Obinutuzumab β for aquaporin-4-positive neuromyelitis optica spectrum disorder: a phase 3 randomized controlled trial.

Authors

Lei Wu, Liangliang Gu, Weihao Fan, Min Wei, Tingjun Dai, Xiaoling Li, Lianchen Xiao, Bin Li, Dai-Shi Tian, Ruisheng Duan, Xiaofeng Li, Yuming Xu, Huaxing Meng, Ting Chen, Feng Gao, Feipeng Zhai, Juan Feng, Huan Yang, Runxiu Zhu, Cun-Jin Zhang, Qiang Meng, Bingmei Deng, Zhaoyou Meng, Feng Qiu, Hongyu Zhou, Wei Qiu, Qing Zhang, Hong Liu, Zhe Wu, Zhe Wang, Li Meng, Zunbo Li, Weizhou Zang, Feng Xiang, Jinjin Liang, Sijun Liu, Xifang Liu, Junbin Chen, Feng Li, Dehui Huang, BeInmost Study Group

Published in

Nature medicine. Aug 10, 2026. Epub Aug 10, 2026.

Abstract

Although CD20-directed B cell depletion has long been used in neuromyelitis optica spectrum disorder (NMOSD), high-quality, large-scale, randomized controlled trials remain limited. In this multicenter, randomized, double-blind phase 3 trial, we evaluated obinutuzumab β (MIL62), a novel glycoengineered type II anti-CD20 monoclonal antibody, in patients with NMOSD. Eligible participants aged 18-70 years with aquaporin-4-immunoglobulin G (AQP4-IgG)-seropositive NMOSD and an Expanded Disability Status Scale (EDSS) score of 7.0 or lower were randomly assigned (1:1) to receive intravenous obinutuzumab β 1,000 mg (n = 45) or placebo (n = 46). The primary outcome-time to first adjudicated relapse on or before week 52-was met: relapse occurred in two of 45 (4.4%) obinutuzumab β-treated participants and in 21 of 46 (45.7%) placebo-treated participants (hazard ratio = 0.069, 95% confidence interval: 0.016-0.296, P < 0.0001). The incidence of grade 3 or higher treatment-related adverse events was similar between the obinutuzumab β group (6.7%) and the placebo group (6.5%). These findings support obinutuzumab β as a glycoengineered type II anti-CD20 therapeutic option for patients with AQP4-IgG⁺ NMOSD. ClinicalTrials.gov identifier: NCT05314010 .

PMID:
42575985
Bibliographic data and abstract were imported from PubMed on 11 Aug 2026.

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