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

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Neuromyelitis Optica Spectrum Disorders

In brief

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

Key facts

Study ID

NCT06413654

Run by

Shanghai Jiaolian Drug Research and Development Co., Ltd

People needed

132

Starts

2024-07-17

Expected to finish

2029-02-28

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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;
• Uncontrolled systemic disease, or any other reason the investigator deems inappropriate for inclusion;
• Abnormal laboratory test results;
• Subjects with a history of alcohol or drug abuse in the 6 months prior to screeing, or who are abusing;
• Subjects with symptoms of severe mental illness who are clinically uncooperative;
• Subjects who were unable to undergo magnetic resonance imaging during the study and who had other conditions that the investigator considered inappropriate to enroll.

Where it is running

• Beijing Tiantan Hospital，Capital Medical University — Beijing, China (enrolling)
• Beijing Tongren Hospital, Capital Medical University — Beijing, China (enrolling)
• Peking University First Hospital — Beijing, China (enrolling)
• The First Medical Center of PLA General Hospital — Beijing, China (enrolling)
• The Third Medical Center of PLA General Hospital — Beijing, China (enrolling)
• Cangzhou Central Hospital — Cangzhou, China (enrolling)
• The Second Xiangya Hospital of Central South University — Changsha, China (enrolling)
• Xiangya Hospital Central South University — Changsha, China (enrolling)
• Sichuan Provincial People's Hospital — Chengdu, China (enrolling)
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, China (enrolling)
• Guangzhou First People's Hospital — Guangzhou, China (enrolling)
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, China (enrolling)
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, China (enrolling)
• The Third Affiliated Hospital, Sun Yat-sen University — Guangzhou, China (enrolling)
• Zhujiang Hospital of Southern Medical University — Guangzhou, China (enrolling)
• The Affiliated Hospital of Guizhou Medical University — Guiyang, China (enrolling)
• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, China (enrolling)
• The Fourth Affiliated Hospital of Harbin Medical University — Harbin, China (enrolling)
• The Second Affiliated Hospital of Harbin Medical University — Harbin, China (enrolling)
• Anhui Provincial Hospital — Hefei, China (enrolling)
• The Second Affiliated Hospital of Anhui Medical University — Hefei, China (enrolling)
• Huizhou First Hospital — Huizhou, China (enrolling)
• The First Affiliated Hospital of Shandong First Medical University — Jinan, China (enrolling)
• Affiliated Hospital of Jining Medical University — Jining, China (enrolling)
• Beijing Anzhen Hospital，Capital Medical University — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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