Psoriasis
Conditions
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.
Interventions
DRUGSecukinumab
300 mg secukinumab
OTHERPlacebo
Placebo followed by 300 mg secukinumab
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow Mediated Dilation (FMD) at Week 12 Followed by Secukinumab 300 mg vs Pooled Placebo Treatment | Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52 | Baseline, 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. |
| Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52 | Baseline, 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. |
| Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Baseline, 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. |
| Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Baseline, 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. |
| Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52 | Baseline, 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. |
| Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52 | Baseline, 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. |
| 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 | Baseline, 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. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52 | Baseline, 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. |
| Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52 | Baseline, 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. |
| Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52 | Baseline, 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. |
| Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52 | Baseline, 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. |
| Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52 | Baseline, 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. |
| Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52 | Baseline, 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. |
| 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 | Baseline, 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. |
| Change From Baseline in Adiponectin at Week 4, 12, 24 and 52 | Baseline, 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. |
| Change From Baseline in Leptin at Week 4, 12, 24 and 52 | Baseline, 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. |
| Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52 | Baseline, 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. |
Countries
Germany
Participant flow
Recruitment details
The study was conducted at 23 centers in Germany.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 48 |
| 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). | 54 |
| 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). | 26 |
| 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). | 23 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 2 | 2 |
| Overall Study | Patient/guardian decision | 1 | 2 | 0 | 1 |
| Overall Study | Progressive disease | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Secukinumab 150 mg | Placebo Followed by 300 mg Secukinumab | Secukinumab 300 mg | Placebo Followed by 150 mg Secukinumab | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 0 Participants | 2 Participants | 1 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 46 Participants | 26 Participants | 46 Participants | 22 Participants | 140 Participants |
| Age, Continuous | 46.0 years STANDARD_DEVIATION 14.4 | 43.7 years STANDARD_DEVIATION 11.4 | 44.2 years STANDARD_DEVIATION 12.9 | 46.8 years STANDARD_DEVIATION 13.1 | 45.2 years STANDARD_DEVIATION 13.2 |
| Region of Enrollment Germany | 54 participants | 26 participants | 48 participants | 23 participants | 151 participants |
| Sex: Female, Male Female | 23 Participants | 8 Participants | 11 Participants | 7 Participants | 49 Participants |
| Sex: Female, Male Male | 31 Participants | 18 Participants | 37 Participants | 16 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 29 / 48 | 36 / 54 | 35 / 49 | 36 / 48 | 43 / 54 | 21 / 26 | 19 / 23 |
| serious Total, serious adverse events | 1 / 48 | 0 / 54 | 2 / 49 | 6 / 48 | 6 / 54 | 0 / 26 | 1 / 23 |
Outcome results
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.
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Secukinumab 300 mg | Flow Mediated Dilation (FMD) at Week 12 Followed by Secukinumab 300 mg vs Pooled Placebo Treatment | 5.23 Percentage maximal increase in diameter | Standard Deviation 5.3 |
| Placebo (Pooled) | Flow Mediated Dilation (FMD) at Week 12 Followed by Secukinumab 300 mg vs Pooled Placebo Treatment | 3.65 Percentage maximal increase in diameter | Standard Deviation 4.07 |
p-value: 0.22395% CI: [-0.72, 3.06]ANCOVA
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.
Time frame: Baseline, Week 4, 12, 24 and 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Secukinumab 300 mg | Change From Baseline in Adiponectin at Week 4, 12, 24 and 52 | Week 52 | -1.1 ug/mL |
| Secukinumab 300 mg | Change From Baseline in Adiponectin at Week 4, 12, 24 and 52 | Week 12 | -0.5 ug/mL |
| Secukinumab 300 mg | Change From Baseline in Adiponectin at Week 4, 12, 24 and 52 | Week 24 | 0.3 ug/mL |
| Secukinumab 300 mg | Change From Baseline in Adiponectin at Week 4, 12, 24 and 52 | Week 4 | -0.5 ug/mL |
| Placebo (Pooled) | Change From Baseline in Adiponectin at Week 4, 12, 24 and 52 | Week 24 | 0.1 ug/mL |
| Placebo (Pooled) | Change From Baseline in Adiponectin at Week 4, 12, 24 and 52 | Week 4 | 0.2 ug/mL |
| Placebo (Pooled) | Change From Baseline in Adiponectin at Week 4, 12, 24 and 52 | Week 12 | -0.2 ug/mL |
| Placebo (Pooled) | Change From Baseline in Adiponectin at Week 4, 12, 24 and 52 | Week 52 | -0.9 ug/mL |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Adiponectin at Week 4, 12, 24 and 52 | Week 4 | -0.1 ug/mL |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Adiponectin at Week 4, 12, 24 and 52 | Week 12 | 0.5 ug/mL |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Adiponectin at Week 4, 12, 24 and 52 | Week 24 | 0.7 ug/mL |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Adiponectin at Week 4, 12, 24 and 52 | Week 52 | -0.4 ug/mL |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Adiponectin at Week 4, 12, 24 and 52 | Week 4 | -0.6 ug/mL |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Adiponectin at Week 4, 12, 24 and 52 | Week 52 | -1.1 ug/mL |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Adiponectin at Week 4, 12, 24 and 52 | Week 12 | 0.3 ug/mL |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Adiponectin at Week 4, 12, 24 and 52 | Week 24 | -0.6 ug/mL |
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.
Time frame: Baseline, Week 4, 12, 24 and 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Secukinumab 300 mg | Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52 | Week 4 | 0.0 Percentage change in Alx-75 |
| Secukinumab 300 mg | Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52 | Week 12 | -0.5 Percentage change in Alx-75 |
| Secukinumab 300 mg | Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52 | Week 24 | 3.0 Percentage change in Alx-75 |
| Secukinumab 300 mg | Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52 | Week 52 | 1.3 Percentage change in Alx-75 |
| Placebo (Pooled) | Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52 | Week 12 | 1.0 Percentage change in Alx-75 |
| Placebo (Pooled) | Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52 | Week 24 | 1.8 Percentage change in Alx-75 |
| Placebo (Pooled) | Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52 | Week 52 | -0.1 Percentage change in Alx-75 |
| Placebo (Pooled) | Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52 | Week 4 | 0.3 Percentage change in Alx-75 |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52 | Week 24 | 1.3 Percentage change in Alx-75 |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52 | Week 12 | -1.1 Percentage change in Alx-75 |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52 | Week 52 | -1.4 Percentage change in Alx-75 |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52 | Week 4 | 1.1 Percentage change in Alx-75 |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52 | Week 52 | -0.9 Percentage change in Alx-75 |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52 | Week 12 | -0.1 Percentage change in Alx-75 |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52 | Week 4 | -0.1 Percentage change in Alx-75 |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52 | Week 24 | 0.7 Percentage change in Alx-75 |
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.
Time frame: Baseline, Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Secukinumab 300 mg | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Internal carotid left | 3.79 millimeter square (mm^2) |
| Secukinumab 300 mg | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Common carotid right | -0.12 millimeter square (mm^2) |
| Secukinumab 300 mg | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Descending abdominal aorta | 8.71 millimeter square (mm^2) |
| Secukinumab 300 mg | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Carotid bifurcation right | -0.77 millimeter square (mm^2) |
| Secukinumab 300 mg | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Carotid bifurcation left | 0.52 millimeter square (mm^2) |
| Secukinumab 300 mg | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Descending thoracic aorta | 2.69 millimeter square (mm^2) |
| Secukinumab 300 mg | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Internal carotid right | -0.69 millimeter square (mm^2) |
| Secukinumab 300 mg | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Common carotid left | 0.17 millimeter square (mm^2) |
| Secukinumab 300 mg | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Ascending thoracic aorta | 15.35 millimeter square (mm^2) |
| Placebo (Pooled) | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Common carotid left | 1.12 millimeter square (mm^2) |
| Placebo (Pooled) | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Internal carotid left | 2.09 millimeter square (mm^2) |
| Placebo (Pooled) | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Common carotid right | 0.30 millimeter square (mm^2) |
| Placebo (Pooled) | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Descending thoracic aorta | -2.94 millimeter square (mm^2) |
| Placebo (Pooled) | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Ascending thoracic aorta | 5.91 millimeter square (mm^2) |
| Placebo (Pooled) | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Carotid bifurcation left | -1.08 millimeter square (mm^2) |
| Placebo (Pooled) | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Descending abdominal aorta | -3.79 millimeter square (mm^2) |
| Placebo (Pooled) | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Internal carotid right | 0.17 millimeter square (mm^2) |
| Placebo (Pooled) | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Carotid bifurcation right | 1.75 millimeter square (mm^2) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Common carotid left | 0.69 millimeter square (mm^2) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Ascending thoracic aorta | 9.92 millimeter square (mm^2) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Descending thoracic aorta | -4.04 millimeter square (mm^2) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Carotid bifurcation left | 3.63 millimeter square (mm^2) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Carotid bifurcation right | -1.26 millimeter square (mm^2) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Common carotid right | -0.38 millimeter square (mm^2) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Internal carotid left | 2.59 millimeter square (mm^2) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Internal carotid right | 0.68 millimeter square (mm^2) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Descending abdominal aorta | 4.56 millimeter square (mm^2) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Internal carotid left | -1.74 millimeter square (mm^2) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Carotid bifurcation right | -1.07 millimeter square (mm^2) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Carotid bifurcation left | 1.12 millimeter square (mm^2) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Descending abdominal aorta | -0.58 millimeter square (mm^2) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Internal carotid right | -1.37 millimeter square (mm^2) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Descending thoracic aorta | 3.16 millimeter square (mm^2) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Common carotid right | -0.14 millimeter square (mm^2) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Common carotid left | 0.12 millimeter square (mm^2) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 | Ascending thoracic aorta | 6.45 millimeter square (mm^2) |
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.
Time frame: Baseline, Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Secukinumab 300 mg | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Internal carotid left | 5.43 mm^2 |
| Secukinumab 300 mg | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Common carotid right | 0.02 mm^2 |
| Secukinumab 300 mg | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Descending abdominal aorta | 10.56 mm^2 |
| Secukinumab 300 mg | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Carotid bifurcation right | -1.64 mm^2 |
| Secukinumab 300 mg | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Carotid bifurcation left | 2.45 mm^2 |
| Secukinumab 300 mg | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Descending thoracic aorta | 3.97 mm^2 |
| Secukinumab 300 mg | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Internal carotid right | -1.07 mm^2 |
| Secukinumab 300 mg | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Common carotid left | 1.42 mm^2 |
| Secukinumab 300 mg | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Ascending thoracic aorta | 14.42 mm^2 |
| Placebo (Pooled) | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Common carotid left | 1.21 mm^2 |
| Placebo (Pooled) | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Internal carotid left | 3.59 mm^2 |
| Placebo (Pooled) | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Common carotid right | 0.23 mm^2 |
| Placebo (Pooled) | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Descending thoracic aorta | 2.55 mm^2 |
| Placebo (Pooled) | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Ascending thoracic aorta | 3.19 mm^2 |
| Placebo (Pooled) | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Carotid bifurcation left | 0.64 mm^2 |
| Placebo (Pooled) | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Descending abdominal aorta | -4.36 mm^2 |
| Placebo (Pooled) | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Internal carotid right | 0.71 mm^2 |
| Placebo (Pooled) | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Carotid bifurcation right | -0.05 mm^2 |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Common carotid left | 0.65 mm^2 |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Ascending thoracic aorta | -15.11 mm^2 |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Descending thoracic aorta | -10.14 mm^2 |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Carotid bifurcation left | 0.58 mm^2 |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Carotid bifurcation right | -3.23 mm^2 |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Common carotid right | -0.80 mm^2 |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Internal carotid left | 1.06 mm^2 |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Internal carotid right | -0.20 mm^2 |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Descending abdominal aorta | 12.46 mm^2 |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Internal carotid left | 0.33 mm^2 |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Carotid bifurcation right | 1.25 mm^2 |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Carotid bifurcation left | 2.60 mm^2 |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Descending abdominal aorta | 11.82 mm^2 |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Internal carotid right | 0.13 mm^2 |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Descending thoracic aorta | 1.14 mm^2 |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Common carotid right | -1.38 mm^2 |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Common carotid left | 1.00 mm^2 |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 | Ascending thoracic aorta | 9.54 mm^2 |
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.
Time frame: Baseline, Week 4, 12, 24 and 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Secukinumab 300 mg | 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 | MCP-1 Week 4 | -7.0 picograms per milliliter (pg/mL) |
| Secukinumab 300 mg | 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 | CCL5 Week 12 | 2116 picograms per milliliter (pg/mL) |
| Secukinumab 300 mg | 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 | CCL5 Week 24 | 7772 picograms per milliliter (pg/mL) |
| Secukinumab 300 mg | 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 | CCL5 Week 52 | 1515 picograms per milliliter (pg/mL) |
| Secukinumab 300 mg | 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 | CCL5 Week 4 | -1000 picograms per milliliter (pg/mL) |
| Secukinumab 300 mg | 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 | MCP-1 Week 12 | 18.4 picograms per milliliter (pg/mL) |
| Secukinumab 300 mg | 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 | MCP-1 Week 24 | 39.8 picograms per milliliter (pg/mL) |
| Secukinumab 300 mg | 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 | MCP-1 Week 52 | 22.1 picograms per milliliter (pg/mL) |
| Secukinumab 300 mg | 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 | MIP-1A Week 4 | -0.1 picograms per milliliter (pg/mL) |
| Secukinumab 300 mg | 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 | MIP-1A Week 12 | 0.2 picograms per milliliter (pg/mL) |
| Secukinumab 300 mg | 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 | MIP-1A Week 24 | -0.2 picograms per milliliter (pg/mL) |
| Secukinumab 300 mg | 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 | MIP-1A Week 52 | 4.3 picograms per milliliter (pg/mL) |
| Secukinumab 300 mg | 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 | MIP-1B Week 4 | -24 picograms per milliliter (pg/mL) |
| Secukinumab 300 mg | 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 | MIP-1B Week 12 | -49 picograms per milliliter (pg/mL) |
| Secukinumab 300 mg | 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 | MIP-1B Week 24 | -52 picograms per milliliter (pg/mL) |
| Secukinumab 300 mg | 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 | MIP-1B Week 52 | -41 picograms per milliliter (pg/mL) |
| Placebo (Pooled) | 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 | MCP-1 Week 12 | 28.6 picograms per milliliter (pg/mL) |
| Placebo (Pooled) | 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 | MIP-1A Week 4 | 0.1 picograms per milliliter (pg/mL) |
| Placebo (Pooled) | 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 | MIP-1B Week 52 | -59 picograms per milliliter (pg/mL) |
| Placebo (Pooled) | 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 | MIP-1A Week 52 | 0.8 picograms per milliliter (pg/mL) |
| Placebo (Pooled) | 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 | MIP-1B Week 24 | -97 picograms per milliliter (pg/mL) |
| Placebo (Pooled) | 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 | MIP-1A Week 12 | 2.2 picograms per milliliter (pg/mL) |
| Placebo (Pooled) | 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 | CCL5 Week 24 | 10000 picograms per milliliter (pg/mL) |
| Placebo (Pooled) | 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 | MIP-1A Week 24 | -0.5 picograms per milliliter (pg/mL) |
| Placebo (Pooled) | 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 | MCP-1 Week 4 | 1.4 picograms per milliliter (pg/mL) |
| Placebo (Pooled) | 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 | MCP-1 Week 24 | 241 picograms per milliliter (pg/mL) |
| Placebo (Pooled) | 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 | CCL5 Week 52 | 3577 picograms per milliliter (pg/mL) |
| Placebo (Pooled) | 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 | CCL5 Week 12 | 5185 picograms per milliliter (pg/mL) |
| Placebo (Pooled) | 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 | MIP-1B Week 4 | -2.6 picograms per milliliter (pg/mL) |
| Placebo (Pooled) | 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 | MCP-1 Week 52 | 25.4 picograms per milliliter (pg/mL) |
| Placebo (Pooled) | 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 | MIP-1B Week 12 | -34 picograms per milliliter (pg/mL) |
| Placebo (Pooled) | 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 | CCL5 Week 4 | 1649 picograms per milliliter (pg/mL) |
| Placebo Followed by 300 mg Secukinumab | 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 | MCP-1 Week 12 | 11.3 picograms per milliliter (pg/mL) |
| Placebo Followed by 300 mg Secukinumab | 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 | MCP-1 Week 4 | -25 picograms per milliliter (pg/mL) |
| Placebo Followed by 300 mg Secukinumab | 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 | MIP-1B Week 12 | -65 picograms per milliliter (pg/mL) |
| Placebo Followed by 300 mg Secukinumab | 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 | MCP-1 Week 24 | -20 picograms per milliliter (pg/mL) |
| Placebo Followed by 300 mg Secukinumab | 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 | MCP-1 Week 52 | -11 picograms per milliliter (pg/mL) |
| Placebo Followed by 300 mg Secukinumab | 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 | MIP-1B Week 52 | -73 picograms per milliliter (pg/mL) |
| Placebo Followed by 300 mg Secukinumab | 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 | MIP-1A Week 4 | 0.5 picograms per milliliter (pg/mL) |
| Placebo Followed by 300 mg Secukinumab | 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 | MIP-1A Week 12 | -3.6 picograms per milliliter (pg/mL) |
| Placebo Followed by 300 mg Secukinumab | 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 | MIP-1B Week 24 | -161 picograms per milliliter (pg/mL) |
