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Clinical Trial Results:
A randomized, double-blind, placebo-controlled, multicenter, exploratory evaluation of surrogate markers of cardiovascular risk in patients with active chronic plaque-type psoriasis treated for 52 weeks with subcutaneous (s.c.) secukinumab (300 mg and 150 mg)

Summary
EudraCT number	2013-002266-40
Trial protocol	DE
Global end of trial date	21 Apr 2016

Results information
Results version number	v1(current)
This version publication date	05 May 2017
First version publication date	05 May 2017
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

CAIN457ADE02

ISRCTN number

US NCT number

NCT02559622

WHO universal trial number (UTN)

Sponsor organisation name

Novartis Pharma AG

Sponsor organisation address

CH-4002, Basel, Switzerland,

Public contact

Novartis Pharma AG, Clinical Disclosure Office, +41 613241111,

Scientific contact

Novartis Pharma AG, Clinical Disclosure Office, +41 613241111,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

21 Apr 2016

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

21 Apr 2016

Was the trial ended prematurely?

Main objective of the trial

The main objective of the study was to evaluate flow mediated dilation (FMD) by Doppler ultrasound at week 12 in subjects treated with 300 milligrams (mg) secukinumab compared to the pooled group of subjects treated with placebo up to week 12.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

01 Apr 2014

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Germany: 151

Worldwide total number of subjects

151

EEA total number of subjects

151

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

140

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The study was conducted at 23 centres in Germany.

Screening details

A total of 151 subjects were randomised and treated in the study.

Period 1 title

Overall period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Carer, Assessor, Subject, Investigator

Are arms mutually exclusive

Yes

Secukinumab 300 mg

Arm description

Subjects were administered with 300 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).

Arm type

Experimental

Investigational medicinal product name

Secukinumab

Investigational medicinal product code

AIN457

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks until week 48 (last injection).

Secukinumab 150 mg

Arm description

Subjects 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).

Arm type

Experimental

Investigational medicinal product name

Secukinumab

Investigational medicinal product code

AIN457

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks until week 48 (last injection).

Placebo followed by 300 mg secukinumab

Arm description

Subjects 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).

Arm type

Experimental

Investigational medicinal product name

Secukinumab

Investigational medicinal product code

AIN457

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects were administered with 300 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks until week 48 (last injection).

Placebo followed by 150 mg secukinumab

Arm description

Subjects 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).

Arm type

Experimental

Investigational medicinal product name

Secukinumab

Investigational medicinal product code

AIN457

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects were administered with 150 mg secukinumab s.c. using pre-filled syringe every week for 4 weeks until week 48 (last injection).

Number of subjects in period 1	Secukinumab 300 mg	Secukinumab 150 mg	Placebo followed by 300 mg secukinumab	Placebo followed by 150 mg secukinumab
Started	48	54	26	23
Completed	47	49	24	20
Not completed	1	5	2	3
Adverse event, non-fatal	-	2	2	2
Progressive disease	-	1	-	-
Subject/guardian decision	1	2	-	1

Baseline characteristics

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Reporting group title

Secukinumab 300 mg

Reporting group description

Subjects were administered with 300 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).

Reporting group title

Secukinumab 150 mg

Reporting group description

Subjects 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).

Reporting group title

Placebo followed by 300 mg secukinumab

Reporting group description

Reporting group title

Placebo followed by 150 mg secukinumab

Reporting group description

Reporting group values	Secukinumab 300 mg	Secukinumab 150 mg	Placebo followed by 300 mg secukinumab	Placebo followed by 150 mg secukinumab	Total
Number of subjects	48	54	26	23	151
Age categorical
Units: Subjects
Adults (18-64 years)	46	46	26	22	140
From 65-84 years	2	8	0	1	11
Age continuous
Units: years
arithmetic mean (standard deviation)	44.2 ( 12.9 )	46 ( 14.4 )	43.7 ( 11.4 )	46.8 ( 13.1 )	-
Gender categorical
Units: Subjects
Female	11	23	8	7	49
Male	37	31	18	16	102

End points

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Reporting group title

Secukinumab 300 mg

Reporting group description

Subjects were administered with 300 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).

Reporting group title

Secukinumab 150 mg

Reporting group description

Subjects 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).

Reporting group title

Placebo followed by 300 mg secukinumab

Reporting group description

Reporting group title

Placebo followed by 150 mg secukinumab

Reporting group description

Subject analysis set title

Placebo (Pooled)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subjects 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).

Primary: Flow Mediated Dilation (FMD) at Week 12 followed by secukinumab 300 mg vs pooled placebo treatment

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End point title

Flow Mediated Dilation (FMD) at Week 12 followed by secukinumab 300 mg vs pooled placebo treatment ^[1]

End point description

Flow Mediated Dilation (FMD) is non-invasive method evaluated by Doppler Ultrasound test, to assess endothelial function. FMD was calculated as the percent maximal deviation from the baseline arterial diameter (D):FMD = 100*[(D maximum – D baseline) / D baseline]. Here, arterial diameter (brachial artery) was measured at rest (1 minute), during inflation of the distal cuff to 100 millimeter of mercury (mmHg) for 4.5 minutes and for 4.5 minutes following deflation. The analysis was performed in Full analysis set (FAS) population, defined as all subjects from the randomized set who received at least one dose of study drug. Here, "Number of subjects analyzed" signifies subjects evaluable for FMD at Week 12 for each arm, respectively.

End point type

Primary

End point timeframe

Week 12

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint was planned to evaluate statistics for the specified arm only.

End point values	Secukinumab 300 mg	Placebo (Pooled)
Number of subjects analysed	39	38
Units: Percentage maximal increase in diameter
arithmetic mean (standard deviation)	5.23 ( 5.3 )	3.65 ( 4.07 )

Flow Mediated Dilation (FMD) at Week 12

Comparison groups

Secukinumab 300 mg v Placebo (Pooled)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.223

Method

ANCOVA

Parameter type

Least Square (LS) mean difference

Point estimate

1.17

Confidence interval

level

95%

sides

2-sided

lower limit

-0.72

upper limit

3.06

Secondary: Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52

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End point title

Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52

End point description

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 (NOT arterial pulse wave velocity) constitutes an improvement in endothelial function. The analysis was performed in FAS population. Here, "Number of subjects analyzed" signifies subjects evaluable for FMD at Week 4, 12, 24 and 52 for each arm, respectively.

End point type

Secondary

End point timeframe

Baseline, Week 4, 12, 24 and 52

End point values	Secukinumab 300 mg	Secukinumab 150 mg	Placebo followed by 300 mg secukinumab	Placebo followed by 150 mg secukinumab
Number of subjects analysed	48	54	26	23
Units: Percentage change in FMD
arithmetic mean (confidence interval 95%)
Week 4 (n = 37,47,21,16)	-0.7 (-1.9 to 0.5)	-0.9 (-2.4 to 0.7)	0.7 (-1 to 2.5)	1.4 (-0.8 to 3.6)
Week 12 (n = 39,48,21,17)	0.5 (-1.1 to 2.1)	0.1 (-1.2 to 1.5)	-0.1 (-2.7 to 2.4)	0.1 (-2.1 to 2.3)
Week 24 (n = 35,39,19,16)	-0.8 (-1.9 to 0.3)	1 (-0.4 to 2.4)	0 (-2.6 to 2.6)	0.9 (-1 to 2.9)
Week 52 (n = 38,43,20,17)	2.1 (0.8 to 3.3)	2.1 (0.7 to 3.4)	2.2 (-0.5 to 4.9)	1.2 (-1 to 3.5)

No statistical analyses for this end point

Secondary: Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52

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End point title

Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52

End point description

Pulse wave analysis was performed on the central aortic pressure waveform as derived by SphygmoCor XCEL from the brachial pressure waveform recorded in a partially-inflated blood pressure cuff around the upper arm. The waveform derivation employs a validated generalized transfer function to convert a brachial waveform to a central waveform and has been shown to produce measurement results corresponding to measurements using intra-arterial pressure catheters. The augmentation index is derived from the waveform by determining the percentage of the central pulse pressure during systole due to wave reflection. AIx was heart-rate corrected to calculate the AIx at a heart rate of 75 bpm, i.e. AIx-75. The analysis was performed in FAS population. Here, "Number of subjects analyzed" signifies subjects evaluable for FMD at Week 4, 12, 24 and 52 for each arm, respectively.

End point type

Secondary

End point timeframe

Baseline, Week 4, 12, 24 and 52

End point values	Secukinumab 300 mg	Secukinumab 150 mg	Placebo followed by 300 mg secukinumab	Placebo followed by 150 mg secukinumab
Number of subjects analysed	48	54	26	23
Units: Percentage change in Alx-75
arithmetic mean (confidence interval 95%)
Week 4 (n = 47,52,25,21)	0 (-2.8 to 2.9)	0.3 (-2 to 2.7)	1.1 (-1.7 to 3.8)	-0.1 (-3 to 2.9)
Week 12 (n = 48,52,26,21)	-0.5 (-3 to 2.1)	1 (-1.7 to 3.8)	-1.1 (-5.4 to 3.3)	-0.1 (-3.4 to 3.2)
Week 24 (n = 47,50,24,21)	3 (0.3 to 5.6)	1.8 (-0.6 to 4.3)	1.3 (-2.7 to 5.3)	0.7 (-2.7 to 4.1)
Week 52 (n = 47,49,25,20)	1.3 (-1.5 to 4.2)	-0.1 (-2.8 to 2.7)	-1.4 (-5.8 to 2.9)	-0.9 (-4.2 to 2.5)

No statistical analyses for this end point

Secondary: Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52

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End point title

Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52

End point description

Regional arterial pulse wave velocity (PWV) was directly related to arterial stiffness and was defined as the time it takes for the blood pressure wave to travel from a proximal site to a distal site (relative to the heart) divided by the distance (PWV = ∆distance/∆time [m/s]). The foot of the arterial pulse wave was being recorded by using the SphygmoCor XCEL device. XCEL simultaneously measures the pressure waveform at the femoral site (using a partially inflated custom blood pressure cuff) and the carotid site (using hand-held applanation tonometry). The foot-to-foot time between the two pressure waveforms was the time interval used in the PWV calculation. The analysis was performed in FAS population. Here, "n" signifies the sum of subjects for all repeated measurements during calculation of mean, evaluable for PWV at defined time-frame for each arm, respectively.

End point type

Secondary

End point timeframe

Baseline, Week 4, 12, 24 and 52

End point values	Secukinumab 300 mg	Secukinumab 150 mg	Placebo followed by 300 mg secukinumab	Placebo followed by 150 mg secukinumab
Number of subjects analysed	48	54	26	23
Units: meters per second (m/s)
arithmetic mean (confidence interval 95%)
Week 4 (n = 192, 262, 133, 104)	0 (-0.2 to 0.2)	-0.2 (-0.3 to 0)	0 (-0.1 to 0.2)	-0.2 (-0.5 to 0.2)
Week 12 (n = 214, 255, 116, 133)	0.4 (0.2 to 0.6)	0.1 (-0.1 to 0.2)	0.1 (-0.2 to 0.4)	0.4 (0.1 to 0.7)
Week 24 (n = 205, 255, 100, 100)	0.2 (-0.1 to 0.5)	0 (-0.2 to 0.1)	0.2 (0.1 to 0.4)	-0.1 (-0.5 to 0.2)
Week 52 (n = 191, 228, 115, 101)	-0.1 (-0.3 to 0)	0.2 (-0.1 to 0.5)	0.1 (-0.2 to 0.4)	-0.2 (-0.6 to 0.2)

No statistical analyses for this end point

Secondary: Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12

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End point title

Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12

End point description

Magnetic resonance imaging (MRI) was used to evaluate vessel wall morphometry to determine plaque burden. As a measure of plaque burden, average wall area was computed by subtracting vessel lumen area from total vessel area. Exploratory 3.0 Tesla MRI technique was applied to assess structure and function of the carotid and the aorta. A 2D axial dark blood T1, T2, proton density weighted spin echo based images and time of flight images were acquired from the bilateral carotid arteries as well as the descending aorta. The analysis was performed in FAS population. Here, "n" signifies subjects evaluable for MRI sub-study at week 12 for each arm, respectively. MRI was applied in a sub-study population of 33 subjects.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Secukinumab 300 mg	Secukinumab 150 mg	Placebo followed by 300 mg secukinumab	Placebo followed by 150 mg secukinumab
Number of subjects analysed	48	54	26	23
Units: millimeter square (mm^2)
arithmetic mean (confidence interval 95%)
Ascending thoracic aorta (n = 10,11,4,6)	15.35 (-8.23 to 38.92)	5.91 (-13.09 to 24.91)	9.92 (-58.24 to 78.08)	6.45 (-9.26 to 22.15)
Descending thoracic aorta (n = 10,11,4,7)	2.69 (-14.18 to 19.56)	-2.94 (-13.44 to 7.57)	-4.04 (-29.61 to 21.53)	3.16 (-13.73 to 20.05)
Carotid bifurcation left (n = 11,11,4,7)	0.52 (-2.72 to 3.77)	-1.08 (-3.85 to 1.69)	3.63 (-7.82 to 15.08)	1.12 (-2.04 to 4.28)
Carotid bifurcation right (n = 11,11,4,7)	-0.77 (-3.6 to 2.06)	1.75 (-0.71 to 4.21)	-1.26 (-7.64 to 5.12)	-1.07 (-4.24 to 2.1)
Common carotid left (n = 11,11,4,6)	0.17 (-1.64 to 1.99)	1.12 (-1.8 to 4.03)	0.69 (-5.21 to 6.59)	0.12 (-1.91 to 2.15)
Common carotid right (n = 11,11,4,7)	-0.12 (-2.17 to 1.92)	0.3 (-2.76 to 3.36)	-0.38 (-6.56 to 5.8)	-0.14 (-1.6 to 1.32)
Internal carotid left (n = 9,10,4,5)	3.79 (-0.19 to 7.78)	2.09 (-0.57 to 4.75)	2.59 (-0.58 to 5.77)	-1.74 (-4.55 to 1.08)
Internal carotid right (n = 11,11,4,7)	-0.69 (-1.9 to 0.51)	0.17 (-1.96 to 2.3)	0.68 (-3.97 to 5.33)	-1.37 (-4.37 to 1.62)
Descending abdominal aorta (n = 8,9,4,6)	8.71 (-6.33 to 23.76)	-3.79 (-21.9 to 14.32)	4.56 (-52.64 to 61.77)	-0.58 (-15.51 to 14.35)

No statistical analyses for this end point

Secondary: Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52

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End point title

Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52

End point description

End point type

Secondary

End point timeframe

Baseline, Week 52

End point values	Secukinumab 300 mg	Secukinumab 150 mg	Placebo followed by 300 mg secukinumab	Placebo followed by 150 mg secukinumab
Number of subjects analysed	48	54	26	23
Units: mm^2
arithmetic mean (confidence interval 95%)
Ascending thoracic aorta (n = 10,11,4,6)	14.42 (-14.93 to 43.76)	3.19 (-17.17 to 23.55)	-15.11 (-28.15 to -2.06)	9.54 (-14.71 to 33.79)
Descending thoracic aorta (n = 10,11,4,7)	3.97 (-13.42 to 21.37)	2.55 (-12.23 to 17.33)	-10.14 (-34.05 to 13.77)	1.14 (-26.76 to 29.05)
Carotid bifurcation left (n = 11,11,4,7)	2.45 (-1.55 to 6.45)	0.64 (-3.59 to 4.88)	0.58 (-9.03 to 10.2)	2.6 (-2.16 to 7.36)
Carotid bifurcation right (n = 11,11,4,7)	-1.64 (-6.02 to 2.74)	-0.05 (-3.62 to 3.51)	-3.23 (-9.86 to 3.4)	1.25 (-3.92 to 6.41)
Common carotid left (n = 11,11,4,6)	1.42 (-0.36 to 3.19)	1.21 (-1.51 to 3.93)	0.65 (-2.82 to 4.13)	1 (-0.83 to 2.82)
Common carotid right (n = 11,11,4,7)	0.02 (-2.54 to 2.58)	0.23 (-2.29 to 2.75)	-0.8 (-6.25 to 4.64)	-1.38 (-3.33 to 0.57)
Internal carotid left (n = 9,10,4,5)	5.43 (1.21 to 9.65)	3.59 (0.59 to 6.6)	1.06 (-2.66 to 4.78)	0.33 (-5.07 to 5.73)
Internal carotid right (n = 11,11,4,7)	-1.07 (-2.12 to -0.03)	0.71 (-1.78 to 3.21)	-0.2 (-3.89 to 3.49)	0.13 (-2.22 to 2.48)
Descending abdominal aorta (n = 8,9,4,6)	10.56 (-8.37 to 29.48)	-4.36 (-17.9 to 9.19)	12.46 (-46.12 to 71.05)	11.82 (-15.26 to 38.9)

No statistical analyses for this end point

Secondary: Change from Baseline in High sensitivity C-reactive protein (hsCRP) at Week 4, 12, 24 and 52

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End point title

Change from Baseline in High sensitivity C-reactive protein (hsCRP) at Week 4, 12, 24 and 52

End point description

High sensitivity C-reactive protein (hsCRP), a soluble biomarker of systemic inflammation was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation. The analysis was performed in FAS population. Here, "n" signifies subjects evaluable for this outcome measure at weeks 4, 12, 24 and 52 for each arm, respectively.

End point type

Secondary

End point timeframe

Baseline, Week 4, 12, 24 and 52

End point values	Secukinumab 300 mg	Secukinumab 150 mg	Placebo followed by 300 mg secukinumab	Placebo followed by 150 mg secukinumab
Number of subjects analysed	48	54	26	23
Units: Milligrams per decilitres (mg/dL)
arithmetic mean (confidence interval 95%)
Week 4 (n = 48,53,26,21)	0 (-0.2 to 0.2)	-0.2 (-0.4 to -0.1)	0 (-0.2 to 0.2)	0.1 (-0.1 to 0.3)
Week 12 (n = 48,54,26,21)	0 (-0.3 to 0.3)	-0.2 (-0.3 to 0)	-0.3 (-0.8 to 0.1)	0.1 (-0.4 to 0.6)
Week 24 (n = 48,52,25,21)	0 (-0.3 to 0.2)	0 (-0.3 to 0.2)	0.1 (-0.2 to 0.4)	-0.4 (-0.9 to 0.1)
Week 52 (n = 48,50,26,20)	-0.1 (-0.3 to 0.1)	-0.2 (-0.4 to 0)	-0.3 (-0.8 to 0.2)	-0.5 (-1.1 to 0)

No statistical analyses for this end point

Secondary: Change from Baseline in S-100 protein B (total) at Week 4, 12, 24 and 52

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End point title

Change from Baseline in S-100 protein B (total) at Week 4, 12, 24 and 52

End point description

S100 calcium-binding protein B (S100B-protein), a soluble biomarker of systemic inflammation was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation. The analysis was performed in FAS population. Here, "n" signifies subjects evaluable for this outcome measure at weeks 4, 12, 24 and 52 for each arm, respectively.

End point type

Secondary

End point timeframe

Baseline, Week 4, 12, 24 and 52

End point values	Secukinumab 300 mg	Secukinumab 150 mg	Placebo followed by 300 mg secukinumab	Placebo followed by 150 mg secukinumab
Number of subjects analysed	48	54	26	23
Units: Micrograms per Litre (ug/L)
arithmetic mean (confidence interval 95%)
Week 4 (n = 48,53,26,22)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Week 12 (n = 48,52,26,22)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Week 24 (n = 48,51,25,22)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Week 52 (n = 48,51,26,22)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)

No statistical analyses for this end point

Secondary: Change from Baseline in Chemokine (c-c motif) ligand 5 (CCL5), Monocyte chemoattractant protein 1 (MCP-1) and Macrophage inflammatory proteins (MIP) 1 alpha and 1 beta at Week 4, 12, 24 and 52

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End point title

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

End point description

Chemokine (c-c motif) ligand 5 (CCL5), Monocyte chemoattractant protein 1 (MCP-1) and Macrophage inflammatory proteins (MIP) 1 alpha (1A) and 1 beta (1B), soluble biomarkers of systemic inflammation were determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation. The analysis was performed in FAS population. Here, "n" signifies subjects evaluable for this outcome measure at weeks 4, 12, 24 and 52 for each arm, respectively.

End point type

Secondary

End point timeframe

Baseline, Week 4, 12, 24 and 52

End point values	Secukinumab 300 mg	Secukinumab 150 mg	Placebo followed by 300 mg secukinumab	Placebo followed by 150 mg secukinumab
Number of subjects analysed	48	4	26	23
Units: picograms per millilitres (pg/mL)
arithmetic mean (confidence interval 95%)
CCL5 Week 4 (n = 48,54,26,22)	-1000 (-3106 to 1094)	1649 (-597 to 3895)	27 (-3943 to 3997)	-2000 (-5056 to 281.3)
CCL5 Week 12 (n = 48,54,26,22)	2116 (-2368 to 6599)	5185 (840.3 to 9530)	4393 (-1598 to 10383)	3002 (-1806 to 7809)
CCL5 Week 24 (n = 48,52,25,22)	7772 (3766 to 11777)	10000 (6437 to 14394)	11000 (2117 to 20176)	9168 (2124 to 16212)
CCL5 Week 52 (n = 48,51,25,22)	1515 (-2478 to 5507)	3577 (-737 to 7891)	-597 (-3340 to 2145)	2308 (-2558 to 7175)
MCP-1 Week 4 (n = 48,54,26,22)	-7 (-21.8 to 7.7)	1.4 (-17.4 to 20.2)	-25 (-57.2 to 8)	17.5 (-43.1 to 78)
MCP-1 Week 12 (n = 48,54,26,22)	18.4 (-1.9 to 38.7)	28.6 (-8.4 to 65.7)	11.3 (-40.9 to 63.5)	21.5 (-18.3 to 61.2)
MCP-1 Week 24 (n = 48,52,25,22)	39.8 (-0.6 to 80.3)	241 (-203 to 685.7)	-20 (-53.9 to 14.2)	33.4 (8.3 to 58.5)
MCP-1 Week 52 (n = 48,51,25,22)	22.1 (-18.1 to 62.4)	25.4 (-21.7 to 72.6)	-11 (-60.6 to 38.6)	109 (-13.3 to 230.9)
MIP-1A Week 4 (n = 48,54,26,22)	-0.1 (-2.1 to 1.9)	0.1 (-1.6 to 1.8)	0.5 (-2.5 to 3.5)	-0.6 (-2.3 to 1.2)
MIP-1A Week 12 (n = 48,54,26,22)	0.2 (-2.8 to 3.3)	2.2 (-1 to 5.3)	-3.6 (-7 to -0.3)	0.9 (-3 to 4.8)
MIP-1A Week 24 (n = 48,52,25,22)	-0.2 (-2.9 to 2.4)	-0.5 (-3.6 to 2.6)	-4.7 (-8.4 to -1)	1.7 (-1.3 to 4.7)
MIP-1A Week 52 (n = 48,51,25,22)	4.3 (-0.1 to 8.7)	0.8 (-3 to 4.5)	1.7 (-6 to 9.5)	20.1 (4.7 to 35.6)
MIP-1B Week 4 (n = 48,54,26,22)	-24 (-50.8 to 3)	-2.6 (-24.8 to 19.5)	-16 (-57.5 to 25.8)	-20 (-54.4 to 15.3)
MIP-1B Week 12 (n = 48,54,26,22)	-49 (-80.9 to -16.6)	-34 (-69 to 1.4)	-65 (-106 to -24.7)	-68 (-116 to -20.5)
MIP-1B Week 24 (n = 48,52,25,22)	-52 (-130 to 26.7)	-97 (-133 to -61.3)	-161 (-207 to -114)	79.4 (-261 to 420.3)
MIP-1B Week 52 (n = 48,51,25,22)	-41 (-73.6 to -8.6)	-59 (-89 to -29.7)	-73 (-122 to -24.2)	-31 (-109 to 46.8)

No statistical analyses for this end point

Secondary: Change from Baseline in Fasting plasma glucose (FPG) at Week 4, 12, 24 and 52

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End point title

Change from Baseline in Fasting plasma glucose (FPG) at Week 4, 12, 24 and 52

End point description

Fasting plasma glucose (FPG), a soluble biomarker of dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on dysglycemia. The analysis was performed in FAS population. Here, "n" signifies subjects evaluable for this outcome measure at weeks 4, 12, 24 and 52 for each arm, respectively.

End point type

Secondary

End point timeframe

Baseline, Week 4, 12, 24 and 52

End point values	Secukinumab 300 mg	Secukinumab 150 mg	Placebo followed by 300 mg secukinumab	Placebo followed by 150 mg secukinumab
Number of subjects analysed	48	54	26	23
Units: mg/dL
arithmetic mean (confidence interval 95%)
Week 4 (n = 47,53,26,22)	1.5 (-1 to 4)	-1.6 (-4.6 to 1.3)	0.9 (-4.4 to 6.1)	0.2 (-5.2 to 5.6)
Week 12 (n = 47,53,26,22)	3.5 (0 to 7)	1.1 (-4 to 6.2)	5.3 (-2.2 to 12.8)	-1.5 (-7.1 to 4)
Week 24 (n = 47,51,25,22)	2.5 (0 to 5)	1.4 (-6.3 to 9.1)	12.1 (-10.8 to 35)	-1.4 (-7.7 to 5)
Week 52 (n = 46,51,26,22)	-0.8 (-3.5 to 2)	0.7 (-3 to 4.4)	8.7 (-7.5 to 25)	0.9 (-6.7 to 8.6)

No statistical analyses for this end point

Secondary: Change from Baseline in Fasting Insulin at Week 4, 12, 24 and 52

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End point title

Change from Baseline in Fasting Insulin at Week 4, 12, 24 and 52

End point description

Fasting Insulin, a soluble biomarker of dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on dysglycemia. The analysis was performed in FAS population. Here, "n" signifies subjects evaluable for this outcome measure at weeks 4, 12, 24 and 52 for each arm, respectively.

End point type

Secondary

End point timeframe

Baseline, Week 4, 12, 24 and 52

End point values	Secukinumab 300 mg	Secukinumab 150 mg	Placebo followed by 300 mg secukinumab	Placebo followed by 150 mg secukinumab
Number of subjects analysed	48	54	26	23
Units: micro units per milliliter (uU/mL)
arithmetic mean (confidence interval 95%)
Week 4 (n = 48,53,26,22)	0.4 (-2 to 2.7)	0.4 (-2.3 to 3)	-4.7 (-17.4 to 8.1)	-0.5 (-4.8 to 3.7)
Week 12 (n = 48,52,26,22)	-1.4 (-5.1 to 2.4)	1.1 (-2.7 to 4.8)	-2.2 (-9.2 to 4.7)	-0.1 (-4.9 to 4.7)
Week 24 (n = 48,51,25,22)	-1 (-4.1 to 2)	0.5 (-3.7 to 4.8)	-5.3 (-18.5 to 8)	-2 (-6.1 to 2)
Week 52 (n = 48,51,26,22)	-0.4 (-4.3 to 3.6)	1.5 (-1.3 to 4.2)	-1.2 (-7.5 to 5.1)	3 (-5.2 to 11.3)

No statistical analyses for this end point

Secondary: Change from Baseline in Homeostatic Model Assessment (HOMA) beta-cell function at Week 4, 12, 24 and 52

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End point title

Change from Baseline in Homeostatic Model Assessment (HOMA) beta-cell function at Week 4, 12, 24 and 52

End point description

Homeostatic Model Assessment (HOMA) beta-cell function, a soluble biomarker of dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on dysglycemia. The analysis was performed in FAS population. Here, "n" signifies subjects evaluable for this outcome measure at weeks 4, 12, 24 and 52 for each arm, respectively.

End point type

Secondary

End point timeframe

Baseline, Week 4, 12, 24 and 52

End point values	Secukinumab 300 mg	Secukinumab 150 mg	Placebo followed by 300 mg secukinumab	Placebo followed by 150 mg secukinumab
Number of subjects analysed	48	54	26	23
Units: Percentage
arithmetic mean (confidence interval 95%)
Week 4 (n = 42,51,24,21)	-18 (-64.7 to 28.2)	-0.2 (-25.7 to 25.3)	-28 (-88.4 to 33)	-8.9 (-38.5 to 20.7)
Week 12 (n = 44,50,23,22)	-16 (-74.4 to 41.5)	3.9 (-32 to 39.8)	-29 (-100 to 41.6)	16.6 (-20.6 to 53.8)
Week 24 (n = 44,50,24,22)	-25 (-53.9 to 3.5)	-8.2 (-40.2 to 23.9)	-35 (-111 to 40.7)	-26 (-63.2 to 12)
Week 52 (n = 43,50,25,22)	11.5 (-40.5 to 63.5)	-1.6 (-32.6 to 29.4)	9.3 (-56.4 to 75.1)	11.6 (-26.6 to 49.7)

No statistical analyses for this end point

Secondary: Change from Baseline in Homeostatic Model Assessment (HOMA) insulin resistance at Week 4, 12, 24 and 52

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End point title

Change from Baseline in Homeostatic Model Assessment (HOMA) insulin resistance at Week 4, 12, 24 and 52

End point description

HOMA insulin resistance, a soluble biomarker of dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on dysglycemia. The analysis was performed in FAS population. Here, "n" signifies subjects evaluable for this outcome measure at weeks 4, 12, 24 and 52 for each arm, respectively.

End point type

Secondary

End point timeframe

Baseline, Week 4, 12, 24 and 52

End point values	Secukinumab 300 mg	Secukinumab 150 mg	Placebo followed by 300 mg secukinumab	Placebo followed by 150 mg secukinumab
Number of subjects analysed	48	54	26	23
Units: Insulin Resistance Index
arithmetic mean (confidence interval 95%)
Week 4 (n = 42,51,24,21)	0.3 (-0.6 to 1.2)	0.1 (-0.9 to 1)	-1.1 (-5.2 to 3.1)	-0.3 (-2 to 1.3)
Week 12 (n = 44,50,23,22)	-0.1 (-1.5 to 1.4)	0.6 (-0.7 to 1.8)	-0.1 (-2.5 to 2.3)	-0.4 (-2 to 1.3)
Week 24 (n = 44,50,24,22)	-0.3 (-1.1 to 0.6)	0.6 (-1.3 to 2.5)	-1.1 (-5 to 2.8)	-0.7 (-2.2 to 0.8)
Week 52 (n = 43,50,25,22)	-0.2 (-1.2 to 0.9)	0.6 (-0.3 to 1.4)	-0.2 (-2.8 to 2.4)	0.7 (-1.9 to 3.4)

No statistical analyses for this end point

Secondary: Change from Baseline in Hemoglobin A1c (glycated hemoglobin) at Week 4, 12, 24 and 52

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End point title

Change from Baseline in Hemoglobin A1c (glycated hemoglobin) at Week 4, 12, 24 and 52

End point description

Hemoglobin A1c (glycated hemoglobin), a soluble biomarker of dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on dysglycemia. The analysis was performed in FAS population. Here, "n" signifies subjects evaluable for this outcome measure at weeks 4, 12, 24 and 52 for each arm, respectively.

End point type

Secondary

End point timeframe

Baseline, Week 4, 12, 24 and 52

End point values	Secukinumab 300 mg	Secukinumab 150 mg	Placebo followed by 300 mg secukinumab	Placebo followed by 150 mg secukinumab
Number of subjects analysed	48	54	26	23
Units: millimoL/moL of Hemoglobin
arithmetic mean (confidence interval 95%)
Week 4 (n = 48,52,26,22)	0.2 (-0.5 to 0.8)	-0.4 (-1 to 0.3)	-0.7 (-2.3 to 1)	-0.4 (-1.2 to 0.4)
Week 12 (n = 48,54,26,22)	0.4 (-0.7 to 1.5)	-0.4 (-2.2 to 1.4)	-1.2 (-3.8 to 1.3)	0.1 (-0.8 to 1)
Week 24 (n = 48,52,25,22)	-0.4 (-1.7 to 1)	-1.2 (-2.9 to 0.5)	-0.1 (-2.4 to 2.1)	-1.2 (-2.9 to 0.6)
Week 52 (n = 48,52,26,22)	-1.1 (-2.3 to 0.1)	-2.8 (-6.1 to 0.4)	-1.9 (-4.3 to 0.6)	-2.1 (-3 to -1.2)

No statistical analyses for this end point

Secondary: Change from Baseline in Sex hormone-binding globulin (SHBG) at Week 4, 12, 24 and 52

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End point title

Change from Baseline in Sex hormone-binding globulin (SHBG) at Week 4, 12, 24 and 52

End point description

Sex hormone-binding globulin (SHBG), a soluble biomarker of dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on dysglycemia. The analysis was performed in FAS population. Here, "n" signifies subjects evaluable for this outcome measure at weeks 4, 12, 24 and 52 for each arm, respectively.

End point type

Secondary

End point timeframe

Baseline, Week 4, 12, 24 and 52

End point values	Secukinumab 300 mg	Secukinumab 150 mg	Placebo followed by 300 mg secukinumab	Placebo followed by 150 mg secukinumab
Number of subjects analysed	48	54	26	23
Units: nmoL/L
arithmetic mean (confidence interval 95%)
Week 4 (n = 48,53,26,21)	0.1 (-1.8 to 2.1)	3.7 (-3 to 10.4)	4.7 (-4.2 to 13.5)	-0.3 (-4 to 3.5)
Week 12 (n = 48,54,26,21)	-0.1 (-3.4 to 3.2)	1.1 (-1.8 to 4.1)	3.7 (-1.6 to 9.1)	4.1 (-0.2 to 8.4)
Week 24 (n = 48,52,25,21)	-1.5 (-5.1 to 2.2)	3.2 (-0.9 to 7.2)	1.7 (-2.9 to 6.3)	2.6 (-1.5 to 6.7)
Week 52 (n = 48,50,26,20)	-3.1 (-10.8 to 4.6)	5.9 (-1.3 to 13)	-2.6 (-14.9 to 9.6)	3.2 (-4.3 to 10.8)

No statistical analyses for this end point

Secondary: Change from Baseline in Adiponectin at Week 4, 12, 24 and 52

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End point title

Change from Baseline in Adiponectin at Week 4, 12, 24 and 52

End point description

Adiponectin, a soluble biomarker of impaired lipid metabolism was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation. The analysis was performed in FAS population. Here, "n" signifies subjects evaluable for this outcome measure at weeks 4, 12, 24 and 52 for each arm, respectively.

End point type

Secondary

End point timeframe

Baseline, Week 4, 12, 24 and 52

End point values	Secukinumab 300 mg	Secukinumab 150 mg	Placebo followed by 300 mg secukinumab	Placebo followed by 150 mg secukinumab
Number of subjects analysed	48	54	26	23
Units: ug/mL
arithmetic mean (confidence interval 95%)
Week 4 (n = 48,53,26,22)	-0.5 (-1 to -0.1)	0.2 (-0.4 to 0.8)	-0.1 (-0.8 to 0.5)	-0.6 (-1.2 to 0)
Week 12 (n = 48,52,26,22)	-0.5 (-1.1 to 0)	-0.2 (-0.7 to 0.3)	0.5 (0.1 to 0.9)	0.3 (-0.7 to 1.3)
Week 24 (n = 48,51,25,22)	0.3 (-0.3 to 0.9)	0.1 (-0.5 to 0.7)	0.7 (-0.3 to 1.8)	-0.6 (-1.6 to 0.3)
Week 52 (n = 48,51,26,22)	-1.1 (-1.6 to -0.6)	-0.9 (-1.5 to -0.3)	-0.4 (-1 to 0.2)	-1.1 (-2 to -0.3)

No statistical analyses for this end point

Secondary: Change from Baseline in Leptin at Week 4, 12, 24 and 52

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End point title

Change from Baseline in Leptin at Week 4, 12, 24 and 52

End point description

Leptin, a soluble biomarker of impaired lipid metabolism was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation. The analysis was performed in FAS population. Here, "n" signifies subjects evaluable for this outcome measure at weeks 4, 12, 24 and 52 for each arm, respectively.

End point type

Secondary

End point timeframe

Baseline, Week 4, 12, 24 and 52

End point values	Secukinumab 300 mg	Secukinumab 150 mg	Placebo followed by 300 mg secukinumab	Placebo followed by 150 mg secukinumab
Number of subjects analysed	48	54	26	23
Units: nanograms per millilitre (ng/mL)
arithmetic mean (confidence interval 95%)
Week 4 (n = 48,53,26,22)	-0.6 (-1.8 to 0.7)	1 (-0.1 to 2.2)	-0.2 (-1.6 to 1.2)	0.3 (-1.2 to 1.9)
Week 12 (n = 48,52,26,22)	0.2 (-0.7 to 1.1)	0.1 (-0.9 to 1.2)	0.7 (-1 to 2.4)	-0.3 (-1.7 to 1.2)
Week 24 (n = 48,51,25,22)	0.2 (-0.7 to 1.2)	1 (-0.5 to 2.4)	-0.3 (-2.8 to 2.3)	-1.4 (-4.9 to 2.1)
Week 52 (n = 48,51,26,22)	0.2 (-1 to 1.3)	-0.5 (-1.6 to 0.7)	-0.4 (-3.8 to 3)	-2.9 (-5.7 to 0)

No statistical analyses for this end point

Secondary: Change from Baseline in Soluble biomarkers of impaired lipid metabolism at Week 4, 12, 24 and 52

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End point title

Change from Baseline in Soluble biomarkers of impaired lipid metabolism at Week 4, 12, 24 and 52

End point description

Soluble biomarkers were determined in fasting blood samples to evaluate the effect of secukinumab on impaired lipid metabolism. Soluble biomarkers included Triglycerides, Total cholesterol, Low density lipoprotein (LDL), High density lipoprotein (HDL), Apolipoprotein A-1 (ApoA-1) and Apolipoprotein B (ApoB). The analysis was performed in FAS population. Here, "n" signifies subjects evaluable for this outcome measure at weeks 4, 12, 24 and 52 for each arm, respectively.

