Peripheral Artery DiseasePhase 2NCT01731990
Safety, Tolerability and Efficacy of ACZ885 on Leg Artery Structure in Patients With Peripheral Artery Disease
A Phase 2 study testing Canakinumab (ACZ885) in people with Peripheral Artery Disease, run by Novartis Pharmaceuticals at 14 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Canakinumab (ACZ885)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 30 Oct 2012to 4 Aug 2016
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
United States8 sites
Novartis Investigative Site
Chicago, Illinois, 60611
Novartis Investigative Site
Columbus, Ohio, 43215
Novartis Investigative Site
Jacksonville, Florida, 32207
Novartis Investigative Site
Jacksonville, Florida, 32216
Novartis Investigative Site
Knoxville, Tennessee, 37920
Novartis Investigative Site
Lutherville, Maryland, 21093
Novartis Investigative Site
Phoenix, Arizona, 85302
Novartis Investigative Site
Richmond, Virginia, 23294
Germany5 sites
Novartis Investigative Site
Hamburg, 20099
Novartis Investigative Site
Hamburg, 22559
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
Mainz, 55116
Novartis Investigative Site
München, 80336
About this study
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.
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.
- Conditions
- Peripheral Artery Disease
- Being tested
- Canakinumab (ACZ885), Placebo
- Keywords
- Peripheral artery disease, Intermittent claudication, magnetic resonance imaging
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canakinumab (ACZ885)Drug
Dosage form: solution for injection Strength: 150 mg/1 mL Mode of administration: subcutaneous use.
PlaceboDrug
Matching placebo of Canakinumab
| Study group | Role | What they receive |
|---|---|---|
| Canakinumab (ACZ885) | Experimental | Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months Receives: Drug: Canakinumab (ACZ885) |
| Placebo | Placebo comparator | Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 months post-dose
Secondary outcomes (3)
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.
Measured: Baseline to 12 months post-dose
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.
Measured: Baseline, 12 months post-dose
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.
Measured: Baseline, 12 months post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study start30 Oct 2012
- Primary completion4 Aug 2016
- Study completion4 Aug 2016
Why it stopped: The study got terminated based on result from primary endpoint analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731990
- Sponsor's protocol ID
- CACZ885M2201
- Other IDs
- 2012-001427-12
- Status last verified
- Apr 2025
- First submitted
- 18 Nov 2012
- Last updated
- 29 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 31277561