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ACZ885 for the Treatment of Abdominal Aortic Aneurysm (AAA)

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE December 5, 2013
First Posted Date  ICMJE December 10, 2013
Results First Submitted Date  ICMJE September 29, 2016
Results First Posted Date  ICMJE November 21, 2016
Last Update Posted Date April 9, 2019
Study Start Date  ICMJE December 2013
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2016)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 5, 2013)
Change From Baseline in Abdominal Aortic Aneurysm (AAA) Size Per Year [ Time Frame: Baseline, end of study (13 month) ]
Growth rate of AAA will be measured from ultrasound assessment.
Change History Complete list of historical versions of study NCT02007252 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2013)
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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ACZ885 for the Treatment of Abdominal Aortic Aneurysm
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Abdominal Aortic Aneurysm (AAA)
Intervention  ICMJE
  • Drug: ACZ885
    ACZ885 150 mg liquid pre-filled syringes were administered s.c..
  • Drug: Placebo
    Matching placebo liquid pre-filled syringes were administered s.c..
Study Arms  ICMJE
  • Experimental: ACZ885
    Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
    Intervention: Drug: ACZ885
  • Placebo Comparator: Placebo
    Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 29, 2016)
65
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2013)
100
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Netherlands,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02007252
Other Study ID Numbers  ICMJE CACZ885X2201
2013-002088-25 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP