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

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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Canakinumab (ACZ885)

Placebo

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring Peripheral artery disease, Intermittent claudication, magnetic resonance imaging

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Canakinumab (ACZ885)

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT01731990

First Posted

November 18, 2012

Last Updated

December 9, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01731990

Brief Title

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

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Terminated

Why Stopped

The study got terminated based on result from primary endpoint analysis

Study Start Date

October 30, 2012 (Actual)

Primary Completion Date

August 4, 2016 (Actual)

Study Completion Date

August 4, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Artery Disease

Keywords

Peripheral artery disease, Intermittent claudication, magnetic resonance imaging

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Canakinumab (ACZ885)

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Canakinumab (ACZ885)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo of Canakinumab

Primary Outcome Measure Information:

Title

Mean Vessel Wall Area Ratio of 12 Months to Baseline

Description

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.

Time Frame

Baseline, 12 months post-dose

Secondary Outcome Measure Information:

Title

Number of Patients With Adverse Events in 12 Months

Description

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.

Time Frame

Baseline to 12 months post-dose

Title

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

Description

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.

Time Frame

Baseline, 12 months post-dose

Title

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

Description

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.

Time Frame

Baseline, 12 months post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85302

Country

United States

Facility Name

Novartis Investigative Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

Country

United States

Facility Name

Novartis Investigative Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Novartis Investigative Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Novartis Investigative Site

City

Lutherville

State/Province

Maryland

ZIP/Postal Code

21093

Country

United States

Facility Name

Novartis Investigative Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

Novartis Investigative Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

Facility Name

Novartis Investigative Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20099

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22559

Country

Germany

Facility Name

Novartis Investigative Site

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

ZIP/Postal Code

55116

Country

Germany

Facility Name

Novartis Investigative Site

City

München

ZIP/Postal Code

80336

Country

Germany

Facility Name

Novartis Investigative Site

City

Amman

ZIP/Postal Code

11941

Country

Jordan

12. IPD Sharing Statement

Citations:

PubMed Identifier

31277561

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.

Results Reference

derived

Links:

URL

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=162

Description

A Plain Language Trial Summary is available on novartisclinicaltrials.com

Peripheral Artery Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial