JS002
DrugJS002: 150mg(1mL) Q2W; Placebo 1mL Q2W.
NCT Number: NCT04781114
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.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 3
The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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 "Exclusion Criteria". (Limit: 15,000 characters.) Inclusion criteria
Exclusion criteria
JS002: 150mg(1mL) Q2W; Placebo 1mL Q2W.
JS002: 300mg(2mL) Q4W; Placebo 2mL Q4W.
Time frame: Up to 24Weeks after dose administration
Percentage change in LDL-C relative to baseline at Week 24
Time frame: Up to 52Weeks after dose administration
Percentage change in LDL-C relative to baseline at Week 52
Time frame: Up to Week 24 and 52Weeks after dose administration
Percentage change in LDL-C relative to baseline at Week 24 and Week 52
Time frame: Up 60Weeks after dose administration
Evaluate the change of clinically significant laboratory tests, vital signs, and electrocardiogram
Time frame: 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).
Time frame: 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).
Time frame: 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).
Shanghai Junshi Bioscience Co., Ltd.
Other
A Phase III, Randomized, Double-blind, Placebo-controlled Clinical Study Evaluating the Efficacy and Safety of JS002 in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia in China
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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