ACZ885 for the Treatment of Abdominal Aortic Aneurysm

NCT02007252 | Terminated Phase 2 Results

• 2 other identifiers: CACZ885X22012013-002088-25
• Study Type: interventional
• Target: 65
• Locations: 5 countries
• Sites: 9

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.

Conditions

Abdominal Aortic Aneurysm (AAA)

Keywords

Abdominal Aortic Aneurysm; AAA; IL-1b; Abdominal ultrasound

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Abdominal Aortic Aneurysm (AAA) Size Per Year

  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

  month 3, month 12

Study Arms (2)

ACZ885

EXPERIMENTAL

Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.

Drug: ACZ885

Placebo

PLACEBO COMPARATOR

Participants received matching placebo to ACZ885 s.c. once per month for 12 months.

Drug: Placebo

Interventions

ACZ885 DRUG

ACZ885 150 mg liquid pre-filled syringes were administered s.c..

ACZ885

Placebo DRUG

Matching placebo liquid pre-filled syringes were administered s.c..

Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects age ≥45 years of age
• Infrarenal abdominal aortic aneurysm with maximum diameter: for men ≥40mm and ≤50mm; for women ≥38mm and ≤48mm.
• On a stable medical regimen for at least 2 weeks prior to dosing, per investigator assessment.
• Have an evaluable ultrasound image at screening for the quantitative determination of the AAA size, per imaging core lab assessment.
• 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.

You may not qualify if:

• Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment.
• Known diabetes by medical history, an HbA1c of ≥6.5% at screening, or on an active diabetic medical regimen.
• History of malignancy of any organ system other than localized basal cell carcinoma of the skin, treated or untreated, within the past 5 years.
• 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.
• 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.
• 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.
• Presence of a non-healing wound or infection, including active urinary tract infections, or any recent process requiring significant tissue healing per investigator assessment.
• Significant illness which has not resolved within four (4) weeks prior to initial dosing or with a life expectancy less than 2 years.
• 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.
• Previous infra-renal aortic surgery
• Planned major surgery
• Known aortic dissection
• 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.
• Subjects should exhibit no signs of clinically concerning unstable acceleration of AAA size or growth rate at the time of enrollment per investigator assessment.
• Known or suspected inherited connective tissue disorders (e.g., Marfan or Vascular Ehlers Danlos syndrome).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (9)

Novartis Investigative Site

Charlottesville, Virginia, 22903, United States

Location

Novartis Investigative Site

Copenhagen, DK-2100, Denmark

Location

Novartis Investigative Site

Kolding, 6000, Denmark

Location

Novartis Investigative Site

Odense C, DK-5000, Denmark

Location

Novartis Investigative Site

Amsterdam, Netherlands

Location

Novartis Investigative Site

Eindhoven, 5623EJ, Netherlands

Location

Novartis Investigative Site

Örebro, 701 16, Sweden

Location

Novartis Investigative Site

Stockholm, 171 76, Sweden

Location

Novartis Investigative Site

Manchester, M23 9LT, United Kingdom

Location

Related Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

canakinumab

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 10, 2013
• Study Start: December 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 5, 2021
• Results First Posted: November 21, 2016

Record last verified: 2019-03

Locations

US (1); NL (2); GB (1); DK (3); SE (2)