Hyperlipemia
Conditions
Brief summary
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy, as well as immunogenicity of JS002 treated repeatedly in patients with hyperlipidemia when combined with statin therapy. In this study, two dose group (150 mg, 300 mg) were set up in this study. 750 subjects are plan to be enrolled (the study drug will be assigned to a 2:1 ratio of JS002 or placebo). Each subject required a maximum of 6 weeks of screening, 52 weeks of treatment, and 8 weeks of follow-up.
Interventions
DRUGJS002
JS002: 150mg(1mL) Q2W; Placebo 1mL Q2W.
DRUGPlacebo
JS002: 300mg(2mL) Q4W; Placebo 2mL Q4W.
Sponsors
Shanghai Junshi Bioscience Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
A limited list of criteria for selection of participants in the clinical study, provided in terms of inclusion and
Exclusion criteria
and suitable for assisting potential participants in identifying clinical studies of interest. Use a bulleted list for each criterion below the headers Inclusion Criteria and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in LDL-C of JS002 | Up to 24Weeks after dose administration | Percentage change in LDL-C relative to baseline at Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other lipid parameters of JS002 | Up to Week 24 and 52Weeks after dose administration | Percentage change in LDL-C relative to baseline at Week 24 and Week 52 |
| The occurrence of adverse events | Up 60Weeks after dose administration | Evaluate the change of clinically significant laboratory tests, vital signs, and electrocardiogram |
| Change in LDL-C of JS002 | Up to 52Weeks after dose administration | Percentage change in LDL-C relative to baseline at Week 52 |
| Pharmacokinetics (PK) of JS002 | Up 60Weeks after dose administration | Evaluation of Serum concentration of JS002.Descriptive statistics include mean (arithmetic mean and geometric mean), standard deviation (SD), coefficient of variation CV% (arithmetic coefficient and geometric coefficient of variation), Median (Median), minimum (Min) and maximum (Max). |
| Pharmacokinetics (PD) of JS002 | Up 60Weeks after dose administration | Evaluation of serum concentrations of free/total PCSK9 and changes from baseline.Descriptive statistics include mean (arithmetic mean and geometric mean), standard deviation (SD), coefficient of variation CV% (arithmetic coefficient and geometric coefficient of variation), Median (Median), minimum (Min) and maximum (Max). |
| The immunogenicity of JS002 | Up 60Weeks after dose administration | To evaluate the production time, duration and proportion of anti JS002 antibody (ADA).ADA positive samples are tested for titer and for neutralizing antibody (Nab). |
Countries
China
Outcome results
None listed