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

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ClinicalTrials.gov Identifier: NCT04031742
Recruitment Status : Not yet recruiting
First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

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 Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 ]
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
Estimated Study Start Date : August 12, 2019
Estimated Primary Completion Date : January 13, 2021
Estimated Study Completion Date : April 21, 2021

Resource links provided by the National Library of Medicine


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




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

Other Outcome Measures:
  1. Number of investigational product-related adverse events. [ Time Frame: Baseline and Week 12 ]
  2. Number of ADA and Nab. [ Time Frame: Baseline and Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Liver transplant history.
  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.

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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT04031742     History of Changes
Other Study ID Numbers: CIBI306A201
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type II
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias