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A Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders

Primary Purpose

Optic Neuromyelitis Spectrum Disease

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
BAT4406F Injection
BAT4406F Placebos
Sponsored by
Bio-Thera Solutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Optic Neuromyelitis Spectrum Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age greater than or equal to the age of 18 and less than or equal to 65 patients, gender not limited; Met the 2015 international NMO diagnostic panel (IPND) criteria for NMOSD, And AQP4-IGG positive patients 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 For subjects who had a relapse before screening, symptoms needed to be stable for at least 4 weeks before randomization 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 The score of EDSS 7 or less Has the fertility of men and women must agree during treatment and 6 months after the last dose of using effective birth control method; Agreed to participate in trials, and books to sign the informed consent Exclusion Criteria: CD19 + b-cell count below the lower limit of normal, b-cell-scavenger drugs used 6 months before baseline or within 5 half-lives of the drug, whichever is older (including but not limited to Rituximab, enalizumab, etc.) ; 6 months prior to the baseline used other monoclonal antibody therapy;Baseline used within five half-life before other biological preparation; 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 Within a month before the filter used intravenous immunoglobulin (IVIG), plasma exchange (PE); 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 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); 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; 6 months prior to screening, except NMOSD need continuous oral or intravenous glucocorticoid dose > 20 mg/day of any more than 21 days Abnormal liver, kidney and bone marrow reserve 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; Comply with any of the following subjects a latent or active TB infection related standards: Current or past people with active TB; In history and/or physical examination during filter tip physical signs or symptoms of active TB; Recent close contact with people with active TB; 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. 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; 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; 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; 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) ; Pregnant or lactating women, and screening or baseline pregnancy test positive female subjects; Researchers think that the other does not fit to participate in this study.

Sites / Locations

  • The First Affiliated Hospital of the Baotou Medical College of Inner Mongolia University of Science and TechnologyRecruiting
  • Beijing Hospital
  • China-japan friendship Hospital
  • The first hospital of Peking University
  • The Central South University Xiang Ya Hospital
  • Xiangya 2nd hospital of central south university
  • First affiliated hospital of chongqing medical university
  • The first affiliated hospital of Dalian Medical University
  • First affiliated hospital of fujian medical university
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • The first hospital affiliated to sun yat-sen university
  • The first People's Hospital of Guangzhou
  • The third hospital affiliated to sun yat-sen university
  • People's Hospital of Zhejiang province
  • Anhui Provincial Hospital
  • Second Affiliated Hospital of Anhui Medical UniversityRecruiting
  • Shandong University Qilu Hospital
  • Jingzhou Central Hospital
  • First Affiliated Hospital of the Kunming Medical University
  • Second Affiliated Hospital of Nanchang University
  • Affiliated Hospital of North Sichuan Medical College
  • Drum Tower Hospital affiliated to Medical College of Nanjing University
  • Southeast university affiliated zhongda hospital
  • The Chinese people's liberation army general hospital in eastern theater
  • The first People's Hospital of Nantong
  • Qingdao municipal hospital
  • Mount Hua Hospital affiliated to Fudan UniversityRecruiting
  • Shuguang hospital affiliated to Shanghai University of Traditional Chinese medicine
  • Zhongshan hospital affiliated to Fudan University
  • Shenzhen city people's hospital
  • Second Hebei Medical University Hospital
  • The Third Hospital of Hebei Medical University
  • First Affiliated Hospital of Suzhou University
  • The Second Affiliated Hospital of Suzhou University
  • The first hospital of shanxi medical university
  • Tianjin Medical University General Hospital
  • The first hospital affiliated to wenzhou medical college
  • Tongji hospital affiliated to tongji medical college huazhong university of science and technology
  • Xiehe hospital affiliated to tongji medical college huazhong university of science and technology
  • Wuxi city people's hospitalRecruiting
  • Second Affiliated Hospital of the People's Liberation Army Air Force Military Medical University
  • Xi'an high-tech Hospital Co. , Ltd.Recruiting
  • Yan 'an University Xianyang Hospital Co. , Ltd.Recruiting
  • Henan province people's hospital
  • Zhengzhou university first affiliated hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group:BAT4406F

Control group:BAT4406F Placebos

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pharmacodynamics
The follow-up time point of peripheral blood before and after the analysis to the medicine CD19 + B lymphocytes proportion/count change
Pharmacodynamics
Serum immunoglobulin (IgG and IgM) levels were measured.
Pharmacodynamics
AQP4-IgG levels were measured.
Pharmacokinetics(PK)
Cmax
Pharmacokinetics(PK)
Tmax
Pharmacokinetics(PK)
Cmin
Pharmacokinetics(PK)
AUC0-tau
Pharmacokinetics(PK)
t1/2
Pharmacokinetics(PK)
CL
Pharmacokinetics(PK)
Vd
Immunogenicity evaluation
Resistant antibody positive rate (ADA)
Immunogenicity evaluation
The titers of Ada positive samples

Secondary Outcome Measures

Vital signs
Number of participants with abnormal vital signs
physical examination
Number of participants with abnormal physical examination findings
Laboratory tests
Number of participants with abnormal laboratory test results
electrocardiogram( ECG )
Number of participants with abnormal ECG readings
Adverse events(AE)
Adverse events (AE) is happening, is happening because of adverse events leading to withdrawal Adverse events associated with drugs The occurrence of Serious adverse events (SAE)
Injection site reactions
Number of participants with injection site reactions

Full Information

First Posted
July 31, 2023
Last Updated
September 12, 2023
Sponsor
Bio-Thera Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT06044350
Brief Title
A Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders
Official Title
A Phase II/III Study to Evaluate the Efficacy and Safety of BAT4406F Injection in Patients With Neuromyelitis Optica Lineage Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bio-Thera Solutions

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a phase II/III multicenter, randomized, double-blind, placebo-controlled study, to investigate the efficacy and safety of BAT4406F injection in patients with neuromyelitis optica lineage disease (NMOSD) who are positive for aquaporin 4 antibody (AQP4-IgG) .
Detailed Description
This study was a phase II/III multicenter, randomized, double-blind, placebo-controlled study, which was divided into screening period (4 weeks) , randomized control period (RCP) , and open-label period (Olp)A total of 162 subjects were enrolled during the screening period and randomly assigned 2:1 to either the BAT4406F group or the placebo group after randomization on Day 1 of the RCP, subjects would receive BAT4406F (at a dose of 500mg) or placebo, intravenously, at D 1 and D 182, respectively. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Neuromyelitis Spectrum Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group:BAT4406F
Arm Type
Experimental
Arm Description
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
Arm Title
Control group:BAT4406F Placebos
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
BAT4406F Injection
Intervention Description
Intravenous infusion; Dosage:500mg/time
Intervention Type
Drug
Intervention Name(s)
BAT4406F Placebos
Intervention Description
Intravenous infusion; Dosage:500mg/time
Primary Outcome Measure Information:
Title
Pharmacodynamics
Description
The follow-up time point of peripheral blood before and after the analysis to the medicine CD19 + B lymphocytes proportion/count change
Time Frame
RCP: Day7, Day14, Day28, Day56, Day84, Day112, Day140, Day182, Day280, Day364. OLP:D7, D28, Day84, Day182, Day280, Day364. Week 40+26n (n=1, 2, 3.....) , Week 52+26n (n=1, 2, 3.....). And OLP maximum period for 3 years
Title
Pharmacodynamics
Description
Serum immunoglobulin (IgG and IgM) levels were measured.
Time Frame
RCP:in Day84、Day182、Day280、Day364. OLP: in Day1、Day84、Day182、Day280、Day364 of every years.And OLP maximum period for 3 years
Title
Pharmacodynamics
Description
AQP4-IgG levels were measured.
Time Frame
RCP:in Day84、Day182、Day280、Day364. OLP: in Day1、Day84、Day182、Day280、Day364 of every years.And OLP maximum period for 3 years
Title
Pharmacokinetics(PK)
Description
Cmax
Time Frame
Through study completion,up to 49 months. And OLP maximum period for 3 years.
Title
Pharmacokinetics(PK)
Description
Tmax
Time Frame
Through study completion,up to 49 months. And OLP maximum period for 3 years.
Title
Pharmacokinetics(PK)
Description
Cmin
Time Frame
Through study completion,up to 49 months. And OLP maximum period for 3 years.
Title
Pharmacokinetics(PK)
Description
AUC0-tau
Time Frame
Through study completion,up to 49 months. And OLP maximum period for 3 years.
Title
Pharmacokinetics(PK)
Description
t1/2
Time Frame
Through study completion,up to 49 months. And OLP maximum period for 3 years.
Title
Pharmacokinetics(PK)
Description
CL
Time Frame
Through study completion,up to 49 months. And OLP maximum period for 3 years.
Title
Pharmacokinetics(PK)
Description
Vd
Time Frame
Through study completion,up to 49 months. And OLP maximum period for 3 years.
Title
Immunogenicity evaluation
Description
Resistant antibody positive rate (ADA)
Time Frame
RCP:in Day84、Day181、Day252、Day364. OLP: in Day84、Day181、Day252、Day364 of every years.And OLP maximum period for 3 years
Title
Immunogenicity evaluation
Description
The titers of Ada positive samples
Time Frame
RCP:in Day84、Day181、Day252、Day364. OLP: in Day84、Day181、Day252、Day364 of every years.And OLP maximum period for 3 years
Secondary Outcome Measure Information:
Title
Vital signs
Description
Number of participants with abnormal vital signs
Time Frame
Through study completion,up to 49 months. And OLP maximum period for 3 years.
Title
physical examination
Description
Number of participants with abnormal physical examination findings
Time Frame
Through study completion,up to 49 months. And OLP maximum period for 3 years.
Title
Laboratory tests
Description
Number of participants with abnormal laboratory test results
Time Frame
Through study completion,up to 49 months. And OLP maximum period for 3 years.
Title
electrocardiogram( ECG )
Description
Number of participants with abnormal ECG readings
Time Frame
Through study completion,up to 49 months. And OLP maximum period for 3 years.
Title
Adverse events(AE)
Description
Adverse events (AE) is happening, is happening because of adverse events leading to withdrawal Adverse events associated with drugs The occurrence of Serious adverse events (SAE)
Time Frame
Through study completion,up to 49 months. And OLP maximum period for 3 years.
Title
Injection site reactions
Description
Number of participants with injection site reactions
Time Frame
Through study completion,up to 49 months. And OLP maximum period for 3 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age greater than or equal to the age of 18 and less than or equal to 65 patients, gender not limited; Met the 2015 international NMO diagnostic panel (IPND) criteria for NMOSD, And AQP4-IGG positive patients 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 For subjects who had a relapse before screening, symptoms needed to be stable for at least 4 weeks before randomization 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 The score of EDSS 7 or less Has the fertility of men and women must agree during treatment and 6 months after the last dose of using effective birth control method; Agreed to participate in trials, and books to sign the informed consent Exclusion Criteria: CD19 + b-cell count below the lower limit of normal, b-cell-scavenger drugs used 6 months before baseline or within 5 half-lives of the drug, whichever is older (including but not limited to Rituximab, enalizumab, etc.) ; 6 months prior to the baseline used other monoclonal antibody therapy;Baseline used within five half-life before other biological preparation; 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 Within a month before the filter used intravenous immunoglobulin (IVIG), plasma exchange (PE); 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 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); 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; 6 months prior to screening, except NMOSD need continuous oral or intravenous glucocorticoid dose > 20 mg/day of any more than 21 days Abnormal liver, kidney and bone marrow reserve 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; Comply with any of the following subjects a latent or active TB infection related standards: Current or past people with active TB; In history and/or physical examination during filter tip physical signs or symptoms of active TB; Recent close contact with people with active TB; 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. 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; 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; 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; 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) ; Pregnant or lactating women, and screening or baseline pregnancy test positive female subjects; Researchers think that the other does not fit to participate in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weining Li, Master
Phone
15202417078
Email
wnli@bio-thera.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaohe Wang, Doctor
Phone
86-20-32203220
Email
zhwang@bio-thera.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangjun Chen, Doctor
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chunfeng Liu, Doctor
Organizational Affiliation
Second Affiliated Hospital of Suzhou University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qun Xue, Doctor
Organizational Affiliation
First Affiliated Hospital of Suzhou University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yan Jiang, Doctor
Organizational Affiliation
Anhui Provincial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuying Zhao, Doctor
Organizational Affiliation
Shandong University Qilu Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Li Guo, Doctor
Organizational Affiliation
Second Hebei Medical University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Meini Zhang, Doctor
Organizational Affiliation
The First Affiliated Hospital of Shanxi Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Huan Yang, Doctor
Organizational Affiliation
The Central South University Xiang Ya Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daishi Tian, Doctor
Organizational Affiliation
Tongji hospital affiliated to Tongji Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuming Xu, Doctor
Organizational Affiliation
The First Affiliated Hospital of Zhengzhou University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jianglong Tu, Doctor
Organizational Affiliation
Second Affiliated Hospital of Nanchang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei Qiu, Doctor
Organizational Affiliation
The third hospital affiliated to sun yat-sen university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yamei Tang, Doctor
Organizational Affiliation
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Honghao Wang, Doctor
Organizational Affiliation
The First People's Hospital of Guangzhou
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaoling Luo, Doctor
Organizational Affiliation
Shenzhen city people's hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aiyu Lin, Doctor
Organizational Affiliation
First Affiliated Hospital of Fujian Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chunming Xie, Doctor
Organizational Affiliation
China University Hospital of Southeast University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiang Li, Doctor
Organizational Affiliation
The first hospital affiliated to wenzhou medical college
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lan Tan, Doctor
Organizational Affiliation
Qingdao City Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fudong Shi, Doctor
Organizational Affiliation
Tianjin Medical University General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juming Yu, Doctor
Organizational Affiliation
Affiliated Hospital of North Sichuan Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jun Guo, Doctor
Organizational Affiliation
The Second Affiliated Hospital of the PLA Air Force Military Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jiewen Zhang, Doctor
Organizational Affiliation
Henan Provincial People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yanghua Tian, Doctor
Organizational Affiliation
Second Affiliated Hospital of Anhui Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jing Ding, Doctor
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ping Chen, Doctor
Organizational Affiliation
Xianyang yanan university hospital co., LTD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zunbo Li, Doctor
Organizational Affiliation
Xi'an high-tech Hospital Co. , Ltd.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qihe Dai, Doctor
Organizational Affiliation
Jingzhou city central hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dan Liu, Doctor
Organizational Affiliation
the first hospital of Baotou medicine college
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Junyan Liu, Doctor
Organizational Affiliation
Hebei Medical University Third Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yiqi Wang, Doctor
Organizational Affiliation
Zhejiang Province People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bo Hu, Doctor
Organizational Affiliation
Xiehe hospital affiliated to tongji medical college
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yanbing Han, Doctor
Organizational Affiliation
First Affiliated Hospital of the Kunming Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Feng Wang, Doctor
Organizational Affiliation
Wuxi city people's hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhanhua Liang, Doctor
Organizational Affiliation
The First Affiliated Hospital of Dalian Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Weihe Zhang, Doctor
Organizational Affiliation
Sino-Japanese Friendship Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiangyang Zhu, Doctor
Organizational Affiliation
Nantong First People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xinfeng Liu, Doctor
Organizational Affiliation
The Chinese people's liberation army general hospital in eastern theater
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Weidong Pan, Doctor
Organizational Affiliation
Shuguang hospital affiliated to Shanghai University of Traditional Chinese medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei Lu, Doctor
Organizational Affiliation
The Central South University Xiang YA II hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Huiyu Feng, Doctor
Organizational Affiliation
The first hospital affiliated to sun yat-sen university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Feng Gao, Doctor
Organizational Affiliation
The first hospital of Peking University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yun Xu, Doctor
Organizational Affiliation
Drum tower hospital affiliated to nanjing university school of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of the Baotou Medical College of Inner Mongolia University of Science and Technology
City
Baotou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Liu
Facility Name
Beijing Hospital
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Yin
Facility Name
China-japan friendship Hospital
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weihe Zhang
Facility Name
The first hospital of Peking University
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Gao
Facility Name
The Central South University Xiang Ya Hospital
City
Changsha
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huan Yang
Facility Name
Xiangya 2nd hospital of central south university
City
Changsha
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Lu
Facility Name
First affiliated hospital of chongqing medical university
City
Chongqing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinyue Qin
Facility Name
The first affiliated hospital of Dalian Medical University
City
Dalian
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhanhua Liang
Facility Name
First affiliated hospital of fujian medical university
City
Fuzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aiyu Lin
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yamei Tang
Facility Name
The first hospital affiliated to sun yat-sen university
City
Guangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huiyu Feng
Facility Name
The first People's Hospital of Guangzhou
City
Guangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Honghao Wang
Facility Name
The third hospital affiliated to sun yat-sen university
City
Guangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Qiu
Facility Name
People's Hospital of Zhejiang province
City
Hangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiqi Wang
Facility Name
Anhui Provincial Hospital
City
Hefei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Jiang
Facility Name
Second Affiliated Hospital of Anhui Medical University
City
Hefei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanghua Tian
Facility Name
Shandong University Qilu Hospital
City
Jinan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuying Zhao
Facility Name
Jingzhou Central Hospital
City
Jingzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qihe Dai
Facility Name
First Affiliated Hospital of the Kunming Medical University
City
Kunming
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanbing Han
Facility Name
Second Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianglong Tu
Facility Name
Affiliated Hospital of North Sichuan Medical College
City
Nanchong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juming Yu
Facility Name
Drum Tower Hospital affiliated to Medical College of Nanjing University
City
Nanjing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Xu
Facility Name
Southeast university affiliated zhongda hospital
City
Nanjing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunming Xie
Facility Name
The Chinese people's liberation army general hospital in eastern theater
City
Nanjing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinfeng Liu
Facility Name
The first People's Hospital of Nantong
City
Nantong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangyang Zhu
Facility Name
Qingdao municipal hospital
City
Qingdao
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lan Tan
Facility Name
Mount Hua Hospital affiliated to Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangjun Chen
Email
xiangjchen@fudan.edu.cn
Facility Name
Shuguang hospital affiliated to Shanghai University of Traditional Chinese medicine
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weidong Fan
Facility Name
Zhongshan hospital affiliated to Fudan University
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Ding
Facility Name
Shenzhen city people's hospital
City
Shenzhen
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoling Luo
Facility Name
Second Hebei Medical University Hospital
City
Shijia Zhuang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Guo
Facility Name
The Third Hospital of Hebei Medical University
City
Shijiazhuang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junyan Liu
Facility Name
First Affiliated Hospital of Suzhou University
City
Suzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qun Xue
Facility Name
The Second Affiliated Hospital of Suzhou University
City
Suzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunfeng Liu
Facility Name
The first hospital of shanxi medical university
City
Taiyuan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meini Zhang
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fudong Shi
Facility Name
The first hospital affiliated to wenzhou medical college
City
Wenzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Li
Facility Name
Tongji hospital affiliated to tongji medical college huazhong university of science and technology
City
Wuhan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daishi Tian
Facility Name
Xiehe hospital affiliated to tongji medical college huazhong university of science and technology
City
Wuhan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Hu
Facility Name
Wuxi city people's hospital
City
Wuxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Wang
Facility Name
Second Affiliated Hospital of the People's Liberation Army Air Force Military Medical University
City
Xi'an
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Guo
Facility Name
Xi'an high-tech Hospital Co. , Ltd.
City
Xi'an
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zunbo Li
Facility Name
Yan 'an University Xianyang Hospital Co. , Ltd.
City
Xianyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Chen
Facility Name
Henan province people's hospital
City
Zhengzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiewen Zhang
Facility Name
Zhengzhou university first affiliated hospital
City
Zhenzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuming Xu

12. IPD Sharing Statement

Learn more about this trial

A Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders

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