- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04179669
Safety and Efficacy of IBI306 in HeFH Patients
August 8, 2023 updated by: Innovent Biologics (Suzhou) Co. Ltd.
A Study to Evaluate Safety and Efficacy of IBI306 in Patients With Heterozygous Familial Hypercholesterolemia
IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol (LDL-C) uptake.
In the phase I study, IBI306 was shown to be safe and well tolerated.
There was robust reduction in LDL-C, Apo(B), non-HDL-C and lipoprotein (a) in healthy subjects.
This study is a randomized, double-blind, placebo-controlled, repeated-dosing, multiple ascending dose trial to evaluate the efficacy and safety of a novel PCSK-9 anti-body, IBI306, in Chinese patients with heterozygous familial hypercholesterolemia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study plans to enroll 148 patients with heterozygous familial hypercholesterolemia. Subjects will maintain a low-fat diet and stable current lipid-lowering therapy for at least 4 weeks and will be randomized into different dose groups at a 1:1 ratio, followed by a 2:1 randomization double-blind treatment with subcutaneous IBI306 150 mg (n=49) or placebo (n=25) every two weeks; or subcutaneous injection of IBI306 450mg (n=49) or placebo (n=25) every four weeks.
Treatment lasts for 12 weeks.
After 12 weeks, each group enters a 12-week open-label treatment, in which IBI306 subjects continue to receive IBI306, and placebo subjects shift to receive IBI306.
The primary endpoint is the percent change in LDL-C levels relative to baseline at 12 weeks.
Secondary endpoints include changes in baseline lipid levels, drug safety, and immunogenicity at 12 weeks and 24 weeks.
The exploratory endpoint is the population pharmacokinetic profile of IBI306 in Chinese subjects with heterozygous familial hypercholesterolemia.
If necessary, the dose of IBI306 will be adjusted accordingly based on the results of the ongoing multi-dose escalation study.
After the open period, the subjects will be given a safety visit for 8 weeks.
Study Type
Interventional
Enrollment (Actual)
149
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China
- Beijing Anzhen Hospital, Capital Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
• Subjects must meet all of the following inclusion criteria in order to be included in the study:
- Provide a signed and dated informed consent form
- Men or women 18 to 70 years of age at screening
- Weight ≥ 40 kg during screening
- Confirmed diagnosis of heterozygous familial hypercholesterolemia
- Maintain a low-fat diet and stabilize the current lipid-lowering therapy
Exclusion Criteria:
• Subjects who do not meet any of the following exclusion criteria cannot be included in the study:
- Patients diagnosed as homozygous familial hypercholesterolemia
- Dialysis or plasmapheresis performed within 4 months prior to screening
- History of liver transplant
- Subjects adjusted for treatment of statins, ezetimibe, niacin, omega-fatty acids within 4 weeks prior to screening
- New York Heart Association (NYHA) grade III or IV heart failure, or recent detection of left ventricular ejection fraction ≤ 30%
- Have serious cardiovascular, cerebrovascular, liver and kidney related diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IBI306
Participants received IBI306 150 mg subcutaneously Q2W or 450mg Q4W for 12 weeks.
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Administered by subcutaneous injection
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Experimental: placebo
Participants received Placebo 150 mg subcutaneously Q2W or 450mg Q4W for 12 weeks.
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Administered by subcutaneous injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of LDL-C decreased from baseline injection.
Time Frame: at 12 weeks
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at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage change of LDL-C from baseline
Time Frame: to 24 weeks
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to 24 weeks
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Changes in LDL-C levels relative to baselin
Time Frame: at 12 and 24 weeks
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at 12 and 24 weeks
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The proportion of patients with LDL-C that were 50% lower than baseline
Time Frame: by 12 weeks and 24 weeks
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by 12 weeks and 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2019
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
November 25, 2019
First Submitted That Met QC Criteria
November 25, 2019
First Posted (Actual)
November 27, 2019
Study Record Updates
Last Update Posted (Actual)
August 9, 2023
Last Update Submitted That Met QC Criteria
August 8, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIBI306C301
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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