Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities (TESLA)

November 1, 2018 updated by: Amgen

2-part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia

A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Masking:

Part A: Open Label Part B: Double Blind

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • Research Site
      • La Louvière, Belgium, 7100
        • Research Site
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5K8
        • Research Site
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Research Site
  • Czechia
      • Brno, Czechia, 656 91
        • Research Site
      • Hradec Kralove, Czechia, 500 05
        • Research Site
      • Uherske Hradiste, Czechia, 686 01
        • Research Site
  • France
      • Dijon, France, 21000
        • Research Site
      • Paris Cedex 13, France, 75651
        • Research Site
  • Hong Kong
      • New Territories, Hong Kong
        • Research Site
  • Italy
      • Pisa, Italy, 56124
        • Research Site
  • Lebanon
      • Beirut, Lebanon, 0000
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Research Site
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Research Site
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Research Site
    • Western Cape
      • Observatory, Western Cape, South Africa, 7925
        • Research Site
  • Spain
      • Madrid, Spain, 28040
        • Research Site
    • Andalucía
      • Cordoba, Andalucía, Spain, 14004
        • Research Site
    • Galicia
      • Lugo, Galicia, Spain, 27003
        • Research Site
  • United States
    • New York
      • New York, New York, United States, 10032
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females ≥ 12 to ≤ 80 years of age
  • Diagnosis of homozygous familial hypercholesterolemia
  • Stable lipid-lowering therapies for at least 4 weeks
  • LDL cholesterol ≥ 130 mg/dl (3.4 mmol/L)
  • Triglyceride ≤ 400 mg/dL (4.5 mmol/L)
  • Bodyweight of ≥ 40 kg at screening.

Exclusion Criteria:

  • LDL or plasma apheresis within 8 weeks prior to randomization
  • New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction < 30%
  • Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months of randomization
  • Planned cardiac surgery or revascularization
  • Uncontrolled cardiac arrhythmia
  • Uncontrolled hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: Evolocumab
Participants received open-label evolocumab 420 mg subcutaneously once a month for 12 weeks.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Experimental: Part B: Evolocumab
Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Placebo Comparator: Part B: Placebo
Participants received double-blind placebo subcutaneously once a month for 12 weeks.
Drug: Placebo
Administered by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time Frame: Baseline and Week 12
LDL-C was quantified using the ultracentrifugation method.
Baseline and Week 12
Part B: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time Frame: Baseline and Week 12
LDL-C was quantified using the ultracentrifugation method.
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A: Change From Baseline in LDL-C at Week 12
Time Frame: Baseline and Week 12
LDL-C was quantified using the ultracentrifugation method.
Baseline and Week 12
Part A: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Part A: Percent Change From Baseline in Apolipoprotein B at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Part A: Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Part A: Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Part A: Percentage of Participants With 15% or Greater Reduction in LDL-C From Baseline at Week 12
Time Frame: Baseline and Week 12
LDL-C was quantified using the ultracentrifugation method.
Baseline and Week 12
Part A: Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Part B: Percent Change From Baseline in LDL-C at the Mean of Weeks 6 and 12
Time Frame: Baseline and Weeks 6 and 12
LDL-C was quantified using the ultracentrifugation method.
Baseline and Weeks 6 and 12
Part B: Percent Change From Baseline in Apolipoprotein B at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Part B: Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 6 and 12
Time Frame: Baseline and Weeks 6 and 12
Baseline and Weeks 6 and 12
Part B: Percent Change From Baseline in Lipoprotein (a) at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Part B: Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 6 and 12
Time Frame: Baseline and Weeks 6 and 12
Baseline and Weeks 6 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2012

Primary Completion (Actual)

January 31, 2014

Study Completion (Actual)

January 31, 2014

Study Registration Dates

First Submitted

February 27, 2012

First Submitted That Met QC Criteria

April 27, 2012

First Posted (Estimate)

May 1, 2012

Study Record Updates

Last Update Posted (Actual)

November 29, 2018

Last Update Submitted That Met QC Criteria

November 1, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110233
  • 2011-005399-40 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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