| Placebo Followed by 300 mg Secukinumab | 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 | MIP-1A Week 24 | -4.7 picograms per milliliter (pg/mL) |
| Placebo Followed by 300 mg Secukinumab | 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 | MIP-1A Week 52 | 1.7 picograms per milliliter (pg/mL) |
| Placebo Followed by 300 mg Secukinumab | 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 | CCL5 Week 4 | 27.0 picograms per milliliter (pg/mL) |
| Placebo Followed by 300 mg Secukinumab | 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 | CCL5 Week 12 | 4393 picograms per milliliter (pg/mL) |
| Placebo Followed by 300 mg Secukinumab | 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 | MIP-1B Week 4 | -16 picograms per milliliter (pg/mL) |
| Placebo Followed by 300 mg Secukinumab | 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 | CCL5 Week 24 | 11000 picograms per milliliter (pg/mL) |
| Placebo Followed by 300 mg Secukinumab | 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 | CCL5 Week 52 | -597 picograms per milliliter (pg/mL) |
| Placebo Followed by 150 mg Secukinumab | 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 | MIP-1B Week 52 | -31 picograms per milliliter (pg/mL) |
| Placebo Followed by 150 mg Secukinumab | 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 | MCP-1 Week 52 | 109 picograms per milliliter (pg/mL) |
| Placebo Followed by 150 mg Secukinumab | 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 | CCL5 Week 24 | 9168 picograms per milliliter (pg/mL) |
| Placebo Followed by 150 mg Secukinumab | 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 | CCL5 Week 4 | -2000 picograms per milliliter (pg/mL) |
| Placebo Followed by 150 mg Secukinumab | 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 | MIP-1B Week 12 | -68 picograms per milliliter (pg/mL) |
| Placebo Followed by 150 mg Secukinumab | 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 | MCP-1 Week 24 | 33.4 picograms per milliliter (pg/mL) |
| Placebo Followed by 150 mg Secukinumab | 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 | MIP-1B Week 4 | -20 picograms per milliliter (pg/mL) |
| Placebo Followed by 150 mg Secukinumab | 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 | CCL5 Week 12 | 3002 picograms per milliliter (pg/mL) |
| Placebo Followed by 150 mg Secukinumab | 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 | MCP-1 Week 4 | 17.5 picograms per milliliter (pg/mL) |
| Placebo Followed by 150 mg Secukinumab | 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 | MIP-1A Week 12 | 0.9 picograms per milliliter (pg/mL) |
| Placebo Followed by 150 mg Secukinumab | 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 | MCP-1 Week 12 | 21.5 picograms per milliliter (pg/mL) |
| Placebo Followed by 150 mg Secukinumab | 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 | MIP-1A Week 24 | 1.7 picograms per milliliter (pg/mL) |
| Placebo Followed by 150 mg Secukinumab | 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 | MIP-1B Week 24 | 79.4 picograms per milliliter (pg/mL) |
| Placebo Followed by 150 mg Secukinumab | 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 | MIP-1A Week 4 | -0.6 picograms per milliliter (pg/mL) |
| Placebo Followed by 150 mg Secukinumab | 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 | CCL5 Week 52 | 2308 picograms per milliliter (pg/mL) |
| Placebo Followed by 150 mg Secukinumab | 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 | MIP-1A Week 52 | 20.1 picograms per milliliter (pg/mL) |
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.
Time frame: Baseline, Week 4, 12, 24 and 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Secukinumab 300 mg | Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52 | Week 4 | 0.4 micro units per millilitre (uU/mL) |
| Secukinumab 300 mg | Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52 | Week 12 | -1.4 micro units per millilitre (uU/mL) |
| Secukinumab 300 mg | Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52 | Week 24 | -1.0 micro units per millilitre (uU/mL) |
| Secukinumab 300 mg | Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52 | Week 52 | -0.4 micro units per millilitre (uU/mL) |
| Placebo (Pooled) | Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52 | Week 12 | 1.1 micro units per millilitre (uU/mL) |
| Placebo (Pooled) | Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52 | Week 24 | 0.5 micro units per millilitre (uU/mL) |
| Placebo (Pooled) | Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52 | Week 52 | 1.5 micro units per millilitre (uU/mL) |
| Placebo (Pooled) | Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52 | Week 4 | 0.4 micro units per millilitre (uU/mL) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52 | Week 24 | -5.3 micro units per millilitre (uU/mL) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52 | Week 12 | -2.2 micro units per millilitre (uU/mL) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52 | Week 52 | -1.2 micro units per millilitre (uU/mL) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52 | Week 4 | -4.7 micro units per millilitre (uU/mL) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52 | Week 52 | 3.0 micro units per millilitre (uU/mL) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52 | Week 12 | -0.1 micro units per millilitre (uU/mL) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52 | Week 4 | -0.5 micro units per millilitre (uU/mL) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52 | Week 24 | -2.0 micro units per millilitre (uU/mL) |
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.
