{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T17:28:29Z","timestamp":1791912509050,"version":"4.3.4"},"reference-count":23,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2023,12,7]],"date-time":"2023-12-07T00:00:00Z","timestamp":1701907200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Ann Clin Transl Neurol"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>To assess the safety, tolerability, and key pharmacodynamic effects of subcutaneous batoclimab, a fully human anti\u2010neonatal Fc receptor monoclonal antibody, in patients with generalized myasthenia gravis and anti\u2010acetylcholine receptor antibodies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A Phase 2a, proof\u2010of\u2010concept, randomized, double\u2010blind, placebo\u2010controlled trial is described. Eligible patients were randomized (1:1:1) to receive once\u2010weekly subcutaneous injections of batoclimab 340\u2009mg, batoclimab 680\u2009mg, or matching placebo for 6\u2009weeks. Subsequently, all patients could enter an open\u2010label extension study where they received batoclimab 340\u2009mg once every 2\u2009weeks for 6\u2009weeks. Primary endpoints were safety, tolerability, and change from baseline in total immunoglobulin G, immunoglobulin G subclasses, and anti\u2010acetylcholine receptor antibodies at 6\u2009weeks post\u2010baseline. Secondary endpoints included changes from baseline to 6\u2009weeks post\u2010baseline for Myasthenia Gravis Activities of Daily Living, Quantitative Myasthenia Gravis, Myasthenia Gravis Composite, and revised 15\u2010item Myasthenia Gravis Quality of Life scores.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Seventeen patients were randomized to batoclimab 680\u2009mg (<jats:italic>n<\/jats:italic>\u2009=\u20096), batoclimab 340\u2009mg (<jats:italic>n<\/jats:italic>\u2009=\u20095), or placebo (<jats:italic>n<\/jats:italic>\u2009=\u20096). Batoclimab was associated with significantly greater reductions in total immunoglobulin G and anti\u2010acetylcholine receptor antibodies from baseline to 6\u2009weeks post\u2010baseline than placebo. Reductions in immunoglobulin G subclasses were generally consistent with total immunoglobulin G. While clinical measures showed directionally favorable improvements over time, the study was not powered to draw conclusions about therapeutic efficacy. No safety issues were identified.<\/jats:p><\/jats:sec><jats:sec><jats:title>Interpretation<\/jats:title><jats:p>The safety profile, pharmacodynamics, and preliminary clinical benefits observed in this study support further investigation of subcutaneous batoclimab injections as a potential patient\u2010administered therapy for seropositive generalized myasthenia gravis.<\/jats:p><\/jats:sec>","DOI":"10.1002\/acn3.51946","type":"journal-article","created":{"date-parts":[[2023,12,8]],"date-time":"2023-12-08T06:43:04Z","timestamp":1702017784000},"page":"194-206","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["Subcutaneous batoclimab in generalized myasthenia gravis: Results from a Phase 2a trial with an open\u2010label extension"],"prefix":"10.1002","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8438-482X","authenticated-orcid":false,"given":"Richard J.","family":"Nowak","sequence":"first","affiliation":[{"name":"Department of Neurology Yale University School of Medicine  New Haven Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ari","family":"Breiner","sequence":"additional","affiliation":[{"name":"Division of Neurology, Department of Medicine The Ottawa Hospital and Ottawa Research Institute, University of Ottawa  Ottawa Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vera","family":"Bril","sequence":"additional","affiliation":[{"name":"Ellen &amp; Martin Prosserman Centre for Neuromuscular Diseases University Health Network, University of Toronto  Toronto Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey A.","family":"Allen","sequence":"additional","affiliation":[{"name":"Department of Neurology University of Minnesota  Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaida","family":"Khan","sequence":"additional","affiliation":[{"name":"Department of Neurology UT Southwestern Medical Center  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Todd","family":"Levine","sequence":"additional","affiliation":[{"name":"HonorHealth Neurology dba Phoenix Neurological Associates  Phoenix Arizona USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel H.","family":"Jacobs","sequence":"additional","affiliation":[{"name":"College of Medicine University of Central Florida  Orlando Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory","family":"Sahagian","sequence":"additional","affiliation":[{"name":"The Neurology Center of Southern California  Carlsbad California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zaeem A.","family":"Siddiqi","sequence":"additional","affiliation":[{"name":"Division of Neurology, Department of Medicine University of Alberta Hospital  Edmonton Alberta Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Xu","sequence":"additional","affiliation":[{"name":"Immunovant Inc.  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William L.","family":"Macias","sequence":"additional","affiliation":[{"name":"Immunovant Inc.  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4241-5135","authenticated-orcid":false,"given":"Michael","family":"Benatar","sequence":"additional","affiliation":[{"name":"Department of Neurology University of Miami  Miami Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"ASCEND MG Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,12,7]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41572\u2010019\u20100079\u2010y"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.3390\/jcm10112235"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jns.2020.116830"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/nejmra1602678"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2020.07.016"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.92.15_supplement.P5.2-079"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/mus.22140"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1212\/wnl.52.7.1487"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1749\u20106632.1998.tb11015.x"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/mus.21185"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/mus.25198"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1210\/jendso\/bvac150.1782"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.26574\/maedica.2022.17.2.404"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.15406\/unoaj.2016.03.00086"},{"key":"e_1_2_8_16_1","unstructured":"Immunovant Inc.Targeted Science Tailored Solutions: Immunovant Corporate Presentation (March 2023). Accessed April 18 2023.https:\/\/d1io3yog0oux5.cloudfront.net\/_9c922b4aece8a754c8f178db35d9da22\/immunovant\/db\/856\/7692\/pdf\/IMVT_Master+Deck_March+2023+vF.pdf(Slide 21)."},{"key":"e_1_2_8_17_1","unstructured":"VYVGART\u00ae (Efgartigimod Alfa\u2010Fcab) Injection for Intravenous Use. Prescribing information. argenx BV.2022."},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1212\/wnl.0000000000007600"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/s1474\u20104422(21)00159\u20109"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1212\/wnl.0000000000011108"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2019.5125"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1182\/bloodadvances.2020002003"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.anai.2017.11.002"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1111\/vox.12760"}],"container-title":["Annals of Clinical and Translational Neurology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/acn3.51946","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,1,21]],"date-time":"2024-01-21T18:37:39Z","timestamp":1705862259000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/acn3.51946"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,12,7]]},"references-count":23,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2024,1]]}},"alternative-id":["10.1002\/acn3.51946"],"URL":"https:\/\/doi.org\/10.1002\/acn3.51946","archive":["Portico"],"relation":{},"ISSN":["2328-9503","2328-9503"],"issn-type":[{"value":"2328-9503","type":"print"},{"value":"2328-9503","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,12,7]]},"assertion":[{"value":"2023-02-18","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-10-26","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-12-07","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}