An Open Label Study of the Effects and Safety of Zanubrutinib in NMOSDs Adult Patients

  • STATUS
    Recruiting
  • End date
    Oct 3, 2024
  • participants needed
    20
  • sponsor
    Xuanwu Hospital, Beijing
Updated on 3 June 2022
prednisone
immunosuppressive agents
azathioprine

Summary

This is an open-label study, to evaluate the efficacy and safety of a BTK inhibitor zanubrutinib in participants with NMOSDs.

Description

This is an open, single-center clinical study to evaluate the efficacy and safety of Zanubrutinib in the treatment of recurrent neuromyelitis optica spectrum disease. Patients were required to be diagnosed with neuromyelitis optic spectrum disease according to the NMOSD diagnostic criteria established by the international NMO Diagnostic Group (IPND) in 2015, and to have had at least two relapses (including first episode) within two years while at least one relapse occurring within the 12 months prior to screening. The AQP4 antibody must be positive during screening.

Details
Condition Neuromyelitis Optica
Treatment Zanubrutinib
Clinical Study IdentifierNCT05356858
SponsorXuanwu Hospital, Beijing
Last Modified on3 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients must meet the NMOSD diagnostic criteria set by the international NMO Diagnostic Group (IPND) in 2015
Serum AQP4-IgG positive
Clinical evidence of at least 2 documented relapse (including first attack) in the last 2 years, with at least 1 relapse within 12 months prior to screening
Extended Disability Status Scale (EDSS) score ≤7.5 at screening
Age 18 to 75 years inclusive, weight at least 35 kg at the time of informed consent
If the patients were using the following baseline treatment for relapse prevention, they must be treated at a steady dose for at least 4 weeks prior to enrollment
Azathioprine, metecophenol ester and other immunosuppressive agents
Oral corticosteroid (≦30mg/ day prednisone tablet or equivalent dose of other hormones)
(patients or their legal representatives) can provide written informed consent
indicating that they understand and agree to comply with the requirements of
the study protocol

Exclusion Criteria

Continuous treatment with strong or moderate CYP3A inhibitors or inducers is required during the study period. Patients were excluded if they had taken a potent or moderate CYP3A inhibitor or inducer within 7 days prior to administration of the study drug (or had stopped taking these drugs for less than 5 half-lives)
Previously treated with BTK inhibitors (e.g., ibrutinib)
Allergic to the study drug or any of the ingredient
Desease relaps (including first episode) within the previous 30 days
Pregnancy or lactation
Previous or current malignancy, except locally recurrent cancers that have received radical treatment (e.g. excised basal or squamous cell skin cancer, cervical or breast cancer in situ)
Currently central nervous system (CNS) disease that may affect the evaluation of NMOSD
Serious and uncontrolled conditions considered by the investigator that could affect safety, compliance and endpoint evaluation, or need for use of a drug not permitted in the protocol
Disease that could affected drug absorption, distribution, metabolism, and excretion determined by the investigator
Any major clinical infection lead to hospitalization or parenteral antibiotic treatment within 1 month prior to screening; Or other infections that may be aggravated due to the study determined by the investigator
Active, latent or undertreated mycobacterium tuberculosis (TB) infection
Known primary immunodeficiency or underlying disease such as human immunodeficiency virus (HIV) infection
Hepatitis B or C virus infection by serological test
Received B-cell targeted therapy (e.g. Rituximab) within 6 months prior to the initial administration of the study drug
Received biologics such as tozizumab within 12 weeks prior to initial administration of the study drug
Received live attenuated vaccine during the screening and study periods, or any live virus vaccine within 8 weeks prior to initial administration
Abnormal and clinically significant in ECG examination during screening
Uncontrolled hypertension (SBP>160 mmHg or DBP ≥ 95 mmHg)
Grade 3 or 4 heart Failure, (NYHA scale)
Severe liver insufficiency (Child-pugh C)
Aspartate aminotransferase (AST)>3 times the upper limit of normal (ULN) and/or alanine aminotransferase (ALT)>3ULN and/or bilirubin >2ULN
Estimated creatinine clearance <30 mL/min or requiring dialysis
Inability to receive MRI scans
A history of clinically significant CNS trauma
Received experimental drug or other experimental treatment within 4 weeks prior to screening or during 5 pharmacokinetic half-lives or duration of biological effects, whichever is longer
Participate in another clinical study
Accept any of the following
BCG vaccination within 1 year prior to screening
Prior bone marrow transplant, hematopoietic stem cell transplant, or systemic radiation therapy
Received intravenous gamma globulin within 30 days prior to screening
Plasmapheresis or leukocyte separation within 90 days prior to screening
Abnormal white blood cell count, neutrophil count, lymphocyte count, or platelet count
during the screening and were considered unsuitable for study by investigator
Inability to swallow capsules or medical conditions that significantly affect gastrointestinal function
A history of severe hemorrhagic disorders such as hemophilia A, hemophilia B, von willebrand disease, or a history of spontaneous bleeding requiring blood transfusion or other medical intervention
History of stroke or intracranial hemorrhage within 6 months prior to screening
Current alcohol, drug or chemical abuse, or history of such abuse within 1 year prior to screening
Anticoagulants or a combination of anticoagulants and antiplatelet agents is ongoing or planned
Any other circumstances in which the investigator or sponsor considers the patient unsuitable for study participation
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