Time frame: Baseline, Week 4, 12, 24 and 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Secukinumab 300 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52 | Week 4 | 1.5 mg/dL |
| Secukinumab 300 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52 | Week 12 | 3.5 mg/dL |
| Secukinumab 300 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52 | Week 24 | 2.5 mg/dL |
| Secukinumab 300 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52 | Week 52 | -0.8 mg/dL |
| Placebo (Pooled) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52 | Week 12 | 1.1 mg/dL |
| Placebo (Pooled) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52 | Week 24 | 1.4 mg/dL |
| Placebo (Pooled) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52 | Week 52 | 0.7 mg/dL |
| Placebo (Pooled) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52 | Week 4 | -1.6 mg/dL |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52 | Week 24 | 12.1 mg/dL |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52 | Week 12 | 5.3 mg/dL |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52 | Week 52 | 8.7 mg/dL |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52 | Week 4 | 0.9 mg/dL |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52 | Week 52 | 0.9 mg/dL |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52 | Week 12 | -1.5 mg/dL |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52 | Week 4 | 0.2 mg/dL |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52 | Week 24 | -1.4 mg/dL |
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.
Time frame: Baseline, Week 4, 12, 24 and 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Secukinumab 300 mg | Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52 | Week 4 | -0.7 Percentage change in FMD |
| Secukinumab 300 mg | Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52 | Week 12 | 0.5 Percentage change in FMD |
| Secukinumab 300 mg | Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52 | Week 24 | -0.8 Percentage change in FMD |
| Secukinumab 300 mg | Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52 | Week 52 | 2.1 Percentage change in FMD |
| Placebo (Pooled) | Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52 | Week 12 | 0.1 Percentage change in FMD |
| Placebo (Pooled) | Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52 | Week 52 | 2.1 Percentage change in FMD |
| Placebo (Pooled) | Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52 | Week 4 | -0.9 Percentage change in FMD |
| Placebo (Pooled) | Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52 | Week 24 | 1.0 Percentage change in FMD |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52 | Week 24 | -0.0 Percentage change in FMD |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52 | Week 52 | 2.2 Percentage change in FMD |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52 | Week 4 | 0.7 Percentage change in FMD |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52 | Week 12 | -0.1 Percentage change in FMD |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52 | Week 52 | 1.2 Percentage change in FMD |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52 | Week 4 | 1.4 Percentage change in FMD |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52 | Week 12 | 0.1 Percentage change in FMD |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52 | Week 24 | 0.9 Percentage change in FMD |
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.
Time frame: Baseline, Week 4, 12, 24 and 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Secukinumab 300 mg | Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52 | Week 4 | 0.2 millimole per mole of Haemoglobin |
| Secukinumab 300 mg | Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52 | Week 12 | 0.4 millimole per mole of Haemoglobin |
| Secukinumab 300 mg | Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52 | Week 24 | -0.4 millimole per mole of Haemoglobin |
| Secukinumab 300 mg | Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52 | Week 52 | -1.1 millimole per mole of Haemoglobin |
| Placebo (Pooled) | Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52 | Week 12 | -0.4 millimole per mole of Haemoglobin |
| Placebo (Pooled) | Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52 | Week 24 | -1.2 millimole per mole of Haemoglobin |
| Placebo (Pooled) | Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52 | Week 52 | -2.8 millimole per mole of Haemoglobin |
| Placebo (Pooled) | Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52 | Week 4 | -0.4 millimole per mole of Haemoglobin |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52 | Week 24 | -0.1 millimole per mole of Haemoglobin |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52 | Week 12 | -1.2 millimole per mole of Haemoglobin |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52 | Week 52 | -1.9 millimole per mole of Haemoglobin |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52 | Week 4 | -0.7 millimole per mole of Haemoglobin |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52 | Week 52 | -2.1 millimole per mole of Haemoglobin |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52 | Week 12 | 0.1 millimole per mole of Haemoglobin |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52 | Week 4 | -0.4 millimole per mole of Haemoglobin |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52 | Week 24 | -1.2 millimole per mole of Haemoglobin |
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.
Time frame: Baseline, Week 4, 12, 24 and 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Secukinumab 300 mg | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52 | Week 4 | 0.0 Milligrams per deciliter (mg/dL) |
| Secukinumab 300 mg | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52 | Week 12 | -0.0 Milligrams per deciliter (mg/dL) |
| Secukinumab 300 mg | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52 | Week 24 | -0.0 Milligrams per deciliter (mg/dL) |
| Secukinumab 300 mg | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52 | Week 52 | -0.1 Milligrams per deciliter (mg/dL) |
| Placebo (Pooled) | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52 | Week 12 | -0.2 Milligrams per deciliter (mg/dL) |
| Placebo (Pooled) | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52 | Week 24 | -0.0 Milligrams per deciliter (mg/dL) |
| Placebo (Pooled) | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52 | Week 52 | -0.2 Milligrams per deciliter (mg/dL) |
| Placebo (Pooled) | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52 | Week 4 | -0.2 Milligrams per deciliter (mg/dL) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52 | Week 24 | 0.1 Milligrams per deciliter (mg/dL) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52 | Week 12 | -0.3 Milligrams per deciliter (mg/dL) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52 | Week 52 | -0.3 Milligrams per deciliter (mg/dL) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52 | Week 4 | -0.0 Milligrams per deciliter (mg/dL) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52 | Week 52 | -0.5 Milligrams per deciliter (mg/dL) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52 | Week 12 | 0.1 Milligrams per deciliter (mg/dL) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52 | Week 4 | 0.1 Milligrams per deciliter (mg/dL) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52 | Week 24 | -0.4 Milligrams per deciliter (mg/dL) |
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.
Time frame: Baseline, Week 4, 12, 24 and 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Secukinumab 300 mg | Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52 | Week 4 | -18 Percentage |
| Secukinumab 300 mg | Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52 | Week 12 | -16 Percentage |
| Secukinumab 300 mg | Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52 | Week 24 | -25 Percentage |
| Secukinumab 300 mg | Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52 | Week 52 | 11.5 Percentage |
| Placebo (Pooled) | Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52 | Week 12 | 3.9 Percentage |
| Placebo (Pooled) | Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52 | Week 24 | -8.2 Percentage |
| Placebo (Pooled) | Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52 | Week 52 | -1.6 Percentage |
| Placebo (Pooled) | Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52 | Week 4 | -0.2 Percentage |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52 | Week 24 | -35 Percentage |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52 | Week 12 | -29 Percentage |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52 | Week 52 | 9.3 Percentage |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52 | Week 4 | -28 Percentage |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52 | Week 52 | 11.6 Percentage |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52 | Week 12 | 16.6 Percentage |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52 | Week 4 | -8.9 Percentage |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52 | Week 24 | -26 Percentage |
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.
Time frame: Baseline, Week 4, 12, 24 and 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Secukinumab 300 mg | Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52 | Week 4 | 0.3 Insulin Resistance Index |
| Secukinumab 300 mg | Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52 | Week 12 | -0.1 Insulin Resistance Index |
| Secukinumab 300 mg | Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52 | Week 24 | -0.3 Insulin Resistance Index |
| Secukinumab 300 mg | Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52 | Week 52 | -0.2 Insulin Resistance Index |
| Placebo (Pooled) | Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52 | Week 12 | 0.6 Insulin Resistance Index |
| Placebo (Pooled) | Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52 | Week 24 | 0.6 Insulin Resistance Index |
| Placebo (Pooled) | Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52 | Week 52 | 0.6 Insulin Resistance Index |
| Placebo (Pooled) | Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52 | Week 4 | 0.1 Insulin Resistance Index |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52 | Week 24 | -1.1 Insulin Resistance Index |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52 | Week 12 | -0.1 Insulin Resistance Index |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52 | Week 52 | -0.2 Insulin Resistance Index |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52 | Week 4 | -1.1 Insulin Resistance Index |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52 | Week 52 | 0.7 Insulin Resistance Index |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52 | Week 12 | -0.4 Insulin Resistance Index |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52 | Week 4 | -0.3 Insulin Resistance Index |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52 | Week 24 | -0.7 Insulin Resistance Index |
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.
Time frame: Baseline, Week 4, 12, 24 and 52
Population: 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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Secukinumab 300 mg | Change From Baseline in Leptin at Week 4, 12, 24 and 52 | Week 4 | -0.6 ng/mL (nanogram per milliliter) |
| Secukinumab 300 mg | Change From Baseline in Leptin at Week 4, 12, 24 and 52 | Week 12 | 0.2 ng/mL (nanogram per milliliter) |
| Secukinumab 300 mg | Change From Baseline in Leptin at Week 4, 12, 24 and 52 | Week 24 | 0.2 ng/mL (nanogram per milliliter) |
| Secukinumab 300 mg | Change From Baseline in Leptin at Week 4, 12, 24 and 52 | Week 52 | 0.2 ng/mL (nanogram per milliliter) |
| Placebo (Pooled) | Change From Baseline in Leptin at Week 4, 12, 24 and 52 | Week 12 | 0.1 ng/mL (nanogram per milliliter) |
| Placebo (Pooled) | Change From Baseline in Leptin at Week 4, 12, 24 and 52 | Week 24 | 1.0 ng/mL (nanogram per milliliter) |
| Placebo (Pooled) | Change From Baseline in Leptin at Week 4, 12, 24 and 52 | Week 52 | -0.5 ng/mL (nanogram per milliliter) |
| Placebo (Pooled) | Change From Baseline in Leptin at Week 4, 12, 24 and 52 | Week 4 | 1.0 ng/mL (nanogram per milliliter) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Leptin at Week 4, 12, 24 and 52 | Week 24 | -0.3 ng/mL (nanogram per milliliter) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Leptin at Week 4, 12, 24 and 52 | Week 12 | 0.7 ng/mL (nanogram per milliliter) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Leptin at Week 4, 12, 24 and 52 | Week 52 | -0.4 ng/mL (nanogram per milliliter) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Leptin at Week 4, 12, 24 and 52 | Week 4 | -0.2 ng/mL (nanogram per milliliter) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Leptin at Week 4, 12, 24 and 52 | Week 52 | -2.9 ng/mL (nanogram per milliliter) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Leptin at Week 4, 12, 24 and 52 | Week 12 | -0.3 ng/mL (nanogram per milliliter) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Leptin at Week 4, 12, 24 and 52 | Week 4 | 0.3 ng/mL (nanogram per milliliter) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Leptin at Week 4, 12, 24 and 52 | Week 24 | -1.4 ng/mL (nanogram per milliliter) |
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.
Time frame: Baseline, Week 4, 12, 24 and 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Secukinumab 300 mg | Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52 | Week 4 (n = 192, 262, 133, 104) | 0.0 meters per second (m/s) |
| Secukinumab 300 mg | Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52 | Week 12 (n = 214, 255, 116, 133) | 0.4 meters per second (m/s) |
| Secukinumab 300 mg | Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52 | Week 24 (n = 205, 255, 100, 100) | 0.2 meters per second (m/s) |
| Secukinumab 300 mg | Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52 | Week 52 (n = 191, 228, 115, 101) | -0.1 meters per second (m/s) |
| Placebo (Pooled) | Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52 | Week 12 (n = 214, 255, 116, 133) | 0.1 meters per second (m/s) |
| Placebo (Pooled) | Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52 | Week 24 (n = 205, 255, 100, 100) | 0.0 meters per second (m/s) |
| Placebo (Pooled) | Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52 | Week 52 (n = 191, 228, 115, 101) | 0.2 meters per second (m/s) |
| Placebo (Pooled) | Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52 | Week 4 (n = 192, 262, 133, 104) | -0.2 meters per second (m/s) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52 | Week 24 (n = 205, 255, 100, 100) | 0.2 meters per second (m/s) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52 | Week 12 (n = 214, 255, 116, 133) | 0.1 meters per second (m/s) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52 | Week 52 (n = 191, 228, 115, 101) | 0.1 meters per second (m/s) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52 | Week 4 (n = 192, 262, 133, 104) | 0 meters per second (m/s) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52 | Week 52 (n = 191, 228, 115, 101) | -0.2 meters per second (m/s) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52 | Week 12 (n = 214, 255, 116, 133) | 0.4 meters per second (m/s) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52 | Week 4 (n = 192, 262, 133, 104) | -0.2 meters per second (m/s) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52 | Week 24 (n = 205, 255, 100, 100) | -0.1 meters per second (m/s) |
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.
Time frame: Baseline, Week 4, 12, 24 and 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Secukinumab 300 mg | Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52 | Week 4 | -0.0 Microgram per Liter (ug/L) |
| Secukinumab 300 mg | Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52 | Week 12 | -0.0 Microgram per Liter (ug/L) |
| Secukinumab 300 mg | Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52 | Week 24 | -0.0 Microgram per Liter (ug/L) |
| Secukinumab 300 mg | Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52 | Week 52 | -0.0 Microgram per Liter (ug/L) |
| Placebo (Pooled) | Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52 | Week 52 | -0.0 Microgram per Liter (ug/L) |
| Placebo (Pooled) | Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52 | Week 24 | 0.0 Microgram per Liter (ug/L) |
| Placebo (Pooled) | Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52 | Week 12 | -0.0 Microgram per Liter (ug/L) |
| Placebo (Pooled) | Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52 | Week 4 | -0.0 Microgram per Liter (ug/L) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52 | Week 24 | 0.0 Microgram per Liter (ug/L) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52 | Week 52 | 0.0 Microgram per Liter (ug/L) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52 | Week 12 | 0.0 Microgram per Liter (ug/L) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52 | Week 4 | 0.0 Microgram per Liter (ug/L) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52 | Week 52 | -0.0 Microgram per Liter (ug/L) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52 | Week 4 | 0.0 Microgram per Liter (ug/L) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52 | Week 12 | 0.0 Microgram per Liter (ug/L) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52 | Week 24 | 0.0 Microgram per Liter (ug/L) |
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.
Time frame: Baseline, Week 4, 12, 24 and 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Secukinumab 300 mg | Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52 | Week 4 | 0.1 nanomole per Liter (nmol/L) |
| Secukinumab 300 mg | Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52 | Week 12 | -0.1 nanomole per Liter (nmol/L) |
| Secukinumab 300 mg | Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52 | Week 24 | -1.5 nanomole per Liter (nmol/L) |
| Secukinumab 300 mg | Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52 | Week 52 | -3.1 nanomole per Liter (nmol/L) |
| Placebo (Pooled) | Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52 | Week 12 | 1.1 nanomole per Liter (nmol/L) |
| Placebo (Pooled) | Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52 | Week 24 | 3.2 nanomole per Liter (nmol/L) |
| Placebo (Pooled) | Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52 | Week 52 | 5.9 nanomole per Liter (nmol/L) |
| Placebo (Pooled) | Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52 | Week 4 | 3.7 nanomole per Liter (nmol/L) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52 | Week 24 | 1.7 nanomole per Liter (nmol/L) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52 | Week 12 | 3.7 nanomole per Liter (nmol/L) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52 | Week 52 | -2.6 nanomole per Liter (nmol/L) |
| Placebo Followed by 300 mg Secukinumab | Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52 | Week 4 | 4.7 nanomole per Liter (nmol/L) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52 | Week 52 | 3.2 nanomole per Liter (nmol/L) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52 | Week 12 | 4.1 nanomole per Liter (nmol/L) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52 | Week 4 | -0.3 nanomole per Liter (nmol/L) |
| Placebo Followed by 150 mg Secukinumab | Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52 | Week 24 | 2.6 nanomole per Liter (nmol/L) |
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.
Time frame: Baseline, Week 4, 12, 24 and 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Secukinumab 300 mg | 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 | Total cholesterol Week 4 | 0.4 mg/dL |
| Secukinumab 300 mg | 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 | ApoA-1 Week 12 | 4.0 mg/dL |
| Secukinumab 300 mg | 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 | ApoA-1 Week 4 | 0.3 mg/dL |
| Secukinumab 300 mg | 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 | HDL Week 4 | -0.6 mg/dL |
| Secukinumab 300 mg | 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 Week 24 | 4.6 mg/dL |
| Secukinumab 300 mg | 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 | HDL Week 52 | 0.1 mg/dL |
| Secukinumab 300 mg | 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 | HDL Week 24 | 1.2 mg/dL |
| Secukinumab 300 mg | 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 | HDL Week 12 | -0.4 mg/dL |
| Secukinumab 300 mg | 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 | Total cholesterol Week 52 | 7.8 mg/dL |
| Secukinumab 300 mg | 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 Week 52 | 64.6 mg/dL |
| Secukinumab 300 mg | 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 Week 12 | -9.3 mg/dL |
| Secukinumab 300 mg | 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 Week 4 | -1.8 mg/dL |
| Secukinumab 300 mg | 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 | Total cholesterol Week 12 | 3.1 mg/dL |
| Secukinumab 300 mg | 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 | ApoB Week 52 | 3.7 mg/dL |
| Secukinumab 300 mg | 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 | ApoB Week 24 | 1.0 mg/dL |
| Secukinumab 300 mg | 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 | LDL Week 12 | 2.9 mg/dL |
| Secukinumab 300 mg | 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 | LDL Week 4 | 1.1 mg/dL |
| Secukinumab 300 mg | 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 | ApoB Week 12 | 4.0 mg/dL |
| Secukinumab 300 mg | 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 | ApoB Week 4 | 1.5 mg/dL |
| Secukinumab 300 mg | 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 | LDL Week 24 | -2.7 mg/dL |
| Secukinumab 300 mg | 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 | Total cholesterol Week 24 | 0.9 mg/dL |
| Secukinumab 300 mg | 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 | ApoA-1 Week 52 | -4.5 mg/dL |
| Secukinumab 300 mg | 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 | ApoA-1 Week 24 | 5.5 mg/dL |
| Secukinumab 300 mg | 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 | LDL Week 52 | 1.7 mg/dL |
| Placebo (Pooled) | 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 | ApoB Week 4 | 3.6 mg/dL |
| Placebo (Pooled) | 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 | Total cholesterol Week 24 | 0.6 mg/dL |
| Placebo (Pooled) | 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 | Total cholesterol Week 52 | 2.3 mg/dL |
| Placebo (Pooled) | 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 | LDL Week 4 | 6.8 mg/dL |
| Placebo (Pooled) | 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 | LDL Week 12 | 2.7 mg/dL |
| Placebo (Pooled) | 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 | LDL Week 24 | -1.3 mg/dL |
| Placebo (Pooled) | 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 | LDL Week 52 | -0.9 mg/dL |
| Placebo (Pooled) | 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 | HDL Week 4 | 0.4 mg/dL |
| Placebo (Pooled) | 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 | HDL Week 12 | 0.2 mg/dL |
| Placebo (Pooled) | 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 | HDL Week 24 | 0.3 mg/dL |
| Placebo (Pooled) | 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 | HDL Week 52 | 1.8 mg/dL |
| Placebo (Pooled) | 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 | ApoA-1 Week 4 | 0.9 mg/dL |
| Placebo (Pooled) | 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 | ApoA-1 Week 12 | 2.4 mg/dL |
| Placebo (Pooled) | 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 | ApoA-1 Week 24 | 2.8 mg/dL |
| Placebo (Pooled) | 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 | ApoA-1 Week 52 | -6.0 mg/dL |
| Placebo (Pooled) | 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 Week 12 | 4.0 mg/dL |
| Placebo (Pooled) | 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 | ApoB Week 12 | 3.4 mg/dL |
| Placebo (Pooled) | 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 | ApoB Week 24 | 2.0 mg/dL |
| Placebo (Pooled) | 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 | ApoB Week 52 | 2.3 mg/dL |
| Placebo (Pooled) | 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 Week 4 | 6.5 mg/dL |
| Placebo (Pooled) | 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 Week 24 | 3.9 mg/dL |
| Placebo (Pooled) | 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 Week 52 | 2.6 mg/dL |
| Placebo (Pooled) | 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 | Total cholesterol Week 4 | 7.1 mg/dL |
| Placebo (Pooled) | 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 | Total cholesterol Week 12 | 3.6 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 | ApoA-1 Week 12 | 7.1 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 | ApoB Week 52 | 6.7 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 | ApoB Week 4 | 2.7 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 | LDL Week 24 | 1.1 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 | Total cholesterol Week 4 | 4.8 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 Week 4 | 12.7 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 Week 24 | 32.8 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 | Total cholesterol Week 52 | 8.9 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 Week 12 | 5.9 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 | HDL Week 12 | 1.0 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 | LDL Week 12 | 9.5 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 | Total cholesterol Week 24 | 7.2 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 | ApoB Week 12 | 7.4 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 | HDL Week 24 | -1.1 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 Week 52 | -6.0 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 | HDL Week 4 | 0.3 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 | ApoA-1 Week 52 | -5.5 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 | HDL Week 52 | -0.3 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 | Total cholesterol Week 12 | 10.0 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 | ApoB Week 24 | 5.6 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 | ApoA-1 Week 24 | 3.0 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 | ApoA-1 Week 4 | 7.7 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 | LDL Week 4 | 5.2 mg/dL |
| Placebo Followed by 300 mg Secukinumab | 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 | LDL Week 52 | 8.2 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 Week 4 | 27.5 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 | ApoA-1 Week 12 | -3.3 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 | LDL Week 24 | -11 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 | ApoA-1 Week 24 | -3.1 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 | ApoA-1 Week 52 | -13 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 | LDL Week 12 | -5.6 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 Week 52 | 11.9 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 | ApoB Week 4 | -2.5 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 | ApoB Week 12 | -1.0 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 | LDL Week 4 | -5.6 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 | Total cholesterol Week 12 | -4.2 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 | ApoB Week 24 | -4.2 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 | Total cholesterol Week 4 | -2.7 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 | ApoB Week 52 | -0.2 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 | Total cholesterol Week 52 | 2.9 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 | HDL Week 12 | -0.5 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 | HDL Week 4 | -1.3 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 Week 12 | 2.7 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 | HDL Week 24 | 0.5 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 | Total cholesterol Week 24 | -3.2 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 | HDL Week 52 | -1.4 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 | LDL Week 52 | 1.1 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 Week 24 | 17.1 mg/dL |
| Placebo Followed by 150 mg Secukinumab | 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 | ApoA-1 Week 4 | -5.5 mg/dL |