Safety, Tolerability and Efficacy of ACZ885 on Leg Artery Structure in Patients With Peripheral Artery Disease

Phase 2TerminatedNCT01731990

Novartis Pharmaceuticals38 enrolled

Overview

This study was designed to assess the safety, tolerability and efficacy of ACZ885 on the leg artery structure and physical activity in patients with atherosclerotic peripheral artery disease and leg pain from walking.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Peripheral Artery Disease

Interventions

Canakinumab (ACZ885)DRUG

Dosage form: solution for injection Strength: 150 mg/1 mL Mode of administration: subcutaneous use.

PlaceboDRUG

Matching placebo of Canakinumab

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Must have a signed informed consent form. * Must be between the ages of 18 and 85 * Must experience leg pain associated with walking and have an ankle brachial index between 0.40 and 0.9 * Must be on stable aspirin and statin doses for at least 6 weeks * Blood pressure within ranges specified in the protocol * Able to communicate well with the Investigator and understand and comply with the study procedures Key Exclusion Criteria: * Recent use of any other experimental drugs * Pregnant or nursing women * Women of child bearing potential unless willing to use contraception as detailed in the protocol * Cannot walk 15 meters (50 feet) * People on restricted medications as listed in the protocol * Any open or non-healing wounds with 3 months of study start or infection within 2 weeks or study start * Significant heart disease * Uncontrolled diabetes * Significant kidney or liver disease * Live vaccinations within 3 months of study start * History of untreated tuberculosis or active tuberculosis (TB) * Patients with metal in their body (excluded due to MRI scan) as detailed in the protocol.

Locations (14)

Novartis Investigative Site

Phoenix, Arizona, United States

Novartis Investigative Site

Jacksonville, Florida, United States

Novartis Investigative Site

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Mean Vessel Wall Area Ratio of 12 Months to Baseline

Peripheral artery wall area (superficial femoral artery) measured using Magnetic Resonance Imaging (MRI) cross-section slices. Mean vessel wall area (mm\^2) was derived by converting total plaque volume (TPV) (mL) of the vessel to mm\^3 by multiplying by 1000, dividing by the number of slices used for the volume calculation, and dividing by the thickness of a slice (3 mm). Least squares mean for ratio of 12 months to baseline was measured from repeated measures mixed effect model with visit, treatment, the treatment-by-visit interaction, baseline and the visit-by-baseline interaction as fixed effects.

Time frame: Baseline, 12 months post-dose

Secondary Outcomes

Number of Patients With Adverse Events in 12 Months

Summary statistics on adverse event is reported. It is categorized as number of patients in total adverse events (non serious and serious AEs), serious adverse event, death.

Time frame: Baseline to 12 months post-dose

Serum Amyloid A (SAA) Level Ratio of 12 Months to Baseline

Least squares mean for ratio of 12 months to baseline was measured from repeated measures mixed effect model with visit, treatment, treatment-by-visit interaction, baseline and the visit-by-baseline interaction as fixed effects.

Time frame: Baseline, 12 months post-dose

High Sensitivity C-reactive Protein (hsCRP) Ratio of 12 Months to Baseline

Time frame: Baseline, 12 months post-dose

Data from ClinicalTrials.gov

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