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

NCT06044350 | Active Not Recruiting Phase 2

• 1 other identifier: BAT-4406F-002-CR
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 45

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) .

Conditions

Optic Neuromyelitis Spectrum Disease

Outcome Measures

Primary Outcomes (12)

• Pharmacodynamics

  The follow-up time point of peripheral blood before and after the analysis to the medicine CD19 + B lymphocytes proportion/count change

  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

• Pharmacodynamics

  Serum immunoglobulin (IgG and IgM) levels were measured.

  RCP:in Day84、Day182、Day280、Day364. OLP: in Day1、Day84、Day182、Day280、Day364 of every years.And OLP maximum period for 3 years

• Pharmacodynamics

  AQP4-IgG levels were measured.

  RCP:in Day84、Day182、Day280、Day364. OLP: in Day1、Day84、Day182、Day280、Day364 of every years.And OLP maximum period for 3 years

• Pharmacokinetics（PK）

  Cmax

  Through study completion,up to 49 months. And OLP maximum period for 3 years.

• Pharmacokinetics（PK）

  Tmax

  Through study completion,up to 49 months. And OLP maximum period for 3 years.

• Pharmacokinetics（PK）

  Cmin

  Through study completion,up to 49 months. And OLP maximum period for 3 years.

• Pharmacokinetics（PK）

  AUC0-tau

  Through study completion,up to 49 months. And OLP maximum period for 3 years.

• Pharmacokinetics（PK）

  t1/2

  Through study completion,up to 49 months. And OLP maximum period for 3 years.

• Pharmacokinetics（PK）

  CL

  Through study completion,up to 49 months. And OLP maximum period for 3 years.

• Pharmacokinetics（PK）

  Vd

  Through study completion,up to 49 months. And OLP maximum period for 3 years.

• Immunogenicity evaluation

  Resistant antibody positive rate (ADA)

  RCP:in Day84、Day181、Day252、Day364. OLP: in Day84、Day181、Day252、Day364 of every years.And OLP maximum period for 3 years

• Immunogenicity evaluation

  The titers of Ada positive samples

  RCP:in Day84、Day181、Day252、Day364. OLP: in Day84、Day181、Day252、Day364 of every years.And OLP maximum period for 3 years

Secondary Outcomes (6)

• Vital signs

  Through study completion,up to 49 months. And OLP maximum period for 3 years.

• physical examination

  Through study completion,up to 49 months. And OLP maximum period for 3 years.

• Laboratory tests

  Through study completion,up to 49 months. And OLP maximum period for 3 years.

• electrocardiogram（ ECG ）

  Through study completion,up to 49 months. And OLP maximum period for 3 years.

• Adverse events（AE）

  Through study completion,up to 49 months. And OLP maximum period for 3 years.

Study Arms (2)

Experimental group：BAT4406F

EXPERIMENTAL

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

Drug: BAT4406F Injection

Control group：BAT4406F Placebos

ACTIVE COMPARATOR

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

Drug: BAT4406F Placebos

Interventions

BAT4406F Injection DRUG

Intravenous infusion; Dosage:500mg/time

Experimental group：BAT4406F

BAT4406F Placebos DRUG

Intravenous infusion; Dosage:500mg/time

Control group：BAT4406F Placebos

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.) ;
• 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；
• 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.

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (45)

The First Affiliated Hospital of the Baotou Medical College of Inner Mongolia University of Science and Technology

Baotou, China

Location

Beijing Hospital

Beijing, China

Location

China-japan friendship Hospital

Beijing, China

Location

The first hospital of Peking University

Beijing, China

Location

The Central South University Xiang Ya Hospital

Changsha, China

Location

Xiangya 2nd hospital of central south university

Changsha, China

Location

First affiliated hospital of chongqing medical university

Chongqing, China

Location

The first affiliated hospital of Dalian Medical University

Dalian, China

Location

First affiliated hospital of fujian medical university

Fuzhou, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, China

Location

The first hospital affiliated to sun yat-sen university

Guangzhou, China

Location

The first People's Hospital of Guangzhou

Guangzhou, China

Location

The third hospital affiliated to sun yat-sen university

Guangzhou, China

Location

People's Hospital of Zhejiang province

Hangzhou, China

Location

Anhui Provincial Hospital

Hefei, China

Location

Second Affiliated Hospital of Anhui Medical University

Hefei, China

Location

Shandong University Qilu Hospital

Jinan, China

Location

Jingzhou Central Hospital

Jingzhou, China

Location

First Affiliated Hospital of the Kunming Medical University

Kunming, China

Location

Second Affiliated Hospital of Nanchang University

Nanchang, China

Location

Affiliated Hospital of North Sichuan Medical College

Nanchong, China

Location

Drum Tower Hospital affiliated to Medical College of Nanjing University

Nanjing, China

Location

Southeast university affiliated zhongda hospital

Nanjing, China

Location

The Chinese people's liberation army general hospital in eastern theater

Nanjing, China

Location

The first People's Hospital of Nantong

Nantong, China

Location

Qingdao municipal hospital

Qingdao, China

Location

Mount Hua Hospital affiliated to Fudan University

Shanghai, China

Location

Shuguang hospital affiliated to Shanghai University of Traditional Chinese medicine

Shanghai, China

Location

Zhongshan hospital affiliated to Fudan University

Shanghai, China

Location

Shenzhen city people's hospital

Shenzhen, China

Location

Second Hebei Medical University Hospital

Shijia Zhuang, China

Location

The Third Hospital of Hebei Medical University

Shijiazhuang, China

Location

First Affiliated Hospital of Suzhou University

Suzhou, China

Location

The Second Affiliated Hospital of Suzhou University

Suzhou, China

Location

The first hospital of shanxi medical university

Taiyuan, China

Location

Tianjin Medical University General Hospital

Tianjin, China

Location

The first hospital affiliated to wenzhou medical college

Wenzhou, China

Location

Tongji hospital affiliated to tongji medical college huazhong university of science and technology

Wuhan, China

Location

Xiehe hospital affiliated to tongji medical college huazhong university of science and technology

Wuhan, China

Location

Wuxi city people's hospital

Wuxi, China

Location

Second Affiliated Hospital of the People's Liberation Army Air Force Military Medical University

Xi'an, China

Location

Xi'an high-tech Hospital Co. , Ltd.

Xi'an, China

Location

Yan 'an University Xianyang Hospital Co. , Ltd.

Xianyang, China

Location

Henan province people's hospital

Zhengzhou, China

Location

Zhengzhou university first affiliated hospital

Zhenzhou, China

Location

Study Officials

• Xiangjun Chen, Doctor

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

• Chunfeng Liu, Doctor

  Second Affiliated Hospital of Suzhou University

  PRINCIPAL INVESTIGATOR

• Qun Xue, Doctor

  First Affiliated Hospital of Suzhou University

  PRINCIPAL INVESTIGATOR

• Yan Jiang, Doctor

  Anhui Provincial Hospital

  PRINCIPAL INVESTIGATOR

• Yuying Zhao, Doctor

  Shandong University Qilu Hospital

  PRINCIPAL INVESTIGATOR

• Li Guo, Doctor

  Second Hebei Medical University Hospital

  PRINCIPAL INVESTIGATOR

• Meini Zhang, Doctor

  The First Affiliated Hospital of Shanxi Medical University

  PRINCIPAL INVESTIGATOR

• Huan Yang, Doctor

  The Central South University Xiang Ya Hospital

  PRINCIPAL INVESTIGATOR

• Daishi Tian, Doctor

  Tongji hospital affiliated to Tongji Medical College

  PRINCIPAL INVESTIGATOR

• Yuming Xu, Doctor

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

• Jianglong Tu, Doctor

  Second Affiliated Hospital of Nanchang University

  PRINCIPAL INVESTIGATOR

• Wei Qiu, Doctor

  The third hospital affiliated to sun yat-sen university

  PRINCIPAL INVESTIGATOR

• Yamei Tang, Doctor

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

• Honghao Wang, Doctor

  The First People's Hospital of Guangzhou

  PRINCIPAL INVESTIGATOR

• Xiaoling Luo, Doctor

  Shenzhen city people's hospital

  PRINCIPAL INVESTIGATOR

• Aiyu Lin, Doctor

  First Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

• Chunming Xie, Doctor

  China University Hospital of Southeast University

  PRINCIPAL INVESTIGATOR

• Xiang Li, Doctor

  The first hospital affiliated to wenzhou medical college

  PRINCIPAL INVESTIGATOR

• Lan Tan, Doctor

  Qingdao City Hospital

  PRINCIPAL INVESTIGATOR

• Fudong Shi, Doctor

  Tianjin Medical University General Hospital

  PRINCIPAL INVESTIGATOR

• Juming Yu, Doctor

  Affiliated Hospital of North Sichuan Medical College

  PRINCIPAL INVESTIGATOR

• Jun Guo, Doctor

  The Second Affiliated Hospital of the PLA Air Force Military Medical University

  PRINCIPAL INVESTIGATOR

• Jiewen Zhang, Doctor

  Henan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Yanghua Tian, Doctor

  Second Affiliated Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

• Jing Ding, Doctor

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

• Ping Chen, Doctor

  Xianyang yanan university hospital co., LTD

  PRINCIPAL INVESTIGATOR

• Zunbo Li, Doctor

  Xi'an high-tech Hospital Co. , Ltd.

  PRINCIPAL INVESTIGATOR

• Qihe Dai, Doctor

  Jingzhou city central hospital

  PRINCIPAL INVESTIGATOR

• Dan Liu, Doctor

  the first hospital of Baotou medicine college

  PRINCIPAL INVESTIGATOR

• Junyan Liu, Doctor

  Hebei Medical University Third Hospital

  PRINCIPAL INVESTIGATOR

• Yiqi Wang, Doctor

  Zhejiang Province People's Hospital

  PRINCIPAL INVESTIGATOR

• Bo Hu, Doctor

  Xiehe hospital affiliated to tongji medical college

  PRINCIPAL INVESTIGATOR

• Yanbing Han, Doctor

  First Affiliated Hospital of the Kunming Medical University

  PRINCIPAL INVESTIGATOR

• Feng Wang, Doctor

  Wuxi city people's hospital

  PRINCIPAL INVESTIGATOR

• Zhanhua Liang, Doctor

  The First Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

• Weihe Zhang, Doctor

  Sino-Japanese Friendship Hospital

  PRINCIPAL INVESTIGATOR

• Xiangyang Zhu, Doctor

  Nantong First People's Hospital

  PRINCIPAL INVESTIGATOR

• Xinfeng Liu, Doctor

  The Chinese people's liberation army general hospital in eastern theater

  PRINCIPAL INVESTIGATOR

• Weidong Pan, Doctor

  Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Wei Lu, Doctor

  The Central South University Xiang YA II hospital

  PRINCIPAL INVESTIGATOR

• Huiyu Feng, Doctor

  The first hospital affiliated to sun yat-sen university

  PRINCIPAL INVESTIGATOR

• Feng Gao, Doctor

  The first hospital of Peking University

  PRINCIPAL INVESTIGATOR

• Yun Xu, Doctor

  Drum tower hospital affiliated to nanjing university school of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: September 21, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

CN (45)