ACZ885 for the Treatment of Abdominal Aortic Aneurysm (AAA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT02007252
First received: December 5, 2013
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

This study is 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 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.


Condition Intervention Phase
Abdominal Aortic Aneurysm (AAA)
Drug: ACZ885
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study of Subcutaneous ACZ885 for the Treatment of Abdominal Aortic Aneurysm

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in Abdominal Aortic Aneurysm (AAA) size per year [ Time Frame: Baseline, end of study (13 month) ] [ Designated as safety issue: No ]
    Growth rate of AAA will be measured from ultrasound assessment.


Secondary Outcome Measures:
  • Number of patients with adverse events, serious adverse events and death to assess safety and tolerability of ACZ885 [ Time Frame: End of study (13 months) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: December 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACZ885
Active ACZ885
Drug: ACZ885
Monthly doses of ACZ885 subcutaneous (s.c.)
Placebo Comparator: Placebo
Placebo to match ACZ885
Drug: Placebo
Monthly doses of placebo to match ACZ885 s.c

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02007252

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

Locations
United States, Virginia
Novartis Investigative Site Not yet recruiting
Charlottesville, Virginia, United States, 22903
Denmark
Novartis Investigative Site Withdrawn
Aalborg, Denmark, DK-9100
Novartis Investigative Site Recruiting
Copenhagen, Denmark, DK-2100
Novartis Investigative Site Recruiting
Kolding, Denmark
Novartis Investigative Site Recruiting
Odense C, Denmark, DK-5000
Netherlands
Novartis Investigative Site Not yet recruiting
Amsterdam, Netherlands
Novartis Investigative Site Not yet recruiting
Eindhoven, Netherlands, 5602ZA
Novartis Investigative Site Not yet recruiting
Utrecht, Netherlands, 3508 GA
Sweden
Novartis Investigative Site Withdrawn
Goteborg, Sweden
Novartis Investigative Site Not yet recruiting
Orebro, Sweden, 701 16
Novartis Investigative Site Not yet recruiting
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02007252     History of Changes
Other Study ID Numbers: CACZ885X2201, 2013-002088-25
Study First Received: December 5, 2013
Last Updated: December 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Abdominal Aortic Aneurysm
AAA
IL-1b
Abdominal ultrasound

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on September 18, 2014