Abdominal aortic aneurysm MedDRA version: 16.0 Level: HLT Classification code 10002889 Term: Aortic aneurysms and dissections System Organ Class: 100000004866
Conditions
Interventions
Trade Name: Ilaris
Product Name: Canakinumab
Product Code: ACZ885
Pharmaceutical Form: Solution for injection in pre-filled syringe
Pharmaceutical form of the placebo: Solution for injection/infusion
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of ACZ885 on AAA size and growth rate as measured with ultrasound at 12 months.;Secondary Objective: 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.;Primary end point(s): To assess the effect of ACZ885 on AAA size and growth rate as measured with ultrasound at 12 months.;Timepoint(s) of evaluation of this end point: At 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;Timepoint(s) of evaluation of this end point: at 1 year | — |
Countries
Denmark, Germany, Netherlands, Sweden, United Kingdom, United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed