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2BU","United Kingdom",{"type":57,"coordinates":1268},[1269,1270],-0.12574,51.50853,{"lat":1270,"lon":1269},{"type":1273,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100573333",false,"NCT06744920","A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis","A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Remibrutinib in Patients With Generalized Myasthenia Gravis, Followed by an Open-label Extension Phase","RELIEVE","Inclusion Criteria:\n\n* Adult patients with gMG (age 18-75 years)\n* Confirmed diagnosis of Myasthenia Gravis Foundation of America (MGFA) Class II-IV gMG at screening and likely not in need of a respirator for the duration of the study, as judged by the Investigator\n* Documented evidence of positive serologic testing for AChR+ antibody or MuSK+ antibody at screening, OR seronegative for both AChR and MuSK antibodies at screening\n* Baseline MG-ADL score ≥ 6 with ≥ 50% of the total score due to non ocular symptoms\n* Participants who have been on a stable dose of standard-of-care treatment as specified in the protocol\n* Able to safely swallow the study medication according to investigator clinical judgement based on a bedside swallowing test or another formal swallowing test in line with local practice, both at Screening and Baseline\n\nExclusion Criteria:\n\n* Prior to baseline have been treated with intravenous immunoglobulins or plasma exchange (IVIg\u002FPLEX) in the past month, with rituximab in the past 6 months, eculizumab in the past 2 months, ravulizumab or other complement inhibitors in the past 3 months, efgartigimod or other anti-FcRn therapies in the past 3 months, or had a thymectomy in the past 6 months or a planned thymectomy during the trial period\n* Women of child bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 1 week after stopping of study treatment\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years","75 Years",{"count":1285,"type":1286},180,"ESTIMATED","INTERVENTIONAL",[1289],"PHASE3","A study to evaluate the efficacy, safety and tolerability of Remibrutinib versus placebo in adult patients with Generalized Myasthenia Gravis who are on stable, standard-of-care (SOC) treatment.",[1292],"Generalized Myasthenia Gravis",[1294,1295,1292,39,1296,1297,1298,1299],"Myasthenia Gravis","gMG","Remibrutinib","placebo-controlled","double-blind","phase III","2026-05-29",{"date":1302,"type":1303},"2026-06-01","ACTUAL",{"date":1305,"type":1303},"2025-02-07",{"date":1307,"type":1286},"2033-02-26",{"name":42,"class":6},129]