New antibody drug aims to stop NMOSD attacks in AQP4-positive patients

NCT ID NCT06044350

Disease control Sponsor: Bio-Thera Solutions Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an investigational drug called BAT4406F in 162 adults with neuromyelitis optica spectrum disorder (NMOSD) who have a specific antibody (AQP4-IgG). The drug is designed to reduce or prevent relapses by targeting certain immune cells. Participants receive either the drug or a placebo, and researchers monitor safety and how well the drug controls the disease over time.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 162 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

neuromyelitis optica

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Optic neuromyelitis spectrum disease

Contacts and locations

Locations

Affiliated Hospital of North Sichuan Medical College

Nanchong, China
Anhui Provincial Hospital

Hefei, China
Beijing Hospital

Beijing, China
China-japan friendship Hospital

Beijing, China
Drum Tower Hospital affiliated to Medical College of Nanjing University

Nanjing, China
First Affiliated Hospital of Suzhou University

Suzhou, China
First Affiliated Hospital of the Kunming Medical University

Kunming, China
First affiliated hospital of chongqing medical university

Chongqing, China
First affiliated hospital of fujian medical university

Fuzhou, China
Henan province people's hospital

Zhengzhou, China
Jingzhou Central Hospital

Jingzhou, China
Mount Hua Hospital affiliated to Fudan University

Shanghai, China
People's Hospital of Zhejiang province

Hangzhou, China
Qingdao municipal hospital

Qingdao, China
Second Affiliated Hospital of Anhui Medical University

Hefei, China
Second Affiliated Hospital of Nanchang University

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

Xi'an, China
Second Hebei Medical University Hospital

Shijia Zhuang, China
Shandong University Qilu Hospital

Jinan, China
Shenzhen city people's hospital

Shenzhen, China
Shuguang hospital affiliated to Shanghai University of Traditional Chinese medicine

Shanghai, China
Southeast university affiliated zhongda hospital

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

Guangzhou, China
The Central South University Xiang Ya Hospital

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

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

Baotou, China
The Second Affiliated Hospital of Suzhou University

Suzhou, China
The Third Hospital of Hebei Medical University

Shijiazhuang, China
The first People's Hospital of Guangzhou

Guangzhou, China
The first People's Hospital of Nantong

Nantong, China
The first affiliated hospital of Dalian Medical University

Dalian, China
The first hospital affiliated to sun yat-sen university

Guangzhou, China
The first hospital affiliated to wenzhou medical college

Wenzhou, China
The first hospital of Peking University

Beijing, China
The first hospital of shanxi medical university

Taiyuan, China
The third hospital affiliated to sun yat-sen university

Guangzhou, China
Tianjin Medical University General Hospital

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

Wuhan, China
Wuxi city people's hospital

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

Xi'an, China
Xiangya 2nd hospital of central south university

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

Wuhan, China
Yan 'an University Xianyang Hospital Co. , Ltd.

Xianyang, China
Zhengzhou university first affiliated hospital

Zhenzhou, China
Zhongshan hospital affiliated to Fudan University

Shanghai, China