A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adult Subjects with Neuromyelitis Optica Spectrum Disorders–Top line efficacy and safety results (Plen02.001)

Name: Work Video:
Duration: 3 min 30 s
Bruce Cree; Jeffrey L. Bennett; Ho Jin Kim; Brian Weinshenker; Sean J. Pittock; Dean M. Wingerchuk; Kazuo Fujihara; Friedemann Paul; Gary Cutter; Romain Marignier; Ari Green; Orhan Aktaş; Hans‐Peter Hartung; Jörn Drappa; Gerard Barron; Soraya Madhani; Jack Ratchford; Dewei She; Eliezer Katz
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'other': [91, 324, 351, 390, 445, 574, 683, 740, 772, 821, 863, 910, 943, 992], 'immune': [92], 'suppressants': [93], 'was': [94, 99, 110, 191, 800, 841, 889, 970, 1018], 'prohibited.': [95], 'The': [96, 106, 201, 266, 522], 'period': [98, 211], 'limited': [100], '6.5': [102], 'months': [103], 'duration.': [105], 'primary': [107, 283], 'outcome': [108], 'measure': [109], 'time': [111], 'first': [113], 'adjudicated': [114, 128, 137, 259], 'attack.': [115], 'Clinical': [116, 423, 427], 'NMOSD': [119, 302], 'attacks': [120, 159, 260], 'developed': [122], 'implemented.': [124], 'all': [129, 205, 221], 'investigator-reported': [130], 'attacks.': [131], 'Patients': [132], 'who': [133], 'experienced': [135], 'completed': [140], 'controlled': [142, 210, 264], 'study': [146, 222, 267], 'offered': [148], 'open': [154, 227], 'label': [155, 228], 'extension': [156, 229], 'study.': [157], 'Acute': [158], 'treated': [161], 'investigator’s': [164], 'choice': [165], 'therapy.': [167], 'Results:': [169], 'On': [171], 'September': [172], '7,': [173], '2018,': [174], 'external': [176], 'data': [177, 271, 295], 'monitoring': [179], '(DSMC)': [181], 'concluded': [182], 'continued': [184], 'enrollment': [185], 'potential': [187], 'exposure': [188], 'placebo': [190], 'longer': [193], 'ethical': [194], 'due': [195], 'demonstrated': [197], 'safety.': [200], 'DSMC': [202], 'recommended': [203], 'participants': [206, 223], 'be': [212, 304], 'moved': [213], 'active': [215], 'continue': [224], 'protocol': [230], 'ongoing': [232], 'assessments.': [234], '230': [235], 'subjects': [236], 'from': [237, 326, 371, 470, 492, 504, 530, 540, 658, 712], '24': [238], 'countries': [239], 'dosed': [243], '(planned': [244], 'sample': [245], 'size:': [246], '252).': [247], '212': [248], 'seropositive': [250], '18': [252], 'anti-AQP4': [256], 'antibodies.': [257], '42': [258], 'occurred': [261], 'period.': [265], 'remains': [268], 'masked': [269], 'lock': [272], 'will': [273, 289, 303], 'occur': [274], 'December': [276], '2018': [277], 'after': [278], 'which': [279, 793, 797, 834, 838, 882, 886, 963, 967, 1011, 1015], 'analysis': [280], 'secondary': [285], 'endpoints': [286], 'occur.': [290], 'Conclusions:': [292], 'Top-line': [294], 'inebilizumab’s': [297], 'presented.': [305], 'Disclosure:': [307], 'Dr.': [308, 335, 365, 374, 406, 429, 459, 482, 487, 