Trial Outcomes & Findings for Evaluation of Cardiovascular Risk Markers in Psoriasis Patients Treated With Secukinumab (NCT NCT02559622)

NCT ID: NCT02559622

Last Updated: 2017-07-13

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 151 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2017-07-13

Participant Flow

The study was conducted at 23 centers in Germany.

Participant milestones

Measure	Secukinumab 300 mg Participants were administered with 300 milligrams (mg) secukinumab subcutaneously (s.c.) using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).	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).	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).	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).
Overall Study STARTED	48	54	26	23
Overall Study COMPLETED	47	49	24	20
Overall Study NOT COMPLETED	1	5	2	3

Reasons for withdrawal

Measure	Secukinumab 300 mg Participants were administered with 300 milligrams (mg) secukinumab subcutaneously (s.c.) using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).	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).	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).	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).
Overall Study Progressive disease	0	1	0	0
Overall Study Adverse Event	0	2	2	2
Overall Study Patient/guardian decision	1	2	0	1

Baseline Characteristics

Evaluation of Cardiovascular Risk Markers in Psoriasis Patients Treated With Secukinumab

Baseline characteristics by cohort

Measure	Secukinumab 300 mg n=48 Participants 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).	Secukinumab 150 mg n=54 Participants 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).	Placebo Followed by 300 mg Secukinumab n=26 Participants 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).	Placebo Followed by 150 mg Secukinumab n=23 Participants 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).	Total n=151 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=5 Participants	46 Participants n=7 Participants	26 Participants n=5 Participants	22 Participants n=4 Participants	140 Participants n=21 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	8 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	11 Participants n=21 Participants
Age, Continuous	44.2 years STANDARD_DEVIATION 12.9 • n=5 Participants	46.0 years STANDARD_DEVIATION 14.4 • n=7 Participants	43.7 years STANDARD_DEVIATION 11.4 • n=5 Participants	46.8 years STANDARD_DEVIATION 13.1 • n=4 Participants	45.2 years STANDARD_DEVIATION 13.2 • n=21 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	23 Participants n=7 Participants	8 Participants n=5 Participants	7 Participants n=4 Participants	49 Participants n=21 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	31 Participants n=7 Participants	18 Participants n=5 Participants	16 Participants n=4 Participants	102 Participants n=21 Participants
Region of Enrollment Germany	48 participants n=5 Participants	54 participants n=7 Participants	26 participants n=5 Participants	23 participants n=4 Participants	151 participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Secukinumab 300 mg n=39 Participants 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).	Placebo (Pooled) n=38 Participants Participants were administered with placebo until week 12 followed by 150 mg or 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg or 300 mg secukinumab respectively every 4 weeks until week 48 (last injection).	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).	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).
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 5.30	3.65 Percentage maximal increase in diameter Standard Deviation 4.07	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Secukinumab 300 mg n=48 Participants 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).	Placebo (Pooled) n=54 Participants Participants were administered with placebo until week 12 followed by 150 mg or 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg or 300 mg secukinumab respectively every 4 weeks until week 48 (last injection).	Placebo Followed by 300 mg Secukinumab n=26 Participants 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).	Placebo Followed by 150 mg Secukinumab n=23 Participants 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).
Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52 Week 12	0.5 Percentage change in FMD Interval -1.1 to 2.1	0.1 Percentage change in FMD Interval -1.2 to 1.5	-0.1 Percentage change in FMD Interval -2.7 to 2.4	0.1 Percentage change in FMD Interval -2.1 to 2.3
Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52 Week 24	-0.8 Percentage change in FMD Interval -1.9 to 0.3	1.0 Percentage change in FMD Interval -0.4 to 2.4	-0.0 Percentage change in FMD Interval -2.6 to 2.6	0.9 Percentage change in FMD Interval -1.0 to 2.9
Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52 Week 52	2.1 Percentage change in FMD Interval 0.8 to 3.3	2.1 Percentage change in FMD Interval 0.7 to 3.4	2.2 Percentage change in FMD Interval -0.5 to 4.9	1.2 Percentage change in FMD Interval -1.0 to 3.5
Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52 Week 4	-0.7 Percentage change in FMD Interval -1.9 to 0.5	-0.9 Percentage change in FMD Interval -2.4 to 0.7	0.7 Percentage change in FMD Interval -1.0 to 2.5	1.4 Percentage change in FMD Interval -0.8 to 3.6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Secukinumab 300 mg n=48 Participants 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).	Placebo (Pooled) n=54 Participants Participants were administered with placebo until week 12 followed by 150 mg or 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg or 300 mg secukinumab respectively every 4 weeks until week 48 (last injection).	Placebo Followed by 300 mg Secukinumab n=26 Participants 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).	Placebo Followed by 150 mg Secukinumab n=23 Participants 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).
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 Interval -2.8 to 2.9	0.3 Percentage change in Alx-75 Interval -2.0 to 2.7	1.1 Percentage change in Alx-75 Interval -1.7 to 3.8	-0.1 Percentage change in Alx-75 Interval -3.0 to 2.9
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 Interval 0.3 to 5.6	1.8 Percentage change in Alx-75 Interval -0.6 to 4.3	1.3 Percentage change in Alx-75 Interval -2.7 to 5.3	0.7 Percentage change in Alx-75 Interval -2.7 to 4.1
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 Interval -3.0 to 2.1	1.0 Percentage change in Alx-75 Interval -1.7 to 3.8	-1.1 Percentage change in Alx-75 Interval -5.4 to 3.3	-0.1 Percentage change in Alx-75 Interval -3.4 to 3.2
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 Interval -1.5 to 4.2	-0.1 Percentage change in Alx-75 Interval -2.8 to 2.7	-1.4 Percentage change in Alx-75 Interval -5.8 to 2.9	-0.9 Percentage change in Alx-75 Interval -4.2 to 2.5

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Secukinumab 300 mg n=48 Participants 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).	Placebo (Pooled) n=54 Participants Participants were administered with placebo until week 12 followed by 150 mg or 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg or 300 mg secukinumab respectively every 4 weeks until week 48 (last injection).	Placebo Followed by 300 mg Secukinumab n=26 Participants 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).	Placebo Followed by 150 mg Secukinumab n=23 Participants 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).
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) Interval -0.2 to 0.2	-0.2 meters per second (m/s) Interval -0.3 to 0.0	0 meters per second (m/s) Interval -0.1 to 0.2	-0.2 meters per second (m/s) Interval -0.5 to 0.2
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) Interval 0.2 to 0.6	0.1 meters per second (m/s) Interval -0.1 to 0.2	0.1 meters per second (m/s) Interval -0.2 to 0.4	0.4 meters per second (m/s) Interval 0.1 to 0.7
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) Interval -0.1 to 0.5	0.0 meters per second (m/s) Interval -0.2 to 0.1	0.2 meters per second (m/s) Interval 0.1 to 0.4	-0.1 meters per second (m/s) Interval -0.5 to 0.2
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) Interval -0.3 to 0.0	0.2 meters per second (m/s) Interval -0.1 to 0.5	0.1 meters per second (m/s) Interval -0.2 to 0.4	-0.2 meters per second (m/s) Interval -0.6 to 0.2

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Secukinumab 300 mg n=48 Participants 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).	Placebo (Pooled) n=54 Participants Participants were administered with placebo until week 12 followed by 150 mg or 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg or 300 mg secukinumab respectively every 4 weeks until week 48 (last injection).	Placebo Followed by 300 mg Secukinumab n=26 Participants 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).	Placebo Followed by 150 mg Secukinumab n=23 Participants 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).
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) Interval -14.18 to 19.56	-2.94 millimeter square (mm^2) Interval -13.44 to 7.57	-4.04 millimeter square (mm^2) Interval -29.61 to 21.53	3.16 millimeter square (mm^2) Interval -13.73 to 20.05
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) Interval -3.6 to 2.06	1.75 millimeter square (mm^2) Interval -0.71 to 4.21	-1.26 millimeter square (mm^2) Interval -7.64 to 5.12	-1.07 millimeter square (mm^2) Interval -4.24 to 2.1
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) Interval -2.17 to 1.92	0.30 millimeter square (mm^2) Interval -2.76 to 3.36	-0.38 millimeter square (mm^2) Interval -6.56 to 5.8	-0.14 millimeter square (mm^2) Interval -1.6 to 1.32
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) Interval -6.33 to 23.76	-3.79 millimeter square (mm^2) Interval -21.9 to 14.32	4.56 millimeter square (mm^2) Interval -52.64 to 61.77	-0.58 millimeter square (mm^2) Interval -15.51 to 14.35
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) Interval -8.23 to 38.92	5.91 millimeter square (mm^2) Interval -13.09 to 24.91	9.92 millimeter square (mm^2) Interval -58.24 to 78.08	6.45 millimeter square (mm^2) Interval -9.26 to 22.15
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) Interval -2.72 to 3.77	-1.08 millimeter square (mm^2) Interval -3.85 to 1.69	3.63 millimeter square (mm^2) Interval -7.82 to 15.08	1.12 millimeter square (mm^2) Interval -2.04 to 4.28
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) Interval -1.64 to 1.99	1.12 millimeter square (mm^2) Interval -1.8 to 4.03	0.69 millimeter square (mm^2) Interval -5.21 to 6.59	0.12 millimeter square (mm^2) Interval -1.91 to 2.15
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) Interval -0.19 to 7.78	2.09 millimeter square (mm^2) Interval -0.57 to 4.75	2.59 millimeter square (mm^2) Interval -0.58 to 5.77	-1.74 millimeter square (mm^2) Interval -4.55 to 1.08
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) Interval -1.9 to 0.51	0.17 millimeter square (mm^2) Interval -1.96 to 2.3	0.68 millimeter square (mm^2) Interval -3.97 to 5.33	-1.37 millimeter square (mm^2) Interval -4.37 to 1.62

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Secukinumab 300 mg n=48 Participants 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).	Placebo (Pooled) n=54 Participants Participants were administered with placebo until week 12 followed by 150 mg or 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg or 300 mg secukinumab respectively every 4 weeks until week 48 (last injection).	Placebo Followed by 300 mg Secukinumab n=26 Participants 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).	Placebo Followed by 150 mg Secukinumab n=23 Participants 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).
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 Interval -14.93 to 43.76	3.19 mm^2 Interval -17.17 to 23.55	-15.11 mm^2 Interval -28.15 to -2.06	9.54 mm^2 Interval -14.71 to 33.79
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 Interval -13.42 to 21.37	2.55 mm^2 Interval -12.23 to 17.33	-10.14 mm^2 Interval -34.05 to 13.77	1.14 mm^2 Interval -26.76 to 29.05
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 Interval -1.55 to 6.45	0.64 mm^2 Interval -3.59 to 4.88	0.58 mm^2 Interval -9.03 to 10.2	2.60 mm^2 Interval -2.16 to 7.36
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 Interval -0.36 to 3.19	1.21 mm^2 Interval -1.51 to 3.93	0.65 mm^2 Interval -2.82 to 4.13	1.00 mm^2 Interval -0.83 to 2.82
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 Interval -2.54 to 2.58	0.23 mm^2 Interval -2.29 to 2.75	-0.80 mm^2 Interval -6.25 to 4.64	-1.38 mm^2 Interval -3.33 to 0.57
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 Interval 1.21 to 9.65	3.59 mm^2 Interval 0.59 to 6.6	1.06 mm^2 Interval -2.66 to 4.78	0.33 mm^2 Interval -5.07 to 5.73
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 Interval -8.37 to 29.48	-4.36 mm^2 Interval -17.9 to 9.19	12.46 mm^2 Interval -46.12 to 71.05	11.82 mm^2 Interval -15.26 to 38.9
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 Interval -6.02 to 2.74	-0.05 mm^2 Interval -3.62 to 3.51	-3.23 mm^2 Interval -9.86 to 3.4	1.25 mm^2 Interval -3.92 to 6.41
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 Interval -2.12 to -0.03	0.71 mm^2 Interval -1.78 to 3.21	-0.20 mm^2 Interval -3.89 to 3.49	0.13 mm^2 Interval -2.22 to 2.48

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Secukinumab 300 mg n=48 Participants 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).	Placebo (Pooled) n=54 Participants Participants were administered with placebo until week 12 followed by 150 mg or 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg or 300 mg secukinumab respectively every 4 weeks until week 48 (last injection).	Placebo Followed by 300 mg Secukinumab n=26 Participants 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).	Placebo Followed by 150 mg Secukinumab n=23 Participants 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).
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) Interval -0.2 to 0.2	-0.2 Milligrams per deciliter (mg/dL) Interval -0.4 to -0.1	-0.0 Milligrams per deciliter (mg/dL) Interval -0.2 to 0.2	0.1 Milligrams per deciliter (mg/dL) Interval -0.1 to 0.3
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) Interval -0.3 to 0.1	-0.2 Milligrams per deciliter (mg/dL) Interval -0.4 to 0.0	-0.3 Milligrams per deciliter (mg/dL) Interval -0.8 to 0.2	-0.5 Milligrams per deciliter (mg/dL) Interval -1.1 to 0.0
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) Interval -0.3 to 0.3	-0.2 Milligrams per deciliter (mg/dL) Interval -0.3 to 0.0	-0.3 Milligrams per deciliter (mg/dL) Interval -0.8 to 0.1	0.1 Milligrams per deciliter (mg/dL) Interval -0.4 to 0.6
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) Interval -0.3 to 0.2	-0.0 Milligrams per deciliter (mg/dL) Interval -0.3 to 0.2	0.1 Milligrams per deciliter (mg/dL) Interval -0.2 to 0.4	-0.4 Milligrams per deciliter (mg/dL) Interval -0.9 to 0.1

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Secukinumab 300 mg n=48 Participants 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).	Placebo (Pooled) n=54 Participants Participants were administered with placebo until week 12 followed by 150 mg or 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg or 300 mg secukinumab respectively every 4 weeks until week 48 (last injection).	Placebo Followed by 300 mg Secukinumab n=26 Participants 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).	Placebo Followed by 150 mg Secukinumab n=23 Participants 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).
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) Interval 0.0 to 0.0	-0.0 Microgram per Liter (ug/L) Interval 0.0 to 0.0	0.0 Microgram per Liter (ug/L) Interval 0.0 to 0.0	-0.0 Microgram per Liter (ug/L) Interval 0.0 to 0.0
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) Interval 0.0 to 0.0	-0.0 Microgram per Liter (ug/L) Interval 0.0 to 0.0	0.0 Microgram per Liter (ug/L) Interval 0.0 to 0.0	0.0 Microgram per Liter (ug/L) Interval 0.0 to 0.0
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) Interval 0.0 to 0.0	-0.0 Microgram per Liter (ug/L) Interval 0.0 to 0.0	0.0 Microgram per Liter (ug/L) Interval 0.0 to 0.0	0.0 Microgram per Liter (ug/L) Interval 0.0 to 0.0
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) Interval 0.0 to 0.0	0.0 Microgram per Liter (ug/L) Interval 0.0 to 0.0	0.0 Microgram per Liter (ug/L) Interval 0.0 to 0.0	0.0 Microgram per Liter (ug/L) Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Secukinumab 300 mg n=48 Participants 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).	Placebo (Pooled) n=54 Participants Participants were administered with placebo until week 12 followed by 150 mg or 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg or 300 mg secukinumab respectively every 4 weeks until week 48 (last injection).	Placebo Followed by 300 mg Secukinumab n=26 Participants 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).	Placebo Followed by 150 mg Secukinumab n=23 Participants 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).
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) Interval -1.9 to 38.7	28.6 picograms per milliliter (pg/mL) Interval -8.4 to 65.7	11.3 picograms per milliliter (pg/mL) Interval -40.9 to 63.5	21.5 picograms per milliliter (pg/mL) Interval -18.3 to 61.2
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) Interval -3106.0 to 1094.0	1649 picograms per milliliter (pg/mL) Interval -597.0 to 3895.0	27.0 picograms per milliliter (pg/mL) Interval -3943.0 to 3997.0	-2000 picograms per milliliter (pg/mL) Interval -5056.0 to 281.3
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) Interval -2478.0 to 5507.0	3577 picograms per milliliter (pg/mL) Interval -737.0 to 7891.0	-597 picograms per milliliter (pg/mL) Interval -3340.0 to 2145.0	2308 picograms per milliliter (pg/mL) Interval -2558.0 to 7175.0
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) Interval -21.8 to 7.7	1.4 picograms per milliliter (pg/mL) Interval -17.4 to 20.2	-25 picograms per milliliter (pg/mL) Interval -57.2 to 8.0	17.5 picograms per milliliter (pg/mL) Interval -43.1 to 78.0
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) Interval -0.6 to 80.3	241 picograms per milliliter (pg/mL) Interval -203.0 to 685.7	-20 picograms per milliliter (pg/mL) Interval -53.9 to 14.2	33.4 picograms per milliliter (pg/mL) Interval 8.3 to 58.5
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) Interval -0.1 to 8.7	0.8 picograms per milliliter (pg/mL) Interval -3.0 to 4.5	1.7 picograms per milliliter (pg/mL) Interval -6.0 to 9.5	20.1 picograms per milliliter (pg/mL) Interval 4.7 to 35.6
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) Interval -50.8 to 3.0	-2.6 picograms per milliliter (pg/mL) Interval -24.8 to 19.5	-16 picograms per milliliter (pg/mL) Interval -57.5 to 25.8	-20 picograms per milliliter (pg/mL) Interval -54.4 to 15.3
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) Interval -130.0 to 26.7	-97 picograms per milliliter (pg/mL) Interval -133.0 to -61.3	-161 picograms per milliliter (pg/mL) Interval -207.0 to -114.0	79.4 picograms per milliliter (pg/mL) Interval -261.0 to 420.3
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) Interval -2368.0 to 6599.0	5185 picograms per milliliter (pg/mL) Interval 840.3 to 9530.0	4393 picograms per milliliter (pg/mL) Interval -1598.0 to 10383.0	3002 picograms per milliliter (pg/mL) Interval -1806.0 to 7809.0
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) Interval 3766.0 to 11777.0	10000 picograms per milliliter (pg/mL) Interval 6437.0 to 14394.0	11000 picograms per milliliter (pg/mL) Interval 2117.0 to 20176.0	9168 picograms per milliliter (pg/mL) Interval 2124.0 to 16212.0
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) Interval -18.1 to 62.4	25.4 picograms per milliliter (pg/mL) Interval -21.7 to 72.6	-11 picograms per milliliter (pg/mL) Interval -60.6 to 38.6	109 picograms per milliliter (pg/mL) Interval -13.3 to 230.9
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) Interval -2.1 to 1.9	0.1 picograms per milliliter (pg/mL) Interval -1.6 to 1.8	0.5 picograms per milliliter (pg/mL) Interval -2.5 to 3.5	-0.6 picograms per milliliter (pg/mL) Interval -2.3 to 1.2
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) Interval -2.8 to 3.3	2.2 picograms per milliliter (pg/mL) Interval -1.0 to 5.3	-3.6 picograms per milliliter (pg/mL) Interval -7.0 to -0.3	0.9 picograms per milliliter (pg/mL) Interval -3.0 to 4.8
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) Interval -2.9 to 2.4	-0.5 picograms per milliliter (pg/mL) Interval -3.6 to 2.6	-4.7 picograms per milliliter (pg/mL) Interval -8.4 to -1.0	1.7 picograms per milliliter (pg/mL) Interval -1.3 to 4.7
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) Interval -80.9 to -16.6	-34 picograms per milliliter (pg/mL) Interval -69.0 to 1.4	-65 picograms per milliliter (pg/mL) Interval -106.0 to -24.7	-68 picograms per milliliter (pg/mL) Interval -116.0 to -20.5
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) Interval -73.6 to -8.6	-59 picograms per milliliter (pg/mL) Interval -89.0 to -29.7	-73 picograms per milliliter (pg/mL) Interval -122.0 to -24.2	-31 picograms per milliliter (pg/mL) Interval -109.0 to 46.8

SECONDARY outcome

Timeframe: 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.

Fasting plasma glucose (FPG), a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.

Outcome measures

Measure	Secukinumab 300 mg n=48 Participants 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).	Placebo (Pooled) n=54 Participants Participants were administered with placebo until week 12 followed by 150 mg or 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg or 300 mg secukinumab respectively every 4 weeks until week 48 (last injection).	Placebo Followed by 300 mg Secukinumab n=26 Participants 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).	Placebo Followed by 150 mg Secukinumab n=23 Participants 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).
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52 Week 12	3.5 mg/dL Interval 0.0 to 7.0	1.1 mg/dL Interval -4.0 to 6.2	5.3 mg/dL Interval -2.2 to 12.8	-1.5 mg/dL Interval -7.1 to 4.0
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52 Week 24	2.5 mg/dL Interval 0.0 to 5.0	1.4 mg/dL Interval -6.3 to 9.1	12.1 mg/dL Interval -10.8 to 35.0	-1.4 mg/dL Interval -7.7 to 5.0
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52 Week 4	1.5 mg/dL Interval -1.0 to 4.0	-1.6 mg/dL Interval -4.6 to 1.3	0.9 mg/dL Interval -4.4 to 6.1	0.2 mg/dL Interval -5.2 to 5.6
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52 Week 52	-0.8 mg/dL Interval -3.5 to 2.0	0.7 mg/dL Interval -3.0 to 4.4	8.7 mg/dL Interval -7.5 to 25.0	0.9 mg/dL Interval -6.7 to 8.6

SECONDARY outcome

Timeframe: 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.

Fasting Insulin, a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.

Outcome measures

Measure	Secukinumab 300 mg n=48 Participants 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).	Placebo (Pooled) n=54 Participants Participants were administered with placebo until week 12 followed by 150 mg or 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg or 300 mg secukinumab respectively every 4 weeks until week 48 (last injection).	Placebo Followed by 300 mg Secukinumab n=26 Participants 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).	Placebo Followed by 150 mg Secukinumab n=23 Participants 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).
Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52 Week 4	0.4 micro units per millilitre (uU/mL) Interval -2.0 to 2.7	0.4 micro units per millilitre (uU/mL) Interval -2.3 to 3.0	-4.7 micro units per millilitre (uU/mL) Interval -17.4 to 8.1	-0.5 micro units per millilitre (uU/mL) Interval -4.8 to 3.7
Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52 Week 12	-1.4 micro units per millilitre (uU/mL) Interval -5.1 to 2.4	1.1 micro units per millilitre (uU/mL) Interval -2.7 to 4.8	-2.2 micro units per millilitre (uU/mL) Interval -9.2 to 4.7	-0.1 micro units per millilitre (uU/mL) Interval -4.9 to 4.7
Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52 Week 24	-1.0 micro units per millilitre (uU/mL) Interval -4.1 to 2.0	0.5 micro units per millilitre (uU/mL) Interval -3.7 to 4.8	-5.3 micro units per millilitre (uU/mL) Interval -18.5 to 8.0	-2.0 micro units per millilitre (uU/mL) Interval -6.1 to 2.0
Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52 Week 52	-0.4 micro units per millilitre (uU/mL) Interval -4.3 to 3.6	1.5 micro units per millilitre (uU/mL) Interval -1.3 to 4.2	-1.2 micro units per millilitre (uU/mL) Interval -7.5 to 5.1	3.0 micro units per millilitre (uU/mL) Interval -5.2 to 11.3

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Secukinumab 300 mg n=48 Participants 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).	Placebo (Pooled) n=54 Participants Participants were administered with placebo until week 12 followed by 150 mg or 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg or 300 mg secukinumab respectively every 4 weeks until week 48 (last injection).	Placebo Followed by 300 mg Secukinumab n=26 Participants 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).	Placebo Followed by 150 mg Secukinumab n=23 Participants 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).
Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52 Week 4	-18 Percentage Interval -64.7 to 28.2	-0.2 Percentage Interval -25.7 to 25.3	-28 Percentage Interval -88.4 to 33.0	-8.9 Percentage Interval -38.5 to 20.7
Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52 Week 12	-16 Percentage Interval -74.4 to 41.5	3.9 Percentage Interval -32.0 to 39.8	-29 Percentage Interval -100.0 to 41.6	16.6 Percentage Interval -20.6 to 53.8
Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52 Week 24	-25 Percentage Interval -53.9 to 3.5	-8.2 Percentage Interval -40.2 to 23.9	-35 Percentage Interval -111.0 to 40.7	-26 Percentage Interval -63.2 to 12.0
Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52 Week 52	11.5 Percentage Interval -40.5 to 63.5	-1.6 Percentage Interval -32.6 to 29.4	9.3 Percentage Interval -56.4 to 75.1	11.6 Percentage Interval -26.6 to 49.7

SECONDARY outcome

Timeframe: 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.

HOMA insulin resistance, a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.

Outcome measures

Measure	Secukinumab 300 mg n=48 Participants 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).	Placebo (Pooled) n=54 Participants Participants were administered with placebo until week 12 followed by 150 mg or 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg or 300 mg secukinumab respectively every 4 weeks until week 48 (last injection).	Placebo Followed by 300 mg Secukinumab n=26 Participants 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).	Placebo Followed by 150 mg Secukinumab n=23 Participants 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).
Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52 Week 4	0.3 Insulin Resistance Index Interval -0.6 to 1.2	0.1 Insulin Resistance Index Interval -0.9 to 1.0	-1.1 Insulin Resistance Index Interval -5.2 to 3.1	-0.3 Insulin Resistance Index Interval -2.0 to 1.3
Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52 Week 12	-0.1 Insulin Resistance Index Interval -1.5 to 1.4	0.6 Insulin Resistance Index Interval -0.7 to 1.8	-0.1 Insulin Resistance Index Interval -2.5 to 2.3	-0.4 Insulin Resistance Index Interval -2.0 to 1.3
Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52 Week 24	-0.3 Insulin Resistance Index Interval -1.1 to 0.6	0.6 Insulin Resistance Index Interval -1.3 to 2.5	-1.1 Insulin Resistance Index Interval -5.0 to 2.8	-0.7 Insulin Resistance Index Interval -2.2 to 0.8
Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52 Week 52	-0.2 Insulin Resistance Index Interval -1.2 to 0.9	0.6 Insulin Resistance Index Interval -0.3 to 1.4	-0.2 Insulin Resistance Index Interval -2.8 to 2.4	0.7 Insulin Resistance Index Interval -1.9 to 3.4

SECONDARY outcome

Timeframe: 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.

Hemoglobin A1c (glycated hemoglobin), a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.

Outcome measures

Measure	Secukinumab 300 mg n=48 Participants 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).	Placebo (Pooled) n=54 Participants Participants were administered with placebo until week 12 followed by 150 mg or 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg or 300 mg secukinumab respectively every 4 weeks until week 48 (last injection).	Placebo Followed by 300 mg Secukinumab n=26 Participants 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).	Placebo Followed by 150 mg Secukinumab n=23 Participants 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).
Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52 Week 4	0.2 millimole per mole of Haemoglobin Interval -0.5 to 0.8	-0.4 millimole per mole of Haemoglobin Interval -1.0 to 0.3	-0.7 millimole per mole of Haemoglobin Interval -2.3 to 1.0	-0.4 millimole per mole of Haemoglobin Interval -1.2 to 0.4
Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52 Week 12	0.4 millimole per mole of Haemoglobin Interval -0.7 to 1.5	-0.4 millimole per mole of Haemoglobin Interval -2.2 to 1.4	-1.2 millimole per mole of Haemoglobin Interval -3.8 to 1.3	0.1 millimole per mole of Haemoglobin Interval -0.8 to 1.0
Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52 Week 24	-0.4 millimole per mole of Haemoglobin Interval -1.7 to 1.0	-1.2 millimole per mole of Haemoglobin Interval -2.9 to 0.5	-0.1 millimole per mole of Haemoglobin Interval -2.4 to 2.1	-1.2 millimole per mole of Haemoglobin Interval -2.9 to 0.6
Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52 Week 52	-1.1 millimole per mole of Haemoglobin Interval -2.3 to 0.1	-2.8 millimole per mole of Haemoglobin Interval -6.1 to 0.4	-1.9 millimole per mole of Haemoglobin Interval -4.3 to 0.6	-2.1 millimole per mole of Haemoglobin Interval -3.0 to 1.2

SECONDARY outcome

Timeframe: 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.

Sex hormone-binding globulin (SHBG), a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.

Outcome measures

Measure	Secukinumab 300 mg n=48 Participants 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).	Placebo (Pooled) n=54 Participants Participants were administered with placebo until week 12 followed by 150 mg or 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg or 300 mg secukinumab respectively every 4 weeks until week 48 (last injection).	Placebo Followed by 300 mg Secukinumab n=26 Participants 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).	Placebo Followed by 150 mg Secukinumab n=23 Participants 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).
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) Interval -5.1 to 2.2	3.2 nanomole per Liter (nmol/L) Interval -0.9 to 7.2	1.7 nanomole per Liter (nmol/L) Interval -2.9 to 6.3	2.6 nanomole per Liter (nmol/L) Interval -1.5 to 6.7
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) Interval -10.8 to 4.6	5.9 nanomole per Liter (nmol/L) Interval -1.3 to 13.0	-2.6 nanomole per Liter (nmol/L) Interval -14.9 to 9.6	3.2 nanomole per Liter (nmol/L) Interval -4.3 to 10.8
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) Interval -1.8 to 2.1	3.7 nanomole per Liter (nmol/L) Interval -3.0 to 10.4	4.7 nanomole per Liter (nmol/L) Interval -4.2 to 13.5	-0.3 nanomole per Liter (nmol/L) Interval -4.0 to 3.5
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) Interval -3.4 to 3.2	1.1 nanomole per Liter (nmol/L) Interval -1.8 to 4.1	3.7 nanomole per Liter (nmol/L) Interval -1.6 to 9.1	4.1 nanomole per Liter (nmol/L) Interval -0.2 to 8.4

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Secukinumab 300 mg n=48 Participants 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).	Placebo (Pooled) n=54 Participants Participants were administered with placebo until week 12 followed by 150 mg or 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg or 300 mg secukinumab respectively every 4 weeks until week 48 (last injection).	Placebo Followed by 300 mg Secukinumab n=26 Participants 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).	Placebo Followed by 150 mg Secukinumab n=23 Participants 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).
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 Interval -15.5 to 12.0	6.5 mg/dL Interval -5.9 to 18.9	12.7 mg/dL Interval -12.2 to 37.7	27.5 mg/dL Interval -6.6 to 61.6
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 Interval -20.8 to 2.3	4.0 mg/dL Interval -9.3 to 17.3	5.9 mg/dL Interval -32.4 to 44.2	2.7 mg/dL Interval -18.3 to 23.8
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 Interval -16.6 to 25.8	3.9 mg/dL Interval -9.1 to 16.9	32.8 mg/dL Interval -19.7 to 85.2	17.1 mg/dL Interval -2.3 to 36.5
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 Interval -6.4 to 7.1	7.1 mg/dL Interval 1.1 to 13.2	4.8 mg/dL Interval -3.2 to 12.8	-2.7 mg/dL Interval -10.0 to 4.7
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 Interval -3.1 to 9.4	3.6 mg/dL Interval -4.1 to 11.2	10.0 mg/dL Interval 2.8 to 17.1	-4.2 mg/dL Interval -11.2 to 2.8
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 Interval -5.2 to 7.1	0.6 mg/dL Interval -4.9 to 6.1	7.2 mg/dL Interval -1.5 to 16.0	-3.2 mg/dL Interval -12.0 to 5.5
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 Interval 0.0 to 15.6	2.3 mg/dL Interval -5.2 to 9.9	8.9 mg/dL Interval 2.1 to 15.7	2.9 mg/dL Interval -5.9 to 11.7
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 Interval -4.6 to 6.8	6.8 mg/dL Interval 0.8 to 12.8	5.2 mg/dL Interval -2.0 to 12.4	-5.6 mg/dL Interval -12.1 to 0.8
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 Interval -2.2 to 7.9	2.7 mg/dL Interval -4.8 to 10.1	9.5 mg/dL Interval 3.4 to 15.5	-5.6 mg/dL Interval -12.7 to 1.5
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 Interval -8.1 to 2.7	-1.3 mg/dL Interval -6.9 to 4.4	1.1 mg/dL Interval -7.4 to 9.5	-11 mg/dL Interval -18.9 to -2.4
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 Interval -6.5 to 9.9	-0.9 mg/dL Interval -8.4 to 6.5	8.2 mg/dL Interval 1.3 to 15.0	1.1 mg/dL Interval -8.4 to 10.5
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 Interval -2.6 to 1.3	0.4 mg/dL Interval -1.5 to 2.2	0.3 mg/dL Interval -2.3 to 2.9	-1.3 mg/dL Interval -4.6 to 2.0
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 Interval -2.4 to 1.6	0.2 mg/dL Interval -1.8 to 2.2	1.0 mg/dL Interval -1.2 to 3.3	-0.5 mg/dL Interval -4.9 to 3.8
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 Interval -1.5 to 3.9	0.3 mg/dL Interval -2.3 to 2.8	-1.1 mg/dL Interval -3.4 to 1.3	0.5 mg/dL Interval -4.1 to 5.1
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 Interval -5.1 to 5.7	0.9 mg/dL Interval -4.0 to 5.7	7.7 mg/dL Interval -0.6 to 15.9	-5.5 mg/dL Interval -12.0 to 1.0
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 Interval -10.0 to 0.9	-6.0 mg/dL Interval -11.6 to -0.3	-5.5 mg/dL Interval -14.9 to 3.9	-13 mg/dL Interval -22.3 to -3.1
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 Interval -2.7 to 5.6	3.6 mg/dL Interval 0.5 to 6.6	2.7 mg/dL Interval -1.1 to 6.5	-2.5 mg/dL Interval -7.7 to 2.8
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 Interval -2.8 to 4.8	2.0 mg/dL Interval -1.3 to 5.3	5.6 mg/dL Interval 1.4 to 9.9	-4.2 mg/dL Interval -10.7 to 2.3
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 Interval -2.2 to 9.6	2.3 mg/dL Interval -1.8 to 6.4	6.7 mg/dL Interval 3.0 to 10.5	-0.2 mg/dL Interval -5.4 to 5.0
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 Interval -44.0 to 173.2	2.6 mg/dL Interval -11.7 to 16.9	-6.0 mg/dL Interval -54.3 to 42.3	11.9 mg/dL Interval -8.6 to 32.3
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 Interval -2.1 to 2.4	1.8 mg/dL Interval -0.5 to 4.2	-0.3 mg/dL Interval -2.9 to 2.4	-1.4 mg/dL Interval -4.6 to 1.8
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 Interval -2.0 to 10.1	2.4 mg/dL Interval -1.9 to 6.8	7.1 mg/dL Interval 1.2 to 12.9	-3.3 mg/dL Interval -12.1 to 5.5
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 Interval -0.9 to 12.0	2.8 mg/dL Interval -3.0 to 8.6	3.0 mg/dL Interval -3.3 to 9.3	-3.1 mg/dL Interval -11.3 to 5.1
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 Interval 0.6 to 7.4	3.4 mg/dL Interval -0.5 to 7.3	7.4 mg/dL Interval 3.9 to 11.0	-1.0 mg/dL Interval -7.0 to 4.9

SECONDARY outcome

Timeframe: 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.

Adiponectin, a soluble biomarker of impaired lipid metabolism was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.

Outcome measures

Measure	Secukinumab 300 mg n=48 Participants 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).	Placebo (Pooled) n=54 Participants Participants were administered with placebo until week 12 followed by 150 mg or 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg or 300 mg secukinumab respectively every 4 weeks until week 48 (last injection).	Placebo Followed by 300 mg Secukinumab n=26 Participants 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).	Placebo Followed by 150 mg Secukinumab n=23 Participants 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).
Change From Baseline in Adiponectin at Week 4, 12, 24 and 52 Week 4	-0.5 ug/mL Interval -1.0 to -0.1	0.2 ug/mL Interval -0.4 to 0.8	-0.1 ug/mL Interval -0.8 to 0.5	-0.6 ug/mL Interval -1.2 to 0.0
Change From Baseline in Adiponectin at Week 4, 12, 24 and 52 Week 12	-0.5 ug/mL Interval -1.1 to 0.0	-0.2 ug/mL Interval -0.7 to 0.3	0.5 ug/mL Interval 0.1 to 0.9	0.3 ug/mL Interval -0.7 to 1.3
Change From Baseline in Adiponectin at Week 4, 12, 24 and 52 Week 24	0.3 ug/mL Interval -0.3 to 0.9	0.1 ug/mL Interval -0.5 to 0.7	0.7 ug/mL Interval -0.3 to 1.8	-0.6 ug/mL Interval -1.6 to 0.3
Change From Baseline in Adiponectin at Week 4, 12, 24 and 52 Week 52	-1.1 ug/mL Interval -1.6 to -0.6	-0.9 ug/mL Interval -1.5 to -0.3	-0.4 ug/mL Interval -1.0 to 0.2	-1.1 ug/mL Interval -2.0 to -0.3

SECONDARY outcome

Timeframe: 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

Leptin, a soluble biomarker of impaired lipid metabolism was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.

Outcome measures

Measure	Secukinumab 300 mg n=48 Participants 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).	Placebo (Pooled) n=54 Participants Participants were administered with placebo until week 12 followed by 150 mg or 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg or 300 mg secukinumab respectively every 4 weeks until week 48 (last injection).	Placebo Followed by 300 mg Secukinumab n=26 Participants 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).	Placebo Followed by 150 mg Secukinumab n=23 Participants 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).
Change From Baseline in Leptin at Week 4, 12, 24 and 52 Week 12	0.2 ng/mL (nanogram per milliliter) Interval -0.7 to 1.1	0.1 ng/mL (nanogram per milliliter) Interval -0.9 to 1.2	0.7 ng/mL (nanogram per milliliter) Interval -1.0 to 2.4	-0.3 ng/mL (nanogram per milliliter) Interval -1.7 to 1.2
Change From Baseline in Leptin at Week 4, 12, 24 and 52 Week 4	-0.6 ng/mL (nanogram per milliliter) Interval -1.8 to 0.7	1.0 ng/mL (nanogram per milliliter) Interval -0.1 to 2.2	-0.2 ng/mL (nanogram per milliliter) Interval -1.6 to 1.2	0.3 ng/mL (nanogram per milliliter) Interval -1.2 to 1.9
Change From Baseline in Leptin at Week 4, 12, 24 and 52 Week 24	0.2 ng/mL (nanogram per milliliter) Interval -0.7 to 1.2	1.0 ng/mL (nanogram per milliliter) Interval -0.5 to 2.4	-0.3 ng/mL (nanogram per milliliter) Interval -2.8 to 2.3	-1.4 ng/mL (nanogram per milliliter) Interval -4.9 to 2.1
Change From Baseline in Leptin at Week 4, 12, 24 and 52 Week 52	0.2 ng/mL (nanogram per milliliter) Interval -1.0 to 1.3	-0.5 ng/mL (nanogram per milliliter) Interval -1.6 to 0.7	-0.4 ng/mL (nanogram per milliliter) Interval -3.8 to 3.0	-2.9 ng/mL (nanogram per milliliter) Interval -5.7 to 0.0

Adverse Events

Secukinumab (300 mg) up to Week 12

Serious events: 1 serious events

Other events: 29 other events

Deaths: 0 deaths

Secukinumab (150 mg) up to Week 12

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Placebo up to Week 12

Serious events: 2 serious events

Other events: 35 other events

Deaths: 0 deaths

Secukinumab (300 mg) After Week 12

Serious events: 6 serious events

Other events: 36 other events

Deaths: 0 deaths

Secukinumab (150 mg) After Week 12

Serious events: 6 serious events

Other events: 43 other events

Deaths: 0 deaths

Placebo Followed by Secukinumab (300 mg) After Week 12

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo Followed by Secukinumab (150 mg) After Week 12

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Secukinumab (300 mg) up to Week 12 n=48 participants at risk Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab up to 12 weeks.	Secukinumab (150 mg) up to Week 12 n=54 participants at risk Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab up to 12 weeks.	Placebo up to Week 12 n=49 participants at risk Participants were administered with placebo up to 12 weeks.	Secukinumab (300 mg) After Week 12 n=48 participants at risk 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).	Secukinumab (150 mg) After Week 12 n=54 participants at risk 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).	Placebo Followed by Secukinumab (300 mg) After Week 12 n=26 participants at risk Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using prefilled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).	Placebo Followed by Secukinumab (150 mg) After Week 12 n=23 participants at risk Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using prefilled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
Ear and labyrinth disorders VESTIBULAR DISORDER	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Gastrointestinal disorders COLITIS	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Gastrointestinal disorders DUODENAL ULCER	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Gastrointestinal disorders GASTRIC ULCER	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Gastrointestinal disorders GASTRITIS EROSIVE	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations ANAL ABSCESS	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations ERYSIPELAS	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations HELICOBACTER INFECTION	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations PNEUMONIA BACTERIAL	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Injury, poisoning and procedural complications CLAVICLE FRACTURE	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Injury, poisoning and procedural complications JOINT DISLOCATION	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Musculoskeletal and connective tissue disorders HAEMARTHROSIS	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	2.0% 1/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Musculoskeletal and connective tissue disorders RHEUMATOID ARTHRITIS	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Musculoskeletal and connective tissue disorders VERTEBRAL FORAMINAL STENOSIS	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OVARIAN CANCER	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Nervous system disorders CEREBRAL INFARCTION	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Reproductive system and breast disorders UTERINE POLYP	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	2.0% 1/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Skin and subcutaneous tissue disorders PSORIASIS	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.

Other adverse events

Measure	Secukinumab (300 mg) up to Week 12 n=48 participants at risk Participants were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 300 mg secukinumab up to 12 weeks.	Secukinumab (150 mg) up to Week 12 n=54 participants at risk Participants were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks followed by 150 mg secukinumab up to 12 weeks.	Placebo up to Week 12 n=49 participants at risk Participants were administered with placebo up to 12 weeks.	Secukinumab (300 mg) After Week 12 n=48 participants at risk 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).	Secukinumab (150 mg) After Week 12 n=54 participants at risk 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).	Placebo Followed by Secukinumab (300 mg) After Week 12 n=26 participants at risk Participants were administered with placebo until week 12 followed by 300 mg secukinumab s.c. using prefilled syringe every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection).	Placebo Followed by Secukinumab (150 mg) After Week 12 n=23 participants at risk Participants were administered with placebo until week 12 followed by 150 mg secukinumab s.c. using prefilled syringe every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection).
Blood and lymphatic system disorders LYMPHADENOPATHY	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	2.0% 1/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Eye disorders CONJUNCTIVITIS ALLERGIC	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Eye disorders DRY EYE	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Eye disorders EYE SWELLING	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	2.0% 1/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Gastrointestinal disorders BURNING MOUTH SYNDROME	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Gastrointestinal disorders CONSTIPATION	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Gastrointestinal disorders DIARRHOEA	4.2% 2/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	2.0% 1/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	5.6% 3/54 • From signing of Informed Consent up to 30 days post last drug treatment.	11.5% 3/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Gastrointestinal disorders DYSPEPSIA	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Gastrointestinal disorders DYSPHAGIA	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	4.2% 2/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Gastrointestinal disorders GASTRITIS	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	4.2% 2/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Gastrointestinal disorders GLOSSITIS	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Gastrointestinal disorders HAEMORRHOIDS	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	4.2% 2/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Gastrointestinal disorders NAUSEA	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Gastrointestinal disorders STOMATITIS	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Gastrointestinal disorders TOOTHACHE	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	4.2% 2/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
General disorders FATIGUE	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
General disorders INJECTION SITE PAIN	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	2.0% 1/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
General disorders OEDEMA PERIPHERAL	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations BRONCHITIS	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	6.2% 3/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations CANDIDA INFECTION	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	4.2% 2/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations CONJUNCTIVITIS	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	7.7% 2/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations ECTHYMA	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations FUNGAL INFECTION	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations GASTROENTERITIS	4.2% 2/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations GASTROINTESTINAL CANDIDIASIS	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations GASTROINTESTINAL INFECTION	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	2.0% 1/49 • From signing of Informed Consent up to 30 days post last drug treatment.	4.2% 2/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations GINGIVITIS	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	2.0% 1/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations HORDEOLUM	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations IMPETIGO	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations LARYNGITIS	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations NASOPHARYNGITIS	20.8% 10/48 • From signing of Informed Consent up to 30 days post last drug treatment.	25.9% 14/54 • From signing of Informed Consent up to 30 days post last drug treatment.	36.7% 18/49 • From signing of Informed Consent up to 30 days post last drug treatment.	43.8% 21/48 • From signing of Informed Consent up to 30 days post last drug treatment.	46.3% 25/54 • From signing of Informed Consent up to 30 days post last drug treatment.	38.5% 10/26 • From signing of Informed Consent up to 30 days post last drug treatment.	43.5% 10/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations ORAL CANDIDIASIS	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations ORAL HERPES	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	4.2% 2/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations OTITIS EXTERNA	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations OTITIS MEDIA	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations PARONYCHIA	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations PERIODONTITIS	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	5.6% 3/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations PHARYNGITIS	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations PULPITIS DENTAL	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations RHINITIS	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	4.1% 2/49 • From signing of Informed Consent up to 30 days post last drug treatment.	4.2% 2/48 • From signing of Informed Consent up to 30 days post last drug treatment.	5.6% 3/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	17.4% 4/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations ROOT CANAL INFECTION	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations SINUSITIS	4.2% 2/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations SKIN CANDIDA	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	2.0% 1/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	5.6% 3/54 • From signing of Informed Consent up to 30 days post last drug treatment.	2.0% 1/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Injury, poisoning and procedural complications ARTHROPOD BITE	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	4.2% 2/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Injury, poisoning and procedural complications BURNS FIRST DEGREE	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Injury, poisoning and procedural complications BURSA INJURY	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Injury, poisoning and procedural complications CONTUSION	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	2.0% 1/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Injury, poisoning and procedural complications LACERATION	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	6.2% 3/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Injury, poisoning and procedural complications MUSCLE RUPTURE	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Injury, poisoning and procedural complications THERMAL BURN	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	4.2% 2/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Musculoskeletal and connective tissue disorders ARTHRALGIA	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	10.2% 5/49 • From signing of Informed Consent up to 30 days post last drug treatment.	10.4% 5/48 • From signing of Informed Consent up to 30 days post last drug treatment.	5.6% 3/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	13.0% 3/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Musculoskeletal and connective tissue disorders BACK PAIN	4.2% 2/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	2.0% 1/49 • From signing of Informed Consent up to 30 days post last drug treatment.	8.3% 4/48 • From signing of Informed Consent up to 30 days post last drug treatment.	7.4% 4/54 • From signing of Informed Consent up to 30 days post last drug treatment.	19.2% 5/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	4.2% 2/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	6.2% 3/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Musculoskeletal and connective tissue disorders SPINAL PAIN	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	2.0% 1/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PYOGENIC GRANULOMA	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN PAPILLOMA	4.2% 2/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Nervous system disorders DIZZINESS	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	2.0% 1/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Nervous system disorders HEADACHE	8.3% 4/48 • From signing of Informed Consent up to 30 days post last drug treatment.	11.1% 6/54 • From signing of Informed Consent up to 30 days post last drug treatment.	4.1% 2/49 • From signing of Informed Consent up to 30 days post last drug treatment.	14.6% 7/48 • From signing of Informed Consent up to 30 days post last drug treatment.	13.0% 7/54 • From signing of Informed Consent up to 30 days post last drug treatment.	7.7% 2/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Nervous system disorders PARAESTHESIA	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Renal and urinary disorders HAEMATURIA	4.2% 2/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	7.7% 2/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Renal and urinary disorders NEPHROLITHIASIS	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Reproductive system and breast disorders DYSMENORRHOEA	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Reproductive system and breast disorders MENOPAUSAL SYMPTOMS	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Respiratory, thoracic and mediastinal disorders COUGH	4.2% 2/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	6.1% 3/49 • From signing of Informed Consent up to 30 days post last drug treatment.	4.2% 2/48 • From signing of Informed Consent up to 30 days post last drug treatment.	7.4% 4/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Respiratory, thoracic and mediastinal disorders NASAL INFLAMMATION	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	2.0% 1/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	5.6% 3/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Respiratory, thoracic and mediastinal disorders RHINITIS ALLERGIC	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	7.7% 2/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Skin and subcutaneous tissue disorders ALOPECIA	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Skin and subcutaneous tissue disorders DERMATITIS	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Skin and subcutaneous tissue disorders DERMATITIS ATOPIC	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Skin and subcutaneous tissue disorders ECZEMA	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Skin and subcutaneous tissue disorders ERYTHEMA	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Skin and subcutaneous tissue disorders INTERTRIGO	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Skin and subcutaneous tissue disorders PAPULE	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Skin and subcutaneous tissue disorders PRURITUS	4.2% 2/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	4.1% 2/49 • From signing of Informed Consent up to 30 days post last drug treatment.	4.2% 2/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Skin and subcutaneous tissue disorders PSORIASIS	4.2% 2/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	2.0% 1/49 • From signing of Informed Consent up to 30 days post last drug treatment.	4.2% 2/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Skin and subcutaneous tissue disorders SEBORRHOEIC DERMATITIS	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	4.1% 2/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Skin and subcutaneous tissue disorders SKIN FISSURES	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Skin and subcutaneous tissue disorders SKIN REACTION	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/49 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/48 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/54 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/26 • From signing of Informed Consent up to 30 days post last drug treatment.	4.3% 1/23 • From signing of Informed Consent up to 30 days post last drug treatment.
Vascular disorders HYPERTENSION	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	1.9% 1/54 • From signing of Informed Consent up to 30 days post last drug treatment.	2.0% 1/49 • From signing of Informed Consent up to 30 days post last drug treatment.	2.1% 1/48 • From signing of Informed Consent up to 30 days post last drug treatment.	3.7% 2/54 • From signing of Informed Consent up to 30 days post last drug treatment.	3.8% 1/26 • From signing of Informed Consent up to 30 days post last drug treatment.	0.00% 0/23 • From signing of Informed Consent up to 30 days post last drug treatment.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862--778--8300

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER