Testing BAT4406F Injection for Neuromyelitis Optica Spectrum Disorders

A Phase II/III Study to Evaluate the Efficacy and Safety of BAT4406F Injection in Patients with Neuromyelitis Optica Lineage Disease

This study is testing if a new injection called BAT4406F can help people with neuromyelitis optica spectrum disorders who have a specific antibody, compared to a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 162 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Bio-Thera Solutions (Industry-sponsored)
• Drugs / interventions: Rituximab, enalizumab, methotrexate, cyclophosphamide, prednisone
• Locations: 45 sites (Baotou and 44 other locations)
• Trial ID: NCT06044350 on ClinicalTrials.gov

What this trial studies

This phase II/III multicenter, randomized, double-blind, placebo-controlled study aims to evaluate the efficacy and safety of BAT4406F injection in patients diagnosed with neuromyelitis optica spectrum disorders (NMOSD) who are positive for aquaporin 4 antibody. The study involves a screening period followed by a randomized control period where participants receive either BAT4406F or a placebo. After the control period, participants may enter an open-label phase based on their condition. The study will enroll a total of 162 subjects and monitor their responses over a specified duration.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a confirmed diagnosis of NMOSD and positive for AQP4-IgG.

Not a fit: Patients with certain exclusions, such as those with specific B-cell counts or those not meeting the relapse criteria, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from NMOSD.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in treating NMOSD with targeted therapies.

Eligibility criteria

Inclusion Criteria:

1. Age greater than or equal to the age of 18 and less than or equal to 65 patients, gender not limited;
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:

1. 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.) ;
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.

Where this trial is running

Baotou and 44 other locations

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

Study contacts

• Principal investigator: Xiangjun Chen, Doctor — Huashan Hospital
• Study coordinator: Weining Li, Master

Conditions Optic Neuromyelitis Spectrum Disease