HyperlipemiaPhase 2NCT04515927
To Evaluate the Efficacy and Safety of JS002 in HoFH Patients
A Phase 2 study testing JS002 in people with Hyperlipemia, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial summary
JS002 is a recombinant human anti-PCSK9 monoclonal antibody. This phase II open-label, single-arm study aims to evaluate the efficacy and safety of JS002 in patients with homozygous familial hypercholesterolemia A dose group (450 mg) was set up in this study.Thirty subjects are planned to be enrolled. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Hyperlipemia
- What is being tested?
- JS002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 17 Aug 2020to 29 Jul 2022
- Phase
- Phase 2
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed informed consent.
- Age ≥12 and ≤75 years old;
- Weight ≥40kg at the time of screening
- Patients diagnosed with HoFH
- Low-density lipoprotein cholesterol (LDL-C) level ≥3.4mmol/L at the time of screening
- Fasting triglycerides ≤4.5 mmol/L;
Who cannot join
- History of NYHA class III-IV heart failure or EF<30%
- History of uncontrolled arrhythmia within 3 months
- History of MI,UA, PCI or CABG, stroke within 3 months.
- History of DVT or pulmonary embolism within 3 months.
- 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
1 site in 1 country.
China1 site
Beijing Anzhen Hospital Capital Medical University
Beijing, Beijing Municipality
About this study
Official title: An Open-label, Single-arm Study Evaluated the Efficacy and Safety of JS002 in Patients With Homozygous Familial Hypercholesterolemia
JS002 is a recombinant human anti-PCSK9 monoclonal antibody. This phase II open-label, single-arm study aims to evaluate the efficacy and safety of JS002 in patients with homozygous familial hypercholesterolemia A dose group (450 mg) was set up in this study.Thirty subjects are planned to be enrolled.
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
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS002Drug
Biological: JS002 Administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| subcutaneous injection of JS002, 450mg, Q4W, 3/13 times. | Experimental | Not described Receives: Drug: JS002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of effectiveness
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Measured: JS002 is administered subcutaneously every 4 weeks, from 12 or 52 weeks after initial administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start17 Aug 2020
- Primary completion6 May 2022
- Study completion29 Jul 2022
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 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
- NCT04515927
- Sponsor's protocol ID
- JS002-004
- Status last verified
- Jul 2024
- First submitted
- 11 Aug 2020
- Last updated
- 24 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm Study Evaluated the Efficacy and Safety of JS002 in Patients With Homozygous Familial Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT04515927
- Acronym / sponsor ID
- JS002-004
- Conditions
- Hyperlipemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 17 Aug 2020 (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 human anti-PCSK9 monoclonal antibody. This phase II open-label, single-arm study aims to evaluate the efficacy and safety of JS002 in patients with homozygous familial hypercholesterolemia A dose group (450 mg) was set up in this study.Thirty subjects are planned to be enrolled.
Each subject required a maximum of 6 weeks of screening, 52 weeks of treatment, and 8 weeks of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subcutaneous injection of JS002, 450mg, Q4W, 3/13 times. | Experimental | Drug: JS002 |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent.
- Age ≥12 and ≤75 years old;
- Weight ≥40kg at the time of screening
- Patients diagnosed with HoFH
- Low-density lipoprotein cholesterol (LDL-C) level ≥3.4mmol/L 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 3 months
- History of MI,UA, PCI or CABG, stroke within 3 months.
- History of DVT or pulmonary embolism within 3 months.
- 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 |
|---|---|---|
| JS002Biological: JS002 Administered by subcutaneous injection | Drug | subcutaneous injection of JS002, 450mg, Q4W, 3/13 times. |
Primary outcome
The primary endpoint of effectiveness
Time frame: JS002 is administered subcutaneously every 4 weeks, from 12 or 52 weeks after initial administration
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
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 24 Jul 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JS002 in people with Hyperlipemia, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site 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 6 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 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The primary endpoint of effectiveness (time frame: JS002 is administered subcutaneously every 4 weeks, from 12 or 52 weeks after initial administration). 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 24 Jul 2024.