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

Innovent Biologics

Status and phase: Completed; Phase 3; Phase 2

Conditions: Homozygous Familial Hypercholesterolemia

Treatments: Biological: IBI306

Study type: Interventional

Funder types: Industry

Identifiers

NCT04031742

CIBI306A201

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Part 1: IBI306

Experimental group

Description:

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

Treatment:

Biological: IBI306

Biological: IBI306

Part 2: IBI306

Experimental group

Description:

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

Treatment:

Biological: IBI306

Biological: IBI306