ACZ885-Phase II study for treatment of abdominal aortic aneurysm V01
Research type
Research Study
Full title
A randomized, double-blind, placebo controlled multiple dose study of subcutaneous ACZ885 for the treatment of abdominal aortic aneurysm
IRAS ID
167680
Contact name
Matt Thompson
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2013-002088-25
Duration of Study in the UK
1 years, 2 months, 6 days
Research summary
An abdominal aortic aneurysm (AAA) is a swelling (aneurysm) of the aorta – the main blood vessel that leads away from the heart, down through the abdomen to the rest of the body.
The abdominal aorta is the largest blood vessel in the body and is usually around 2cm wide – roughly the width of a garden hose. However, it can swell to over 5.5cm – what doctors class as a large AAA. The bulging occurs when the wall of the aorta weakens. Although what causes this weakness is unclear, smoking and high blood pressure are thought to increase the risk of an aneurysm.
AAAs are most common in men aged over 65. A rupture accounts for more than 1 in 50 of all deaths in this group and a total of 6,000 deaths in England and Wales each year. AAAs vary in size. As a rule, once you develop an AAA, it tends gradually to get larger. The speed at which it gets larger varies from person to person. However, on average, an AAA tends to get larger by about 10% per year.
The chance of rupture is low if an AAA is small. However, the risk of rupture increases with increasing size. This is much like a balloon - the larger you blow it up, the greater the pressure, and the greater the chance it will burst. The diameter of an AAA can be measured by an ultrasound scan. The following gives overall risk figures for the size (diameter) of the aneurysm:
• 40 mm-55 mm: about a 1 in 100 chance of rupture per year.
• 55 mm-60 mm: about a 10 in 100 chance of rupture per year.
• 60 mm-69 mm: about a 15 in 100 chance of rupture per year.
• 70 mm-79 mm: about a 35 in 100 chance of rupture per year.
• 80 mm or more: about a 50 in 100 chance of rupture per year.
The study is being sponsored by Novartis and the purpose of this study is designed to assess the safety, tolerability and efficacy of a drug referenced ACZ885 on aneurysmal growth in subjects diagnosed with AAA. This will provide data to enable decisions regarding the further development of ACZ885 for subjects with AAA. The design of this study addresses the primary objective of evaluating the change in the AAA size as a result of treatment with ACZ885. The study is a non-confirmatory, double-blind, randomised, placebo-controlled two-arm parallel group study. Eligible subjects will be asked to consent to entering the study for a period of 14 months, which will entail approximately 14 visit, and will receive one dose per month of 150mg of ACZ885 or placebo subcutaneously as randomised in a 1:1 ratio. The size of the AAA will be followed using ultra sound (sonography) over the course of the study. For every visit, patients will be asked to fast overnight for at least 10 hours but will continue their medications as per their regular routine for all visits. A total of 5 ultrasound scans will be performed during the study. The study will consist of up to a 30 day screening period, a 12 month treatment period and an end of study evaluation which will take place approximately 1 month after the last drug administration.
Subjects considered to be eligible comprise of male and female =45 years of age with AAA of 3.8 to 5.0cm in diameter. Approximately 100 subjects will be enrolled across approximately 10 sites globally with a goal of at least 80 subjects expected to complete. The study population will include subjects who have provided written informed consent, passed screening assessment and comply with inclusion/exclusion criteria.
Before starting the study, patients will have a screening visit and will be asked about their health and medical history. They will be physically examined and vital signs will be measured. Patients will have an ECG, blood and urine will be taken for laboratory testing. Females will have a pregnancy test. Tests will also be done for illegal ‘street’ drugs, for HIV/AIDS, hepatitis B and C, and tuberculosis but the results of these tests will not be captured in the study database. If patients test positive for any of these tests, they will not be allowed to enroll in the study.REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/0018
Date of REC Opinion
23 Mar 2015
REC opinion
Further Information Favourable Opinion