A Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD)
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B001 Injection in Aquaporin-4 Antibody Positive Patients With Neuromyelitis Optica Spectrum Disorder
1 other identifier
interventional
132
1 country
51
Brief Summary
To evaluate the efficacy and safety of B001 injection in aquaporin-4 antibody positive patients with neuromyelitis optica spectrum disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2024
Typical duration for phase_2
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2024
CompletedFirst Posted
Study publicly available on registry
May 14, 2024
CompletedStudy Start
First participant enrolled
July 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2029
May 5, 2026
April 1, 2026
3.3 years
May 9, 2024
April 29, 2026
Conditions
Outcome Measures
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.
Approximately 48 weeks
Secondary Outcomes (5)
Change in Expanded Disability Status Scale (EDSS) Score
Approximately 48 weeks
Change in Vision Acuity/ Low contrast visual acuity (VA/LCVA)
Approximately 48 weeks
Annualized relapse rate (ARR)
Approximately 3 years
Change in Opticospinal Impairment Scale (OSIS)
Approximately 48 weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Approximately 3 years
Study Arms (2)
B001 injection
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- Subjects who have participated in any drug clinical trials within 28 days prior to the first dose;
- Received hematopoietic stem cell transplantation、 lymphatic irradiation before first dose;
- Pregnant or lactating women; Subjects with birth plans during the trial;
- Subjects who had undergone major surgery within 2 months prior to screening or were scheduled to undergo major surgery during the trial;
- Subjects with severe, progressive, or uncontrolled disease who have been assessed by the investigator to be at increased risk of participating in the study;
- A history of gastrointestinal perforation and/or fistula within 6 months prior to screening;
- 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;
- Subjects with severe or persistent infection currently or within the 1 months prior to screening;
- Subjects with positive gamma interferon release test;
- Subjects who currently have active hepatitis or have a history of severe liver disease;
- Abnormal laboratory test results;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Beijing Anzhen Hospital，Capital Medical University
Beijing, China
Beijing Tiantan Hospital，Capital Medical University
Beijing, China
Beijing Tongren Hospital, Capital Medical University
Beijing, China
Peking University First Hospital
Beijing, China
The First Medical Center of PLA General Hospital
Beijing, China
The Third Medical Center of PLA General Hospital
Beijing, China
Cangzhou Central Hospital
Cangzhou, China
The Second Xiangya Hospital of Central South University
Changsha, China
Xiangya Hospital Central South University
Changsha, China
Sichuan Provincial People's Hospital
Chengdu, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Guangzhou First People's Hospital
Guangzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
Zhujiang Hospital of Southern Medical University
Guangzhou, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, China
Anhui Provincial Hospital
Hefei, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, China
Huizhou First Hospital
Huizhou, China
The First Affiliated Hospital of Shandong First Medical University
Jinan, China
Affiliated Hospital of Jining Medical University
Jining, China
First Affiliated Hospital of Kunming Medical University
Kunming, China
First People's Hospital of Yunnan Province
Kunming, China
Jiangxi Provincial People's Hospital
Nanchang, China
Nanyang Central Hospital
Nanyang, China
Qilu Hospital of Shandong University (Qingdao)
Qingdao, China
The First Hospital of China Medical University
Shenyang, China
Shenzhen Hospital of University of Hong Kong
Shenzhen, China
The Second Hospital of Hebei Medical University
Shijiazhuang, China
Taihe Hospital
Shiyan, China
First Hospital of Shanxi Medical University
Taiyuan, China
Shanxi Provincial People's Hospital
Taiyuan, China
Tianjin Medical University General Hospital
Tianjin, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Renmin Hospital of Wuhan University
Wuhan, China
Tongji Hospital
Wuhan, China
The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University
Xi'an, China
Xi'an International Medical Center Hospital
Xi'an, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Zhongshan Hospital Xiamen University
Xiamen, China
Yan'an University Xianyang Hospital
Xianyang, China
Yantai Mountain Hospital in Yantai City
Yantai, China
The Central Hospital of Yongzhou
Yongzhou, China
Zaozhuang Municipal Hospital
Zaozhuang, China
Henan Provincial People's Hospital
Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Zigong First People's Hospital
Zigong, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2024
First Posted
May 14, 2024
Study Start
July 17, 2024
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
February 28, 2029
Last Updated
May 5, 2026
Record last verified: 2026-04