Trial Outcomes & Findings for Safety & Effectiveness on Vascular Structure and Function of ACZ885 in Atherosclerosis and Either T2DM or IGT Patients (NCT NCT00995930)
NCT ID: NCT00995930
Last Updated: 2015-06-29
Results Overview
Participants were monitored for adverse events, serious adverse events and death throughout the study.
COMPLETED
PHASE2
189 participants
12 months
2015-06-29
Participant Flow
Participants were randomized in a 1:1 ratio to each treatment arm.
Participant milestones
| Measure |
Placebo
SQ monthly
|
ACZ885
150 mg SQ monthly
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
95
|
|
Overall Study
Safety Analysis Set
|
94
|
95
|
|
Overall Study
Pharmacokinetic (PK) Analysis Set
|
0
|
95
|
|
Overall Study
Pharmacodynamic (PD) Analysis Set
|
92
|
92
|
|
Overall Study
Imaging Analysis Set
|
92
|
92
|
|
Overall Study
COMPLETED
|
73
|
67
|
|
Overall Study
NOT COMPLETED
|
21
|
28
|
Reasons for withdrawal
| Measure |
Placebo
SQ monthly
|
ACZ885
150 mg SQ monthly
|
|---|---|---|
|
Overall Study
Protocol deviation
|
2
|
5
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Administrative problems
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
|
Overall Study
Adverse Event
|
11
|
14
|
Baseline Characteristics
Safety & Effectiveness on Vascular Structure and Function of ACZ885 in Atherosclerosis and Either T2DM or IGT Patients
Baseline characteristics by cohort
| Measure |
Placebo
n=94 Participants
SQ monthly
|
ACZ885
n=95 Participants
150 mg SQ monthly
|
Total
n=189 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.9 Years
STANDARD_DEVIATION 6.92 • n=5 Participants
|
61.7 Years
STANDARD_DEVIATION 7.85 • n=7 Participants
|
61.8 Years
STANDARD_DEVIATION 7.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Safety analysis set: The safety analysis set included all randomized participants who received at least one dose of study drug.
Participants were monitored for adverse events, serious adverse events and death throughout the study.
Outcome measures
| Measure |
Placebo
n=94 Participants
SQ monthly
|
ACZ885
n=95 Participants
150 mg SQ monthly
|
|---|---|---|
|
Number of Participants With Adverse Events, Serious Adverse Events and Death
Adverse events (serious and non-serious)
|
80 Number of participants
|
77 Number of participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Death
Serious adverse events
|
14 Number of participants
|
25 Number of participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Death
Deaths
|
0 Number of participants
|
1 Number of participants
|
PRIMARY outcome
Timeframe: baseline, 3 months, 12 monthsPopulation: Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.
Two axial, ECG-gated, steady state free precession (SSFP) 'cine' images were acquired during breath-hold to determine aortic distensibility. The first image was obtained at the level of the right pulmonary artery through the ascending and proximal descending aorta and the second through the distal aorta below the diaphragm. Imaging of the aorta also enabled evaluation of the plaque burden and additional vascular function measures.
Outcome measures
| Measure |
Placebo
n=92 Participants
SQ monthly
|
ACZ885
n=92 Participants
150 mg SQ monthly
|
|---|---|---|
|
Change From Baseline in Aortic Distensibility
3 months, proximal ascending region (n=61,63)
|
-0.0001 mmHg^-1
Standard Error 0.0001
|
0.0001 mmHg^-1
Standard Error 0.0001
|
|
Change From Baseline in Aortic Distensibility
12 months, proximal ascending region (n=56,55)
|
-0.0001 mmHg^-1
Standard Error 0.0001
|
-0.0001 mmHg^-1
Standard Error 0.0001
|
PRIMARY outcome
Timeframe: baseline, 3 months, 12 monthsPopulation: Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.
For assessment of atherosclerotic plaque burden of the aorta, vessel wall images of the aorta were acquired with an ECG gated double-inversion recovery (black blood) fast spin echo sequence applied breath-holding. Using an oblique sagittal image of the aorta as a pilot, serial axial images were acquired to cover a section of the descending thoracic aorta. The midpoint of the right pulmonary artery in cross section was used as the anatomical reference for the first slice in baseline and follow-up scans. For assessment of the atherosclerotic plaque burden in the carotids, vessel wall images were acquired with an axial ECG gated PD (proton density) weighted black blood sequence. The carotid bifurcation was used as the anatomical reference for all three imaging time points (baseline, 12 weeks, 48 weeks) with axial slice planes acquired below the bifurcation region. The mean values reported here for the carotid are reported for the proximal common carotid region.
Outcome measures
| Measure |
Placebo
n=92 Participants
SQ monthly
|
ACZ885
n=92 Participants
150 mg SQ monthly
|
|---|---|---|
|
Change From Baseline in Plaque Burden (Aortic Vessel Wall Area and Carotid Vessel Wall Area)
aortic, proximal ascending, 3 months (n=69,62)
|
14.80 mm^2
Standard Error 6.86
|
-0.51 mm^2
Standard Error 6.62
|
|
Change From Baseline in Plaque Burden (Aortic Vessel Wall Area and Carotid Vessel Wall Area)
aortic, proximal ascending, 12 months (n=61,53)
|
30.58 mm^2
Standard Error 10.46
|
8.71 mm^2
Standard Error 10.49
|
|
Change From Baseline in Plaque Burden (Aortic Vessel Wall Area and Carotid Vessel Wall Area)
carotid, mean (right and left), 3 months (n=66,59)
|
1.41 mm^2
Standard Error 1.10
|
-0.29 mm^2
Standard Error 1.12
|
|
Change From Baseline in Plaque Burden (Aortic Vessel Wall Area and Carotid Vessel Wall Area)
carotid, mean (right and left), 12 mos. (n=55,48)
|
3.50 mm^2
Standard Error 1.51
|
0.73 mm^2
Standard Error 1.48
|
SECONDARY outcome
Timeframe: baseline, 3 months, 12 monthsPopulation: Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.
Utilizing the SphygmoCor Device, ECG leads placed at the carotid and femoral arteries provided the measure of the pulse wave at that particular arterial location. The distance between the two vascular beds divided by the pulse wave time shift provided a measure of the pulse wave velocity.
Outcome measures
| Measure |
Placebo
n=92 Participants
SQ monthly
|
ACZ885
n=92 Participants
150 mg SQ monthly
|
|---|---|---|
|
Change From Baseline in Pulse Wave Velocity and Pulse Wave Velocity Error
pulse wave velocity, 3 months(n=45,38)
|
-0.39 ms^-1
Standard Error 0.39
|
-0.03 ms^-1
Standard Error 0.39
|
|
Change From Baseline in Pulse Wave Velocity and Pulse Wave Velocity Error
pulse wave velocity, 12 months(n=35,31)
|
-0.36 ms^-1
Standard Error 0.35
|
-0.26 ms^-1
Standard Error 0.35
|
|
Change From Baseline in Pulse Wave Velocity and Pulse Wave Velocity Error
pulse wave velocity error, 3 months (n=45,38)
|
-0.01 ms^-1
Standard Error 0.05
|
-0.03 ms^-1
Standard Error 0.05
|
|
Change From Baseline in Pulse Wave Velocity and Pulse Wave Velocity Error
pulse wave velocity error, 12 months (n=35,31)
|
-0.01 ms^-1
Standard Error 0.06
|
0.06 ms^-1
Standard Error 0.06
|
SECONDARY outcome
Timeframe: baseline, 3 months, 12 monthsPopulation: Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.
During the carotid MRI acquisition, in addition to the PD weighted ECG gated double inversion fast spin echo sequences T1 and T2 weighted sequences were acquired. In combination with the PD weighted images, the multi-contrast images were analyzed to determine regions of interest with contrast patterns consistent with the presence of necrotic lipid core, calcification and fibrous tissue in participants who had complex carotid plaque present in the bifurcation region.
Outcome measures
| Measure |
Placebo
n=5 Participants
SQ monthly
|
ACZ885
n=3 Participants
150 mg SQ monthly
|
|---|---|---|
|
Change From Baseline in Plaque Composition
hemorrhage area, left carotid, 3 months
|
0.006 mm^2
Standard Deviation 0.0114
|
-0.000 mm^2
Standard Deviation 0.0200
|
|
Change From Baseline in Plaque Composition
hemorrhage area, left carotid, 12 months
|
0.018 mm^2
Standard Deviation 0.0205
|
0.007 mm^2
Standard Deviation 0.0115
|
|
Change From Baseline in Plaque Composition
lipid composition, left carotid, 3 months
|
0.000 mm^2
Standard Deviation 0.0000
|
0.003 mm^2
Standard Deviation 0.0115
|
|
Change From Baseline in Plaque Composition
lipid composition, left carotid, 12 months
|
-0.000 mm^2
Standard Deviation 0.0122
|
0.007 mm^2
Standard Deviation 0.0058
|
|
Change From Baseline in Plaque Composition
calcium composition,right carotid, 3 mos.(n=4,3)
|
-0.005 mm^2
Standard Deviation 0.0058
|
-0.003 mm^2
Standard Deviation 0.0058
|
|
Change From Baseline in Plaque Composition
calcium composition,right carotid, 12 mos.(n=4,3)
|
0.000 mm^2
Standard Deviation 0.0082
|
0.000 mm^2
Standard Deviation 0.0000
|
|
Change From Baseline in Plaque Composition
hemorrhage area,right carotid, 3 months (n=4,3)
|
0.003 mm^2
Standard Deviation 0.0096
|
-0.000 mm^2
Standard Deviation 0.0100
|
|
Change From Baseline in Plaque Composition
hemorrhage area, right carotid, 12 months (n=4,3)
|
0.008 mm^2
Standard Deviation 0.0330
|
0.003 mm^2
Standard Deviation 0.0208
|
|
Change From Baseline in Plaque Composition
lipid composition, right carotid, 3 months (n=4,3)
|
-0.005 mm^2
Standard Deviation 0.0058
|
0.003 mm^2
Standard Deviation 0.0058
|
|
Change From Baseline in Plaque Composition
lipid composition, right carotid, 12 mos.(n=4,3)
|
0.008 mm^2
Standard Deviation 0.0171
|
0.017 mm^2
Standard Deviation 0.0115
|
|
Change From Baseline in Plaque Composition
calcium composition, left carotid, 3 months
|
0.002 mm^2
Standard Deviation 0.0045
|
0.003 mm^2
Standard Deviation 0.0058
|
|
Change From Baseline in Plaque Composition
calcium composition, left carotid, 12 months
|
0.002 mm^2
Standard Deviation 0.0045
|
0.003 mm^2
Standard Deviation 0.0058
|
SECONDARY outcome
Timeframe: baseline, 3 months, 12 monthsPopulation: Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.
Arterial strain was computed directly from the cine SSFP images and the change in lumen diameters over the cardiac cycle. The value was independent of pulse pressure and is unitless ratio derived from the maximum to minimum lumen diameters diastole and systole, respectively..
Outcome measures
| Measure |
Placebo
n=92 Participants
SQ monthly
|
ACZ885
n=92 Participants
150 mg SQ monthly
|
|---|---|---|
|
Change From Baseline in Aortic Strain
proximal ascending, 3 months(n=67,64)
|
-0.005 ratio
Standard Error 0.005
|
0.002 ratio
Standard Error 0.005
|
|
Change From Baseline in Aortic Strain
proximal ascending, 12 months(n=59,59)
|
0.001 ratio
Standard Error 0.005
|
-0.002 ratio
Standard Error 0.005
|
SECONDARY outcome
Timeframe: baseline, 3 months, 12 monthsPopulation: Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.
Blood samples were collected to analyze hsCRP.
Outcome measures
| Measure |
Placebo
n=92 Participants
SQ monthly
|
ACZ885
n=92 Participants
150 mg SQ monthly
|
|---|---|---|
|
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)
12 months (n=73,68)
|
1.04 mg/L
Interval 0.83 to 1.31
|
0.51 mg/L
Interval 0.41 to 0.64
|
|
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)
3 months (n=82,79)
|
0.93 mg/L
Interval 0.76 to 1.14
|
0.48 mg/L
Interval 0.39 to 0.58
|
SECONDARY outcome
Timeframe: baseline, 3 months, 12 monthsPopulation: Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.
Blood samples were collected to analyze fasting plasma glucose.
Outcome measures
| Measure |
Placebo
n=92 Participants
SQ monthly
|
ACZ885
n=92 Participants
150 mg SQ monthly
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose
3 months (n=79,75)
|
0.95 mmol/L
Interval 0.89 to 1.01
|
1.00 mmol/L
Interval 0.94 to 1.06
|
|
Change From Baseline in Fasting Plasma Glucose
12 months (n=71,62)
|
0.95 mmol/L
Interval 0.87 to 1.02
|
0.99 mmol/L
Interval 0.92 to 1.07
|
SECONDARY outcome
Timeframe: baseline, 3 months, 12 monthsPopulation: Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.
Blood samples were collected to analyze HbA1c.
Outcome measures
| Measure |
Placebo
n=92 Participants
SQ monthly
|
ACZ885
n=92 Participants
150 mg SQ monthly
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c)
3 months (n=81,77)
|
1.00 percentage
Interval 0.97 to 1.02
|
0.99 percentage
Interval 0.97 to 1.02
|
|
Change From Baseline in Hemoglobin A1c (HbA1c)
12 months (n=72,65)
|
1.00 percentage
Interval 0.96 to 1.04
|
0.96 percentage
Interval 0.96 to 1.03
|
SECONDARY outcome
Timeframe: baseline, 3 months, 12 monthsPopulation: Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.
Blood samples were collected to analyze the 2 hour glucose post OGTT.
Outcome measures
| Measure |
Placebo
n=92 Participants
SQ monthly
|
ACZ885
n=92 Participants
150 mg SQ monthly
|
|---|---|---|
|
Change From Baseline in 2 Hour Glucose Post Oral Glucose Tolerance Test (OGTT)
3 months (n=79,74)
|
0.92 mmol/L
Interval 0.85 to 0.99
|
0.98 mmol/L
Interval 0.9 to 1.05
|
|
Change From Baseline in 2 Hour Glucose Post Oral Glucose Tolerance Test (OGTT)
12 months (n=71,62)
|
0.93 mmol/L
Interval 0.84 to 1.01
|
0.95 mmol/L
Interval 0.88 to 1.04
|
SECONDARY outcome
Timeframe: baseline, 3 months, 12 monthsPopulation: Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.
Blood samples were collected to analyze beta cell function. Beta cell function was calculated by the Homeostasis Model Assessments (of beta cell function (HOMA-B) as follows: HOMA-B: The product of 20 and basal insulin (µU/mL) levels divided by the value of basal glucose (mmol/L) concentrations minus 3.5 \[i.e., HOMA-B = 20\*basal insulin/(basal glucose-3.5)\].
Outcome measures
| Measure |
Placebo
n=92 Participants
SQ monthly
|
ACZ885
n=92 Participants
150 mg SQ monthly
|
|---|---|---|
|
Change From Baseline in Beta Cell Function (HOMA-B)
HOMA-B, 3 months (n=77,70)
|
1.11 percentage of beta cell function
Interval 0.91 to 1.35
|
0.99 percentage of beta cell function
Interval 0.82 to 1.2
|
|
Change From Baseline in Beta Cell Function (HOMA-B)
HOMA-B, 12 months (n=71,60)
|
1.03 percentage of beta cell function
Interval 0.84 to 1.26
|
0.91 percentage of beta cell function
Interval 0.75 to 1.1
|
SECONDARY outcome
Timeframe: baseline, 3 months, 12 monthsPopulation: Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.
Blood samples were collected to analyze insulin resistance. Insulin resistance was calculated by the Homeostasis Model Assessments of insulin resistance (HOMA-IR)) as follows: HOMA-IR: The product of basal glucose (mmol/L) and insulin (µU/mL) levels divided by 22.5 \[i.e., HOMA-IR = basal glucose\*basal insulin/22.5\].
Outcome measures
| Measure |
Placebo
n=92 Participants
SQ monthly
|
ACZ885
n=92 Participants
150 mg SQ monthly
|
|---|---|---|
|
Change From Baseline Insulin Resistance (HOMA-IR)
HOMA-R, 3 months (n=77,70)
|
1.00 IR score
Interval 0.85 to 1.18
|
1.09 IR score
Interval 0.93 to 1.28
|
|
Change From Baseline Insulin Resistance (HOMA-IR)
HOMA-R, 12 months (n=71,60)
|
0.93 IR score
Interval 0.77 to 1.13
|
0.97 IR score
Interval 0.8 to 1.16
|
SECONDARY outcome
Timeframe: pre-dose, 0.167 day post dose 1, 7 days post dose 1, 14 days post dose 1, every 30 days post each dose from doses 1 through 12, 60 days post dose 12, 90 days post dose 12Population: Only participants from the PK analysis set, who had evaluable data at each time point, were included in the analysis for that time point. The PK analysis set included randomized participants from the ACZ885 arm who received at least one dose of study medication.
Blood samples were collected to analyze the ACZ885 serum concentrations.
Outcome measures
| Measure |
Placebo
n=95 Participants
SQ monthly
|
ACZ885
150 mg SQ monthly
|
|---|---|---|
|
Pharmacokinetics: ACZ885 Serum Concentrations
30 days post dose 12 (n=66)
|
10887 ng/mL
Standard Deviation 4785
|
—
|
|
Pharmacokinetics: ACZ885 Serum Concentrations
pre-dose (n=91)
|
0 ng/mL
Standard Deviation 0
|
—
|
|
Pharmacokinetics: ACZ885 Serum Concentrations
0.167 day post dose 1 (n=94)
|
480 ng/mL
Standard Deviation 648
|
—
|
|
Pharmacokinetics: ACZ885 Serum Concentrations
7 days post dose 1 (n=95)
|
10107 ng/mL
Standard Deviation 4369
|
—
|
|
Pharmacokinetics: ACZ885 Serum Concentrations
14 days post dose 1 (n=93)
|
9138 ng/mL
Standard Deviation 3527
|
—
|
|
Pharmacokinetics: ACZ885 Serum Concentrations
30 days post dose 1 (n=90)
|
5936 ng/mL
Standard Deviation 2281
|
—
|
|
Pharmacokinetics: ACZ885 Serum Concentrations
30 days post dose 2 (n=86)
|
8136 ng/mL
Standard Deviation 3299
|
—
|
|
Pharmacokinetics: ACZ885 Serum Concentrations
30 days post dose 3 (n=81)
|
9278 ng/mL
Standard Deviation 3795
|
—
|
|
Pharmacokinetics: ACZ885 Serum Concentrations
30 days post dose 4 (n=78)
|
10183 ng/mL
Standard Deviation 4552
|
—
|
|
Pharmacokinetics: ACZ885 Serum Concentrations
30 days post dose 5 (n=78)
|
10164 ng/mL
Standard Deviation 4209
|
—
|
|
Pharmacokinetics: ACZ885 Serum Concentrations
30 days post dose 6 (n=77)
|
10254 ng/mL
Standard Deviation 3916
|
—
|
|
Pharmacokinetics: ACZ885 Serum Concentrations
30 days post dose 7 (n=76)
|
10368 ng/mL
Standard Deviation 4840
|
—
|
|
Pharmacokinetics: ACZ885 Serum Concentrations
30 days post dose 8 (n=71)
|
9745 ng/mL
Standard Deviation 4436
|
—
|
|
Pharmacokinetics: ACZ885 Serum Concentrations
30 days post dose 9 (n=69)
|
10407 ng/mL
Standard Deviation 3967
|
—
|
|
Pharmacokinetics: ACZ885 Serum Concentrations
30 days post dose 10 (n=71)
|
10635 ng/mL
Standard Deviation 4697
|
—
|
|
Pharmacokinetics: ACZ885 Serum Concentrations
30 days post dose 11 (n=70)
|
10612 ng/mL
Standard Deviation 4434
|
—
|
|
Pharmacokinetics: ACZ885 Serum Concentrations
60 days post dose 12 (n=66)
|
4575 ng/mL
Standard Deviation 2362
|
—
|
|
Pharmacokinetics: ACZ885 Serum Concentrations
90 days post dose 12 (n=88)
|
3241 ng/mL
Standard Deviation 2883
|
—
|
Adverse Events
ACZ885 150mg
Placebo
Serious adverse events
| Measure |
ACZ885 150mg
n=95 participants at risk
ACZ885 150mg
|
Placebo
n=94 participants at risk
SQ monthly
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/95
|
1.1%
1/94
|
|
Cardiac disorders
Acute myocardial infarction
|
2.1%
2/95
|
1.1%
1/94
|
|
Cardiac disorders
Angina pectoris
|
2.1%
2/95
|
2.1%
2/94
|
|
Cardiac disorders
Angina unstable
|
1.1%
1/95
|
0.00%
0/94
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/95
|
1.1%
1/94
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/95
|
1.1%
1/94
|
|
Cardiac disorders
Cardiac failure
|
1.1%
1/95
|
1.1%
1/94
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/95
|
2.1%
2/94
|
|
Cardiac disorders
Myocardial ischaemia
|
1.1%
1/95
|
0.00%
0/94
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
1.1%
1/95
|
0.00%
0/94
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/95
|
1.1%
1/94
|
|
General disorders
Non-cardiac chest pain
|
1.1%
1/95
|
0.00%
0/94
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/95
|
1.1%
1/94
|
|
Infections and infestations
Epiglottitis
|
1.1%
1/95
|
0.00%
0/94
|
|
Infections and infestations
Furuncle
|
1.1%
1/95
|
0.00%
0/94
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/95
|
1.1%
1/94
|
|
Infections and infestations
Localised infection
|
1.1%
1/95
|
0.00%
0/94
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/95
|
0.00%
0/94
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.00%
0/95
|
1.1%
1/94
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
1/95
|
0.00%
0/94
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/95
|
1.1%
1/94
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.1%
1/95
|
0.00%
0/94
|
|
Investigations
Hepatic enzyme increased
|
1.1%
1/95
|
0.00%
0/94
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/95
|
1.1%
1/94
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/95
|
1.1%
1/94
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/95
|
1.1%
1/94
|
|
Musculoskeletal and connective tissue disorders
Gouty tophus
|
1.1%
1/95
|
0.00%
0/94
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/95
|
1.1%
1/94
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.1%
1/95
|
0.00%
0/94
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.1%
1/95
|
0.00%
0/94
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/95
|
1.1%
1/94
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
1.1%
1/95
|
0.00%
0/94
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
1.1%
1/95
|
0.00%
0/94
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
1.1%
1/95
|
0.00%
0/94
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/95
|
1.1%
1/94
|
|
Nervous system disorders
Dizziness
|
1.1%
1/95
|
0.00%
0/94
|
|
Nervous system disorders
Hydrocephalus
|
1.1%
1/95
|
0.00%
0/94
|
|
Nervous system disorders
Intraventricular haemorrhage
|
1.1%
1/95
|
0.00%
0/94
|
|
Nervous system disorders
Syncope
|
1.1%
1/95
|
0.00%
0/94
|
|
Nervous system disorders
Transient ischaemic attack
|
2.1%
2/95
|
0.00%
0/94
|
|
Psychiatric disorders
Anxiety
|
1.1%
1/95
|
0.00%
0/94
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.1%
1/95
|
0.00%
0/94
|
|
Renal and urinary disorders
Renal failure
|
1.1%
1/95
|
0.00%
0/94
|
|
Reproductive system and breast disorders
Epididymitis
|
1.1%
1/95
|
0.00%
0/94
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/95
|
1.1%
1/94
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/95
|
1.1%
1/94
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
1.1%
1/95
|
0.00%
0/94
|
|
Vascular disorders
Peripheral artery thrombosis
|
1.1%
1/95
|
0.00%
0/94
|
|
Vascular disorders
Peripheral vascular disorder
|
1.1%
1/95
|
0.00%
0/94
|
Other adverse events
| Measure |
ACZ885 150mg
n=95 participants at risk
ACZ885 150mg
|
Placebo
n=94 participants at risk
SQ monthly
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
5/95
|
6.4%
6/94
|
|
Gastrointestinal disorders
Nausea
|
4.2%
4/95
|
7.4%
7/94
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/95
|
5.3%
5/94
|
|
General disorders
Asthenia
|
2.1%
2/95
|
5.3%
5/94
|
|
General disorders
Fatigue
|
2.1%
2/95
|
8.5%
8/94
|
|
General disorders
Influenza like illness
|
4.2%
4/95
|
5.3%
5/94
|
|
General disorders
Non-cardiac chest pain
|
3.2%
3/95
|
8.5%
8/94
|
|
Infections and infestations
Nasopharyngitis
|
12.6%
12/95
|
19.1%
18/94
|
|
Infections and infestations
Upper respiratory tract infection
|
9.5%
9/95
|
10.6%
10/94
|
|
Investigations
Blood creatine phosphokinase increased
|
5.3%
5/95
|
3.2%
3/94
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.1%
1/95
|
5.3%
5/94
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
4/95
|
5.3%
5/94
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.2%
4/95
|
7.4%
7/94
|
|
Nervous system disorders
Dizziness
|
5.3%
5/95
|
5.3%
5/94
|
|
Nervous system disorders
Headache
|
4.2%
4/95
|
5.3%
5/94
|
|
Renal and urinary disorders
Renal failure
|
2.1%
2/95
|
6.4%
6/94
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
5/95
|
2.1%
2/94
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.1%
2/95
|
6.4%
6/94
|
|
Vascular disorders
Hypertension
|
3.2%
3/95
|
5.3%
5/94
|
Additional Information
Study Director
Novartis Pharmaceuticals
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