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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01588496
First received: February 27, 2012
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

A study to determine the safety, tolerability, and efficacy of Evolocumab (AMG145) in subjects with homozygous familial hypercholesterolemia.


Condition Intervention Phase
Homozygous Familial Hypercholesterolemia
Biological: Evolocumab (AMG145)
Other: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 2 Part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of Evolocumab (AMG145) in Subjects With Homozygous Familial Hypercholesterolemia Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability, and Efficacy of Evolocumab (AMG145) in Subjects With Homozygous Familial Hypercholesterolemia Part B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of Evolocumab (AMG145) in Subjects With Homozygous Familial Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Percent change from baseline in low density lipoprotein cholesterol at week 12 for Part A and B [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in low density lipoprotein-cholesterol at week 12 for Part A and B


Secondary Outcome Measures:
  • Change from baseline in low density lipoprotein-cholesterol at week 12 for Part A [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in low density lipoprotein-cholesterol at week 12 for Part A

  • Percent change from baseline in non-high density lipoprotein cholesterol at week 12 for Part A [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in non-high density lipoprotein cholesterol at week 12 for Part A

  • Percent change from baseline in apolipoprotein B at week 12 for Part A [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in apolipoprotein B at week 12 for Part A

  • Percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio at week 12 for Part A [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio at week 12 for Part A

  • Percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio at week 12 for Part A [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio at week 12 for Part A

  • Response rate of subjects with 15% or greater reduction in low density lipoprotein-cholesterol from baseline to Week 12 for Part A [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Response rate of subjects with 15% or greater reduction in low density lipoprotein-cholesterol from baseline to Week 12 for Part A

  • Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) at week 12 for Part A [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) at week 12 for Part A

  • Mean percent change from baseline in low density lipoprotein-cholesterol at weeks 6 and 12 for Part B [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Mean percent change from baseline in low density lipoprotein-cholesterol at weeks 6 and 12 for Part B

  • Percent change from baseline in apolipoprotein B week 12 for Part B [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in apolipoprotein B week 12 for Part B

  • Mean percent change from baseline in Apolipoprotein B at weeks 6 and 12 for Part B [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Mean percent change from baseline in Apolipoprotein B at weeks 6 and 12 for Part B

  • Percent change from baseline in Lipoprotein (a) at week 12 for Part B [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in Lipoprotein (a) at week 12 for Part B

  • Mean percent change from baseline in Lipoprotein (a) at weeks 6 and 12 for Part B [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Mean percent change from baseline in Lipoprotein (a) at weeks 6 and 12 for Part B


Enrollment: 58
Study Start Date: April 2012
Study Completion Date: March 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Part A: Evolocumab (AMG145)
Subcutaneous Evolocumab (AMG145) Open Label
Biological: Evolocumab (AMG145)
Subcutaneous Evolocumab (AMG145) Open Label
Active Comparator: Part B: Evolocumab (AMG145)
Subcutaneous Evolocumab (AMG145)
Biological: Evolocumab (AMG145)
Subcutaneous Evolocumab (AMG145)
Placebo Comparator: Part B: Placebo
Subcutaneous Placebo
Other: Placebo
Subcutaneous Placebo

Detailed Description:

Study Masking:

Part A: Open Label Part B: Double Blind

  Eligibility

Ages Eligible for Study:   12 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 Failure 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588496

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

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01588496     History of Changes
Other Study ID Numbers: 20110233
Study First Received: February 27, 2012
Last Updated: June 27, 2014
Health Authority: Czech Republic: State Institute for Drug Control (SUKL)
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Italy: Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO
Turkey: Ministry of Health, the Republic of Turkey
South Africa: MCC
Brazil: ANVISA (Agencia Nacional de Vigilancia Sanitária)
Hong Kong: Department of Health
New Zealand: MEDSAFE (New Zealand Medicines and Medical Devices Safety Authority)
Canada: Canadian Agency is Health Canada _ Biologics and Genetic Therapies Directorate.
United States: Food and Drug Administration
Lebanon: Institutional Review Board

Keywords provided by Amgen:
hypercholesterolemia
familial hypercholesterolemia
homozygous familial hypercholesterolemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Dyslipidemias
Genetic Diseases, Inborn
Hyperlipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders
Lipid Metabolism, Inborn Errors
Metabolic Diseases
Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on October 20, 2014