A Phase 2/3 interventional study of B001 and Placebo in Neuromyelitis Optica Spectrum Disorders, sponsored by Shanghai Jiaolian Drug Research and Development Co., Ltd. Recruiting at 51 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Shanghai Jiaolian Drug Research and Development Co., Ltd · Phase 2/3, Interventional, and Treatment
To evaluate the efficacy and safety of B001 injection in aquaporin-4 antibody positive patients with neuromyelitis optica spectrum disorder.
162 studies on the registry are indexed under Neuromyelitis Optica; 72 are open to participants now.
This study's planned enrollment of 132 is above the median of 25 across 97 interventional studies indexed under Neuromyelitis Optica.
Browse Neuromyelitis Optica studies →Shanghai Jiaolian Drug Research and Development Co., Ltd is the lead sponsor of 7 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: B001
Other: Placebo
The subjects will receive IV dose of B001 on Day 1 and Day 15 of RCP
The subjects will receive IV dose of placebo matched to B001 on Day 1 and Day 15 of the RCP
Time to first NMOSD Attack During RCP
The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD.
Time frame: Approximately 48 weeks
Change in Expanded Disability Status Scale (EDSS) Score
EDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS consists of 7 FS (visual FS, brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, and cerebral FS) which are used to derive EDSS score ranging from 0 (normal neurological exam) to 10 (death from MS).
Time frame: Approximately 48 weeks
Change in Vision Acuity/ Low contrast visual acuity (VA/LCVA)
Change in VA/LCVA
Time frame: Approximately 48 weeks
Annualized relapse rate (ARR)
Annualized attack rate is defined as total number of attacks divided by total person years.
Time frame: Approximately 3 years
Change in Opticospinal Impairment Scale (OSIS)
Change in OSIS
Time frame: Approximately 48 weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Time frame: Approximately 3 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shanghai Jiaolian Drug Research and Development Co., Ltd