Abdominal Aortic Aneurysm (AAA)Phase 2AAANCT02007252
ACZ885 for the Treatment of Abdominal Aortic Aneurysm
A Phase 2 study testing ACZ885 in people with Abdominal Aortic Aneurysm (AAA), run by Novartis Pharmaceuticals at 9 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm (AAA)
- What is being tested?
- ACZ885
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Dec 2013to Oct 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
- 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).
- Uncontrolled or refractory hypertension per Investigator determination.
- Live vaccinations within 3 months prior to randomization, or live vaccinations planned during the study.
- History of untreated tuberculosis infection or evidence of active tuberculosis (TB) infection.
- History of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study.
- History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- A positive Hepatitis B surface antigen or Hepatitis C test result whether at screening or historically.
- 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.
- Underlying immune disorders, autoimmunity or immunodeficiency.
- History of drug or alcohol abuse within the 12 months prior to dosing.
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Denmark3 sites
Novartis Investigative Site
Copenhagen, DK-2100
Novartis Investigative Site
Kolding, 6000
Novartis Investigative Site
Odense C, DK-5000
Netherlands2 sites
Novartis Investigative Site
Amsterdam
Novartis Investigative Site
Eindhoven, 5623EJ
Sweden2 sites
Novartis Investigative Site
Örebro, 701 16
Novartis Investigative Site
Stockholm, 171 76
United States1 site
Novartis Investigative Site
Charlottesville, Virginia, 22903
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study of Subcutaneous ACZ885 for the Treatment of Abdominal Aortic Aneurysm
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)
- Being tested
- ACZ885, Placebo
- Keywords
- Abdominal Aortic Aneurysm, AAA, IL-1b, Abdominal ultrasound
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACZ885Drug
ACZ885 150 mg liquid pre-filled syringes were administered s.c..
PlaceboDrug
Matching placebo liquid pre-filled syringes were administered s.c..
| Study group | Role | What they receive |
|---|---|---|
| ACZ885 | Experimental | Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months. Receives: Drug: ACZ885 |
| Placebo | Placebo comparator | Participants received matching placebo to ACZ885 s.c. once per month for 12 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: month 3, month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: The results of a third interim analysis (ad hoc) indicated a lack of efficacy and futility in continuing the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Abdominal Aortic Aneurysm (AAA)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007252
- Sponsor's protocol ID
- CACZ885X2201
- Other IDs
- 2013-002088-25
- Acronym
- AAA
- Status last verified
- Mar 2019
- First submitted
- 5 Dec 2013
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study of Subcutaneous ACZ885 for the Treatment of Abdominal Aortic Aneurysm
- ClinicalTrials.gov ID
- NCT02007252
- Acronym / sponsor ID
- AAA / CACZ885X2201
- Conditions
- Abdominal Aortic Aneurysm (AAA)
- Keywords
- Abdominal Aortic Aneurysm, AAA, IL-1b, Abdominal ultrasound
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The results of a third interim analysis (ad hoc) indicated a lack of efficacy and futility in continuing the trial.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 10 Dec 2013 (estimated)
- Results
- Posted 21 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACZ885 | Experimental | Drug: ACZ885Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received matching placebo to ACZ885 s.c. once per month for 12 months. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACZ885ACZ885 150 mg liquid pre-filled syringes were administered s.c.. | Drug | ACZ885 |
| PlaceboMatching placebo liquid pre-filled syringes were administered s.c.. | Drug | Placebo |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACZ885 in people with Abdominal Aortic Aneurysm (AAA), run by Novartis Pharmaceuticals at 9 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Denmark, Netherlands, Sweden, United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Abdominal Aortic Aneurysm (AAA) Size Per Year (time frame: month 3, month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.