A Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders
NCT ID: NCT06044350
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
162 participants
INTERVENTIONAL
2023-08-01
2026-05-31
Brief Summary
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Detailed Description
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If any of the following conditions occur, subjects can enter OLP from RCP: 1. Subjects who complete the 52-week RCP study without recurrence of NMOSD can enter Olp within 14 days after the end of the RCP study. 2. In the stage of RCP, NMOSD recurred. After rescue therapy, the patients with stable condition could enter OLP within 28 days after diagnosis. Subjects continued to participate in the RCP study if they were not identified by CEC as having a relapse upon examination. 3. When a protocol-defined first relapse event of 35 cases is observed, or when all 162 subjects have completed randomization and 12 months have elapsed since the first dose in the last of these subjects, or when recommended by the Independent Data Monitoring Committee (IDMC) , the RCP study should be stopped for enrolled subjects, and all enrolled subjects at the RCP stage should stop the RCP study within 14 days of entry into OLP, after which subjects will receive BAT4406F injection at the same dose as RCP, at d 1 of OLP. After termination of the RCP study with BAT4406F every 6 months, subjects were given the option of enrolling in the OLP study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental group：BAT4406F
RCP：Intravenous infusion; Dosage:500mg/time; Time of administration:The drug was given at D 1 and D 182 respectively OLP：Intravenous infusion; Dosage:500mg/time; Time of administration: After D1 dosing, Every 6 months to 1 times
BAT4406F Injection
Intravenous infusion; Dosage:500mg/time
Control group：BAT4406F Placebos
RCP：Intravenous infusion; Dosage:500mg/time; Time of administration:The drug was given at D 1 and D 182 respectively OLP：Intravenous infusion; Dosage:500mg/time; Time of administration: After D1 dosing, Every 6 months to 1 times
BAT4406F Placebos
Intravenous infusion; Dosage:500mg/time
Interventions
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BAT4406F Injection
Intravenous infusion; Dosage:500mg/time
BAT4406F Placebos
Intravenous infusion; Dosage:500mg/time
Eligibility Criteria
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Inclusion Criteria
2. Met the 2015 international NMO diagnostic panel (IPND) criteria for NMOSD, And AQP4-IGG positive patients
3. Screening before 2 times at least 2 years experience with clinical records of relapse，or experienced at least 1 clinically documented recurrence within 1 year prior to screening
4. For subjects who had a relapse before screening, symptoms needed to be stable for at least 4 weeks before randomization
5. Into the group of former dosage of corticosteroids under 30 mg and prednisone equivalent，and the trial drug must be used within a month after the withdrawal of hormones
6. The score of EDSS 7 or less
7. Has the fertility of men and women must agree during treatment and 6 months after the last dose of using effective birth control method;
8. Agreed to participate in trials, and books to sign the informed consent
Exclusion Criteria
2. 6 months prior to the baseline used other monoclonal antibody therapy;Baseline used within five half-life before other biological preparation;
3. Used it for 3 months prior to the baseline McCaw phenol ester, azathioprine and methotrexate;6 months prior to the baseline using cyclophosphamide;Baseline before five half-life
4. Within a month before the filter used intravenous immunoglobulin (IVIG), plasma exchange (PE);
5. Within 4 weeks before screening received vaccine or live attenuated;Within 2 weeks before the baseline received inactivated vaccine;Baseline received within 4 weeks before the new coronavirus vaccine
6. In another clinical study and the baseline from the test drug treatment under three months or 5 half-life of the drug (the long time limit shall prevail);
7. This test for monoclonal antibody has a history of allergies, known in drug allergy patients;Serious drug allergy or for two or over two kinds of food or drugs；
8. 6 months prior to screening, except NMOSD need continuous oral or intravenous glucocorticoid dose \> 20 mg/day of any more than 21 days
9. Abnormal liver, kidney and bone marrow reserve
10. HIV positive at HIV history or enrollment screening; History of hepatitis B Andor hepatitis C or Hepatitis B surface antigen (HBSAG) positivity at screening \[ or Hepatitis B core antibody positive, hepatitis B surface antibody negative, Hepatitis B virus deoxynucleotides (HBV DNA) quantification exceeding normal range \] ; Or Hepatitis C virus (HCV) antibody positive \[ with HCV-rna quantitation exceeding the normal range \] , Treponema pallidum antibody positive at the time of enrollment;
11. Comply with any of the following subjects a latent or active TB infection related standards:
1. Current or past people with active TB;
2. In history and/or physical examination during filter tip physical signs or symptoms of active TB;
3. Recent close contact with people with active TB;
4. At the time of screening, the positive result of TB infected T cells was found. A test could be repeated if the subject's first tb-infected t-cell test result was inconclusive, and the patient was excluded from this study if the test result was inconclusive (or positive) again.
12. Covid-19 infection was diagnosed with clinical symptoms or signs consistent with 2019 coronavirus (COVID-19) infection (eg, fever, dry cough, dyspnea, sore throat, and fatigue) within 4 weeks before screening or during screening, or upon appropriate laboratory testing (at the discretion of the investigator or in accordance with local regulations) . If COVID-19 infection is confirmed before screening, appropriate laboratory testing is required to confirm that the infection has been cured;
13. Suffering from metabolic, hematological, renal, hepatic, pulmonary, neuroendocrine, cardiac, infectious, gastrointestinal or other autoimmune diseases, the researchers believe there is an unacceptable risk to patients, or it may affect NMOSD assessment;
14. According to the researchers, there was a history of drug and alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 125 mL of wine) in the 12 months before screening；
15. Subjects who are unable to undergo an MRI scan (for example, are allergic to Gd-containing MRI contrast media, have a pacemaker, defibrillator, or other metallic object with internal or external limitations to performing an MRI scan) ;
16. Pregnant or lactating women, and screening or baseline pregnancy test positive female subjects;
17. Researchers think that the other does not fit to participate in this study.
18 Years
65 Years
ALL
No
Sponsors
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Bio-Thera Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Xiangjun Chen, Doctor
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital
Chunfeng Liu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital of Suzhou University
Qun Xue, Doctor
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Suzhou University
Yan Jiang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Anhui Provincial Hospital
Yuying Zhao, Doctor
Role: PRINCIPAL_INVESTIGATOR
Shandong University Qilu Hospital
Li Guo, Doctor
Role: PRINCIPAL_INVESTIGATOR
Second Hebei Medical University Hospital
Meini Zhang, Doctor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Shanxi Medical University
Huan Yang, Doctor
Role: PRINCIPAL_INVESTIGATOR
The Central South University Xiang Ya Hospital
Daishi Tian, Doctor
Role: PRINCIPAL_INVESTIGATOR
Tongji hospital affiliated to Tongji Medical College
Yuming Xu, Doctor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Zhengzhou University
Jianglong Tu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital of Nanchang University
Wei Qiu, Doctor
Role: PRINCIPAL_INVESTIGATOR
The third hospital affiliated to sun yat-sen university
Yamei Tang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Honghao Wang, Doctor
Role: PRINCIPAL_INVESTIGATOR
The First People's Hospital of Guangzhou
Xiaoling Luo, Doctor
Role: PRINCIPAL_INVESTIGATOR
Shenzhen city people's hospital
Aiyu Lin, Doctor
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Fujian Medical University
Chunming Xie, Doctor
Role: PRINCIPAL_INVESTIGATOR
China University Hospital of Southeast University
Xiang Li, Doctor
Role: PRINCIPAL_INVESTIGATOR
The first hospital affiliated to wenzhou medical college
Lan Tan, Doctor
Role: PRINCIPAL_INVESTIGATOR
Qingdao City Hospital
Fudong Shi, Doctor
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University General Hospital
Juming Yu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Affiliated Hospital of North Sichuan Medical College
Jun Guo, Doctor
Role: PRINCIPAL_INVESTIGATOR
The Second Affiliated Hospital of the PLA Air Force Military Medical University
Jiewen Zhang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Henan Provincial People's Hospital
Yanghua Tian, Doctor
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital of Anhui Medical University
Jing Ding, Doctor
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Ping Chen, Doctor
Role: PRINCIPAL_INVESTIGATOR
Xianyang yanan university hospital co., LTD
Zunbo Li, Doctor
Role: PRINCIPAL_INVESTIGATOR
Xi'an high-tech Hospital Co. , Ltd.
Qihe Dai, Doctor
Role: PRINCIPAL_INVESTIGATOR
Jingzhou city central hospital
Dan Liu, Doctor
Role: PRINCIPAL_INVESTIGATOR
the first hospital of Baotou medicine college
Junyan Liu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hebei Medical University Third Hospital
Yiqi Wang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Province People's Hospital
Bo Hu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Xiehe hospital affiliated to tongji medical college
Yanbing Han, Doctor
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of the Kunming Medical University
Feng Wang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Wuxi city people's hospital
Zhanhua Liang, Doctor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Dalian Medical University
Weihe Zhang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Sino-Japanese Friendship Hospital
Xiangyang Zhu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Nantong First People's Hospital
Xinfeng Liu, Doctor
Role: PRINCIPAL_INVESTIGATOR
The Chinese people's liberation army general hospital in eastern theater
Weidong Pan, Doctor
Role: PRINCIPAL_INVESTIGATOR
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Wei Lu, Doctor
Role: PRINCIPAL_INVESTIGATOR
The Central South University Xiang YA II hospital
Huiyu Feng, Doctor
Role: PRINCIPAL_INVESTIGATOR
The first hospital affiliated to sun yat-sen university
Feng Gao, Doctor
Role: PRINCIPAL_INVESTIGATOR
The first hospital of Peking University
Yun Xu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Drum tower hospital affiliated to nanjing university school of medicine
Locations
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The First Affiliated Hospital of the Baotou Medical College of Inner Mongolia University of Science and Technology
Baotou, , China
Beijing Hospital
Beijing, , China
China-japan friendship Hospital
Beijing, , China
The first hospital of Peking University
Beijing, , China
The Central South University Xiang Ya Hospital
Changsha, , China
Xiangya 2nd hospital of central south university
Changsha, , China
First affiliated hospital of chongqing medical university
Chongqing, , China
The first affiliated hospital of Dalian Medical University
Dalian, , China
First affiliated hospital of fujian medical university
Fuzhou, , China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, , China
The first hospital affiliated to sun yat-sen university
Guangzhou, , China
The first People's Hospital of Guangzhou
Guangzhou, , China
The third hospital affiliated to sun yat-sen university
Guangzhou, , China
People's Hospital of Zhejiang province
Hangzhou, , China
Anhui Provincial Hospital
Hefei, , China
Second Affiliated Hospital of Anhui Medical University
Hefei, , China
Shandong University Qilu Hospital
Jinan, , China
Jingzhou Central Hospital
Jingzhou, , China
First Affiliated Hospital of the Kunming Medical University
Kunming, , China
Second Affiliated Hospital of Nanchang University
Nanchang, , China
Affiliated Hospital of North Sichuan Medical College
Nanchong, , China
Drum Tower Hospital affiliated to Medical College of Nanjing University
Nanjing, , China
Southeast university affiliated zhongda hospital
Nanjing, , China
The Chinese people's liberation army general hospital in eastern theater
Nanjing, , China
The first People's Hospital of Nantong
Nantong, , China
Qingdao municipal hospital
Qingdao, , China
Mount Hua Hospital affiliated to Fudan University
Shanghai, , China
Shuguang hospital affiliated to Shanghai University of Traditional Chinese medicine
Shanghai, , China
Zhongshan hospital affiliated to Fudan University
Shanghai, , China
Shenzhen city people's hospital
Shenzhen, , China
Second Hebei Medical University Hospital
Shijia Zhuang, , China
The Third Hospital of Hebei Medical University
Shijiazhuang, , China
First Affiliated Hospital of Suzhou University
Suzhou, , China
The Second Affiliated Hospital of Suzhou University
Suzhou, , China
The first hospital of shanxi medical university
Taiyuan, , China
Tianjin Medical University General Hospital
Tianjin, , China
The first hospital affiliated to wenzhou medical college
Wenzhou, , China
Tongji hospital affiliated to tongji medical college huazhong university of science and technology
Wuhan, , China
Xiehe hospital affiliated to tongji medical college huazhong university of science and technology
Wuhan, , China
Wuxi city people's hospital
Wuxi, , China
Second Affiliated Hospital of the People's Liberation Army Air Force Military Medical University
Xi'an, , China
Xi'an high-tech Hospital Co. , Ltd.
Xi'an, , China
Yan 'an University Xianyang Hospital Co. , Ltd.
Xianyang, , China
Henan province people's hospital
Zhengzhou, , China
Zhengzhou university first affiliated hospital
Zhenzhou, , China
Countries
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Other Identifiers
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BAT-4406F-002-CR
Identifier Type: -
Identifier Source: org_study_id
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