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A Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD)

ConditionNeuromyelitis Optica Spectrum Disorders
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Jiaolian Drug Research and Development Co., Ltd

About this trial

To evaluate the efficacy and safety of B001 injection in aquaporin-4 antibody positive patients with neuromyelitis optica spectrum disorder.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed NMOSD patients;

Experienced at least 1 recurrence of NMOSD within 1 year or at least 2 recurrence within 2 years prior to screening;

The blood pregnancy tests were negative within 7 days before the first dose in fertile female subjects. The fertile subjects and the male subjects whose partner are fertile woman agree to use reliable contraception during the study period and within 6 months after the study drug discontinuation;

Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent; Willing to follow and able to complete all test procedures.

Disqualifiers

Subjects with severe NMOSD were judged by the researcher to be unfit to participate in this study;

Subjects with chronic active immune system diseases undergoing systematic treatment;

Received anti-CD20 or other cell depletion therapy within 6 months before first dose;

Received the prescribed drug treatment at the prescribed time before first dose;

Trial design

Design model

Parallel

Treatments tested in this trial

  • B001

    Drug

    The subjects will receive IV dose of B001 on Day 1 and Day 15 of RCP

  • Placebo

    Other intervention

    The subjects will receive IV dose of placebo matched to B001 on Day 1 and Day 15 of the RCP

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: B001 injectionExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Change in Vision Acuity/ Low contrast visual acuity (VA/LCVA)

Change in VA/LCVA

Time frame
Approximately 48 weeks
3

Annualized relapse rate (ARR)

Annualized attack rate is defined as total number of attacks divided by total person years.

Time frame
Approximately 3 years
4

Change in Opticospinal Impairment Scale (OSIS)

Change in OSIS

Time frame
Approximately 48 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Jiaolian Drug Research and Development Co., Ltd

Lead sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Collaborator

Source ClinicalTrials.gov
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