search
Back to results

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

Primary Purpose

Homozygous Familial Hypercholesterolemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Evolocumab
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Homozygous Familial Hypercholesterolemia focused on measuring hypercholesterolemia, familial hypercholesterolemia, homozygous familial hypercholesterolemia

Eligibility Criteria

12 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Part A: Evolocumab

Part B: Evolocumab

Part B: Placebo

Arm Description

Participants received open-label evolocumab 420 mg subcutaneously once a month for 12 weeks.

Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.

Participants received double-blind placebo subcutaneously once a month for 12 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 27, 2012
Last Updated
November 1, 2018
Sponsor
Amgen
search

1. Study Identification

Unique Protocol Identification Number
NCT01588496
Brief Title
Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities
Acronym
TESLA
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 5, 2012 (Actual)
Primary Completion Date
January 31, 2014 (Actual)
Study Completion Date
January 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH).
Detailed Description
Study Masking: Part A: Open Label Part B: Double Blind

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Homozygous Familial Hypercholesterolemia
Keywords
hypercholesterolemia, familial hypercholesterolemia, homozygous familial hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A: Evolocumab
Arm Type
Experimental
Arm Description
Participants received open-label evolocumab 420 mg subcutaneously once a month for 12 weeks.
Arm Title
Part B: Evolocumab
Arm Type
Experimental
Arm Description
Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
Arm Title
Part B: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received double-blind placebo subcutaneously once a month for 12 weeks.
Intervention Type
Biological
Intervention Name(s)
Evolocumab
Other Intervention Name(s)
AMG 145, Repatha
Intervention Description
Administered by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered by subcutaneous injection
Primary Outcome Measure Information:
Title
Part A: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Description
LDL-C was quantified using the ultracentrifugation method.
Time Frame
Baseline and Week 12
Title
Part B: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Description
LDL-C was quantified using the ultracentrifugation method.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Part A: Change From Baseline in LDL-C at Week 12
Description
LDL-C was quantified using the ultracentrifugation method.
Time Frame
Baseline and Week 12
Title
Part A: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
Time Frame
Baseline and Week 12
Title
Part A: Percent Change From Baseline in Apolipoprotein B at Week 12
Time Frame
Baseline and Week 12
Title
Part A: Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12
Time Frame
Baseline and Week 12
Title
Part A: Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
Time Frame
Baseline and Week 12
Title
Part A: Percentage of Participants With 15% or Greater Reduction in LDL-C From Baseline at Week 12
Description
LDL-C was quantified using the ultracentrifugation method.
Time Frame
Baseline and Week 12
Title
Part A: Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) at Week 12
Time Frame
Baseline and Week 12
Title
Part B: Percent Change From Baseline in LDL-C at the Mean of Weeks 6 and 12
Description
LDL-C was quantified using the ultracentrifugation method.
Time Frame
Baseline and Weeks 6 and 12
Title
Part B: Percent Change From Baseline in Apolipoprotein B at Week 12
Time Frame
Baseline and Week 12
Title
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
Title
Part B: Percent Change From Baseline in Lipoprotein (a) at Week 12
Time Frame
Baseline and Week 12
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5K8
Country
Canada
Facility Name
Research Site
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7K9
Country
Canada
Facility Name
Research Site
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Research Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Research Site
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
Research Site
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Research Site
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Research Site
City
New Territories
Country
Hong Kong
Facility Name
Research Site
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Research Site
City
Beirut
ZIP/Postal Code
0000
Country
Lebanon
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Research Site
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Research Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Research Site
City
Observatory
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Research Site
City
Cordoba
State/Province
Andalucía
ZIP/Postal Code
14004
Country
Spain
Facility Name
Research Site
City
Lugo
State/Province
Galicia
ZIP/Postal Code
27003
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
29353350
Citation
Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7.
Results Reference
background
PubMed Identifier
25282520
Citation
Raal FJ, Honarpour N, Blom DJ, Hovingh GK, Xu F, Scott R, Wasserman SM, Stein EA; TESLA Investigators. Inhibition of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): a randomised, double-blind, placebo-controlled trial. Lancet. 2015 Jan 24;385(9965):341-50. doi: 10.1016/S0140-6736(14)61374-X. Epub 2014 Oct 1.
Results Reference
derived
PubMed Identifier
24014831
Citation
Stein EA, Honarpour N, Wasserman SM, Xu F, Scott R, Raal FJ. Effect of the proprotein convertase subtilisin/kexin 9 monoclonal antibody, AMG 145, in homozygous familial hypercholesterolemia. Circulation. 2013 Nov 5;128(19):2113-20. doi: 10.1161/CIRCULATIONAHA.113.004678. Epub 2013 Sep 6.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities

We'll reach out to this number within 24 hrs