B001: Phase 1 Trial Data for Neuromyelitis Optica Spectrum Disorder Treatment

April 2022 to June 2024 trial data for a phase 1b, randomized, double-blind, placebo-controlled study of the anti-CD20 monoclonal antibody B001 in aquaporin-4 immunoglobulin G-positive neuromyelitis optica spectrum disorder (NMOSD). The dataset includes safety, pharmacokinetic, pharmacodynamic, and preliminary efficacy results from 22 randomized patients across three dose levels. The data sheet was authored by Dongmei Jia and shared under a CC-BY-4.0 license.

Use Cases

• Analyze dose-limiting toxicity and safety profiles based on reported adverse event rates and types
• Model pharmacokinetic exposure based on dose escalation results and supra-proportional increases
• Assess pharmacodynamic B-cell depletion efficacy based on sustained near-zero cell counts over 24 weeks
• Evaluate preliminary clinical efficacy based on the reported absence of NMOSD relapses during the study period

Strengths

• Data originates from a registered, structured clinical trial (NCT05145361) with a defined 3+1 randomization and dose escalation design
• Includes results from 22 randomized patients with specific breakdowns across three dose levels and a placebo group
• Reports specific pharmacokinetic and pharmacodynamic outcomes, including B-cell depletion levels and exposure increases

Limitations

• Row count and column-level documentation are absent; field semantics must be inferred after download
• The 909.5 KB file size suggests the dataset is a document summary rather than raw patient-level data, limiting analytical scope

Provenance

Source

figshare, author Dongmei Jia

Collection Method

Data collected from a multicenter randomized, double-blind clinical trial.

Time Range

April 2022 to June 2024

Freshness

Last updated 2026-04-16 05:24:49

Geography

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