Clinical trial NCT06413654: A Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Neuromyelitis Optica Spectrum Disorders
Lead sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Pharmaceuticals Holding Co., Ltd
First posted: 2024-05-14
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Time to first NMOSD Attack During RCP
timeFrame: Approximately 48 weeks
Secondary outcomes:
measure: Change in Expanded Disability Status Scale (EDSS) Score
timeFrame: Approximately 48 weeks
measure: Change in Vision Acuity/ Low contrast visual acuity (VA/LCVA)
timeFrame: Approximately 48 weeks
measure: Annualized relapse rate (ARR)
timeFrame: Approximately 3 years
measure: Change in Opticospinal Impairment Scale (OSIS)
timeFrame: Approximately 48 weeks
measure: Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Approximately 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital，Capital Medical University
city: Beijing
country: China
facility: Beijing Tiantan Hospital，Capital Medical University
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: The First Medical Center of PLA General Hospital
city: Beijing
country: China
facility: The Third Medical Center of PLA General Hospital
city: Cangzhou
country: China
facility: Cangzhou Central Hospital
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
city: Guangzhou
country: China
facility: The Third Affiliated Hospital, Sun Yat-sen University
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Hefei
country: China
facility: The Second Affiliated Hospital of Anhui Medical University
city: Huizhou
country: China
facility: Huizhou First Hospital
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical University
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
city: Kunming
country: China
facility: First People's Hospital of Yunnan Province
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
city: Nanyang
country: China
facility: Nanyang Central Hospital
city: Qingdao
country: China
facility: Qilu Hospital of Shandong University (Qingdao)
city: Shenyang
country: China
facility: The First Hospital of China Medical University
city: Shenzhen
country: China
facility: Shenzhen Hospital of University of Hong Kong
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
city: Shiyan
country: China
facility: Taihe Hospital
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
city: Taiyuan
country: China
facility: Shanxi Provincial People's Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Wuhan
country: China
facility: Tongji Hospital
city: Xi'an
country: China
facility: The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University
city: Xi'an
country: China
facility: Xi'an International Medical Center Hospital
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
city: Xianyang
country: China
facility: Yan'an University Xianyang Hospital
city: Yantai
country: China
facility: Yantai Mountain Hospital in Yantai City
city: Yongzhou
country: China
facility: The Central Hospital of Yongzhou
city: Zaozhuang
country: China
facility: Zaozhuang Municipal Hospital
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Zigong
country: China
facility: Zigong First People's Hospital
Study officials:
References: