Phase II study for the treatment of abdominal aortic aneurysm

• Register: EUCTR
• Last refreshed on: 11 April 2016
• Main ID: EUCTR2013-002088-25-NL
• Date of registration: 16/10/2013
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Phase II study for the treatment of abdominal aortic aneurysm
• Scientific title: A randomized, double-blind, placebo controlled multiple dose study of subcutaneous ACZ885 for the treatment of abdominal aortic aneurysm
• Date of first enrolment: 23/12/2013
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002088-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Denmark, Germany, Netherlands, Sweden, United Kingdom, United States

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

Key inclusion & exclusion 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 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

abdominal aortic aneurysm
MedDRA version: 14.1 Level: HLT Classification code 10002889 Term: Aortic aneurysms and dissections System Organ Class: 100000004866

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

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 in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: At 1 year

Secondary Objective: 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.

Main Objective: To assess the effect of ACZ885 on AAA size and growth rate as measured with ultrasound at 12 months.

Primary end point(s): To assess the effect of ACZ885 on AAA size and growth rate as measured with ultrasound at 12 months.

Secondary Outcome(s)

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

Secondary ID(s)

CACZ885X2201

Source(s) of Monetary Support

Novartis Pharma Services AG