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

Amgen

Status and phase: Completed; Phase 3; Phase 2

Conditions: Homozygous Familial Hypercholesterolemia

Treatments: Drug: Placebo; Biological: Evolocumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01588496

20110233

2011-005399-40 (EudraCT Number)

Details and patient eligibility

About

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

Full description

Study Masking:

Part A: Open Label Part B: Double Blind

Enrollment: 58 patients

Sex: All

Ages: 12 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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58 participants in 3 patient groups, including a placebo group

Part A: Evolocumab

Experimental group

Description:

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

Treatment:

Biological: Evolocumab

Part B: Evolocumab

Experimental group

Description:

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

Treatment:

Biological: Evolocumab

Part B: Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo