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

Sponsor

Innovent Biologics (Suzhou) Co. Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04031742

Collaborator

(none)

Enrollment

Location

Arms

18.7

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A study to evaluate safety and efficacy of IBI306 in subjects with homozygous familial hypercholesterolemia.

Condition or Disease	Intervention/Treatment	Phase
Homozygous Familial Hypercholesterolemia	Biological: IBI306 Biological: IBI306	Phase 2/Phase 3

Detailed Description

Part 1: open-label, two-arm, randomized, multicenter. Part 2: open-label, single-arm, multicenter.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 2b/3 Study to Assess the Efficacy and Safety of IBI306 in Subjects With Homozygous Familial Hypercholesterolemia. Part 1 - Open-label, Two-arm, Multicenter Pilot Study to Evaluate Efficacy and Safety of IBI 306 in Subjects With Homozygous Familial Hypercholesterolemia. Part 2 - Open-label, Single-arm, Multicenter Study to Evaluate Efficacy and Safety of IBI 306 in Subjects With Homozygous Familial Hypercholesterolemia

Actual Study Start Date :

Sep 29, 2019

Anticipated Primary Completion Date :

Jan 13, 2021

Anticipated Study Completion Date :

Apr 21, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Part 1: IBI306

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

Biological: IBI306

Administered by subcutaneous injection

Experimental: Part 2: IBI306

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

Biological: IBI306

Administered by subcutaneous injection

Outcome Measures

Primary Outcome Measures

Part 1: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C). [Baseline and Week 12]
Part 2: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) [Baseline and Week 12]

Other Outcome Measures

Number of investigational product-related adverse events. [Baseline and Week 12]
Number of ADA and Nab. [Baseline and Week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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:

Liver transplant history.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Anzhen Hospital， Capital Medical University	Beijing		China

Sponsors and Collaborators

Innovent Biologics (Suzhou) Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Innovent Biologics (Suzhou) Co. Ltd.

ClinicalTrials.gov Identifier:

NCT04031742

Other Study ID Numbers:

CIBI306A201

First Posted:

Jul 24, 2019

Last Update Posted:

Nov 17, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hyperlipoproteinemia Type II

Hypercholesterolemia

Study Results

No Results Posted as of Nov 17, 2020