498, 509, 524, 534, 552, 558, 630, 652, 661, 667, 693, 706, 718, 724, 756, 781, 798, 805, 825, 839, 847, 870, 887, 894, 916, 927, 951, 968, 976, 999, 1016], 'Cree': [309], 'has': [310, 337, 367, 376, 408, 431, 461, 500, 511, 526, 536, 554, 560, 632, 654, 663, 669, 695, 708, 720, 726, 758, 807, 849, 896, 929, 978], 'received': [311, 338, 368, 377, 409, 432, 462, 501, 512, 527, 537, 561, 633, 655, 670, 696, 709, 727, 759, 808, 850, 897, 930, 979], 'personal': [312, 339, 378, 410, 433, 502, 513, 538, 562, 634, 671, 697, 728, 760, 809, 851, 898, 931, 980], 'compensation': [313, 340, 379, 411, 434, 503, 514, 539, 563, 635, 672, 698, 729, 761, 810, 852, 899, 932, 981], 'consulting,': [315, 342, 381, 436, 565, 674, 731, 763, 812, 854, 901, 934, 983], 'serving': [316, 343, 382, 437, 566, 675, 732, 764, 813, 855, 902, 935, 984], 'scientific': [319, 346, 385, 440, 569, 678, 735, 767, 816, 858, 905, 938, 987], 'advisory': [320, 347, 386, 441, 570, 679, 736, 768, 817, 859, 906, 939, 988], 'board,': [321, 348, 387, 442, 571, 680, 737, 769, 818, 860, 907, 940, 989], 'speaking,': [322, 349, 388, 443, 572, 681, 738, 770, 819, 861, 908, 941, 990], 'activities': [325, 352, 391, 446, 575, 684, 741, 773, 822, 864, 911, 944, 993], 'Abbvie,': [327], 'Akili,': [328], 'Biogen,': [329, 541, 602, 715, 745], 'EMD': [330, 356, 372], 'Serono,': [331, 357, 399], 'GeNeuro': [332], 'Novartis.': [334, 508, 717], 'Bennett': [336, 366], 'Clene': [354], 'Nanomedicine,': [355], 'Equillium': [358], 'Inc,': [359, 609], 'Frequency': [360], 'Therapeutics,': [361, 454, 606, 611, 627], 'Viela': [363, 779, 791, 868, 880, 914, 925, 949, 961], 'Bio.': [364, 780, 869, 950, 998], 'research': [369, 490, 528, 656, 710, 795, 836, 884, 965, 1013], 'support': [370, 491, 529, 657, 711], 'Serono.': [373], 'Kim': [375, 407], 'Celltrion,': [393], 'Eisai,': [394, 545], 'HanAll': [395], 'BioPharma,': [396], 'MediImmune,': [397], 'Merck': [398], 'Novartis': [400], 'Pharmaceuticals,': [401, 494, 578, 581, 583, 593], 'Sanofi': [402], 'Genzyme,': [403, 612, 747], 'Teva-Handok.': [405], 'editorial': [414, 517, 638, 701], 'capacity': [415, 518, 639, 702], 'co-editor': [417], 'MS': [419], 'Journal-Experimental,': [420], 'Translational': [421], 'Journal': [425, 645], 'Neurology.': [428], 'Weinshenker': [430, 460], 'Novartis,': [448, 544, 589, 620, 752], 'Alexion,': [449], 'MedImmune,': [450, 505], 'Caladrius': [451], 'Biosciences,': [452], 'Brainstorm': [453, 604], 'Chugai,': [455], 'Roivant': [457], 'Sciences.': [458, 705], 'royalty,': [463], 'license': [464], 'fees,': [465], 'contractual': [467], 'rights': [468], 'payments': [469], 'RSR': [471], 'Ltd,': [472], 'Oxford': [473], 'University,': [474], 'Hospices': [475], 'Civil': [476], 'de': [477], 'Lyon,': [478], 'MVZ': [479], 'Labor': [480], 'PD': [481], 'Volkmann': [483], 'und': [484], 'Kollegen': [485], 'GbR.': [486], 'Pittock': [488], 'receives': [489], 