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

Phase 2

Terminated

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Canakinumab (ACZ885)	Canakinumab (ACZ885)	Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
Placebo	Placebo	Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months

Primary Outcome Measures

Name	Time	Method
Mean Vessel Wall Area Ratio of 12 Months to Baseline	Baseline, 12 months post-dose	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.

Secondary Outcome Measures

Name	Time	Method
High Sensitivity C-reactive Protein (hsCRP) Ratio of 12 Months to Baseline	Baseline, 12 months post-dose	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.
Serum Amyloid A (SAA) Level Ratio of 12 Months to Baseline	Baseline, 12 months post-dose	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.
Number of Patients With Adverse Events in 12 Months	Baseline to 12 months post-dose	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.