ACZ885 for the Treatment of Abdominal Aortic Aneurysm

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.