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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Peripheral Artery Disease

Treatments: Drug: Canakinumab (ACZ885); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01731990

2012-001427-12

CACZ885M2201

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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38 participants in 2 patient groups, including a placebo group

Canakinumab (ACZ885)

Experimental group

Description:

Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months

Treatment:

Drug: Canakinumab (ACZ885)

Placebo

Placebo Comparator group

Description:

Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months

Treatment:

Drug: Placebo