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NCT06413654

PHASE2/PHASE3

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

Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2024-07-17

Completion Date

2029-02-28

Last Updated

2025-01-27

Healthy Volunteers

Conditions

Neuromyelitis Optica Spectrum Disorders

Interventions

DRUG

B001

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

OTHER

Placebo

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

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.

Locations (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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (51)