NMO Spectrum DisorderEarly Phase 1NCT05145361
Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)
A Early Phase 1 study testing B001 injection in people with NMO Spectrum Disorder, run by Shanghai Pharmaceuticals Holding Co., Ltd at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NMO Spectrum Disorder
- What is being tested?
- B001 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 4 sitesChina
- Study dates
- 7 Apr 2022to 15 Dec 2026
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality, 100050
Yunxing Song, +86 17813230827, songyx@sphchina.com
Xinghu Zhang
- Recruiting
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Yunxing Song, +86 17813230827, songyx@sphchina.com
Meini Zhang
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Chao Zhang, MD, 022-60814587, chaozhang@tmu.edu.can
Fu-Dong Shi, MD,PhD
- Recruiting
Tangdu hospital,fourth military medical university
Xi’an, Shanxi, 710038
Shicao Li, 0086-029-84717761, tangduec@126.com
Jun Guo
About this study
Official title: A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of B001 in Subjects With Aquaporin-4 Antibody (AQP4-IgG) Positive Neuromyelitis Optic Spectrum Disorder (NMOSD)
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.
- Conditions
- NMO Spectrum Disorder
- Being tested
- B001 injection, Placebo
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B001 injectionDrug
B001 injection 50mg/5mL Intravenous solution
PlaceboBiological
Placebo 5mL Intravenous solution
| Study group | Role | What they receive |
|---|---|---|
| B001 injection | Experimental | Subjects randomized to this arm will receive B001 twice, at day 1 and day 15, up to the end of the study. Receives: Drug: B001 injection |
| Placebo | Placebo comparator | Subjects randomized to this arm will receive Placebo twice, at day 1 and day 15, up to the end of the study. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Measurement of DLT in all subjects.
Measured: Up to 18 days.
Evaluate incidence of treatment-emergent adverse events [Safety and Tolerability].
Measured: Up to 1 year
Secondary outcomes (16)
Maximum serum concentration (Cmax) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Measured: Through study completion, up to 2 years
Time of maximum serum concentration (Tmax) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Measured: Through study completion, up to 2 years
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-14D) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Measured: Through study completion, up to 2 years
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Measured: Through study completion, up to 2 years
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Measured: Through study completion, up to 2 years
Accumulation ratio of maximum serum concentration (Rac_Cmax) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Measured: Through study completion, up to 2 years
Accumulation ratio of area under the serum concentration-time curve (Rac_AUC) of the Dosing Interval (0-14D) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Measured: Through study completion, up to 2 years
Terminal rate constant(λz) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Measured: Through study completion, up to 2 years
Half-life (t1/2) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Measured: Through study completion, up to 2 years
Total clearance(CL) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Measured: Through study completion, up to 2 years
Volume of distribution(Vz) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Measured: Through study completion, up to 2 years
Percentage of area under the serum concentration-time curve (AUC 0-infinity) obtained by extrapolation (%AUCex) of B001.
To characterize the PK (Pharmacokinetics) of B001.
Measured: Through study completion, up to 2 years
Percentage of subjects with ADA to B001 and neutralizing resistance (Nab)
Measured: Through study completion, up to 2 years
Time to First Protocol-Defined Relapse (TFR) in the Double-Blind Period
Measured: Through study completion, up to 2 years
Change in Expanded Disability Status Scale (EDSS) Score
The EDSS provides a total score on a scale that ranges from 0 to 10 in 0.5 increments that represent higher levels of disability. Increasing disability is reflected in an increasing EDSS score.
Measured: Through study completion, up to 2 years
Time to EDSS Worsening
Measured: Through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start7 Apr 2022
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NMO Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fu-Dong Shi, MD,PhD, Principal investigator, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145361
- Sponsor's protocol ID
- B001-103
- Status last verified
- Aug 2025
- First submitted
- 21 Nov 2021
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jia D, Wang H, Jiang W, Shen Y, Guo J, Zhao D, Zhang M, Meng H, Xue H, Song Y, Yao Q, Xie N, Zhang C. A novel recombinant anti-cluster of differentiation 20 humanized monoclonal antibody (B001) for the treatment of neuromyelitis optica spectrum disorder: a phase 1, multicenter randomized, double-blind trial. Front Immunol. 2026 Apr 16;17:1676908. doi: 10.3389/fimmu.2026.1676908. eCollection 2026.
PubMed 42079612