NCT01731990

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2012

Typical duration for phase_2

Geographic Reach
3 countries

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2016

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 22, 2017

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

3.8 years

First QC Date

November 18, 2012

Results QC Date

July 21, 2017

Last Update Submit

April 25, 2025

Conditions

Peripheral Artery Disease

Keywords

Peripheral artery diseaseIntermittent claudicationmagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Number of Patients With Adverse Events in 12 Months

    Baseline to 12 months post-dose

  • Serum Amyloid A (SAA) Level Ratio of 12 Months to Baseline

    Baseline, 12 months post-dose

  • High Sensitivity C-reactive Protein (hsCRP) Ratio of 12 Months to Baseline

    Baseline, 12 months post-dose

Study Arms (2)

Canakinumab (ACZ885)

EXPERIMENTAL

Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months

Drug: Canakinumab (ACZ885)

Placebo

PLACEBO COMPARATOR

Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months

Drug: Placebo

Interventions

Canakinumab (ACZ885)DRUG

Dosage form: solution for injection Strength: 150 mg/1 mL Mode of administration: subcutaneous use.

Canakinumab (ACZ885)
PlaceboDRUG

Matching placebo of Canakinumab

Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Novartis Investigative Site

Phoenix, Arizona, 85302, United States

Location

Novartis Investigative Site

Jacksonville, Florida, 32207, United States

Location

Novartis Investigative Site

Jacksonville, Florida, 32216, United States

Location

Novartis Investigative Site

Chicago, Illinois, 60611, United States

Location

Novartis Investigative Site

Lutherville, Maryland, 21093, United States

Location

Novartis Investigative Site

Columbus, Ohio, 43215, United States

Location

Novartis Investigative Site

Knoxville, Tennessee, 37920, United States

Location

Novartis Investigative Site

Richmond, Virginia, 23294, United States

Location

Novartis Investigative Site

Hamburg, 20099, Germany

Location

Novartis Investigative Site

Hamburg, 22559, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

Mainz, 55116, Germany

Location

Novartis Investigative Site

München, 80336, Germany

Location

Novartis Investigative Site

Amman, 11941, Jordan

Location

Related Publications (1)

  • 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.

    PMID: 31277561DERIVED

Related Links

MeSH Terms

Conditions

Peripheral Arterial DiseaseIntermittent Claudication

Interventions

canakinumab

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Study was terminated after the third interim analysis based on result from primary outcome analysis.

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2012

First Posted

November 22, 2012

Study Start

October 30, 2012

Primary Completion

August 4, 2016

Study Completion

August 4, 2016

Last Updated

April 29, 2025

Results First Posted

August 22, 2017

Record last verified: 2025-04

Locations

DE(5)JO(1)US(8)