E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Abdominal aortic aneurysm |
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E.1.1.1 | Medical condition in easily understood language |
Abdominal aortic aneurysm |
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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 | 16.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10002889 |
E.1.2 | Term | Aortic aneurysms and dissections |
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 AAA size and growth rate as measured with ultrasound at 12 months. |
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E.2.2 | Secondary objectives of the trial |
The purpose of the study is to provide data to enable decisions regarding the further development of ACZ885 for subjects with abdominal aortic aneurysms. The design of this study addresses the primary objective of evaluating the change in aneurysmal size in subjects with AAA as a result of treatment with ACZ885. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male and female subjects age ≥45 years of age
• Infrarenal abdominal aortic aneurysm with maximum diameter:
• for men ≥40mm and ≤50mm
• for women ≥38mm and ≤48mm
• On a stable medical regimen for at least 2 weeks prior to dosing
• Have an evaluable ultrasound image at screening for thequantitative determination of the AAA size
• At screening and pre-dose on Day 1, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for at least three minutes.
Sitting vital signs should be within the following ranges:
oral body temperature between 35.0-37.5°C
systolic blood pressure, 90-170 mm Hg
diastolic blood pressure, 50-100 mm Hg
pulse rate, 40 - 100 bpm |
|
E.4 | Principal exclusion criteria |
•Known diabetes by medical history, a HbA1c of ≥6.5% at screening, or on an active diabetic medical regimen
• Women of child bearing potential unless using effective methods of contraception
• Subjects on the following medications:
1) Chronic systemic steroid treatment or other systemic immunosuppression. Use oftopical, ophthalmic or inhaled steroids at doses not considered to have systemic effects is allowed. Temporary use of steroids (e.g., for asthma exacerbations) are allowed if last steroid use is more than 1 month prior to screening and the anticipated frequency of requiring such steroids are less than once per year.
2) Any biologic drugs targeting the immune system, e.g., TNF blockers, anakinra, rituximab, abatacept, tocilizumab. Any previous history of the use of such biologics is also an excluded.
• Presence of a non-healing wound or infection, including active urinary tract infections, or any recent process requiring significant tissue healing per investigator assessment. Other active infections
within 2 weeks will be excluded.
• Previous infra-renal aortic surgery
• Known aortic dissection
• Subjects should exhibit no signs of clinically concerning unstable acceleration of AAA size or growth rate at the time of enrollment per investigator assessment |
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E.5 End points |
E.5.1 | Primary end point(s) |
To assess the effect of ACZ885 on AAA size and growth rate as measured with ultrasound at 12 months. |
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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) |
To assess the safety and tolerability of monthly 150 mg subcutaneous doses of ACZ885 in subjects with AAA over a treatment period of 12 months. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 |
Denmark |
Netherlands |
Sweden |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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Study completion: The study will complete when the last subject completes their Study Completion visit, and any repeat assessments associated with this visit
have been documented and followed-up appropriately by the Investigator.
Early study termination: The study can be terminated at any time for any reason by Novartis. The subject should be seen as soon as possible and treated as a prematurely withdrawn subject. The investigator may be informed of additional procedures to be followed. |
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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 | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |