Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities

Homozygous Familial Hypercholesterolemia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01588496
• Other study ID #: 20110233
• Secondary ID: 2011-005399-40
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 5, 2012
• Est. completion date: January 31, 2014

Study information

• Verified date: November 2018
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Study Masking:

Part A: Open Label Part B: Double Blind

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 31, 2014
• Est. primary completion date: January 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Homozygous Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Intervention

Biological:
• Evolocumab
Administered by subcutaneous injection

Drug:
• Placebo
Administered by subcutaneous injection

Locations

Country	Name	City	State
Belgium	Research Site	Bruxelles
Belgium	Research Site	La Louvière
Canada	Research Site	Chicoutimi	Quebec
Canada	Research Site	London	Ontario
Czechia	Research Site	Brno
Czechia	Research Site	Hradec Kralove
Czechia	Research Site	Uherske Hradiste
France	Research Site	Dijon
France	Research Site	Paris Cedex 13
Hong Kong	Research Site	New Territories
Italy	Research Site	Pisa
Lebanon	Research Site	Beirut
Netherlands	Research Site	Amsterdam
New Zealand	Research Site	Christchurch
South Africa	Research Site	Johannesburg	Gauteng
South Africa	Research Site	Observatory	Western Cape
Spain	Research Site	Cordoba	Andalucía
Spain	Research Site	Lugo	Galicia
Spain	Research Site	Madrid
United States	Research Site	Cincinnati	Ohio
United States	Research Site	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czechia,  France,  Hong Kong,  Italy,  Lebanon,  Netherlands,  New Zealand,  South Africa,  Spain, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12	LDL-C was quantified using the ultracentrifugation method.	Baseline and Week 12
Primary	Part B: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12	LDL-C was quantified using the ultracentrifugation method.	Baseline and Week 12
Secondary	Part A: Change From Baseline in LDL-C at Week 12	LDL-C was quantified using the ultracentrifugation method.	Baseline and Week 12
Secondary	Part A: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12		Baseline and Week 12
Secondary	Part A: Percent Change From Baseline in Apolipoprotein B at Week 12		Baseline and Week 12
Secondary	Part A: Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12		Baseline and Week 12
Secondary	Part A: Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12		Baseline and Week 12
Secondary	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.	Baseline and Week 12
Secondary	Part A: Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) at Week 12		Baseline and Week 12
Secondary	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.	Baseline and Weeks 6 and 12
Secondary	Part B: Percent Change From Baseline in Apolipoprotein B at Week 12		Baseline and Week 12
Secondary	Part B: Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 6 and 12		Baseline and Weeks 6 and 12
Secondary	Part B: Percent Change From Baseline in Lipoprotein (a) at Week 12		Baseline and Week 12
Secondary	Part B: Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 6 and 12		Baseline and Weeks 6 and 12

External Links

•   AmgenTrials clinical trials website