Brief Title
ACZ885 for the Treatment of Abdominal Aortic Aneurysm
Official Title
A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study of Subcutaneous ACZ885 for the Treatment of Abdominal Aortic Aneurysm
Brief Summary
This study was designed to assess the safety, tolerability and efficacy of ACZ885 on
aneurysmal growth rate in subjects with abdominal aortic aneurysms (AAA). The purpose of the
study was to provide data to enable decisions regarding the further development of ACZ885 for
subjects with abdominal aortic aneurysms. The design of this study addressed the primary
objective of evaluating the change in aneurysmal size in subjects with AAA as a result of
treatment with ACZ885.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Change From Baseline in Abdominal Aortic Aneurysm (AAA) Size Per Year
Condition
Abdominal Aortic Aneurysm (AAA)
Intervention
ACZ885
Study Arms / Comparison Groups
ACZ885
Description: Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
65
Start Date
December 2013
Completion Date
October 2015
Primary Completion Date
October 2015
Eligibility Criteria
Key Inclusion Criteria:
1. Male and female subjects age ≥45 years of age
2. Infrarenal abdominal aortic aneurysm with maximum diameter: for men ≥40mm and ≤50mm;
for women ≥38mm and ≤48mm.
3. On a stable medical regimen for at least 2 weeks prior to dosing, per investigator
assessment.
4. Have an evaluable ultrasound image at screening for the quantitative determination of
the AAA size, per imaging core lab assessment.
5. At screening, vital signs should be within the following ranges: (a) oral body
temperature between 35.0-37.5°C; (b) systolic blood pressure, 90-170 mm Hg; (c)
diastolic blood pressure, 50-100 mm Hg; (d) pulse rate, 40 - 100 bpm.
Key Exclusion Criteria:
1. Use of other investigational drugs at the time of enrollment, or within 5 half-lives
of enrollment.
2. Known diabetes by medical history, an HbA1c of ≥6.5% at screening, or on an active
diabetic medical regimen.
3. History of malignancy of any organ system other than localized basal cell carcinoma of
the skin, treated or untreated, within the past 5 years.
4. Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using effective methods of contraception during
dosing and 30-day follow up period of the study.
5. Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial
dosing, or longer if required by local regulation.
6. Subjects on the following medications: (a) Chronic systemic steroid treatment or other
systemic immunosuppression; (b) Any biologic drugs targeting the immune system, along
with a history of any previous use of such drugs.
7. Presence of a non-healing wound or infection, including active urinary tract
infections, or any recent process requiring significant tissue healing per
investigator assessment.
8. Significant illness which has not resolved within four (4) weeks prior to initial
dosing or with a life expectancy less than 2 years.
9. Any of the following concomitant hepatic or renal conditions or diseases: (a)
Nephrotic syndrome, or eGFR less than 30 mL/min/1.73 m2 per CRCL formula; (b) Prior
organ transplant requiring immunosuppressive therapy; (c) Known active or recurrent
hepatic disorder.
10. Previous infra-renal aortic surgery
11. Planned major surgery
12. Known aortic dissection
13. Subjects with eligible AAA diameter, but with known slow growth (<2mm/year) or known
stable AAA size over the prior one year of surveillance per investigator assessment.
14. Subjects should exhibit no signs of clinically concerning unstable acceleration of AAA
size or growth rate at the time of enrollment per investigator assessment.
15. Known or suspected inherited connective tissue disorders (e.g., Marfan or Vascular
Ehlers Danlos syndrome).
16. Recently unstable clinically significant cardiac disease within 3 months of screening,
including but not limited to, unstable angina, acute myocardial infarction, and
congestive heart failure (NYHA class IV).
17. Uncontrolled or refractory hypertension per Investigator determination.
18. Live vaccinations within 3 months prior to randomization, or live vaccinations planned
during the study.
19. History of untreated tuberculosis infection or evidence of active tuberculosis (TB)
infection.
20. History of multiple and recurring allergies or allergy to the investigational
compound/compound class being used in this study.
21. History of immunodeficiency diseases, including a positive HIV (ELISA and Western
blot) test result.
22. A positive Hepatitis B surface antigen or Hepatitis C test result whether at screening
or historically.
23. For USA sites utilizing CT angiograms, subjects with a history of a previous reaction
to contrast agent, a known sensitivity to iodine and known allergies (e.g, shellfish
allergy), or other hypersensitivities to contrast agents.
24. Underlying immune disorders, autoimmunity or immunodeficiency.
25. History of drug or alcohol abuse within the 12 months prior to dosing.
Gender
All
Ages
45 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Novartis Pharmaceuticals, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT02007252
Organization ID
CACZ885X2201
Secondary IDs
2013-002088-25
Responsible Party
Sponsor
Study Sponsor
Novartis Pharmaceuticals
Study Sponsor
Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals
Verification Date
March 2019