[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644671":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":31,"locations":37,"responsibleParty":61,"collaborators":30,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":30,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":30,"enrollmentInfo":72,"targetDuration":30,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":30,"overallStatus":40,"whyStopped":30,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"TG Therapeutics, Inc.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Randomized controlled period (RCP)","EXPERIMENTAL","Responder participants from efgartigimod induction period will be randomised 1:1 ratio to receive either ublituximab or ublituximab matching-placebo intravenous (IV) infusion.",[13,14],"Drug: Ublituximab","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Open-label period (OLP): Ublituximab","Non-responder participants from efgartigimod induction period will receive ublituximab IV infusion.",[13],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Ublituximab","Administered as an IV infusion.",[16,9],[26],"BRIUMVI",{"type":21,"name":28,"description":23,"armGroupLabels":29,"otherNames":30},"Placebo",[9],null,[32],{"name":33,"role":34,"phone":35,"phoneExt":30,"email":36},"TG Therapeutics Clinical Support Team","CONTACT","1-877-575-8489","clinicalsupport@tgtxinc.com",[38,52],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":30},"TG Therapeutics Investigational Trial Site","RECRUITING","Colorado Springs","Colorado","80919","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-104.82136,38.83388,{"lat":50,"lon":49},{"facility":39,"status":40,"city":53,"state":54,"zip":55,"country":44,"countryCode":45,"cosmosGeoPoint":56,"geoPoint":60,"contacts":30},"Clearwater","Florida","33761",{"type":47,"coordinates":57},[58,59],-82.8001,27.96585,{"lat":59,"lon":58},{"type":62,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","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",false,"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.","ALL","18 Years",{"count":73,"type":74},120,"ESTIMATED","INTERVENTIONAL",[77],"PHASE2","The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod.",[80],"Myasthenia Gravis","2026-06-22",{"date":83,"type":84},"2026-06-29","ACTUAL",{"date":86,"type":74},"2026-07-30",{"date":88,"type":74},"2030-01-01",{"name":5,"class":6},2]