ArticleNeurology and therapy2026
Safety and Efficacy of Obinutuzumab β (MIL62), a Novel Glycoengineered Type II Anti-CD20 Monoclonal Antibody, in Patients with Neuromyelitis Optica Spectrum Disorder: A Multicenter, Single-Arm, Phase Ib Clinical Trial.
Article in Neurology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05314010 (A Multicenter, Phase Ib/III Study to Evaluate the Safety and Efficacy of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder), which is not on this map. Not yet cited in PubMed.
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A Multicenter, Phase Ib/III Study to Evaluate the Safety and Efficacy of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)
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15 authors.
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Abstract
introductionTo evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of obinutuzumab β, a novel glycoengineered type II anti-CD20 monoclonal antibody, in patients with neuromyelitis optica spectrum disorder (NMOSD).
methodsIn this multicenter, open-label, single-arm, phase Ib trial (NCT05314010), 11 aquaporin protein-4 (AQP4)-IgG-positive patients with NMOSD received obinutuzumab β at 500 mg or 1000 mg on days 1 of weeks 1 and 3. Patients in the 500-mg group could escalate to 1000 mg after 24 weeks if tolerated. Evaluations occurred at specified weeks (24-208), with 1000-mg doses on days 1 of weeks 25, 27, and every 26 weeks thereafter in patients who are relapse-free. Safety, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity were assessed.
resultsAll participants with 500 mg (n = 3) transitioned to 1000 mg after 24 weeks. During the entire study period, all 11 participants experienced at least one treatment-emergent adverse event (TEAE); 90.9% had treatment-related adverse events (TRAEs). Serious adverse events were reported in 54.5%, with 27.3% related to obinutuzumab β. No TEAEs or TRAEs led to treatment discontinuation, withdrawal, or death. Two patients had early relapses on days 26 and 27 post-first dose, respectively; one withdrew immediately, while the other remained on treatment for 1 year. The 2-year disease relapse-free rate was 81.8% [95% confidence interval (CI): 44.7%, 95.1%], and the annualized relapse rate (ARR) declined from 1.3 before 2-year treatment to 0.2 (95% CI: 0.1, 0.2) after obinutuzumab β, representing an 87.7% reduction.
conclusionObinutuzumab β demonstrated manageable safety and may have promising efficacy against NMOSD. Despite the lack of a comparator group, the results support evaluation in phase III trials. CLINICAL
trial registrationhttps://clinicaltrials.gov/ (#NCT05314010).
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