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

Recruiting now · Early Phase 1 · Has a placebo group

Conditions studied: NMO Spectrum Disorder

In brief

The objectives of this phase Ib study are to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenic profiles of B001 in subjects with aquaporin-4 antibody (AQP4-IgG) positive NMOSD.

Key facts

Study ID

NCT05145361

Run by

Shanghai Pharmaceuticals Holding Co., Ltd

People needed

45

Starts

2022-04-07

Expected to finish

2026-12-15

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• NMOSD as defined by either of the following 2015 criteria with anti-AQP4 antibody (Ab) seropositive status at screening
• Clinical evidence of at least 1 documented relapse in last 12 months prior to screening
• Expanded Disability Status Scale (EDSS) score from 0 to 7.5 inclusive at screening
• Age 18 to 70 years, inclusive at the time of informed consent

You may not qualify if…

• 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.
• 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.
• 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.
• Known active infection within 3 months prior to baseline
• Pregnancy or lactation.
• History of severe allergic reaction to a biologic agent
• Evidence of chronic active hepatitis B or C
• Evidence of active tuberculosis
• Following laboratory abnormalities at screening*:
• White blood cells (WBC) <4.0 x10\^3/microliter (μL)
• Absolute neutrophil count (ANC)
• Absolute lymphocyte count <0.5 x10\^3/μL
• Platelet count <80 x 10\^9/ L
• Aspartate aminotransferase (AST) or alanine aminotransferase
• History of drug or alcohol abuse within 6 months prior to baseline
• Receipt of any live or live attenuated vaccine within 4 weeks prior to baseline
• 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.

Where it is running

• Beijing Tiantan Hospital Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• First Hospital of Shanxi Medical University — Taiyuan, Shanxi, China (enrolling)
• Tangdu hospital,fourth military medical university — Xi’an, Shanxi, China (enrolling)
• Tianjin Medical University General Hospital — Tianjin, Tianjin Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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