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

• Status: Terminated
• Trial end date: 2016-08-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

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.