Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia

NCT05621070 | Recruiting Phase 3

• 1 other identifier: JS002-007
• Study Type: interventional
• Target: 582
• Locations: 1 country
• Sites: 1

Brief Summary

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, PK/PD profile, immunogenicity as well as complete delivery of auto-injector by patients of JS002 as monotherapy in patients with primary hypercholesterolaemia and mixed dyslipidemia. In this study, two dose cohorts(150 mg, 450 mg) are set up, and 582 subjects are planned to be enrolled (randomizedly assigned to JS002 or placebo 150/450 mg group in a 2:1:2:1 ratio).A screening period (≤6 weeks), a double-blind treatment period (12 weeks), an open-label treatment period (40 weeks), and a follow-up period (8 weeks) will be required.

Conditions

Primary Hypercholesterolaemia and Mixed Dyslipidemia

Outcome Measures

Primary Outcomes (2)

• Percent Change From Baseline in LDL-C at Week 12

  Percent Change From Baseline in LDL-C at Week 12 in statin intolerance subjects

  Baseline and week 12

• Percent Change From Baseline in LDL-C at Week 12

  Percent Change From Baseline in LDL-C at Week 12 in ITT subjects

  Baseline and week 12

Secondary Outcomes (6)

• Change From Baseline in LDL-C at Week 12

  Baseline and week 12

• Percent Change From Baseline in LDL-C at Week 24,52

  Baseline and week 24,52

• Change From Baseline in LDL-C at Week 24,52

  Baseline and week 24,52

• Percent Change From Baseline in other lipid parameters such as non-HDL-C, ApoB, TC, et al. at Week 12, 24, 52

  Baseline and week 12, 24, 52

• Percentage of Participants With LDL-C Less Than 1.8 mmol/L(70 mg/dL)

  Baseline and week 12, 24, 52

Other Outcomes (1)

• Number of Participants with anti-drug antibodies (ADAs)

  From baseline to week 60

Study Arms (4)

JS002 150mg Q2W

EXPERIMENTAL

JS002 150mg Q2W SC for 52 weeks

Drug: JS002

JS002 450mg Q4W

PLACEBO COMPARATOR

JS002 450mg Q4W SC for 52 weeks

Drug: JS002

Placebo Q2W

PLACEBO COMPARATOR

Placebo Q2W SC for 12 weeks, then switch to JS002 150mg Q2W SC for 40 weeks

Drug: Placebo

Placebo Q4W

PLACEBO COMPARATOR

Placebo Q4W SC for 12 weeks, then switch to JS002 450mg Q4W SC for 40 weeks

Drug: Placebo

Interventions

JS002 DRUG

JS002 will be administered per auto-injector. Participants will receive JS002 every 2 weeks subcutaneously.

JS002 150mg Q2W

Placebo DRUG

Placebo will be administered per auto-injector. Participants will receive placebo every 2 weeks subcutaneously.

Placebo Q2W

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Age 18\~80 years old
• Subject who has not achieve LDL-C goal as categorized by their CV risk at screening
• Fasting TG≤4.5mmol/L by central laboratory at screening
• Statin intolerance subject must have a history of statin intolerance as evidenced

You may not qualify if:

• History of hemorrhagic stroke
• NYHA III or IV heart failure, or known LVEF\< 30% within 1 year before randomization
• Uncontrolled serious cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, within 90 days prior to randomization
• Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke, deep vein thrombosis or pulmonary embolism within 90 days prior to randomization
• Planned cardiac surgery or revascularization
• Uncontrolled hypertension defined as sitting systolic blood pressure(SBP) \> 160 mmHg or diastolic BP (DBP) \> 100 mmHg
• Type 1 diabetes, poorly controlled type 2 diabetes (HbA1c \> 8%), newly diagnosed type 2 diabetes (within 90 days of randomization)
• Others factors not suitable for participation judged by PI

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related Publications (1)

• Shao C, Zhang S, Cheng Z, Yang K, Wang G, Shi X, Yang H, Ji Y, Li H, Zhang S, Ma J, Pei Z, Zhang Y, Li Y, Li L, Zheng Y, Shao C, Zhang M, Hao Y, Tang YD. Efficacy and safety of ongericimab in Chinese statin-intolerant patients with primary hypercholesterolemia or mixed dyslipidemia: a randomized, placebo-controlled phase 3 trial. Atherosclerosis. 2025 Aug;407:120408. doi: 10.1016/j.atherosclerosis.2025.120408. Epub 2025 Jun 16.

  PMID: 40543299 DERIVED

Central Study Contacts

Qiu'e Wan, PM

CONTACT

86 17710342522; qiu.e_wan@junshipharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 17, 2022
• Study Start: February 3, 2023
• Primary Completion: September 23, 2024
• Study Completion: September 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)