Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD) (NCT05145361) | Clinical Trial Compass
RecruitingEarly Phase 1
Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)
China45 participantsStarted 2022-04-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Dose-limiting toxicity (DLT)
Timeframe: Up to 18 days.
2
Evaluate incidence of treatment-emergent adverse events [Safety and Tolerability].