Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)

Launched by SHANGHAI PHARMACEUTICALS HOLDING CO., LTD · Dec 2, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called B001 Injection for people with Neuromyelitis Optic Spectrum Disorder (NMOSD), a condition that affects the central nervous system. The main goal of the trial is to find out how well this treatment works, how safe it is, and how it affects the body over time. To take part in the study, participants need to be between 18 and 70 years old and have a confirmed diagnosis of NMOSD, specifically those who have tested positive for a particular antibody known as anti-AQP4.

Participants should have experienced at least one relapse of their condition in the past year and have a specific level of disability, which will be assessed using a standard scale. However, certain individuals are not eligible, including those who have recently received specific treatments for NMOSD or other serious health issues that could interfere with the trial. If someone joins the study, they can expect regular check-ups, monitoring of their health, and to contribute to important research that could help improve treatments for NMOSD in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. NMOSD as defined by either of the following 2015 criteria with anti-AQP4 antibody (Ab) seropositive status at screening
• • 2. Clinical evidence of at least 1 documented relapse in last 12 months prior to screening
• • 3. Expanded Disability Status Scale (EDSS) score from 0 to 7.5 inclusive at screening
• • 4. Age 18 to 70 years, inclusive at the time of informed consent
• Exclusion Criteria:
• • 1. Any previous treatment with anti-CD20, eculizumab, anti-BLyS monoclonal antibody (e.g., belimumab), any other treatment for prevention of multiple sclerosis (MS) relapse (e.g., interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) within 6 months prior to baseline.
• • 2. Received immunosuppression such as azathioprine, mycophenolate mofetil, methotrexate, cyclophosphamide, tacrolimus, mitoxantrone, cyclosporine A, etc, and rug therapy, biological agents such as satralizumab, tocilizumab, eculizumab, etc, 3 months prior to the first administration.
• • 3. Evidence of serious uncontrolled concomitant diseases that may preclude participant participation, as described; Other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency.
• • 4. Known active infection within 3 months prior to baseline
• • 5. Pregnancy or lactation.
• • 6. History of severe allergic reaction to a biologic agent
• • 7. Evidence of chronic active hepatitis B or C
• • 8. Evidence of active tuberculosis
• 9. Following laboratory abnormalities at screening\*:
• • 1. White blood cells (WBC) \<4.0 x10\^3/microliter (μL)
• • 2. Absolute neutrophil count (ANC)
• • 3. Absolute lymphocyte count \<0.5 x10\^3/μL
• • 4. Platelet count \<80 x 10\^9/ L
• • 5. Aspartate aminotransferase (AST) or alanine aminotransferase
• • 10. History of drug or alcohol abuse within 6 months prior to baseline
• • 11. Receipt of any live or live attenuated vaccine within 4 weeks prior to baseline
• • 12. Uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg), diabetes, gastrointestinal diseases, etc.; or the investigator believes that there is anything inappropriate reasons for selection.