Evaluation of Cardiovascular Risk Markers in Psoriasis Pa... | NCT02559622 | Trialant
NCT02559622
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Jul 13, 2017Actual
Enrollment
151Actual
Phase
Phase 3
Conditions
Psoriasis
Interventions
Secukinumab
Placebo
Placebo
Secukinumab
Countries
Germany
Protocol Section
Identification Module
NCT ID
NCT02559622
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CAIN457ADE02
Secondary IDs
Not provided
Brief Title
Evaluation of Cardiovascular Risk Markers in Psoriasis Patients Treated With Secukinumab
Official Title
A Randomized, Double-blind, Placebo-controlled, Multicenter, Exploratory Evaluation of Surrogate Markers of Cardiovascular Risk in Patients With Active Chronic Plaque-type Psoriasis Treated for up to 52 Weeks With Subcutaneous (s.c.) Secukinumab (300 mg or 150 mg).
Acronym
CARIMA
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Apr 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2014
Primary Completion Date
Apr 2016Actual
Completion Date
Apr 2016Actual
First Submitted Date
Aug 4, 2015
First Submission Date that Met QC Criteria
Sep 23, 2015
First Posted Date
Sep 24, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 19, 2017
Results First Submitted that Met QC Criteria
Apr 19, 2017
Results First Posted Date
Jul 13, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 19, 2017
Last Update Posted Date
Jul 13, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study was to explore the effect of treatment with 300 mg or with 150 mg secukinumab (administered weekly for 4 weeks followed by four-weekly administration) on endothelial dysfunction and arterial stiffness after 12 weeks and for up to 52 weeks in subjects with chronic plaque-type psoriasis. Furthermore soluble biomarkers were assessed to evaluate the influence of secukinumab on cardiovascular risk. Magnetic resonance imaging (MRI) was performed in a sub-population to assess the treatment effect on arterial vessel wall morphometry in atherosclerosis prone vascular beds.
Detailed Description
Not provided
Conditions Module
Conditions
Psoriasis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
151Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
300 mg secukinumab
Experimental
300 mg secukinumab every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection)
Drug: Secukinumab
150 mg secukinumab
Experimental
150 mg secukinumab every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection)
Drug: Secukinumab
Placebo followed by 300 mg secukinumab
Other
Placebo until week 12 followed by 300 mg secukinumab every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection)
Other: Placebo
Placebo followed by 150 mg secukinumab
Other
Placebo until week 12 followed by 150 mg secukinumab every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection)
Other: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Secukinumab
Drug
300 mg secukinumab
300 mg secukinumab
AIN457
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Flow Mediated Dilation (FMD) at Week 12 Followed by Secukinumab 300 mg vs Pooled Placebo Treatment
Flow Mediated Dilation (FMD) is non-invasive method evaluated by Doppler Ultrasound test, to assess endothelial function. FMD was calculated as the percent maximal deviation from the baseline arterial diameter (D):FMD = 100*[(D maximum - D baseline) / D baseline]. Here, arterial diameter (brachial artery) was measured at rest (1 minute), during inflation of the distal cuff to 100 millimeter of mercury (mmHg) for 4.5 minutes and for 4.5 minutes following deflation.
Week 12
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52
FMD is non-invasive method evaluated by Doppler Ultrasound test, to assess endothelial function. FMD was calculated as the percent maximal deviation from the baseline arterial diameter (D):FMD = 100*[(D maximum - D baseline) / D baseline]. Here, arterial diameter (brachial artery) was measured at rest (1 minute), during inflation of the distal cuff to 100 mmHg for 4.5 minutes and for 4.5 minutes following deflation. A positive change in FMD constitutes an improvement in endothelial function.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Chronic moderate to severe plaque type psoriasis for at least 6 months prior to randomization with a Psoriasis Area and Severity Index (PASI) score ≥ 10 at randomization.
Inadequate response, intolerance or contraindication to cyclosporine, methotrexate and psoralen plus ultraviolet A light treatment (PUVA) as documented in the patient's medical history or reported by the patient or determined by the investigator at screening. Relative contraindications such as interference of patient's lifestyle with the treatment are accepted.
Key Exclusion Criteria:
Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttata psoriasis) at screening or randomization.
Ongoing use of prohibited psoriasis and non-psoriasis treatments.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Novartis Investigative Site
Augsburg
86179
Germany
Novartis Investigative Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
The study was conducted at 23 centers in Germany.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Secukinumab 300 mg
Participants were administered with 300 milligrams (mg) secukinumab subcutaneously (s.c.) using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52
Pulse wave analysis was performed on the central aortic pressure waveform as derived by SphygmoCor XCEL from the brachial pressure waveform recorded in a partially-inflated blood pressure cuff around the upper arm. The waveform derivation employs a validated generalized transfer function to convert a brachial waveform to a central waveform and has been shown to produce measurement results corresponding to measurements using intra-arterial pressure catheters. The augmentation index is derived from the waveform by determining the percentage of the central pulse pressure during systole due to wave reflection. AIx was heart-rate corrected to calculate the AIx at a heart rate of 75 bpm, i.e. AIx-75.
Baseline, Week 4, 12, 24 and 52
Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52
Regional arterial pulse wave velocity (PWV) was directly related to arterial stiffness and was defined as the time it takes for the blood pressure wave to travel from a proximal site to a distal site (relative to the heart) divided by the distance (PWV = ∆distance/∆time [m/s]). The foot of the arterial pulse wave was being recorded by using the SphygmoCor XCEL device. XCEL simultaneously measures the pressure waveform at the femoral site (using a partially inflated custom blood pressure cuff) and the carotid site (using hand-held applanation tonometry). The foot-to-foot time between the two pressure waveforms was the time interval used in the PWV calculation.
Baseline, Week 4, 12, 24 and 52
Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12
Magnetic resonance imaging (MRI) was used to evaluate vessel wall morphometry to determine plaque burden. As a measure of plaque burden, average wall area was computed by subtracting vessel lumen area from total vessel area. Exploratory 3.0 Tesla MRI technique was applied to assess structure and function of the carotid and the aorta. A 2D axial dark blood T1, T2, proton density weighted spin echo based images and time of flight images were acquired from the bilateral carotid arteries as well as the descending aorta.
Baseline, Week 12
Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52
Magnetic resonance imaging (MRI) was used to evaluate vessel wall morphometry to determine plaque burden. As a measure of plaque burden, average wall area was computed by subtracting vessel lumen area from total vessel area. Exploratory 3.0 Tesla MRI technique was applied to assess structure and function of the carotid and the aorta. A 2D axial dark blood T1, T2, proton density weighted spin echo based images and time of flight images were acquired from the bilateral carotid arteries as well as the descending aorta.
Baseline, Week 52
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52
High sensitivity C-reactive protein (hsCRP), a soluble biomarker of systemic inflammation was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.
Baseline, Week 4, 12, 24 and 52
Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52
S100 calcium-binding protein B (S100B-protein), a soluble biomarker of systemic inflammation was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.
Baseline, Week 4, 12, 24 and 52
Change From Baseline in Chemokine (C-c Motif) Ligand 5 (CCL5), Monocyte Chemoattractant Protein 1 (MCP-1) and Macrophage Inflammatory Proteins (MIP) 1 Alpha and 1 Beta at Week 4, 12, 24 and 52
Chemokine (c-c motif) ligand 5 (CCL5), Monocyte chemoattractant protein 1 (MCP-1) and Macrophage inflammatory proteins (MIP) 1 alpha (1A) and 1 beta (1B), soluble biomarkers of systemic inflammation were determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.
Baseline, Week 4, 12, 24 and 52
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52
Fasting plasma glucose (FPG), a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.
Baseline, Week 4, 12, 24 and 52
Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52
Fasting Insulin, a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.
Baseline, Week 4, 12, 24 and 52
Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52
Homeostatic Model Assessment (HOMA) beta-cell function, a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.
Baseline, Week 4, 12, 24 and 52
Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52
HOMA insulin resistance, a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.
Baseline, Week 4, 12, 24 and 52
Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52
Hemoglobin A1c (glycated hemoglobin), a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.
Baseline, Week 4, 12, 24 and 52
Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52
Sex hormone-binding globulin (SHBG), a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.
Baseline, Week 4, 12, 24 and 52
Change From Baseline in Triglycerides, Total Cholesterol, Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Apolipoprotein A-1 (ApoA-1) and Apolipoprotein B (ApoB) at Week 4, 12, 24 and 52
Triglycerides, Total cholesterol, Low density lipoprotein (LDL), High density lipoprotein (HDL), Apolipoprotein A-1 (ApoA-1) and Apolipoprotein B (ApoB), soluble biomarkers of impaired lipid metabolism were determined in fasting blood samples to evaluate the effect of secukinumab on impaired lipid metabolism.
Baseline, Week 4, 12, 24 and 52
Change From Baseline in Adiponectin at Week 4, 12, 24 and 52
Adiponectin, a soluble biomarker of impaired lipid metabolism was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.
Baseline, Week 4, 12, 24 and 52
Change From Baseline in Leptin at Week 4, 12, 24 and 52
Leptin, a soluble biomarker of impaired lipid metabolism was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.
Baseline, Week 4, 12, 24 and 52
Berlin
10789
Germany
Novartis Investigative Site
Berlin
13187
Germany
Novartis Investigative Site
Bielefeld
33647
Germany
Novartis Investigative Site
Bochum
44791
Germany
Novartis Investigative Site
Bonn
53105
Germany
Novartis Investigative Site
Darmstadt
64283
Germany
Novartis Investigative Site
Dresden
01307
Germany
Novartis Investigative Site
Duisburg
47166
Germany
Novartis Investigative Site
Essen
45147
Germany
Novartis Investigative Site
Frankfurt
60590
Germany
Novartis Investigative Site
Freiburg im Breisgau
79104
Germany
Novartis Investigative Site
Gera
07548
Germany
Novartis Investigative Site
Hamburg
20354
Germany
Novartis Investigative Site
Heidelberg
69120
Germany
Novartis Investigative Site
Homburg
66421
Germany
Novartis Investigative Site
Langenau
89129
Germany
Novartis Investigative Site
Lübeck
23538
Germany
Novartis Investigative Site
Mainz
55131
Germany
Novartis Investigative Site
München
81675
Germany
Novartis Investigative Site
Münster
48149
Germany
Novartis Investigative Site
Stade
21682
Germany
Novartis Investigative Site
Ulm
89081
Germany
Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
FG002
Placebo Followed by 300 mg Secukinumab
Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
FG003
Placebo Followed by 150 mg Secukinumab
Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
FG00048 subjects
FG00154 subjects
FG00226 subjects
FG00323 subjects
COMPLETED
FG00047 subjects
FG00149 subjects
FG00224 subjects
FG00320 subjects
NOT COMPLETED
FG0001 subjects
FG0015 subjects
FG0022 subjects
FG0033 subjects
Type
Comment
Reasons
Progressive disease
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Adverse Event
FG0000 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
Patient/guardian decision
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0031 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Secukinumab 300 mg
Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
BG001
Secukinumab 150 mg
Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
BG002
Placebo Followed by 300 mg Secukinumab
Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
BG003
Placebo Followed by 150 mg Secukinumab
Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00048
BG00154
BG00226
BG00323
BG004151
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00044.2± 12.9
BG00146.0± 14.4
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00011
BG00123
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Germany
Title
Measurements
BG00048
BG00154
BG002
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
Flow Mediated Dilation (FMD) at Week 12 Followed by Secukinumab 300 mg vs Pooled Placebo Treatment
Flow Mediated Dilation (FMD) is non-invasive method evaluated by Doppler Ultrasound test, to assess endothelial function. FMD was calculated as the percent maximal deviation from the baseline arterial diameter (D):FMD = 100*[(D maximum - D baseline) / D baseline]. Here, arterial diameter (brachial artery) was measured at rest (1 minute), during inflation of the distal cuff to 100 millimeter of mercury (mmHg) for 4.5 minutes and for 4.5 minutes following deflation.
The analysis was performed in Full analysis set (FAS) population, defined as all participants from the randomized set who received at least one dose of study drug. Here, "Number analyzed" signifies participants evaluable for FMD at Week 12 for each arm, respectively.
Posted
Mean
Standard Deviation
Percentage maximal increase in diameter
Week 12
ID
Title
Description
OG000
Secukinumab 300 mg
Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG001
Placebo (Pooled)
Participants were administered with placebo until week 12 followed by 150 mg or 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg or 300 mg secukinumab respectively every 4 weeks until week 48 (last injection).
Units
Counts
Participants
OG00039
OG00138
Title
Denominators
Categories
Title
Measurements
OG0005.23± 5.30
OG0013.65± 4.07
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.2230
Least Square (LS) mean difference
1.17
2-Sided
95
-0.72
3.06
Superiority
Secondary
Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52
FMD is non-invasive method evaluated by Doppler Ultrasound test, to assess endothelial function. FMD was calculated as the percent maximal deviation from the baseline arterial diameter (D):FMD = 100*[(D maximum - D baseline) / D baseline]. Here, arterial diameter (brachial artery) was measured at rest (1 minute), during inflation of the distal cuff to 100 mmHg for 4.5 minutes and for 4.5 minutes following deflation. A positive change in FMD constitutes an improvement in endothelial function.
The analysis was performed in FAS population. Here, "Number analyzed" signifies participants evaluable for FMD at weeks 4, 12, 24 and 52 for each arm, respectively.
Posted
Mean
95% Confidence Interval
Percentage change in FMD
Baseline, Week 4, 12, 24 and 52
ID
Title
Description
OG000
Secukinumab 300 mg
Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG001
Secukinumab 150 mg
Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
OG002
Placebo Followed by 300 mg Secukinumab
Secondary
Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52
Pulse wave analysis was performed on the central aortic pressure waveform as derived by SphygmoCor XCEL from the brachial pressure waveform recorded in a partially-inflated blood pressure cuff around the upper arm. The waveform derivation employs a validated generalized transfer function to convert a brachial waveform to a central waveform and has been shown to produce measurement results corresponding to measurements using intra-arterial pressure catheters. The augmentation index is derived from the waveform by determining the percentage of the central pulse pressure during systole due to wave reflection. AIx was heart-rate corrected to calculate the AIx at a heart rate of 75 bpm, i.e. AIx-75.
The analysis was performed in FAS population. Here, "Number analyzed" signifies participants evaluable for pulse wave analysis at weeks 4, 12, 24 and 52 for each arm, respectively.
Posted
Mean
95% Confidence Interval
Percentage change in Alx-75
Baseline, Week 4, 12, 24 and 52
ID
Title
Description
OG000
Secukinumab 300 mg
Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG001
Secukinumab 150 mg
Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
Secondary
Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52
Regional arterial pulse wave velocity (PWV) was directly related to arterial stiffness and was defined as the time it takes for the blood pressure wave to travel from a proximal site to a distal site (relative to the heart) divided by the distance (PWV = ∆distance/∆time [m/s]). The foot of the arterial pulse wave was being recorded by using the SphygmoCor XCEL device. XCEL simultaneously measures the pressure waveform at the femoral site (using a partially inflated custom blood pressure cuff) and the carotid site (using hand-held applanation tonometry). The foot-to-foot time between the two pressure waveforms was the time interval used in the PWV calculation.
The analysis was performed in FAS population. Here, "n" signifies the sum of participants for all repeated measurements during calculation of mean, evaluable for pulse wave velocity (PWV) at Week 4, 12, 24 and 52 for each arm, respectively.
Posted
Mean
95% Confidence Interval
meters per second (m/s)
Baseline, Week 4, 12, 24 and 52
ID
Title
Description
OG000
Secukinumab 300 mg
Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG001
Secukinumab 150 mg
Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
Secondary
Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12
Magnetic resonance imaging (MRI) was used to evaluate vessel wall morphometry to determine plaque burden. As a measure of plaque burden, average wall area was computed by subtracting vessel lumen area from total vessel area. Exploratory 3.0 Tesla MRI technique was applied to assess structure and function of the carotid and the aorta. A 2D axial dark blood T1, T2, proton density weighted spin echo based images and time of flight images were acquired from the bilateral carotid arteries as well as the descending aorta.
The analysis was performed in FAS population. Here, "Number analyzed" signifies participants evaluable for MRI sub-study at week 12 for each arm, respectively. MRI was applied in a sub-study population of 33 participants.
Posted
Mean
95% Confidence Interval
millimeter square (mm^2)
Baseline, Week 12
ID
Title
Description
OG000
Secukinumab 300 mg
Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG001
Secukinumab 150 mg
Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
Secondary
Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52
Magnetic resonance imaging (MRI) was used to evaluate vessel wall morphometry to determine plaque burden. As a measure of plaque burden, average wall area was computed by subtracting vessel lumen area from total vessel area. Exploratory 3.0 Tesla MRI technique was applied to assess structure and function of the carotid and the aorta. A 2D axial dark blood T1, T2, proton density weighted spin echo based images and time of flight images were acquired from the bilateral carotid arteries as well as the descending aorta.
The analysis was performed in FAS population. Here, "Number analyzed" signifies participants evaluable for MRI sub-study at week 52 for each arm, respectively. MRI was applied in a sub-study population of 33 participants.
Posted
Mean
95% Confidence Interval
mm^2
Baseline, Week 52
ID
Title
Description
OG000
Secukinumab 300 mg
Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG001
Secukinumab 150 mg
Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
OG002
Secondary
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52
High sensitivity C-reactive protein (hsCRP), a soluble biomarker of systemic inflammation was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.
The analysis was performed in FAS population. Here, "Number analyzed" signifies participants evaluable for hsCRP at week 4, 12, 24 and 52 for each arm, respectively.
Posted
Mean
95% Confidence Interval
Milligrams per deciliter (mg/dL)
Baseline, Week 4, 12, 24 and 52
ID
Title
Description
OG000
Secukinumab 300 mg
Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG001
Secukinumab 150 mg
Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
OG002
Placebo Followed by 300 mg Secukinumab
Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
Secondary
Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52
S100 calcium-binding protein B (S100B-protein), a soluble biomarker of systemic inflammation was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.
The analysis was performed in FAS population. Here, "Number analyzed" signifies participants evaluable for S100B-protein at week 4, 12, 24 and 52 for each arm, respectively.
Posted
Mean
95% Confidence Interval
Microgram per Liter (ug/L)
Baseline, Week 4, 12, 24 and 52
ID
Title
Description
OG000
Secukinumab 300 mg
Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG001
Secukinumab 150 mg
Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
OG002
Placebo Followed by 300 mg Secukinumab
Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
Secondary
Change From Baseline in Chemokine (C-c Motif) Ligand 5 (CCL5), Monocyte Chemoattractant Protein 1 (MCP-1) and Macrophage Inflammatory Proteins (MIP) 1 Alpha and 1 Beta at Week 4, 12, 24 and 52
Chemokine (c-c motif) ligand 5 (CCL5), Monocyte chemoattractant protein 1 (MCP-1) and Macrophage inflammatory proteins (MIP) 1 alpha (1A) and 1 beta (1B), soluble biomarkers of systemic inflammation were determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.
The analysis was performed in FAS population. Here, "Number analyzed" signifies participants evaluable for CCL5, MCP-1, MIP-1A and MIP-1B at week 4, 12, 24 and 52 for each arm, respectively.
Posted
Mean
95% Confidence Interval
picograms per milliliter (pg/mL)
Baseline, Week 4, 12, 24 and 52
ID
Title
Description
OG000
Secukinumab 300 mg
Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG001
Secukinumab 150 mg
Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
OG002
Placebo Followed by 300 mg Secukinumab
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52
Fasting plasma glucose (FPG), a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.
The analysis was performed in FAS population. Here, "Number analyzed" signifies participants evaluable for FPG at week 4, 12, 24 and 52 for each arm, respectively.
Posted
Mean
95% Confidence Interval
mg/dL
Baseline, Week 4, 12, 24 and 52
ID
Title
Description
OG000
Secukinumab 300 mg
Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG001
Secukinumab 150 mg
Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
OG002
Placebo Followed by 300 mg Secukinumab
Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
Secondary
Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52
Fasting Insulin, a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.
The analysis was performed in FAS population. Here, "Number analyzed" signifies participants evaluable for Fasting Insulin of Dysglycemia at week 4, 12, 24 and 52 for each arm, respectively.
Posted
Mean
95% Confidence Interval
micro units per millilitre (uU/mL)
Baseline, Week 4, 12, 24 and 52
ID
Title
Description
OG000
Secukinumab 300 mg
Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG001
Secukinumab 150 mg
Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
OG002
Placebo Followed by 300 mg Secukinumab
Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
Secondary
Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52
Homeostatic Model Assessment (HOMA) beta-cell function, a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.
The analysis was performed in FAS population. Here, "Number analyzed" signifies participants evaluable for HOMA beta-cell function of Dysglycemia at week 4, 12, 24 and 52 for each arm, respectively.
Posted
Mean
95% Confidence Interval
Percentage
Baseline, Week 4, 12, 24 and 52
ID
Title
Description
OG000
Secukinumab 300 mg
Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG001
Secukinumab 150 mg
Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
OG002
Placebo Followed by 300 mg Secukinumab
Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
Secondary
Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52
HOMA insulin resistance, a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.
The analysis was performed in FAS population. Here, "Number analyzed" signifies participants evaluable for HOMA insulin resistance of Dysglycemia at week 4, 12, 24 and 52 for each arm, respectively.
Posted
Mean
95% Confidence Interval
Insulin Resistance Index
Baseline, Week 4, 12, 24 and 52
ID
Title
Description
OG000
Secukinumab 300 mg
Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG001
Secukinumab 150 mg
Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
OG002
Placebo Followed by 300 mg Secukinumab
Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
Secondary
Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52
Hemoglobin A1c (glycated hemoglobin), a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.
The analysis was performed in FAS population. Here, "Number analyzed" signifies participants evaluable for Hemoglobin A1c of Dysglycemia at week 4, 12, 24 and 52 for each arm, respectively.
Posted
Mean
95% Confidence Interval
millimole per mole of Haemoglobin
Baseline, Week 4, 12, 24 and 52
ID
Title
Description
OG000
Secukinumab 300 mg
Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG001
Secukinumab 150 mg
Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
OG002
Placebo Followed by 300 mg Secukinumab
Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
Secondary
Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52
Sex hormone-binding globulin (SHBG), a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.
The analysis was performed in FAS population. Here, "Number analyzed" signifies participants evaluable for SHBG of Dysglycemia at week 4, 12, 24 and 52 for each arm, respectively.
Posted
Mean
95% Confidence Interval
nanomole per Liter (nmol/L)
Baseline, Week 4, 12, 24 and 52
ID
Title
Description
OG000
Secukinumab 300 mg
Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG001
Secukinumab 150 mg
Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
OG002
Placebo Followed by 300 mg Secukinumab
Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
Secondary
Change From Baseline in Triglycerides, Total Cholesterol, Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Apolipoprotein A-1 (ApoA-1) and Apolipoprotein B (ApoB) at Week 4, 12, 24 and 52
Triglycerides, Total cholesterol, Low density lipoprotein (LDL), High density lipoprotein (HDL), Apolipoprotein A-1 (ApoA-1) and Apolipoprotein B (ApoB), soluble biomarkers of impaired lipid metabolism were determined in fasting blood samples to evaluate the effect of secukinumab on impaired lipid metabolism.
The analysis was performed in FAS population. Here, "Number analyzed" signifies participants evaluable for Triglycerides, Total cholesterol, LDL, HDL, ApoA-1 and ApoB of impaired lipid metabolism at week 4, 12, 24 and 52 for each arm, respectively.
Posted
Mean
95% Confidence Interval
mg/dL
Baseline, Week 4, 12, 24 and 52
ID
Title
Description
OG000
Secukinumab 300 mg
Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG001
Secukinumab 150 mg
Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
OG002
Placebo Followed by 300 mg Secukinumab
Secondary
Change From Baseline in Adiponectin at Week 4, 12, 24 and 52
Adiponectin, a soluble biomarker of impaired lipid metabolism was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.
The analysis was performed in FAS population. Here, "Number analyzed" signifies participants evaluable for Adiponectin of impaired lipid metabolism at week 4, 12, 24 and 52 for each arm, respectively.
Posted
Mean
95% Confidence Interval
ug/mL
Baseline, Week 4, 12, 24 and 52
ID
Title
Description
OG000
Secukinumab 300 mg
Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG001
Secukinumab 150 mg
Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
OG002
Placebo Followed by 300 mg Secukinumab
Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
Secondary
Change From Baseline in Leptin at Week 4, 12, 24 and 52
Leptin, a soluble biomarker of impaired lipid metabolism was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.
The analysis was performed in FAS population. Here, "Number analyzed" signifies participants evaluable for Leptin of impaired lipid metabolism at week 4, 12, 24 and 52 for each arm, respectively
Posted
Mean
95% Confidence Interval
ng/mL (nanogram per milliliter)
Baseline, Week 4, 12, 24 and 52
ID
Title
Description
OG000
Secukinumab 300 mg
Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG001
Secukinumab 150 mg
Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
OG002
Placebo Followed by 300 mg Secukinumab
Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
Time Frame
From signing of Informed Consent up to 30 days post last drug treatment.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Secukinumab (300 mg) up to Week 12
Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab up to 12 weeks.
1
48
29
48
EG001
Secukinumab (150 mg) up to Week 12
Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab up to 12 weeks.
0
54
36
54
EG002
Placebo up to Week 12
Participants were administered with placebo up to 12 weeks.
2
49
35
49
EG003
Secukinumab (300 mg) After Week 12
Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
6
48
36
48
EG004
Secukinumab (150 mg) After Week 12
Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
6
54
43
54
EG005
Placebo Followed by Secukinumab (300 mg) After Week 12
Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using prefilled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
0
26
21
26
EG006
Placebo Followed by Secukinumab (150 mg) After Week 12
Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using prefilled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
1
23
19
23
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
VESTIBULAR DISORDER
Ear and labyrinth disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG0031 affected48 at risk
EG0040 affected54 at risk
EG0050 affected26 at risk
EG0060 affected23 at risk
COLITIS
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
DUODENAL ULCER
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
GASTRIC ULCER
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
GASTRITIS EROSIVE
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
ANAL ABSCESS
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
ERYSIPELAS
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
HELICOBACTER INFECTION
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
PNEUMONIA BACTERIAL
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
CLAVICLE FRACTURE
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
JOINT DISLOCATION
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
HAEMARTHROSIS
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0021 affected49 at risk
EG003
RHEUMATOID ARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
VERTEBRAL FORAMINAL STENOSIS
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
OVARIAN CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
CEREBRAL INFARCTION
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
TRANSIENT ISCHAEMIC ATTACK
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
UTERINE POLYP
Reproductive system and breast disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0021 affected49 at risk
EG003
PSORIASIS
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
LYMPHADENOPATHY
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected48 at risk
EG0012 affected54 at risk
EG0021 affected49 at risk
EG0030 affected48 at risk
EG0040 affected54 at risk
EG0050 affected26 at risk
EG0060 affected23 at risk
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
CONJUNCTIVITIS ALLERGIC
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0012 affected54 at risk
EG0020 affected49 at risk
EG003
DRY EYE
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
EYE SWELLING
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected54 at risk
EG0021 affected49 at risk
EG003
BURNING MOUTH SYNDROME
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected48 at risk
EG0012 affected54 at risk
EG0021 affected49 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected54 at risk
EG0020 affected49 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
GASTRITIS
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
GLOSSITIS
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
HAEMORRHOIDS
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected48 at risk
EG0012 affected54 at risk
EG0020 affected49 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
TOOTHACHE
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
FATIGUE
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0012 affected54 at risk
EG0020 affected49 at risk
EG003
INJECTION SITE PAIN
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0021 affected49 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected48 at risk
EG0011 affected54 at risk
EG0020 affected49 at risk
EG003
CANDIDA INFECTION
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
CONJUNCTIVITIS
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
ECTHYMA
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
FUNGAL INFECTION
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0002 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
GASTROINTESTINAL CANDIDIASIS
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
GASTROINTESTINAL INFECTION
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0021 affected49 at risk
EG003
GINGIVITIS
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0021 affected49 at risk
EG003
HORDEOLUM
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0012 affected54 at risk
EG0020 affected49 at risk
EG003
IMPETIGO
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
LARYNGITIS
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG00010 affected48 at risk
EG00114 affected54 at risk
EG00218 affected49 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
ORAL HERPES
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0012 affected54 at risk
EG0020 affected49 at risk
EG003
OTITIS EXTERNA
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
OTITIS MEDIA
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
PARONYCHIA
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
PERIODONTITIS
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0012 affected54 at risk
EG0020 affected49 at risk
EG003
PULPITIS DENTAL
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
RHINITIS
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected54 at risk
EG0022 affected49 at risk
EG003
ROOT CANAL INFECTION
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0002 affected48 at risk
EG0011 affected54 at risk
EG0020 affected49 at risk
EG003
SKIN CANDIDA
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0012 affected54 at risk
EG0020 affected49 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0012 affected54 at risk
EG0021 affected49 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0013 affected54 at risk
EG0021 affected49 at risk
EG003
ARTHROPOD BITE
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
BURNS FIRST DEGREE
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
BURSA INJURY
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0012 affected54 at risk
EG0021 affected49 at risk
EG003
LACERATION
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
MUSCLE RUPTURE
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
THERMAL BURN
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected54 at risk
EG0020 affected49 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected48 at risk
EG0012 affected54 at risk
EG0025 affected49 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected48 at risk
EG0012 affected54 at risk
EG0021 affected49 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
SPINAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0021 affected49 at risk
EG003
PYOGENIC GRANULOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
SKIN PAPILLOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0002 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected48 at risk
EG0011 affected54 at risk
EG0021 affected49 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0004 affected48 at risk
EG0016 affected54 at risk
EG0022 affected49 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected48 at risk
EG0012 affected54 at risk
EG0020 affected49 at risk
EG003
NEPHROLITHIASIS
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
DYSMENORRHOEA
Reproductive system and breast disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
MENOPAUSAL SYMPTOMS
Reproductive system and breast disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected48 at risk
EG0010 affected54 at risk
EG0023 affected49 at risk
EG003
NASAL INFLAMMATION
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected54 at risk
EG0021 affected49 at risk
EG003
RHINITIS ALLERGIC
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected54 at risk
EG0020 affected49 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0012 affected54 at risk
EG0020 affected49 at risk
EG003
DERMATITIS
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
DERMATITIS ATOPIC
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
ECZEMA
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected48 at risk
EG0012 affected54 at risk
EG0020 affected49 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
INTERTRIGO
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
PAPULE
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected48 at risk
EG0010 affected54 at risk
EG0022 affected49 at risk
EG003
PSORIASIS
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected48 at risk
EG0010 affected54 at risk
EG0021 affected49 at risk
EG003
SEBORRHOEIC DERMATITIS
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0022 affected49 at risk
EG003
SKIN FISSURES
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
SKIN REACTION
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected54 at risk
EG0020 affected49 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected48 at risk
EG0011 affected54 at risk
EG0021 affected49 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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 (ie, data from all sites) in the clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Novartis Pharmaceuticals
862--778--8300
ID
Term
D011565
Psoriasis
Ancestor Terms
ID
Term
D017444
Skin Diseases, Papulosquamous
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C555450
secukinumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0
BG0040
Between 18 and 65 years
BG00046
BG00146
BG00226
BG00322
BG004140
>=65 years
BG0002
BG0018
BG0020
BG0031
BG00411
43.7
± 11.4
BG00346.8± 13.1
BG00445.2± 13.2
8
BG0037
BG00449
Male
BG00037
BG00131
BG00218
BG00316
BG004102
26
BG00323
BG004151
Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG003
Placebo Followed by 150 mg Secukinumab
Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
Units
Counts
Participants
OG00048
OG00154
OG00226
OG00323
Title
Denominators
Categories
Week 4
ParticipantsOG00037
ParticipantsOG00147
ParticipantsOG00221
ParticipantsOG00316
Title
Measurements
OG000-0.7(-1.9 to 0.5)
OG001-0.9(-2.4 to 0.7)
OG0020.7(-1.0 to 2.5)
OG003
Week 12
ParticipantsOG00039
ParticipantsOG00148
ParticipantsOG00221
ParticipantsOG00317
Week 24
ParticipantsOG00035
ParticipantsOG00139
ParticipantsOG00219
ParticipantsOG00316
Week 52
ParticipantsOG00038
ParticipantsOG00143
ParticipantsOG00220
ParticipantsOG00317
OG002
Placebo Followed by 300 mg Secukinumab
Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG003
Placebo Followed by 150 mg Secukinumab
Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
Units
Counts
Participants
OG00048
OG00154
OG00226
OG00323
Title
Denominators
Categories
Week 4
ParticipantsOG00047
ParticipantsOG00152
ParticipantsOG00225
ParticipantsOG00321
Title
Measurements
OG0000.0(-2.8 to 2.9)
OG0010.3(-2.0 to 2.7)
OG0021.1(-1.7 to 3.8)
OG003
Week 12
ParticipantsOG00048
ParticipantsOG00152
ParticipantsOG00226
ParticipantsOG00321
Week 24
ParticipantsOG00047
ParticipantsOG00150
ParticipantsOG00224
ParticipantsOG00321
Week 52
ParticipantsOG00047
ParticipantsOG00149
ParticipantsOG00225
ParticipantsOG00320
OG002
Placebo Followed by 300 mg Secukinumab
Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG003
Placebo Followed by 150 mg Secukinumab
Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
Units
Counts
Participants
OG00048
OG00154
OG00226
OG00323
Title
Denominators
Categories
Week 4 (n = 192, 262, 133, 104)
Title
Measurements
OG0000.0(-0.2 to 0.2)
OG001-0.2(-0.3 to 0.0)
OG0020(-0.1 to 0.2)
OG003-0.2(-0.5 to 0.2)
Week 12 (n = 214, 255, 116, 133)
Title
Measurements
OG0000.4(0.2 to 0.6)
OG0010.1(-0.1 to 0.2)
OG0020.1(-0.2 to 0.4)
OG003
Week 24 (n = 205, 255, 100, 100)
Title
Measurements
OG0000.2(-0.1 to 0.5)
OG0010.0(-0.2 to 0.1)
OG0020.2(0.1 to 0.4)
OG003
Week 52 (n = 191, 228, 115, 101)
Title
Measurements
OG000-0.1(-0.3 to 0.0)
OG0010.2(-0.1 to 0.5)
OG0020.1(-0.2 to 0.4)
OG003
OG002
Placebo Followed by 300 mg Secukinumab
Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG003
Placebo Followed by 150 mg Secukinumab
Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
Units
Counts
Participants
OG00048
OG00154
OG00226
OG00323
Title
Denominators
Categories
Ascending thoracic aorta
ParticipantsOG00010
ParticipantsOG00111
ParticipantsOG0024
ParticipantsOG0036
Title
Measurements
OG00015.35(-8.23 to 38.92)
OG0015.91(-13.09 to 24.91)
OG0029.92(-58.24 to 78.08)
OG003
Descending thoracic aorta
ParticipantsOG00010
ParticipantsOG00111
ParticipantsOG0024
ParticipantsOG0037
Carotid bifurcation left
ParticipantsOG00011
ParticipantsOG00111
ParticipantsOG0024
ParticipantsOG0037
Carotid bifurcation right
ParticipantsOG00011
ParticipantsOG00111
ParticipantsOG0024
ParticipantsOG0037
Common carotid left
ParticipantsOG00011
ParticipantsOG00111
ParticipantsOG0024
ParticipantsOG0036
Common carotid right
ParticipantsOG00011
ParticipantsOG00111
ParticipantsOG0024
ParticipantsOG0037
Internal carotid left
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG0024
ParticipantsOG0035
Internal carotid right
ParticipantsOG00011
ParticipantsOG00111
ParticipantsOG0024
ParticipantsOG0037
Descending abdominal aorta
ParticipantsOG0008
ParticipantsOG0019
ParticipantsOG0024
ParticipantsOG0036
Placebo Followed by 300 mg Secukinumab
Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG003
Placebo Followed by 150 mg Secukinumab
Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
Units
Counts
Participants
OG00048
OG00154
OG00226
OG00323
Title
Denominators
Categories
Ascending thoracic aorta
ParticipantsOG00010
ParticipantsOG00111
ParticipantsOG0024
ParticipantsOG0036
Title
Measurements
OG00014.42(-14.93 to 43.76)
OG0013.19(-17.17 to 23.55)
OG002-15.11(-28.15 to -2.06)
OG003
Descending thoracic aorta
ParticipantsOG00010
ParticipantsOG00111
ParticipantsOG0024
ParticipantsOG0037
Carotid bifurcation left
ParticipantsOG00011
ParticipantsOG00111
ParticipantsOG0024
ParticipantsOG0037
Carotid bifurcation right
ParticipantsOG00011
ParticipantsOG00111
ParticipantsOG0024
ParticipantsOG0037
Common carotid left
ParticipantsOG00011
ParticipantsOG00111
ParticipantsOG0024
ParticipantsOG0036
Common carotid right
ParticipantsOG00011
ParticipantsOG00111
ParticipantsOG0024
ParticipantsOG0037
Internal carotid left
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG0024
ParticipantsOG0035
Internal carotid right
ParticipantsOG00011
ParticipantsOG00111
ParticipantsOG0024
ParticipantsOG0037
Descending abdominal aorta
ParticipantsOG0008
ParticipantsOG0019
ParticipantsOG0024
ParticipantsOG0036
OG003
Placebo Followed by 150 mg Secukinumab
Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
Units
Counts
Participants
OG00048
OG00154
OG00226
OG00323
Title
Denominators
Categories
Week 4
ParticipantsOG00048
ParticipantsOG00153
ParticipantsOG00226
ParticipantsOG00321
Title
Measurements
OG0000.0(-0.2 to 0.2)
OG001-0.2(-0.4 to -0.1)
OG002-0.0(-0.2 to 0.2)
OG003
Week 12
ParticipantsOG00048
ParticipantsOG00154
ParticipantsOG00226
ParticipantsOG00321
Week 24
ParticipantsOG00048
ParticipantsOG00152
ParticipantsOG00225
ParticipantsOG00321
Week 52
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00226
ParticipantsOG00320
OG003
Placebo Followed by 150 mg Secukinumab
Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
Units
Counts
Participants
OG00048
OG00154
OG00226
OG00323
Title
Denominators
Categories
Week 4
ParticipantsOG00048
ParticipantsOG00153
ParticipantsOG00226
ParticipantsOG00322
Title
Measurements
OG000-0.0(-0.0 to -0.0)
OG001-0.0(-0.0 to 0.0)
OG0020.0(-0.0 to 0.0)
OG003
Week 12
ParticipantsOG00048
ParticipantsOG00152
ParticipantsOG00226
ParticipantsOG00322
Week 24
ParticipantsOG00048
ParticipantsOG00151
ParticipantsOG00225
ParticipantsOG00322
Week 52
ParticipantsOG00048
ParticipantsOG00151
ParticipantsOG00226
ParticipantsOG00322
Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG003
Placebo Followed by 150 mg Secukinumab
Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
Units
Counts
Participants
OG00048
OG00154
OG00226
OG00323
Title
Denominators
Categories
CCL5 Week 4
ParticipantsOG00048
ParticipantsOG00154
ParticipantsOG00226
ParticipantsOG00322
Title
Measurements
OG000-1000(-3106 to 1094)
OG0011649(-597 to 3895)
OG00227.0(-3943 to 3997)
OG003
CCL5 Week 12
ParticipantsOG00048
ParticipantsOG00154
ParticipantsOG00226
ParticipantsOG00322
CCL5 Week 24
ParticipantsOG00048
ParticipantsOG00152
ParticipantsOG00225
ParticipantsOG00322
CCL5 Week 52
ParticipantsOG00048
ParticipantsOG00151
ParticipantsOG00225
ParticipantsOG00322
MCP-1 Week 4
ParticipantsOG00048
ParticipantsOG00154
ParticipantsOG00226
ParticipantsOG00322
MCP-1 Week 12
ParticipantsOG00048
ParticipantsOG00154
ParticipantsOG00226
ParticipantsOG00322
MCP-1 Week 24
ParticipantsOG00048
ParticipantsOG00152
ParticipantsOG00225
ParticipantsOG00322
MCP-1 Week 52
ParticipantsOG00048
ParticipantsOG00151
ParticipantsOG00225
ParticipantsOG00322
MIP-1A Week 4
ParticipantsOG00048
ParticipantsOG00154
ParticipantsOG00226
ParticipantsOG00322
MIP-1A Week 12
ParticipantsOG00048
ParticipantsOG00154
ParticipantsOG00226
ParticipantsOG00322
MIP-1A Week 24
ParticipantsOG00048
ParticipantsOG00152
ParticipantsOG00225
ParticipantsOG00322
MIP-1A Week 52
ParticipantsOG00048
ParticipantsOG00151
ParticipantsOG00225
ParticipantsOG00322
MIP-1B Week 4
ParticipantsOG00048
ParticipantsOG00154
ParticipantsOG00226
ParticipantsOG00322
MIP-1B Week 12
ParticipantsOG00048
ParticipantsOG00154
ParticipantsOG00226
ParticipantsOG00322
MIP-1B Week 24
ParticipantsOG00048
ParticipantsOG00152
ParticipantsOG00225
ParticipantsOG00322
MIP-1B Week 52
ParticipantsOG00048
ParticipantsOG00151
ParticipantsOG00225
ParticipantsOG00322
OG003
Placebo Followed by 150 mg Secukinumab
Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
Units
Counts
Participants
OG00048
OG00154
OG00226
OG00323
Title
Denominators
Categories
Week 4
ParticipantsOG00047
ParticipantsOG00153
ParticipantsOG00226
ParticipantsOG00322
Title
Measurements
OG0001.5(-1.0 to 4.0)
OG001-1.6(-4.6 to 1.3)
OG0020.9(-4.4 to 6.1)
OG003
Week 12
ParticipantsOG00047
ParticipantsOG00153
ParticipantsOG00226
ParticipantsOG00322
Week 24
ParticipantsOG00047
ParticipantsOG00151
ParticipantsOG00225
ParticipantsOG00322
Week 52
ParticipantsOG00046
ParticipantsOG00151
ParticipantsOG00226
ParticipantsOG00322
OG003
Placebo Followed by 150 mg Secukinumab
Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
Units
Counts
Participants
OG00048
OG00154
OG00226
OG00323
Title
Denominators
Categories
Week 4
ParticipantsOG00048
ParticipantsOG00153
ParticipantsOG00226
ParticipantsOG00322
Title
Measurements
OG0000.4(-2.0 to 2.7)
OG0010.4(-2.3 to 3.0)
OG002-4.7(-17.4 to 8.1)
OG003
Week 12
ParticipantsOG00048
ParticipantsOG00152
ParticipantsOG00226
ParticipantsOG00322
Week 24
ParticipantsOG00048
ParticipantsOG00151
ParticipantsOG00225
ParticipantsOG00322
Week 52
ParticipantsOG00048
ParticipantsOG00151
ParticipantsOG00226
ParticipantsOG00322
OG003
Placebo Followed by 150 mg Secukinumab
Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
Units
Counts
Participants
OG00048
OG00154
OG00226
OG00323
Title
Denominators
Categories
Week 4
ParticipantsOG00042
ParticipantsOG00151
ParticipantsOG00224
ParticipantsOG00321
Title
Measurements
OG000-18(-64.7 to 28.2)
OG001-0.2(-25.7 to 25.3)
OG002-28(-88.4 to 33.0)
OG003
Week 12
ParticipantsOG00044
ParticipantsOG00150
ParticipantsOG00223
ParticipantsOG00322
Week 24
ParticipantsOG00044
ParticipantsOG00150
ParticipantsOG00224
ParticipantsOG00322
Week 52
ParticipantsOG00043
ParticipantsOG00150
ParticipantsOG00225
ParticipantsOG00322
OG003
Placebo Followed by 150 mg Secukinumab
Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
Units
Counts
Participants
OG00048
OG00154
OG00226
OG00323
Title
Denominators
Categories
Week 4
ParticipantsOG00042
ParticipantsOG00151
ParticipantsOG00224
ParticipantsOG00321
Title
Measurements
OG0000.3(-0.6 to 1.2)
OG0010.1(-0.9 to 1.0)
OG002-1.1(-5.2 to 3.1)
OG003
Week 12
ParticipantsOG00044
ParticipantsOG00150
ParticipantsOG00223
ParticipantsOG00322
Week 24
ParticipantsOG00044
ParticipantsOG00150
ParticipantsOG00224
ParticipantsOG00322
Week 52
ParticipantsOG00043
ParticipantsOG00150
ParticipantsOG00225
ParticipantsOG00322
OG003
Placebo Followed by 150 mg Secukinumab
Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
Units
Counts
Participants
OG00048
OG00154
OG00226
OG00323
Title
Denominators
Categories
Week 4
ParticipantsOG00048
ParticipantsOG00152
ParticipantsOG00226
ParticipantsOG00322
Title
Measurements
OG0000.2(-0.5 to 0.8)
OG001-0.4(-1.0 to 0.3)
OG002-0.7(-2.3 to 1.0)
OG003
Week 12
ParticipantsOG00048
ParticipantsOG00154
ParticipantsOG00226
ParticipantsOG00322
Week 24
ParticipantsOG00048
ParticipantsOG00152
ParticipantsOG00225
ParticipantsOG00322
Week 52
ParticipantsOG00048
ParticipantsOG00152
ParticipantsOG00226
ParticipantsOG00322
OG003
Placebo Followed by 150 mg Secukinumab
Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
Units
Counts
Participants
OG00048
OG00154
OG00226
OG00323
Title
Denominators
Categories
Week 4
ParticipantsOG00048
ParticipantsOG00153
ParticipantsOG00226
ParticipantsOG00321
Title
Measurements
OG0000.1(-1.8 to 2.1)
OG0013.7(-3.0 to 10.4)
OG0024.7(-4.2 to 13.5)
OG003
Week 12
ParticipantsOG00048
ParticipantsOG00154
ParticipantsOG00226
ParticipantsOG00321
Week 24
ParticipantsOG00048
ParticipantsOG00152
ParticipantsOG00225
ParticipantsOG00321
Week 52
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00226
ParticipantsOG00320
Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).
OG003
Placebo Followed by 150 mg Secukinumab
Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
Units
Counts
Participants
OG00048
OG00154
OG00226
OG00323
Title
Denominators
Categories
Triglycerides Week 4
ParticipantsOG00048
ParticipantsOG00153
ParticipantsOG00226
ParticipantsOG00321
Title
Measurements
OG000-1.8(-15.5 to 12.0)
OG0016.5(-5.9 to 18.9)
OG00212.7(-12.2 to 37.7)
OG003
Triglycerides Week 12
ParticipantsOG00048
ParticipantsOG00154
ParticipantsOG00226
ParticipantsOG00321
Triglycerides Week 24
ParticipantsOG00048
ParticipantsOG00152
ParticipantsOG00225
ParticipantsOG00321
Triglycerides Week 52
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00226
ParticipantsOG00320
Total cholesterol Week 4
ParticipantsOG00048
ParticipantsOG00153
ParticipantsOG00226
ParticipantsOG00321
Total cholesterol Week 12
ParticipantsOG00048
ParticipantsOG00154
ParticipantsOG00226
ParticipantsOG00321
Total cholesterol Week 24
ParticipantsOG00048
ParticipantsOG00152
ParticipantsOG00225
ParticipantsOG00321
Total cholesterol Week 52
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00226
ParticipantsOG00320
LDL Week 4
ParticipantsOG00048
ParticipantsOG00153
ParticipantsOG00226
ParticipantsOG00321
LDL Week 12
ParticipantsOG00048
ParticipantsOG00154
ParticipantsOG00226
ParticipantsOG00321
LDL Week 24
ParticipantsOG00048
ParticipantsOG00152
ParticipantsOG00225
ParticipantsOG00321
LDL Week 52
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00226
ParticipantsOG00320
HDL Week 4
ParticipantsOG00048
ParticipantsOG00153
ParticipantsOG00226
ParticipantsOG00321
HDL Week 12
ParticipantsOG00048
ParticipantsOG00154
ParticipantsOG00226
ParticipantsOG00321
HDL Week 24
ParticipantsOG00048
ParticipantsOG00152
ParticipantsOG00225
ParticipantsOG00321
HDL Week 52
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00226
ParticipantsOG00320
ApoA-1 Week 4
ParticipantsOG00048
ParticipantsOG00153
ParticipantsOG00226
ParticipantsOG00321
ApoA-1 Week 12
ParticipantsOG00048
ParticipantsOG00154
ParticipantsOG00226
ParticipantsOG00321
ApoA-1 Week 24
ParticipantsOG00048
ParticipantsOG00152
ParticipantsOG00225
ParticipantsOG00321
ApoA-1 Week 52
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00226
ParticipantsOG00320
ApoB Week 4
ParticipantsOG00048
ParticipantsOG00153
ParticipantsOG00226
ParticipantsOG00321
ApoB Week 12
ParticipantsOG00048
ParticipantsOG00154
ParticipantsOG00226
ParticipantsOG00321
ApoB Week 24
ParticipantsOG00048
ParticipantsOG00152
ParticipantsOG00225
ParticipantsOG00321
ApoB Week 52
ParticipantsOG00048
ParticipantsOG00150
ParticipantsOG00226
ParticipantsOG00320
OG003
Placebo Followed by 150 mg Secukinumab
Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
Units
Counts
Participants
OG00048
OG00154
OG00226
OG00323
Title
Denominators
Categories
Week 4
ParticipantsOG00048
ParticipantsOG00153
ParticipantsOG00226
ParticipantsOG00322
Title
Measurements
OG000-0.5(-1.0 to -0.1)
OG0010.2(-0.4 to 0.8)
OG002-0.1(-0.8 to 0.5)
OG003
Week 12
ParticipantsOG00048
ParticipantsOG00152
ParticipantsOG00226
ParticipantsOG00322
Week 24
ParticipantsOG00048
ParticipantsOG00151
ParticipantsOG00225
ParticipantsOG00322
Week 52
ParticipantsOG00048
ParticipantsOG00151
ParticipantsOG00226
ParticipantsOG00322
OG003
Placebo Followed by 150 mg Secukinumab
Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).