E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Peripheral Artery Disease |
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E.1.1.1 | Medical condition in easily understood language |
Peripheral Artery Disease |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003611 |
E.1.2 | Term | Atherosclerosis of arteries of the extremities, unspecified |
E.1.2 | System Organ Class | 100000004866 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• To assess the effect of ACZ885 on peripheral artery wall morphometry using MRI techniques at 12 months. |
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E.2.2 | Secondary objectives of the trial |
• To assess the safety and tolerability of monthly subcutaneous doses of 150 mg ACZ885 in patients with moderate peripheral artery disease and intermittent claudication.
• To assess the effect of ACZ885 on serum amyloid A protein and high-sensitivity C reactive protein levels
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Exploratory pharmacogenetic study to investigate the association between genetic factors (genotypes) and clinical assessments (phenotypes) |
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E.3 | Principal inclusion criteria |
•Must have a signed informed consent form.
•Must be between the ages of 18 and 85
•Must experience leg pain associated with exertion and have a resting ankle brachial index between 0.40 and 0.90
•Must be on stable aspirin 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 |
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E.4 | Principal 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 non-healing wounds or active infection within 2 weeks or study start
•Clinical evidence of critical limb ischemia including new or non-healing ulcers
•Significant heart disease
•Myocardial infarction, stroke, major surgical procedure within 3 months of enrollment
•Uncontrolled diabetes as defined by a fasting glucose lever of 13 mmol/L or 240 mg/dL or a HbA1C greater than 9% at screening. As per assessment schedule, both should be measured at screening. Thereafter, HbA1C may be monitored at the investigator`s discretion as dictated by normal care for diabetics.
•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.
•History of malignancy of any organ system other than localized basal cell carcinoma of the skin, treated or untreated, within the past 5 years, regardsless of whether there is evidence of local recurrence or metastases |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Mean vessel wall volume
• 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
•Number of patients with adverse events
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
•Change from baseline in high sensitivity C-reactive protein (hsCRP) at 12 month post-dose |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
baseline to 12 months post-dose |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Germany |
Israel |
United States |
Jordan |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |