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ACZ885 for the Treatment of Abdominal Aortic Aneurysm | Clinical Trials | Clareo Health

TERMINATEDPHASE2

ACZ885 for the Treatment of Abdominal Aortic Aneurysm

A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study of Subcutaneous ACZ885 for the Treatment of Abdominal Aortic Aneurysm

NCT02007252•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

45 - No limit years

Sex

ALL

Healthy Volunteers

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
+15 more criteria

Locations (9)

Novartis Investigative Site

Charlottesville, Virginia, United States

Novartis Investigative Site

Copenhagen, Denmark

Novartis Investigative Site

Kolding, Denmark

Novartis Investigative Site

Odense C, Denmark

Novartis Investigative Site

Amsterdam, Netherlands

Novartis Investigative Site

Eindhoven, Netherlands

Novartis Investigative Site

Örebro, Sweden

Novartis Investigative Site

Stockholm, Sweden

Novartis Investigative Site

Manchester, United Kingdom

Key Dates

Start Date

December 1, 2013

Primary Completion Date

October 1, 2015

Completion Date

October 1, 2015

Last Updated

January 5, 2021

Enrollment

ACTUAL participants

Conditions

Abdominal Aortic Aneurysm (AAA)

Interventions

ACZ885

DRUG

Placebo

DRUG

Evaluation of the Aortoseal™ for Sealing and Fixation of AAA Endovascular Grafts to Aortic Wall

NCT06586021

Abdominal Aortic Aneurysm (AAA)

View study

COMPLETEDNA

Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System

NCT01726257

Abdominal Aortic Aneurysm (AAA)

View study

TERMINATEDEARLY_PHASE1

CCR2 AAA Pilot Study

NCT04592991

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 5, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

ACZ885 for the Treatment of Abdominal Aortic Aneurysm

Inclusion Criteria

Exclusion Criteria

Evaluation of the Aortoseal™ for Sealing and Fixation of AAA Endovascular Grafts to Aortic Wall

Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System

CCR2 AAA Pilot Study

Predictors of AAA Expansion and/or Rupture