NCT05145361RecruitingEarly Phase 1
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)
Shanghai Pharmaceuticals Holding Co., Ltd4 sites in 1 country45 target enrollmentStarted: April 7, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Recruiting
- Enrollment
- 45
- Locations
- 4
- Primary Endpoint
- Dose-limiting toxicity (DLT)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: B001 injection (Drug)
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.
Intervention: Placebo (Biological)
Outcomes
Primary Outcomes
Dose-limiting toxicity (DLT)
Time Frame: Up to 18 days.
Measurement of DLT in all subjects.
Evaluate incidence of treatment-emergent adverse events [Safety and Tolerability].
Time Frame: Up to 1 year
Secondary Outcomes
- Time of maximum serum concentration (Tmax) of B001.(Through study completion, up to 2 years)
- Maximum serum concentration (Cmax) of B001.(Through study completion, up to 2 years)
- Terminal rate constant(λz) of B001.(Through study completion, up to 2 years)
- Half-life (t1/2) of B001.(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.(Through study completion, up to 2 years)
- Change in Expanded Disability Status Scale (EDSS) Score(Through study completion, up to 2 years)
- Time to First Protocol-Defined Relapse (TFR) in the Double-Blind Period(Through study completion, up to 2 years)
- Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-14D) of B001.(Through study completion, up to 2 years)
- Accumulation ratio of maximum serum concentration (Rac_Cmax) of B001.(Through study completion, up to 2 years)
- Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of B001.(Through study completion, up to 2 years)
- Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of B001.(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.(Through study completion, up to 2 years)
- Volume of distribution(Vz) of B001.(Through study completion, up to 2 years)
- Percentage of subjects with ADA to B001 and neutralizing resistance (Nab)(Through study completion, up to 2 years)
- Total clearance(CL) of B001.(Through study completion, up to 2 years)
- Time to EDSS Worsening(Through study completion, up to 2 years)
Investigators
Study Sites (4)
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