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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002088-25 | EudraCT Number |
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The results of a third interim analysis (ad hoc) indicated a lack of efficacy and futility in continuing the trial.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACZ885 | Experimental | Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months. |
|
| Placebo | Placebo Comparator | Participants received matching placebo to ACZ885 s.c. once per month for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACZ885 | Drug | ACZ885 150 mg liquid pre-filled syringes were administered s.c.. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Charlottesville | Virginia | 22903 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
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A total of 65 participants were randomized in a 1:1 ratio to one of the two treatment groups. One participant discontinued prior to taking any study medication. As such, the participant flow is based on 64 randomized participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | ACZ885 | Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months. |
| FG001 | Placebo | Participants received matching placebo to ACZ885 s.c. once per month for 12 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ACZ885 | Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months. |
| BG001 | Placebo | Participants received matching placebo to ACZ885 s.c. once per month for 12 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The pharmacodynamic analysis set, which included randomized participants who received at least one dose of study drug, was considered for the analysis. However, only participants with values at each time point were analyzed. | Posted | Least Squares Mean | 90% Confidence Interval | millimeter/year | month 3, month 12 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ACZ885 | Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C541220 | canakinumab |
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| Placebo |
| Drug |
Matching placebo liquid pre-filled syringes were administered s.c.. |
|
| Copenhagen |
| DK-2100 |
| Denmark |
| Novartis Investigative Site | Kolding | 6000 | Denmark |
| Novartis Investigative Site | Odense C | DK-5000 | Denmark |
| Novartis Investigative Site | Amsterdam | Netherlands |
| Novartis Investigative Site | Eindhoven | 5623EJ | Netherlands |
| Novartis Investigative Site | Örebro | 701 16 | Sweden |
| Novartis Investigative Site | Stockholm | 171 76 | Sweden |
| Novartis Investigative Site | Manchester | M23 9LT | United Kingdom |
| Adverse Event |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants received matching placebo to ACZ885 s.c. once per month for 12 months. |
|
|
|
| 2 |
| 31 |
| 28 |
| 31 |
| EG001 | Placebo | Participants received matching placebo to ACZ885 s.c. once per month for 12 months. | 0 | 33 | 28 | 33 |
| Aortic aneurysm | Vascular disorders | MedDRA | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Energy increased | General disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA | Systematic Assessment |
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| Injection site hypersensitivity | General disorders | MedDRA | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA | Systematic Assessment |
|
| Malaise | General disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Vestibular neuronitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA | Systematic Assessment |
|
| Occult blood positive | Investigations | MedDRA | Systematic Assessment |
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| Prostatic specific antigen increased | Investigations | MedDRA | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Bladder cancer stage 0, with cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Breast cyst | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Telangiectasia | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Intermittent claudication | Vascular disorders | MedDRA | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| D001018 |
| Aortic Diseases |