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ACZ885 for the Treatment of Abdominal Aortic Aneurysm (AAA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02007252
Recruitment Status : Terminated (The results of a third interim analysis (ad hoc) indicated a lack of efficacy and futility in continuing the trial.)
First Posted : December 10, 2013
Results First Posted : November 21, 2016
Last Update Posted : April 9, 2019
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm (AAA) Drug: ACZ885 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study of Subcutaneous ACZ885 for the Treatment of Abdominal Aortic Aneurysm
Study Start Date : December 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Canakinumab

Arm Intervention/treatment
Experimental: ACZ885
Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
Drug: ACZ885
ACZ885 150 mg liquid pre-filled syringes were administered s.c..

Placebo Comparator: Placebo
Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
Drug: Placebo
Matching placebo liquid pre-filled syringes were administered s.c..

Primary Outcome Measures :
  1. Change From Baseline in Abdominal Aortic Aneurysm (AAA) Size Per Year [ Time Frame: month 3, month 12 ]
    Size of the AAA was determined using an abdominal ultrasound technique at baseline, 3 months, and 12 months after treatment with study drug. Growth rate (in mm/year) was calculated from the change in AAA size compared to baseline

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02007252

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United States, Virginia
Novartis Investigative Site
Charlottesville, Virginia, United States, 22903
Novartis Investigative Site
Copenhagen, Denmark, DK-2100
Novartis Investigative Site
Kolding, Denmark, 6000
Novartis Investigative Site
Odense C, Denmark, DK-5000
Novartis Investigative Site
Amsterdam, Netherlands
Novartis Investigative Site
Eindhoven, Netherlands, 5623EJ
Novartis Investigative Site
Orebro, Sweden, 701 16
Novartis Investigative Site
Stockholm, Sweden, 171 76
United Kingdom
Novartis Investigative Site
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT02007252    
Other Study ID Numbers: CACZ885X2201
2013-002088-25 ( EudraCT Number )
First Posted: December 10, 2013    Key Record Dates
Results First Posted: November 21, 2016
Last Update Posted: April 9, 2019
Last Verified: March 2019
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Abdominal Aortic Aneurysm
Abdominal ultrasound
Additional relevant MeSH terms:
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Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases