":39},{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":152,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},"100549418","a-study-evaluating-the-real-world-experience-of-participants-treated-with-briumvi-ublituximab-xiiy-for-relapsing-multiple-sclerosis-rms-100549418","NCT06433752","A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)","REal World ExperieNce With BRIUMVI® (UblituximAB-xiiy) Treated Patients: A Longitudinal REgistry Study (ENABLE)","ENABLE","Inclusion Criteria:\n\n1. Confirmed Multiple Sclerosis (MS) diagnosis.\n2. Participants who have not received any BRIUMVI® (ublituximab-xiiy) infusion prior to study start. Participants who have been prescribed BRIUMVI® (ublituximab-xiiy) but have not yet received their first infusion on Day 1 of 150 milligrams (mg) can be included.\n\nExclusion Criteria:\n\n1. Have received any live or live-attenuated vaccines (including for varicella-zoster virus or measles) within 4 weeks prior to first BRIUMVI® (ublituximab-xiiy) administration or any non-live vaccines within 2 weeks prior to first BRIUMVI® (ublituximab-xiiy) administration.\n2. Any active infection (e.g., active Hepatitis B virus \\[HBV\\])\n3. Concurrent participation in any interventional MS trials, or planned concurrent treatment with other Multiple Sclerosis Disease Modifying Therapy (MS DMT) during the study period.",{"count":149,"type":21},2000,"The purpose of this study is to evaluate safety, effiectiveness, and to gain insight into the treatment experience of participants prescribed BRIUMVI® (ublituximab-xiiy) in the real-world setting",[78,133],{"date":112,"type":32},{"date":154,"type":32},"2024-07-22",{"date":156,"type":21},"2032-04-01",{"name":38,"class":39},90,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":125,"minAge":17,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":169,"conditions":170,"keywords":171,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},"100527111","a-study-evaluating-the-presence-and-concentration-of-briumvi-ublituximab-in-breast-milk-100527111","NCT06143514","A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk","A Post-marketing Study Evaluating the Presence and Concentration of BRIUMVI™ in Breast Milk (PROVIDE)","PROVIDE","Inclusion Criteria:\n\nMaternal Criteria:\n\n* Participant has independently decided to be treated with BRIUMVI™ prior to providing consent to participate in the study\n* Diagnosis of RMS, to include clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS)\n* Willing to breastfeed or pump regularly during the study period to maintain milk supply and exclusively pump breast milk for the 24-hour period of breast milk collection Day 1 post IV dose\n* Plans to continue feeding infant breast milk at least throughout the duration of the study and is not weaning\n\nInfant Criteria:\n\n* Gestational age at delivery ≥35 weeks\n* Birthweight \\> 10th percentile\n* Weight \\> 10th percentile as reported by the mother at the time of enrollment\n\nExclusion Criteria:\n\nMaternal Criteria:\n\n* Any active infection or other condition that would prevent the individual from breastfeeding\n* History of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from 1 or both breasts\n* History of mastectomy\n* Evidence of mastitis or any other significant active infection at Day 1 (pre-dose) that would prevent collection of milk from one or both breasts\n* Current use of drugs known to transfer to the breast milk and with established or potential deleterious effects for the infant, including but not limited to aspirin (risk of Reye's syndrome), tetracyclines or fluoroquinolones\n\nInfant Criteria:\n\n\\- Any abnormality noted or clinically significant medical condition, including cardiac, pulmonary, and liver disease, glucose instability, or active infection at the time of screening that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the trial difficult or would put the infant at risk by participating in the study",{"count":168,"type":21},16,"The primary objective of the lactation study is to characterize the presence and concentration of BRIUMVI™ in breast milk among breastfeeding participants who receive BRIUMVI™ therapeutically for the treatment of relapsing forms of multiple sclerosis (RMS).",[78],[133],{"date":112,"type":32},{"date":174,"type":32},"2024-03-26",{"date":176,"type":21},"2026-06-30",{"name":38,"class":39},5,{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":190,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},"100506713","phase-3-study-to-evaluate-safety-efficacy-and-pharmacokinetics-pk-of-a-modified-regimen-of-ublituximab-100506713","NCT05877963","Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab","Evaluating Safety, Efficacy and Pharmacokinetics of a Modified Regimen of Ublituximab (ENHANCE )","ENHANCE","Inclusion Criteria:\n\n* Diagnosis of RMS (2017 Revised McDonald criteria).\n* Participants must meet one of the following prior treatment definitions:\n\n  1. Participants naïve to treatment.\n  2. Participants previously treated with a disease modifying therapy (DMT) who have discontinued treatment prior to consent and meet the washout requirements.\n* Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.\n* Neurologically stable for \\> 30 days prior to first dose of ublituximab.\n* Female participants of childbearing potential must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 6 months after the last dose of ublituximab.\n* Part C: participants currently treated with an anti-CD20 agent for at least 6 months and meet the washout requirements prior to W1D1.\n* Part C: Discontinuation of current anti-CD20 must be due to suboptimal experience\n\nExclusion Criteria:\n\n* History of any serious 3 Infusion Related Reaction (IRR) on prior anti-CD20 therapy.\n* Primary-progressive multiple sclerosis (PPMS) or inactive Secondary Progressive MS (SPMS).\n* Active chronic (or stable but treated with immune therapy) disease of the immune system other than MS (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.).\n* Current evidence or known history of clinically significant infection, including: chronic, recurrent, or ongoing active viral, bacterial, or fungal infectious disease requiring long term systemic treatment such as, but not limited to chronic urinary tract infection, chronic pulmonary infection with bronchiectasis, tuberculosis, or active hepatitis C virus (HCV).\n* Previous serious opportunistic or atypical infection.\n* Evidence of chronic active or history of hepatitis B virus (HBV) infection as evidenced by a detectable hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb), or chronic hepatitis C infection. Participants with positive hepatitis C virus antibody (HCV Ab) are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).\n* History or evidence (clinical, radiological, or biomarker) of suspected or confirmed progressive multifocal leukoencephalopathy (PML).\n* Receipt of any live or live-attenuated vaccines (including vaccines for varicella-zoster virus or measles) within 4 weeks prior to first study drug administration.\n* Participants requiring treatment with intravenous immune globulin (IVIG) for decreased immunoglobulins within the 12 months prior to W1D1.\n* Any active malignancies other than adequately treated basal, squamous cell or in situ carcinoma.\n* Participants who have ever received ublituximab, alemtuzumab, cyclophosphamide, mitoxantrone, cladribine, or daclizumab (including for non-MS indications).\n\nNote: Other Inclusion\u002FExclusion criteria may apply.","65 Years",{"count":189,"type":21},800,[75],"The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhancing lesions in participants who had a suboptimal experience on prior anti-CD20 therapy in Part C. The study consists of 3 parts: Part A is single-armed and open-label, Part B is randomized, double-blind, placebo-controlled, and Part C is single-armed and open-label.",[78],{"date":112,"type":32},{"date":195,"type":32},"2023-06-13",{"date":197,"type":21},"2027-12-01",{"name":38,"class":39},47,{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":207,"enrollmentInfo":208,"targetDuration":126,"studyType":130,"phases":4,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":4},"100640292","long-term-follow-up-ltfu-of-participants-who-received-azer-cel-100640292","NCT07577583","Long-term Follow-up (LTFU) of Participants Who Received Azer-Cel","Long-term Follow-up (LTFU) of Study Participants Who Received Azer-Cel, An Allogeneic Chimeric Antigen Receptor T-Cell Product, in a TG Therapeutics, Inc., Clinical Study","Inclusion Criteria:\n\n1. Received at least 1 dose of azer-cel in TG-Azercel -101 study.\n2. Signed informed consent form (ICF).\n3. Willingness and ability to adhere to the study schedule and all other protocol requirements.\n\nExclusion Citeria:\n\n1\\. No unique exclusion criteria apply to this study.","62 Years",{"count":209,"type":21},32,"The main objective of this study is to collect data on the long-term safety of azer-cel, primarily through the capture of clinical events of interest (CEI) for up to 15 years following participation in TG-Azercel -101 study.",[101],"2026-05-05",{"date":214,"type":32},"2026-05-11",{"date":216,"type":21},"2027-05-01",{"date":218,"type":21},"2039-12-01",{"name":38,"class":39},{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":187,"enrollmentInfo":227,"targetDuration":4,"studyType":22,"phases":229,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":4},"100631683","phase-2-a-study-to-evaluate-pharmacokinetics-pk-and-safety-of-subcutaneous-sc-ublituximab-administered-at-various-injection-sites-and-relative-bioavailability-via-autoinjector-ai-versus-syringe-subcutaneously-in-participants-with-multiple-sclerosis-ms-100631683","NCT07503873","A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)","A Phase 2, Multicenter, Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector Device Versus Syringe in Patients With Multiple Sclerosis","Inclusion Criteria:\n\n1. Diagnosis of relapsing multiple sclerosis (RMS) (2017 Revised McDonald criteria).\n2. Expanded Disability Status Scale (EDSS) score less than or equal to (≤) 5.5 at screening.\n3. Neurologically stable for more than (\\>) 30 days prior to screening and Day 1.\n4. Female participants of childbearing potential must consent to use an effective method of contraception from consent and for 6 months after the last dose of ublituximab.\n\nExclusion Criteria:\n\n1. Primary-progressive multiple sclerosis (PPMS) or inactive secondary progressive multiple sclerosis (SPMS).\n2. Active chronic disease of the immune system other than MS or immunodeficiency syndrome.\n3. Participants with significantly impaired bone marrow function or significant leukopenia or thrombocytopenia.\n4. Participants who received any approved therapy to treat MS within 5 half-lives of the medication prior to screening.\n5. Treatment with any investigational agent within 5 half-lives of the investigational drug prior to screening.\n6. Females who are pregnant or nursing.\n\nNote: Other protocol-specified Inclusion\u002FExclusion criteria may apply.",{"count":228,"type":21},350,[24],"The purpose of this study is to evaluate the PK and safety of ublituximab SC at different sites of administration and relative bioavailability of ublituximab SC with an AI device versus syringe.",[133],"2026-03-26",{"date":234,"type":32},"2026-03-31",{"date":236,"type":21},"2026-03-21",{"date":238,"type":21},"2029-05-30",{"name":38,"class":39},""]