HyperlipemiaPhase 3NCT05532800
The Efficacy and Safety of JS002 PFS and AI in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia
A Phase 3 study testing JS002 in people with Hyperlipemia, run by Shanghai Junshi Bioscience Co., Ltd. at 21 sites in China.
Trial summary
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of JS002 prefilled syringes and prefilled autosyringes in patients with primary hypercholesterolemia and mixed hyperlipidemia when combined with statin… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperlipemia
- What is being tested?
- JS002
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- 21 sitesChina
- Study dates
- 28 Feb 2022to 9 Feb 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Age 18~80 years old;
- Stable optimized LLT at least 4 weeks before randomization;
- Two times of Fasting triglycerides ≤4.5 mmol/L(400mg/dL)at the time of screening;
Who cannot join
- History of NYHA class III-IV heart failure or EF<30%;
- History of uncontrolled arrhythmia within 90 days;
- History of MI,UA, PCI or CABG, stroke within 90 days;
- Known hemorrhagic stroke disease;
- Planned cardiac surgery or revascularization.
- Uncontrolled hypertension.
- Uncontrolled diabetes mellitius (HbA1c>8.0%）.
- Other conditions that the researchers considered inappropriate to participate in the study.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
China21 sites
Beijing Anzhen Hospital，Capital Medical University
Beijing, Beijing Municipality, 100029
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100192
The First Hospital of Jilin University
Changchun, Jilin, 130061
The Second Xiangya Hospital Of Central South University
Changsha, Hunan, 410008
Changzhou Second People's Hospital
Changzhou, Jiangsu, 213004
Dalian Municipal Central Hospital
Dalian, Liaoning, 116089
Daqing People's Hospital
Daqing, Heilongjiang, 163711
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Jingzhou Central Hospital
Jingzhou, Hubei, 434020
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121011
Nanchang First Hospital
Nanchang, Jiangxi, 330008
Nanchang Third Hospital
Nanchang, Jiangxi, 330008
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330008
Taizhou Hospital Of Zhejiang Province
Taizhou, Zhejiang, 317000
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300122
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325015
Xianyang Hospital of Yan'an University
Xianyang, Shanxi, 716099
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221004
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of JS002 Prefilled Syringes(PFS) and Prefilled Autosyringes(AI) in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of JS002 prefilled syringes and prefilled autosyringes in patients with primary hypercholesterolemia and mixed hyperlipidemia when combined with statin therapy.
In this study, one dose group (150 mg) were set up in this study. 240 subjects are plan to be enrolled (the study drug will be assigned to a 2:1 :2:1ratio of JS002 PFS / placebo or JS002 AI / placebo ).
Each subject required a maximum of 6 weeks of screening, 12 weeks of treatment, and 8 weeks of follow-up.
- Conditions
- Hyperlipemia
- Being tested
- JS002, Placebo
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS002Drug
JS002:150mg(1mL) Q2W PFS, Placebo: 1mL Q2W PFS.
PlaceboDrug
JS002:150mg(1mL) Q2W AI, Placebo: 1mL Q2W AI.
| Study group | Role | What they receive |
|---|---|---|
| JS002 | Experimental | Cobort 1:150 mg/1mL Q2W PFS,Cobort 2:150 mg/1mL Q2W AI Receives: Drug: JS002 |
| Placebo | Placebo comparator | Cobort 1:/1mL Q2W PFS,Cobort 2:1mL Q2W AI Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C with JS002 PFS
Percentage change in LDL-C relative to baseline at Week 12 with JS002 PFS
Measured: at week 12
LDL-C with JS002 AI
Percentage change in LDL-C relative to baseline at Week 12 with JS002 AI
Measured: at week 12
Secondary outcomes (8)
LDL-C with JS002 PFS
The absolute change in LDL-C relative to baseline with JS002 PFS
Measured: at week 12
LDL-C with JS002 AI
The absolute change in LDL-C relative to baseline with JS002 AI
Measured: at week 12
lipid parameters
Percentages and absolute change in other lipid parameters to baseline with JS002 PFS and JS002 AI
Measured: at week 12
LDL-C reduction≥50 with JS002 PFS
Proportion of subjects with a ≥50% reduction in serum LDL-C at 12 weeks after subcutaneous treatment with JS002 PFS from baseline
Measured: at week 12
LDL-C reduction≥50 with JS002 AI
Proportion of subjects with a ≥50% reduction in serum LDL-C at 12 weeks after subcutaneous treatment with JS002 AI from baseline
Measured: at week 12
LDL-C dropped to < 70 mg/dL with JS002 PFS
Proportion of subjects whose serum LDL-C dropped to < 70 mg/dL (1.8 mmol/L) at 12 weeks after subcutaneous injection of JS002 PFS
Measured: at week 12
LDL-C dropped to < 70 mg/dL with JS002 AI
Proportion of subjects whose serum LDL-C dropped to < 70 mg/dL (1.8 mmol/L) at 12 weeks after subcutaneous injection of JS002 AI
Measured: at week 12
full dose
Proportion of subjects receiving full dose of JS002 AI during treatment (weeks 0, 2, 4, 6, 8, 10)
Measured: at week 0, 2, 4, 6, 8, 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start28 Feb 2022
- Primary completion9 Feb 2023
- Study completion9 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532800
- Sponsor's protocol ID
- JS002-006
- Status last verified
- Mar 2023
- First submitted
- 5 Sep 2022
- Last updated
- 15 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of JS002 Prefilled Syringes(PFS) and Prefilled Autosyringes(AI) in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia
- ClinicalTrials.gov ID
- NCT05532800
- Acronym / sponsor ID
- JS002-006
- Conditions
- Hyperlipemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of JS002 prefilled syringes and prefilled autosyringes in patients with primary hypercholesterolemia and mixed hyperlipidemia when combined with statin therapy.
In this study, one dose group (150 mg) were set up in this study. 240 subjects are plan to be enrolled (the study drug will be assigned to a 2:1 :2:1ratio of JS002 PFS / placebo or JS002 AI / placebo ).
Each subject required a maximum of 6 weeks of screening, 12 weeks of treatment, and 8 weeks of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JS002 | Experimental | Drug: JS002Cobort 1:150 mg/1mL Q2W PFS,Cobort 2:150 mg/1mL Q2W AI |
| Placebo | Placebo comparator | Drug: PlaceboCobort 1:/1mL Q2W PFS,Cobort 2:1mL Q2W AI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent.
- Age 18~80 years old;
- Stable optimized LLT at least 4 weeks before randomization;
- Two times of Fasting triglycerides ≤4.5 mmol/L(400mg/dL)at the time of screening;
Key exclusion criteria (8 listed)
- History of NYHA class III-IV heart failure or EF<30%;
- History of uncontrolled arrhythmia within 90 days;
- History of MI,UA, PCI or CABG, stroke within 90 days;
- Known hemorrhagic stroke disease;
- Planned cardiac surgery or revascularization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JS002JS002:150mg(1mL) Q2W PFS, Placebo: 1mL Q2W PFS. | Drug | JS002 |
| PlaceboJS002:150mg(1mL) Q2W AI, Placebo: 1mL Q2W AI. | Drug | Placebo |
Primary outcome
LDL-C with JS002 PFS
Time frame: at week 12
Percentage change in LDL-C relative to baseline at Week 12 with JS002 PFS
LDL-C with JS002 AI
Time frame: at week 12
Percentage change in LDL-C relative to baseline at Week 12 with JS002 AI
8 secondary outcomes
LDL-C with JS002 PFS
Time frame: at week 12
LDL-C with JS002 AI
Time frame: at week 12
lipid parameters
Time frame: at week 12
LDL-C reduction≥50 with JS002 PFS
Time frame: at week 12
LDL-C reduction≥50 with JS002 AI
Time frame: at week 12
LDL-C dropped to < 70 mg/dL with JS002 PFS
Time frame: at week 12
LDL-C dropped to < 70 mg/dL with JS002 AI
Time frame: at week 12
full dose
Time frame: at week 0, 2, 4, 6, 8, 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JS002 in people with Hyperlipemia, run by Shanghai Junshi Bioscience Co., Ltd. at 21 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-C with JS002 PFS (time frame: at week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.