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

December 9, 2020 updated by: Novartis Pharmaceuticals

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20099
        • Novartis Investigative Site
      • Hamburg, Germany, 22559
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Novartis Investigative Site
      • Mainz, Germany, 55116
        • Novartis Investigative Site
      • München, Germany, 80336
        • Novartis Investigative Site
  • Jordan
      • Amman, Jordan, 11941
        • Novartis Investigative Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85302
        • Novartis Investigative Site
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Novartis Investigative Site
      • Jacksonville, Florida, United States, 32216
        • Novartis Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Novartis Investigative Site
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • Novartis Investigative Site
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Novartis Investigative Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Novartis Investigative Site
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Canakinumab (ACZ885)
Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
Drug: Canakinumab (ACZ885)
Dosage form: solution for injection Strength: 150 mg/1 mL Mode of administration: subcutaneous use.
PLACEBO_COMPARATOR: Placebo
Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
Drug: Placebo
Matching placebo of Canakinumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Vessel Wall Area Ratio of 12 Months to Baseline
Time Frame: Baseline, 12 months post-dose
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Adverse Events in 12 Months
Time Frame: Baseline to 12 months post-dose
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
Serum Amyloid A (SAA) Level Ratio of 12 Months to Baseline
Time Frame: Baseline, 12 months post-dose
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
High Sensitivity C-reactive Protein (hsCRP) Ratio of 12 Months to Baseline
Time Frame: Baseline, 12 months post-dose
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 30, 2012

Primary Completion (ACTUAL)

August 4, 2016

Study Completion (ACTUAL)

August 4, 2016

Study Registration Dates

First Submitted

November 18, 2012

First Submitted That Met QC Criteria

November 21, 2012

First Posted (ESTIMATE)

November 22, 2012

Study Record Updates

Last Update Posted (ACTUAL)

December 30, 2020

Last Update Submitted That Met QC Criteria

December 9, 2020

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CACZ885M2201
  • 2012-001427-12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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