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

Peripheral Artery Disease Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01731990
• Other study ID #: CACZ885M2201
• Secondary ID: 2012-001427-12
• Status: Terminated
• Phase: Phase 2
• Start date: October 30, 2012
• Est. completion date: August 4, 2016

Study information

• Verified date: March 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: August 4, 2016
• Est. primary completion date: August 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Drug:
• Canakinumab (ACZ885)
Dosage form: solution for injection Strength: 150 mg/1 mL Mode of administration: subcutaneous use.
• Placebo
Matching placebo of Canakinumab

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	München
Jordan	Novartis Investigative Site	Amman
United States	Novartis Investigative Site	Chicago	Illinois
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Jacksonville	Florida
United States	Novartis Investigative Site	Jacksonville	Florida
United States	Novartis Investigative Site	Knoxville	Tennessee
United States	Novartis Investigative Site	Lutherville	Maryland
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany,  Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Vessel Wall Area Ratio of 12 Months to Baseline	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.	Baseline, 12 months post-dose
Secondary	Number of Patients With Adverse Events in 12 Months	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.	Baseline to 12 months post-dose
Secondary	Serum Amyloid A (SAA) Level Ratio of 12 Months to Baseline	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.	Baseline, 12 months post-dose
Secondary	High Sensitivity C-reactive Protein (hsCRP) Ratio of 12 Months to Baseline	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.	Baseline, 12 months post-dose

External Links

•   A Plain Language Trial Summary is available on novartisclinicaltrials.com