A Study to Evaluate Safety and Efficacy of IBI306, a PCSK9 Monoclonal Antibody in Chinese Subjects With Homozygous Familial Hypercholesterolemia

August 8, 2023 updated by: Innovent Biologics (Suzhou) Co. Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2
  • 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

  • China
      • Beijing, China
        • Beijing Anzhen Hospital, Capital Medical University

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:

  1. Males and females ≥ 18 to ≤ 80 years of age
  2. Diagnosis of homozygous familial hypercholesterolemia
  3. LDL cholesterol ≥ 130 mg/dL (3.4mmol/L)
  4. Triglyceride ≤ 400 mg/dL (4.5 mmol/L)
  5. Bodyweight of ≥ 40 kg at screening

Exclusion Criteria:

  1. History of liver transplant
  2. Uncontrolled hypertension
  3. Moderate to severe renal dysfunction
  4. Active liver disease or hepatic dysfunction
  5. Known sensitivity to any of the products to be administered during dosing

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: IBI306
Participants receive open-label IBI306 150 mg subcutaneously Q2W or 450 mg Q4W for 12 weeks.
Biological: IBI306
Administered by subcutaneous injection
Experimental: Part 2: IBI306
Participants receive open-label 450 mg Q4W subcutaneously for 12 weeks.
Biological: IBI306
Administered by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part 1: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C).
Time Frame: Baseline and Week 12
Baseline and Week 12
Part 2: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
Time Frame: Baseline and Week 12
Baseline and Week 12

Other Outcome Measures

Outcome Measure
Time Frame
Number of investigational product-related adverse events.
Time Frame: Baseline and Week 12
Baseline and Week 12
Number of ADA and Nab.
Time Frame: Baseline and Week 12
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

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)

September 29, 2019

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

July 22, 2019

First Submitted That Met QC Criteria

July 22, 2019

First Posted (Actual)

July 24, 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

  • CIBI306A201

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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