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Optic Neuromyelitis Spectrum DiseasePhase 2NCT06044350

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

A Phase 2 study testing BAT4406F Injection in people with Optic Neuromyelitis Spectrum Disease, run by Bio-Thera Solutions at 45 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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) . Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Optic Neuromyelitis Spectrum Disease
What is being tested?
BAT4406F Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
162 participants
Where
45 sitesChina
Study dates
1 Aug 2023to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

China45 sites

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

    Baotou

  • Beijing Hospital

    Beijing

  • China-japan friendship Hospital

    Beijing

  • The first hospital of Peking University

    Beijing

  • The Central South University Xiang Ya Hospital

    Changsha

  • Xiangya 2nd hospital of central south university

    Changsha

  • First affiliated hospital of chongqing medical university

    Chongqing

  • The first affiliated hospital of Dalian Medical University

    Dalian

  • First affiliated hospital of fujian medical university

    Fuzhou

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

    Guangzhou

  • The first hospital affiliated to sun yat-sen university

    Guangzhou

  • The first People's Hospital of Guangzhou

    Guangzhou

  • The third hospital affiliated to sun yat-sen university

    Guangzhou

  • People's Hospital of Zhejiang province

    Hangzhou

  • Anhui Provincial Hospital

    Hefei

  • Second Affiliated Hospital of Anhui Medical University

    Hefei

  • Shandong University Qilu Hospital

    Jinan

  • Jingzhou Central Hospital

    Jingzhou

  • First Affiliated Hospital of the Kunming Medical University

    Kunming

  • Second Affiliated Hospital of Nanchang University

    Nanchang

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong

  • Drum Tower Hospital affiliated to Medical College of Nanjing University

    Nanjing

  • Southeast university affiliated zhongda hospital

    Nanjing

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

    Nanjing

  • The first People's Hospital of Nantong

    Nantong

  • Qingdao municipal hospital

    Qingdao

  • Mount Hua Hospital affiliated to Fudan University

    Shanghai

  • Shuguang hospital affiliated to Shanghai University of Traditional Chinese medicine

    Shanghai

  • Zhongshan hospital affiliated to Fudan University

    Shanghai

  • Shenzhen city people's hospital

    Shenzhen

  • Second Hebei Medical University Hospital

    Shijia Zhuang

  • The Third Hospital of Hebei Medical University

    Shijiazhuang

  • First Affiliated Hospital of Suzhou University

    Suzhou

  • The Second Affiliated Hospital of Suzhou University

    Suzhou

  • The first hospital of shanxi medical university

    Taiyuan

  • Tianjin Medical University General Hospital

    Tianjin

  • The first hospital affiliated to wenzhou medical college

    Wenzhou

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

    Wuhan

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

    Wuhan

  • Wuxi city people's hospital

    Wuxi

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

    Xi'an

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

    Xi'an

  • Yan 'an University Xianyang Hospital Co. , Ltd.

    Xianyang

  • Henan province people's hospital

    Zhengzhou

  • Zhengzhou university first affiliated hospital

    Zhenzhou

Other trials in China

About this study

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

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) .

Read the 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.

Being tested
BAT4406F Injection, BAT4406F Placebos

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAT4406F InjectionDrug

    Intravenous infusion; Dosage:500mg/time

  • BAT4406F PlacebosDrug

    Intravenous infusion; Dosage:500mg/time

Study groups in NCT06044350
Study groupRoleWhat they receive
Experimental group：BAT4406FExperimentalRCP：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
Receives: Drug: BAT4406F Injection
Control group：BAT4406F PlacebosActive comparatorRCP：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
Receives: Drug: BAT4406F Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacodynamics

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

    Measured: 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

  2. Pharmacodynamics

    Serum immunoglobulin (IgG and IgM) levels were measured.

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

  3. Pharmacodynamics

    AQP4-IgG levels were measured.

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

  4. Pharmacokinetics（PK）

    Cmax

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

  5. Pharmacokinetics（PK）

    Tmax

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

  6. Pharmacokinetics（PK）

    Cmin

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

  7. Pharmacokinetics（PK）

    AUC0-tau

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

  8. Pharmacokinetics（PK）

    t1/2

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

  9. Pharmacokinetics（PK）

    CL

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

  10. Pharmacokinetics（PK）

    Vd

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

  11. Immunogenicity evaluation

    Resistant antibody positive rate (ADA)

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

  12. Immunogenicity evaluation

    The titers of Ada positive samples

    Measured: 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)

  1. Vital signs

    Number of participants with abnormal vital signs

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

  2. physical examination

    Number of participants with abnormal physical examination findings

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

  3. Laboratory tests

    Number of participants with abnormal laboratory test results

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

  4. electrocardiogram（ ECG ）

    Number of participants with abnormal ECG readings

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

  5. 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)

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

  6. Injection site reactions

    Number of participants with injection site reactions

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start1 Aug 2023
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
162 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06044350
Sponsor's protocol ID
BAT-4406F-002-CR
Status last verified
Sep 2026
First submitted
31 Jul 2023
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BAT4406F Injection in people with Optic Neuromyelitis Spectrum Disease, run by Bio-Thera Solutions at 45 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacodynamics (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). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06044350.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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