'Alexion': [493, 531], 'Medimmune,': [495, 618, 690, 748], 'Grifols.': [497], 'Wingerchuk': [499, 510, 525], 'Celgene,': [506, 751], 'as': [519, 802, 843, 891, 972, 1020], 'co-Editor-in-Chief': [520], 'Neurologist.': [523], 'TerumoBCT.': [533], 'Fujihara': [535], 'Mitsubishi-Tanabe,': [542], 'Takeda,': [543], 'Nihon,': [546], 'Teijin,': [547], 'Ono,': [548], 'Asahi': [549], 'Medical,': [550], 'Apothecom.': [551], 'Paul': [553], 'nothing': [555, 664, 721], 'disclose.': [557, 666, 723], 'Cutter': [559, 631, 653], 'AMO': [577], 'Biolinerx,': [579], 'Horizon': [580], 'Hisun': [582], 'Merck,': [584, 749], 'Merck/Pfizer,': [585], 'Opko': [586], 'Biologics,': [587], 'Neurim,': [588], 'Ophazyme,': [590], 'Sanofi-Aventis,': [591], 'Reata': [592], 'Receptos/Celgene,': [594], 'Teva': [595, 624], 'pharmaceuticals,': [596, 625], 'NHLBI,': [597], 'NICHD,': [598], 'Atara': [599], 'Biotherapeutics,': [600], 'Axon,': [601], 'Argenix,': [603], 'Cell': [605], 'Charleston': [607], 'Labs': [608], 'Click': [610], 'Genentech,': [613], 'GW': [614], 'Pharma,': [615, 689], 'Klein-Buendel': [616], 'Incorporated,': [617], 'Medday,': [619], 'Roche,': [621, 753], 'Scifluor,': [622], 'Somahlution,': [623], 'TG': [626], 'UT': [628], 'Houston.': [629], 'Statistical': [641], 'editor': [642], 'American': [648], 'Society': [649], 'Nephrology.': [651], 'Via': [659], 'MGFA.': [660], 'Marignier': [662], 'Green': [668, 694, 707], 'Inception': [686, 704, 713], 'Sciences,': [687, 714], 'Mylan': [688], 'Bionure.': [692], 'Aktas': [719], 'Hartung': [725], 'Bayer': [743], 'Healthcare,': [744], 'Geneuro,': [746], 'Receptos': [750], 'CSL': [754], 'Behring.': [755], 'Drappa': [757, 782, 799], 'Medimmune/Astrazeneca': [775, 947], 'prior': [776], 'joining': [778], 'holds': [783, 827, 872, 918, 953, 1001], 'stock': [784, 786, 828, 830, 873, 875, 919, 921, 954, 956, 1002, 1004], 'and/or': [785, 829, 874, 920, 955, 1003], 'options': [787, 831, 876, 922, 957, 1005], 'Astrazeneca': [789], 'Bio,': [792, 881], 'sponsored': [794, 835, 883, 964, 1012], 'involved': [801, 842, 890, 971, 1019], 'investigator.': [804, 845, 893, 974, 1022], 'Barron': [806, 826, 840], 'Medimmune/Astrazeneca.': [824], 'AstraZeneca,': [833], '.': [846, 975], 'Madhani': [848, 871, 888], 'Medimmune/Astrazeneca,': [866, 913], 'Astrazeneca,': [878, 924], 'Ratchford': [895, 917], 'Bio..': [915], 'Bio’s.': [926], 'She': [928, 952, 969], 'Dewei': [946], 'AstraZeneca': [959], 'Bio': [962, 1010], 'Katz': [977, 1000, 1017], 'MedImmune': [995, 1007], 'Veiela': [997, 1009]}, 'cited_by_api_url': 'https://api.openalex.org/works?filter=cites:W2960422897', 'counts_by_year': [{'year': 2022, 'cited_by_count': 1}, {'year': 2021, 'cited_by_count': 1}, {'year': 2020, 'cited_by_count': 1}, {'year': 2019, 'cited_by_count': 6}], 'updated_date': '2025-01-05T16:01:06.400000', 'created_date': '2019-07-23'}
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