A Phase 2 interventional study of Canakinumab (ACZ885) and Placebo in Peripheral Artery Disease, sponsored by Novartis Pharmaceuticals. Terminated at 14 sites in 3 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 38 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
Drug: Canakinumab (ACZ885)
Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
Drug: Placebo
Dosage form: solution for injection Strength: 150 mg/1 mL Mode of administration: subcutaneous use.
Matching placebo of Canakinumab
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.
Time frame: Baseline, 12 months post-dose
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 12 months post-dose
| Milestone | Canakinumab (ACZ885) | Placebo |
|---|---|---|
| Started | 18 | 20 |
| Completed | 14 | 12 |
| Not completed | 4 | 8 |
| Withdrew: Adverse event | 1 | 5 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Protocol deviation | 1 | 2 |
| Withdrew: Death | 1 | 0 |
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.
| Ratio | Canakinumab (ACZ885) | Placebo |
|---|---|---|
| Mean Vessel Wall Area Ratio of 12 Months to Baseline | 1.05 ± 0.03 | 0.99 ± 0.04 |
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.
| Participants | Canakinumab (ACZ885) | Placebo |
|---|---|---|
| Total Adverse events | 16 | 20 |
| Serious Adverse events | 10 | 10 |
| Death | 1 | 0 |
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.
| Ratio | Canakinumab (ACZ885) | Placebo |
|---|---|---|
| Serum Amyloid A (SAA) Level Ratio of 12 Months to Baseline | 0.62 ± 0.12 | 0.79 ± 0.17 |
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.
| Ratio | Canakinumab (ACZ885) | Placebo |
|---|---|---|
| High Sensitivity C-reactive Protein (hsCRP) Ratio of 12 Months to Baseline | 0.62 ± 0.14 | 0.83 ± 0.20 |
Collected over Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Canakinumab (ACZ885) | — | 10/18 (55.6%) | 16/18 (88.9%) |
| Placebo | — | 10/20 (50%) | 17/20 (85%) |
| Event | Canakinumab (ACZ885) | Placebo |
|---|---|---|
| Peripheral arterial occlusive diseaseVascular disorders | 3/18 | 2/20 |
| Coronary artery diseaseCardiac disorders | 2/18 | 1/20 |
| Non-cardiac chest painGeneral disorders | 0/18 | 2/20 |
| Angina pectorisCardiac disorders | 1/18 | 0/20 |
| Atrioventricular block completeCardiac disorders | 1/18 | 0/20 |
| Myocardial infarctionCardiac disorders | 1/18 | 0/20 |
| Sinus bradycardiaCardiac disorders | 1/18 | 0/20 |
| Abdominal pain upperGastrointestinal disorders | 1/18 | 0/20 |
| Gastric ulcerGastrointestinal disorders | 1/18 | 0/20 |
| Mesenteric arterial occlusionGastrointestinal disorders | 1/18 | 0/20 |
| Event | Canakinumab (ACZ885) | Placebo |
|---|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 5/18 | 0/20 |
| Upper respiratory tract infectionInfections and infestations | 4/18 | 4/20 |
| NasopharyngitisInfections and infestations | 2/18 | 4/20 |
| ConstipationGastrointestinal disorders | 3/18 | 0/20 |
| NauseaGastrointestinal disorders | 3/18 | 1/20 |
| FatigueGeneral disorders | 3/18 | 2/20 |
| InsomniaPsychiatric disorders | 3/18 | 1/20 |
| Angina pectorisCardiac disorders | 2/18 | 1/20 |
| BradycardiaCardiac disorders | 2/18 | 0/20 |
| Abdominal pain upperGastrointestinal disorders | 2/18 | 2/20 |
safety analysis set: All patients that received any study drug were included in the safety analysis set
| Age, Continuous(years) | Canakinumab (ACZ885) | Placebo | Total |
|---|---|---|---|
| Mean | 66.0 ± 8.64 | 63.5 ± 7.98 | 64.7 ± 8.29 |
| Sex: Female, Male(Participants) | Canakinumab (ACZ885) | Placebo | Total |
|---|---|---|---|
| Female | 4 | 7 | 11 |
| Male | 14 | 13 | 27 |
This study is terminated, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals