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New treatment option for NMO Spectrum Disorder
Official title Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)
ClinicalTrials.gov ID: NCT05145361
What this study is testing
What is B001 injection?
B001 injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nmo spectrum disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join if
- Any previous treatment with anti-CD20, eculizumab, anti-BLyS monoclonal antibody (e.g., belimumab), any other treatment for prevention of multiple...
- Received immunosuppression such as azathioprine, mycophenolate mofetil, methotrexate, cyclophosphamide, tacrolimus, mitoxantrone, cyclosporine A...
- Evidence of serious uncontrolled concomitant diseases that may preclude participant participation, as described; Other nervous system disease...
- Known active infection within 3 months prior to baseline
- Pregnancy or lactation.
- History of severe allergic reaction to a biologic agent
See the full eligibility 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
- 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...
- Received immunosuppression such as azathioprine, mycophenolate mofetil, methotrexate, cyclophosphamide, tacrolimus, mitoxantrone, cyclosporine A, etc, and rug therapy, biological agents such as satralizumab...
- Evidence of serious uncontrolled concomitant diseases that may preclude participant participation, as described; Other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Taiyuan, Shanxi, China
- Xi’an, Shanxi, China
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Taiyuan, Shanxi, China; Xi’an, Shanxi, China; Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.