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

Homozygous Familial Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04031742
• Other study ID #: CIBI306A201
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 29, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: August 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Homozygous Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Intervention

Biological:
• IBI306
Administered by subcutaneous injection
• IBI306
Administered by subcutaneous injection

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of investigational product-related adverse events.		Baseline and Week 12
Other	Number of ADA and Nab.		Baseline and Week 12
Primary	Part 1: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C).		Baseline and Week 12
Primary	Part 2: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)		Baseline and Week 12