Trial reportFrontiers in immunology2026
A novel recombinant anti-cluster of differentiation 20 humanized monoclonal antibody (B001) for the treatment of neuromyelitis optica spectrum disorder: a phase 1, multicenter randomized, double-blind trial.
Trial report in Frontiers in immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05145361 (A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of B001 in Subjects With Aquaporin-4 Antibody), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of B001 in Subjects With Aquaporin-4 Antibody (AQP4-IgG) Positive Neuromyelitis Optic Spectrum Disorder (NMOSD)
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Introduction: B001 is a recombinant humanized anti-CD20 monoclonal antibody targeting CD20+ B cells, that has demonstrated superior B cell depletion and anti-proliferative and cytotoxic effects compared to rituximab in a pre-clinical study. The present phase 1b trial assessed the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of B001 in aquaporin-4 immunoglobulin G-positive neuromyelitis optica spectrum disorder (NMOSD). Methods: This phase 1b randomized, double-blind, placebo-controlled trial screened 25 NMOSD patients (April 2022-June 2024). Twenty-two patients received intravenous B001 (350, 700 or 1,000 mg) or placebo via a 3 + 3 dose escalation design, randomized 3:1 to active drug or placebo on days 1 and 15. The primary endpoints were the occurrence of dose-limiting toxicity (DLT) and to recommend the dosage for the phase 2 trial. Results: Among 22 randomized patients (350 mg: Conclusion: B001 demonstrated favorable safety and tolerability, with 700 mg selected as the recommended phase 2 dose. Clinical Trial Registration: https://clinicaltrials.gov/study/NCT05145361, identifier NCT05145361.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.