Safety, Tolerability and Efficacy of ACZ885 on Leg Artery Structure in Patients With Peripheral Artery Disease
NCT ID: NCT01731990
Last Updated: 2025-04-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
38 participants
INTERVENTIONAL
2012-10-30
2016-08-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Canakinumab (ACZ885)
Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
Canakinumab (ACZ885)
Dosage form: solution for injection Strength: 150 mg/1 mL Mode of administration: subcutaneous use.
Placebo
Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
Placebo
Matching placebo of Canakinumab
Interventions
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Canakinumab (ACZ885)
Dosage form: solution for injection Strength: 150 mg/1 mL Mode of administration: subcutaneous use.
Placebo
Matching placebo of Canakinumab
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Jacksonville, Florida, United States
Novartis Investigative Site
Jacksonville, Florida, United States
Novartis Investigative Site
Chicago, Illinois, United States
Novartis Investigative Site
Lutherville, Maryland, United States
Novartis Investigative Site
Columbus, Ohio, United States
Novartis Investigative Site
Knoxville, Tennessee, United States
Novartis Investigative Site
Richmond, Virginia, United States
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Heidelberg, , Germany
Novartis Investigative Site
Mainz, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Amman, , Jordan
Countries
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References
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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.
Related Links
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A Plain Language Trial Summary is available on www.novctrd.com
Other Identifiers
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2012-001427-12
Identifier Type: -
Identifier Source: secondary_id
CACZ885M2201
Identifier Type: -
Identifier Source: org_study_id
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