Neuromyelitis Optica Spectrum Disorders
Conditions
Brief summary
To evaluate the efficacy and safety of B001 injection in aquaporin-4 antibody positive patients with neuromyelitis optica spectrum disorder.
Interventions
DRUGB001
The subjects will receive IV dose of B001 on Day 1 and Day 15 of RCP
OTHERPlacebo
The subjects will receive IV dose of placebo matched to B001 on Day 1 and Day 15 of the RCP
Sponsors
Shanghai Jiaolian Drug Research and Development Co., Ltd
Shanghai Pharmaceuticals Holding Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Confirmed NMOSD patients; 2. Experienced at least 1 recurrence of NMOSD within 1 year or at least 2 recurrence within 2 years prior to screening; 3. 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; 4. 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.
Exclusion criteria
1. Subjects with severe NMOSD were judged by the researcher to be unfit to participate in this study; 2. Subjects with chronic active immune system diseases undergoing systematic treatment; 3. Received anti-CD20 or other cell depletion therapy within 6 months before first dose; 4. Received the prescribed drug treatment at the prescribed time before first dose; 5. Subjects who have participated in any drug clinical trials within 28 days prior to the first dose; 6. Received hematopoietic stem cell transplantation、 lymphatic irradiation before first dose; 7. Pregnant or lactating women; Subjects with birth plans during the trial; 8. Subjects who had undergone major surgery within 2 months prior to screening or were scheduled to undergo major surgery during the trial; 9. Subjects with severe, progressive, or uncontrolled disease who have been assessed by the investigator to be at increased risk of participating in the study; 10. A history of gastrointestinal perforation and/or fistula within 6 months prior to screening; 11. Subjects who received a live or attenuated vaccine within 4 weeks prior to initial administration, or who plan to receive vaccination during the study period; 12. Subjects with severe or persistent infection currently or within the 1 months prior to screening; 13. Subjects with positive gamma interferon release test; 14. Subjects who currently have active hepatitis or have a history of severe liver disease; 15. Uncontrolled systemic disease, or any other reason the investigator deems inappropriate for inclusion; 16. Abnormal laboratory test results; 17. Subjects with a history of alcohol or drug abuse in the 6 months prior to screeing, or who are abusing; 18. Subjects with symptoms of severe mental illness who are clinically uncooperative; 19. Subjects who were unable to undergo magnetic resonance imaging during the study and who had other conditions that the investigator considered inappropriate to enroll.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first NMOSD Attack During RCP | Approximately 48 weeks | The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Expanded Disability Status Scale (EDSS) Score | Approximately 48 weeks | 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). |
| Change in Vision Acuity/ Low contrast visual acuity (VA/LCVA) | Approximately 48 weeks | Change in VA/LCVA |
| Annualized relapse rate (ARR) | Approximately 3 years | Annualized attack rate is defined as total number of attacks divided by total person years. |
| Change in Opticospinal Impairment Scale (OSIS) | Approximately 48 weeks | Change in OSIS |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Approximately 3 years | 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. |
Countries
China
Contacts
CONTACTFuDong Shi
Outcome results
None listed