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NCT05145361 | Recruiting | NMO Spectrum Disorder

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

Shanghai Pharmaceuticals Holding Co., Ltd

Brief 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.

Condition or disease

NMO Spectrum Disorder

Intervention/treatment

B001 injection

Placebo

Phase

Early Phase 1

Study Type : Interventional
Estimated Enrollment : 45 participants
Masking : Double
Primary Purpose : Treatment
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)
Actual Study Start Date : April 7, 2022
Estimated Primary Completion Date : April 15, 2024
Estimated Study Completion Date : December 15, 2024
Arm Intervention/treatment

Experimental: B001 injection

Subjects randomized to this arm will receive B001 twice, at day 1 and day 15, up to the end of the study.

Drug: B001 injection

Placebo Comparator: Placebo

Subjects randomized to this arm will receive Placebo twice, at day 1 and day 15, up to the end of the study.

Biological: Placebo
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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.
  • 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.
Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)

Location Details

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

China, Beijing

Beijing Tiantan Hospital Capital Medical University

Beijing, Beijing, China, 100050

Recruiting

China, Shanxi

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China, 030001

Recruiting

China, Shanxi

Tangdu hospital,fourth military medical university

Xi'an, Shanxi, China, 710038

Recruiting

China, Tianjin

Tianjin Medical University General Hospital

Tianjin, Tianjin, China, 300052