Clinical trial NCT01731990: Safety, Tolerability and Efficacy of ACZ885 on Leg Artery Structure in Patients With Peripheral Artery Disease
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability and Effects on Arterial Structure and Function of ACZ885 in Patients With Intermittent Claudication.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Peripheral Artery Disease
Keywords: Peripheral artery disease
Intermittent claudication
magnetic resonance imaging
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-11-22
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Mean Vessel Wall Area Ratio of 12 Months to Baseline
timeFrame: Baseline, 12 months post-dose
Secondary outcomes:
measure: Number of Patients With Adverse Events in 12 Months
timeFrame: Baseline to 12 months post-dose
measure: Serum Amyloid A (SAA) Level Ratio of 12 Months to Baseline
timeFrame: Baseline, 12 months post-dose
measure: High Sensitivity C-reactive Protein (hsCRP) Ratio of 12 Months to Baseline
timeFrame: Baseline, 12 months post-dose
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Jacksonville
country: United States
facility: Novartis Investigative Site
state: Florida
city: Jacksonville
country: United States
facility: Novartis Investigative Site
state: Florida
city: Chicago
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Lutherville
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Knoxville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Amman
country: Jordan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Russell KS, Yates DP, Kramer CM, Feller A, Mahling P, Colin L, Clough T, Wang T, LaPerna L, Patel A, Lawall H, Shennak MM, Fulmer J, Nikol S, Smith WB, Muller OJ, Ratchford EV, Basson CT. A randomized, placebo-controlled trial of canakinumab in patients with peripheral artery disease. Vasc Med. 2019 Oct;24(5):414-421. doi: 10.1177/1358863X19859072. Epub 2019 Jul 5.