Homozygous Familial HypercholesterolemiaPhase 2/3NCT04031742
A Study to Evaluate Safety and Efficacy of IBI306, a PCSK9 Monoclonal Antibody in Chinese Subjects With Homozygous Familial Hypercholesterolemia
A Phase 2/3 study testing IBI306 in people with Homozygous Familial Hypercholesterolemia, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
A study to evaluate safety and efficacy of IBI306 in subjects with homozygous familial hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Homozygous Familial Hypercholesterolemia
- What is being tested?
- IBI306
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2019to 30 Dec 2021
- Phase
- Phase 2/3
- 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
- Males and females ≥ 18 to ≤ 80 years of age
- Diagnosis of homozygous familial hypercholesterolemia
- LDL cholesterol ≥ 130 mg/dL (3.4mmol/L)
- Triglyceride ≤ 400 mg/dL (4.5 mmol/L)
- Bodyweight of ≥ 40 kg at screening
Who cannot join
- History of liver transplant
- Uncontrolled hypertension
- Moderate to severe renal dysfunction
- Active liver disease or hepatic dysfunction
- Known sensitivity to any of the products to be administered during dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2b/3 Study to Assess the Efficacy and Safety of IBI306 in Subjects With Homozygous Familial Hypercholesterolemia.
A study to evaluate safety and efficacy of IBI306 in subjects with homozygous familial hypercholesterolemia.
Read the detailed description
This is a phase 2b/3 study to assess the efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia. Part 1 is an open-label, two-arm, multicenter pilot study to evaluate efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia. Part 2 is an open-label, single-arm, multicenter study to evaluate efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia.
- Conditions
- Homozygous Familial Hypercholesterolemia
- Being tested
- IBI306
- Medical subject headings
- Homozygous Familial Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI306Biological
Administered by subcutaneous injection
IBI306Biological
Administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Part 1: IBI306 | Experimental | Participants receive open-label IBI306 150 mg subcutaneously Q2W or 450 mg Q4W for 12 weeks. Receives: Biological: IBI306 |
| Part 2: IBI306 | Experimental | Participants receive open-label 450 mg Q4W subcutaneously for 12 weeks. Receives: Biological: IBI306 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C).
Measured: Baseline and Week 12
Part 2: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start29 Sep 2019
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Homozygous Familial HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 \[ Time Frame: Baseline and Week 12 \]
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031742
- Sponsor's protocol ID
- CIBI306A201
- Status last verified
- Aug 2023
- First submitted
- 22 Jul 2019
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2b/3 Study to Assess the Efficacy and Safety of IBI306 in Subjects With Homozygous Familial Hypercholesterolemia.
- ClinicalTrials.gov ID
- NCT04031742
- Acronym / sponsor ID
- CIBI306A201
- Conditions
- Homozygous Familial Hypercholesterolemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Sep 2019 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 24 Jul 2019 (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.
A study to evaluate safety and efficacy of IBI306 in subjects with homozygous familial hypercholesterolemia.
Detailed description
This is a phase 2b/3 study to assess the efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia. Part 1 is an open-label, two-arm, multicenter pilot study to evaluate efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia. Part 2 is an open-label, single-arm, multicenter study to evaluate efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]
| Arm | Type | Receives |
|---|---|---|
| Part 1: IBI306 | Experimental | Biological: IBI306Participants receive open-label IBI306 150 mg subcutaneously Q2W or 450 mg Q4W for 12 weeks. |
| Part 2: IBI306 | Experimental | Biological: IBI306Participants receive open-label 450 mg Q4W subcutaneously for 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females ≥ 18 to ≤ 80 years of age
- Diagnosis of homozygous familial hypercholesterolemia
- LDL cholesterol ≥ 130 mg/dL (3.4mmol/L)
- Triglyceride ≤ 400 mg/dL (4.5 mmol/L)
- Bodyweight of ≥ 40 kg at screening
Key exclusion criteria (5 listed)
- History of liver transplant
- Uncontrolled hypertension
- Moderate to severe renal dysfunction
- Active liver disease or hepatic dysfunction
- Known sensitivity to any of the products to be administered during dosing
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 |
|---|---|---|
| IBI306Administered by subcutaneous injection | Biological | Part 1: IBI306 |
| IBI306Administered by subcutaneous injection | Biological | Part 2: IBI306 |
Primary outcome
Part 1: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C).
Time frame: Baseline and Week 12
Part 2: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline and 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 9 Aug 2023.
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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 2/3 study testing IBI306 in people with Homozygous Familial Hypercholesterolemia, run by Innovent Biologics (Suzhou) 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 5 inclusion and 5 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 9 Aug 2023. 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 combined 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.
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?
Part 1: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C). (time frame: Baseline and 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 9 Aug 2023.