Trial Outcomes & Findings for ACZ885 for the Treatment of Abdominal Aortic Aneurysm (NCT NCT02007252)
NCT ID: NCT02007252
Last Updated: 2021-01-05
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
month 3, month 12
Results posted on
2021-01-05
Participant Flow
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.
Participant milestones
| Measure |
ACZ885
Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
|
Placebo
Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
33
|
|
Overall Study
Safety Analysis Set
|
31
|
33
|
|
Overall Study
Pharmacodynamic Analysis Set
|
31
|
33
|
|
Overall Study
COMPLETED
|
20
|
22
|
|
Overall Study
NOT COMPLETED
|
11
|
11
|
Reasons for withdrawal
| Measure |
ACZ885
Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
|
Placebo
Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
|
|---|---|---|
|
Overall Study
Administrative problems
|
3
|
7
|
|
Overall Study
Abnormal laboratory value(s)
|
1
|
0
|
|
Overall Study
Adverse Event
|
7
|
4
|
Baseline Characteristics
ACZ885 for the Treatment of Abdominal Aortic Aneurysm
Baseline characteristics by cohort
| Measure |
ACZ885
n=31 Participants
Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
|
Placebo
n=33 Participants
Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.4 Years
STANDARD_DEVIATION 7.44 • n=5 Participants
|
70.8 Years
STANDARD_DEVIATION 5.84 • n=7 Participants
|
70.1 Years
STANDARD_DEVIATION 6.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: month 3, month 12Population: 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.
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
Outcome measures
| Measure |
ACZ885
n=31 Participants
Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
|
Placebo
n=33 Participants
Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
|
|---|---|---|
|
Change From Baseline in Abdominal Aortic Aneurysm (AAA) Size Per Year
Month 3 (n=23,31)
|
0.781 millimeter/year
Interval -0.942 to 5.504
|
2.519 millimeter/year
Interval 1.03 to 4.008
|
|
Change From Baseline in Abdominal Aortic Aneurysm (AAA) Size Per Year
Month 12 (n=20,23)
|
2.538 millimeter/year
Interval 1.465 to 3.612
|
2.581 millimeter/year
Interval 1.612 to 3.549
|
Adverse Events
ACZ885
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ACZ885
n=31 participants at risk
Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
|
Placebo
n=33 participants at risk
Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Hip fracture
|
3.2%
1/31
|
0.00%
0/33
|
|
Vascular disorders
Aortic aneurysm
|
3.2%
1/31
|
0.00%
0/33
|
Other adverse events
| Measure |
ACZ885
n=31 participants at risk
Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
|
Placebo
n=33 participants at risk
Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.2%
1/31
|
0.00%
0/33
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/31
|
6.1%
2/33
|
|
Cardiac disorders
Atrial fibrillation
|
6.5%
2/31
|
0.00%
0/33
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/31
|
3.0%
1/33
|
|
Eye disorders
Cataract
|
0.00%
0/31
|
3.0%
1/33
|
|
Gastrointestinal disorders
Abdominal pain
|
9.7%
3/31
|
3.0%
1/33
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.5%
2/31
|
0.00%
0/33
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
1/31
|
3.0%
1/33
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/31
|
3.0%
1/33
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/31
|
6.1%
2/33
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/31
|
3.0%
1/33
|
|
Gastrointestinal disorders
Nausea
|
3.2%
1/31
|
0.00%
0/33
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/31
|
3.0%
1/33
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/31
|
3.0%
1/33
|
|
General disorders
Energy increased
|
3.2%
1/31
|
0.00%
0/33
|
|
General disorders
Fatigue
|
6.5%
2/31
|
0.00%
0/33
|
|
General disorders
Impaired healing
|
3.2%
1/31
|
3.0%
1/33
|
|
General disorders
Influenza like illness
|
0.00%
0/31
|
3.0%
1/33
|
|
General disorders
Injection site hypersensitivity
|
3.2%
1/31
|
0.00%
0/33
|
|
General disorders
Injection site pain
|
3.2%
1/31
|
3.0%
1/33
|
|
General disorders
Injection site swelling
|
9.7%
3/31
|
6.1%
2/33
|
|
General disorders
Malaise
|
3.2%
1/31
|
0.00%
0/33
|
|
General disorders
Oedema peripheral
|
0.00%
0/31
|
12.1%
4/33
|
|
Infections and infestations
Erysipelas
|
3.2%
1/31
|
0.00%
0/33
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/31
|
3.0%
1/33
|
|
Infections and infestations
Influenza
|
0.00%
0/31
|
3.0%
1/33
|
|
Infections and infestations
Nasopharyngitis
|
16.1%
5/31
|
9.1%
3/33
|
|
Infections and infestations
Pneumonia
|
6.5%
2/31
|
3.0%
1/33
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/31
|
3.0%
1/33
|
|
Infections and infestations
Rhinitis
|
6.5%
2/31
|
3.0%
1/33
|
|
Infections and infestations
Sinusitis
|
3.2%
1/31
|
0.00%
0/33
|
|
Infections and infestations
Tooth infection
|
0.00%
0/31
|
3.0%
1/33
|
|
Infections and infestations
Upper respiratory tract infection
|
6.5%
2/31
|
3.0%
1/33
|
|
Infections and infestations
Urinary tract infection
|
6.5%
2/31
|
3.0%
1/33
|
|
Infections and infestations
Vestibular neuronitis
|
3.2%
1/31
|
0.00%
0/33
|
|
Injury, poisoning and procedural complications
Contusion
|
3.2%
1/31
|
3.0%
1/33
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/31
|
3.0%
1/33
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
3.2%
1/31
|
3.0%
1/33
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/31
|
3.0%
1/33
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/31
|
6.1%
2/33
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/31
|
6.1%
2/33
|
|
Investigations
Blood creatinine increased
|
3.2%
1/31
|
0.00%
0/33
|
|
Investigations
Blood glucose increased
|
0.00%
0/31
|
3.0%
1/33
|
|
Investigations
International normalised ratio increased
|
3.2%
1/31
|
0.00%
0/33
|
|
Investigations
Occult blood positive
|
6.5%
2/31
|
0.00%
0/33
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/31
|
3.0%
1/33
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/31
|
3.0%
1/33
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.2%
1/31
|
6.1%
2/33
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
3.2%
1/31
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
2/31
|
6.1%
2/33
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.9%
4/31
|
9.1%
3/33
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
3.2%
1/31
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.2%
1/31
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.2%
1/31
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.2%
1/31
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
3.2%
1/31
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/31
|
3.0%
1/33
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage 0, with cancer in situ
|
3.2%
1/31
|
0.00%
0/33
|
|
Nervous system disorders
Amnesia
|
3.2%
1/31
|
0.00%
0/33
|
|
Nervous system disorders
Dizziness
|
0.00%
0/31
|
3.0%
1/33
|
|
Nervous system disorders
Headache
|
6.5%
2/31
|
0.00%
0/33
|
|
Nervous system disorders
Sciatica
|
3.2%
1/31
|
3.0%
1/33
|
|
Nervous system disorders
Syncope
|
3.2%
1/31
|
0.00%
0/33
|
|
Nervous system disorders
Transient ischaemic attack
|
3.2%
1/31
|
0.00%
0/33
|
|
Psychiatric disorders
Depression
|
3.2%
1/31
|
0.00%
0/33
|
|
Psychiatric disorders
Insomnia
|
3.2%
1/31
|
3.0%
1/33
|
|
Renal and urinary disorders
Urinary retention
|
3.2%
1/31
|
3.0%
1/33
|
|
Reproductive system and breast disorders
Breast cyst
|
3.2%
1/31
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
3.2%
1/31
|
6.1%
2/33
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.7%
3/31
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/31
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.2%
1/31
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/31
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/31
|
3.0%
1/33
|
|
Skin and subcutaneous tissue disorders
Blister
|
3.2%
1/31
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.2%
1/31
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
3.2%
1/31
|
0.00%
0/33
|
|
Vascular disorders
Aortic aneurysm
|
3.2%
1/31
|
6.1%
2/33
|
|
Vascular disorders
Hot flush
|
0.00%
0/31
|
3.0%
1/33
|
|
Vascular disorders
Hypertension
|
12.9%
4/31
|
9.1%
3/33
|
|
Vascular disorders
Intermittent claudication
|
3.2%
1/31
|
0.00%
0/33
|
|
Vascular disorders
Thrombophlebitis
|
3.2%
1/31
|
0.00%
0/33
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER