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HyperlipemiaPhase 3NCT04781114

The Safety and Efficacy of Multiple-dose of JS002 in Subject With Hyperlipidemia

A Phase 3 study testing JS002 in people with Hyperlipemia, run by Shanghai Junshi Bioscience Co., Ltd. at 57 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. 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
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
806 participants
Where
57 sitesChina
Study dates
23 Dec 2020to 16 Jan 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

None listed.

Who cannot join

  • Known HoFH;
  • History of NYHA class III-IV heart failure;
  • History of uncontrolled arrhythmia, Unstable angina,MI, PCI,CABG, DVT or pulmonary embolism within 3 months.
  • Uncontrolled hypertension.
  • Uncontrolled diabetes mellitius (HbA1c>8.0%）.
  • Other conditions that investigators considered inappropriate to participate in the study.

Trial locations and contacts

57 sites in 1 country.

57 sites in 1 country

China57 sites

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100000

  • Beijing Chaoyang Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100000

  • Beijing Tongren Hospital Affiliated to Capital Medical University City:Beijing

    Beijing, Beijing Municipality, 100000

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100000

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100000

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233000

  • First Hospital of Jilin University

    Changchun, Jilin, 130000

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin, 130033

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410100

  • The Second People's Hospital of Changzhou

    Changzhou, Jiangsu, 213000

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610000

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400000

  • The central hospital of Dalian

    Dalian, Liaoning, 116000

  • Daqingshi People's Hospital

    Daqing, Heilongjiang, 163316

  • The 900 Hospital of the Joint Service Support Force of the People's Liberation Army of China

    Fuzhou, Fujian, 350000

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350000

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 5100000

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510000

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510000

  • Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550000

  • The Fourth Affiliated Hospital of Harbin Medical University

    Haerbin, Heilongjiang, 15000

  • Hainan General Hospital

    Haikou, Hainan, 570100

  • Jinan Central Hospital

    Jinan, Shandong, 250000

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250000

  • Jingzhou Central Hospital

    Jingzhou, Hubei, 434000

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning, 121000

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730000

  • The First Hospital of Lanzhou University City:Lanzhou

    Lanzhou, Gansu, 730000

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471000

  • The First Hospital of Nanchang

    Nanchang, Jiangxi, 330000

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

  • Zhongda Hospital Southeast Universty

    Nanjing, Jiangsu, 210009

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530000

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200000

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200000

  • Shanghai Changhai Hospital

    Shanghai, Shanghai Municipality, 200000

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200000

  • The People's Hospital of Liaoning Provincial

    Shenyang, Liaoning, 110000

  • General Hospital of the PLA Northern Theater Command

    Shenyang, Liaoning, 110020

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518000

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030000

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi, 030000

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 318000

  • Teda International Cardiovascular Hospital

    Tianjin, Tianjin Municipality, 300000

  • Tianjin First Central Hospital

    Tianjin, Tianjin Municipality, 300000

  • Tianjin People's Hospital

    Tianjin, Tianjin Municipality, 300000

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

  • The First Affiliated Hospital of the Air Force Medical University

    Xian, Shanxi, 710000

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xian, Shanxi, 710000

  • Xianyang Hospital of Yan 'an University

    Xianyang, Shanxi, 712000

  • Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225000

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: 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

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.

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; Placebo 1mL Q2W.

  • PlaceboDrug

    JS002: 300mg(2mL) Q4W; Placebo 2mL Q4W.

Study groups in NCT04781114
Study groupRoleWhat they receive
JS002ExperimentalCohort 1: 150 mg/1mL Q2W Subcutaneous(SC); Cohort 2: 300/2mL mg Q4W Subcutaneous(SC);
Receives: Drug: JS002
PlaceboPlacebo comparatorCohort 1: 1mL Q2W Subcutaneous(SC); Cohort 2: 2mL Q4W Subcutaneous(SC);
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in LDL-C of JS002

    Percentage change in LDL-C relative to baseline at Week 24

    Measured: Up to 24Weeks after dose administration

Secondary outcomes (6)

  1. Change in LDL-C of JS002

    Percentage change in LDL-C relative to baseline at Week 52

    Measured: Up to 52Weeks after dose administration

  2. Other lipid parameters of JS002

    Percentage change in LDL-C relative to baseline at Week 24 and Week 52

    Measured: Up to Week 24 and 52Weeks after dose administration

  3. The occurrence of adverse events

    Evaluate the change of clinically significant laboratory tests, vital signs, and electrocardiogram

    Measured: Up 60Weeks after dose administration

  4. The immunogenicity of JS002

    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).

    Measured: Up 60Weeks after dose administration

  5. Pharmacokinetics (PK) of JS002

    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).

    Measured: Up 60Weeks after dose administration

  6. Pharmacokinetics (PD) of JS002

    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).

    Measured: Up 60Weeks after dose administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2021
  2. Study start23 Dec 2020
  3. Primary completion25 May 2022
  4. Study completion16 Jan 2023

Resources

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
806 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04781114
Sponsor's protocol ID
JS002-003
Status last verified
Feb 2021
First submitted
24 Feb 2021
Last updated
19 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang X, Qiu M, Cheng Z, Ji X, Chen J, Zhu H, Tang Y, Huang Z, Su G, Wang G, Huang Z, Yao Z, Lin J, Sun Y, Li S, Shao C, Zhao Y, Bai X, Han Y. Efficacy and Safety of Ongericimab in Chinese Patients With Primary Hypercholesterolemia and Mixed Dyslipidemia. J Am Heart Assoc. 2024 Jun 4;13(11):e033669. doi: 10.1161/JAHA.123.033669. Epub 2024 May 31.

    PubMed 38818934

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 57 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 0 inclusion and 6 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 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 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?

Change in LDL-C of JS002 (time frame: Up to 24Weeks after dose administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04781114, which also lists 1 linked publication.

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 19 Apr 2023.

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