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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01731990
First received: November 18, 2012
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

This study is 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.


Condition Intervention Phase
Peripheral Artery Disease
Drug: ACZ885
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Mean vessel wall volume [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Peripheral artery wall area (superficial femoral artery) measured using MRI cross-section slices. Mean vessel wall volume is the average, for each MRI, over the individual slices of cross- sectional area of the vessel wall measured.


Secondary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: baseline to 12 months post-dose ] [ Designated as safety issue: Yes ]
    Summary statistics on adverse event will be reported. It will be categorized as total adverse events, serious adverse event, death.

  • Change from baseline in Serum amyloid A (SAA) level at 12 months post dose [ Time Frame: Baseline to 12 months post-dose ] [ Designated as safety issue: No ]
  • Change from baseline in high sensitivity C-reactive protein (hsCRP) at 12 month post-dose [ Time Frame: Baseline to 12 months post-dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: October 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACZ885
1 mL ACZ885 given as a subcutaneous injection
Drug: ACZ885
Placebo Comparator: Placebo
1 mL placebo given as a subcutaneous injection
Drug: Placebo
Matching placebo of CACZ88%M

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have a signed informed consent form.
  • Must be between the ages of 18 and 80
  • Must experience leg pain associated with walking when walking less than 400 meters and have an ankle brachial index between 0.50 and 0.85
  • Must be on stable asprin and statin doses for at least 6 weeks
  • Blood pressure within ranges specificed in the protocol
  • Able to communicate well with the Investigator and understand and comply with the study procedures

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 50 meters
  • 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 with 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731990

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

Locations
United States, Arizona
Novartis Investigative Site Recruiting
Glendale, Arizona, United States, 85301
United States, Florida
Novartis Investigative Site Withdrawn
Fleming Island, Florida, United States, 32003
Novartis Investigative Site Recruiting
Jacksonville, Florida, United States, 32207
Novartis Investigative Site Recruiting
Jacksonville, Florida, United States, 32216
Novartis Investigative Site Recruiting
Port Orange, Florida, United States, 32127
United States, Illinois
Novartis Investigative Site Not yet recruiting
Chicago, Illinois, United States, 606011
United States, Ohio
Novartis Investigative Site Recruiting
Columbus, Ohio, United States, 43215
Novartis Investigative Site Recruiting
Dayton, Ohio, United States, 45439
United States, Tennessee
Novartis Investigative Site Recruiting
Knoxville, Tennessee, United States, 37920
United States, Virginia
Novartis Investigative Site Recruiting
Richmond, Virginia, United States, 23294
Germany
Novartis Investigative Site Not yet recruiting
Hamburg, Germany, 20099
Novartis Investigative Site Not yet recruiting
Hamburg, Germany, 22559
Novartis Investigative Site Not yet recruiting
Karlsbad, Germany, 76307
Novartis Investigative Site Not yet recruiting
Mainz, Germany, 55116
Jordan
Novartis Investigative Site Recruiting
Amman, Jordan, 11941
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01731990     History of Changes
Other Study ID Numbers: CACZ885M2201, 2012-001427-12
Study First Received: November 18, 2012
Last Updated: May 6, 2014
Health Authority: United States: Food and Drug Administration
Jordan: Jordan Food and Drug Administration
Germany: Paul-Ehrlich-Institut
Israel: Ministry of Health

Keywords provided by Novartis:
Peripheral artery disease
Intermittent claudication
magnetic resonance imaging

Additional relevant MeSH terms:
Intermittent Claudication
Peripheral Arterial Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Atherosclerosis
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014