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

Primary Purpose

Homozygous Familial Hypercholesterolemia

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

IBI306

About this trial

This is an interventional treatment trial for Homozygous Familial Hypercholesterolemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Beijing Anzhen Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Part 1: IBI306

Part 2: IBI306

Arm Description

Participants receive open-label IBI306 150 mg subcutaneously Q2W or 450 mg Q4W for 12 weeks.

Participants receive open-label 450 mg Q4W subcutaneously for 12 weeks.

Outcomes

Primary Outcome Measures

Part 1: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C).

Part 2: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)

Secondary Outcome Measures

Full Information

NCT ID

NCT04031742

First Posted

July 22, 2019

Last Updated

August 8, 2023

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04031742

Brief Title

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

Official Title

Phase 2b/3 Study to Assess the Efficacy and Safety of IBI306 in Subjects With Homozygous Familial Hypercholesterolemia.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

September 29, 2019 (Actual)

Primary Completion Date

December 30, 2021 (Actual)

Study Completion Date

December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Homozygous Familial Hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

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)

Allocation

Non-Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1: IBI306

Arm Type

Experimental

Arm Description

Participants receive open-label IBI306 150 mg subcutaneously Q2W or 450 mg Q4W for 12 weeks.

Arm Title

Part 2: IBI306

Arm Type

Experimental

Arm Description

Participants receive open-label 450 mg Q4W subcutaneously for 12 weeks.

Intervention Type

Biological

Intervention Name(s)

IBI306

Intervention Description

Administered by subcutaneous injection

Intervention Type

Biological

Intervention Name(s)

IBI306

Intervention Description

Administered by subcutaneous injection

Primary Outcome Measure Information:

Title

Part 1: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C).

Time Frame

Baseline and Week 12

Title

Part 2: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)

Time Frame

Baseline and Week 12

Other Pre-specified Outcome Measures:

Title

Number of investigational product-related adverse events.

Time Frame

Baseline and Week 12

Title

Number of ADA and Nab.

Time Frame

Baseline and Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Facility Information:

Facility Name

Beijing Anzhen Hospital, Capital Medical University

City

Beijing

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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