End point type

Secondary

End point timeframe

Baseline, Week 4, 12, 24 and 52

End point values	Secukinumab 300 mg	Secukinumab 150 mg	Placebo followed by 300 mg secukinumab	Placebo followed by 150 mg secukinumab
Number of subjects analysed	48	54	26	23
Units: mg/dL
arithmetic mean (confidence interval 95%)
Triglycerides Week 4 (n = 48,53,26,21)	-1.8 (-15.5 to 12)	6.5 (-5.9 to 18.9)	12.7 (-12.2 to 37.7)	27.5 (-6.6 to 61.6)
Triglycerides Week 12 (n = 48,54,26,21)	-9.3 (-20.8 to 2.3)	4 (-9.3 to 17.3)	5.9 (-32.4 to 44.2)	2.7 (-18.3 to 23.8)
Triglycerides Week 24 (n = 48,52,25,21)	4.6 (-16.6 to 25.8)	3.9 (-9.1 to 16.9)	32.8 (-19.7 to 85.2)	17.1 (-2.3 to 36.5)
Triglycerides Week 52 (n = 48,50,26,20)	64.6 (-44 to 173.2)	2.6 (-11.7 to 16.9)	-6 (-54.3 to 42.3)	11.9 (-8.6 to 32.3)
Total cholesterol Week 4 (n = 48,53,26,21)	0.4 (-6.4 to 7.1)	7.1 (1.1 to 13.2)	4.8 (-3.2 to 12.8)	-2.7 (-10 to 4.7)
Total cholesterol Week 12 (n = 48,54,26,21)	3.1 (-3.1 to 9.4)	3.6 (-4.1 to 11.2)	10 (2.8 to 17.1)	-4.2 (-11.2 to 2.8)
Total cholesterol Week 24 (n = 48,52,25,21)	0.9 (-5.2 to 7.1)	0.6 (-4.9 to 6.1)	7.2 (-1.5 to 16)	-3.2 (-12 to 5.5)
Total cholesterol Week 52 (n = 48,50,26,20)	7.8 (0 to 15.6)	2.3 (-5.2 to 9.9)	8.9 (2.1 to 15.7)	2.9 (-5.9 to 11.7)
LDL Week 4 (n = 48,53,26,21)	1.1 (-4.6 to 6.8)	6.8 (0.8 to 12.8)	5.2 (-2 to 12.4)	-5.6 (-12.1 to 0.8)
LDL Week 12 (n = 48,54,26,21)	2.9 (-2.2 to 7.9)	2.7 (-4.8 to 10.1)	9.5 (3.4 to 15.5)	-5.6 (-12.7 to 1.5)
LDL Week 24 (n = 48,52,25,21)	-2.7 (-8.1 to 2.7)	-1.3 (-6.9 to 4.4)	1.1 (-7.4 to 9.5)	-11 (-18.9 to -2.4)
LDL Week 52 (n = 48,50,26,20)	1.7 (-6.5 to 9.9)	-0.9 (-8.4 to 6.5)	8.2 (1.3 to 15)	1.1 (-8.4 to 10.5)
HDL Week 4 (n = 48,53,26,21)	-0.6 (-2.6 to 1.3)	0.4 (-1.5 to 2.2)	0.3 (-2.3 to 2.9)	-1.3 (-4.6 to 2)
HDL Week 12 (n = 48,54,26,21)	-0.4 (-2.4 to 1.6)	0.2 (-1.8 to 2.2)	1 (-1.2 to 3.3)	-0.5 (-4.9 to 3.8)
HDL Week 24 (n = 48,52,25,21)	1.2 (-1.5 to 3.9)	0.3 (-2.3 to 2.8)	-1.1 (-3.4 to 1.3)	0.5 (-4.1 to 5.1)
HDL Week 52 (n = 48,50,26,20)	0.1 (-2.1 to 2.4)	1.8 (-0.5 to 4.2)	-0.3 (-2.9 to 2.4)	-1.4 (-4.6 to 1.8)
ApoA-1 Week 4 (n = 48,53,26,21)	0.3 (-5.1 to 5.7)	0.9 (-4 to 5.7)	7.7 (-0.6 to 15.9)	-5.5 (-12 to 1)
ApoA-1 Week 12 (n = 48,54,26,21)	4 (-2 to 10.1)	2.4 (-1.9 to 6.8)	7.1 (1.2 to 12.9)	-3.3 (-12.1 to 5.5)
ApoA-1 Week 24 (n = 48,52,25,21)	5.5 (-0.9 to 12)	2.8 (-3 to 8.6)	3 (-3.3 to 9.3)	-3.1 (-11.3 to 5.1)
ApoA-1 Week 52 (n = 48,50,26,20)	-4.5 (-10 to 0.9)	-6 (-11.6 to -0.3)	-5.5 (-14.9 to 3.9)	-13 (-22.3 to -3.1)
ApoB Week 4 (n = 48,53,26,21)	1.5 (-2.7 to 5.6)	3.6 (0.5 to 6.6)	2.7 (-1.1 to 6.5)	-2.5 (-7.7 to 2.8)
ApoB Week 12 (n = 48,54,26,21)	4 (0.6 to 7.4)	3.4 (-0.5 to 7.3)	7.4 (3.9 to 11)	-1 (-7 to 4.9)
ApoB Week 24 (n = 48,52,25,21)	1 (-2.8 to 4.8)	2 (-1.3 to 5.3)	5.6 (1.4 to 9.9)	-4.2 (-10.7 to 2.3)
ApoB Week 52 (n = 48,50,26,20)	3.7 (-2.2 to 9.6)	2.3 (-1.8 to 6.4)	6.7 (3 to 10.5)	-0.2 (-5.4 to 5)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse Events were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

19.0

Reporting group title

Secukinumab (300 mg) up to Week 12

Reporting group description

Subjects 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.

Reporting group title

Secukinumab (150 mg) up to Week 12

Reporting group description

Subjects 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.

Reporting group title

Placebo up to Week 12

Reporting group description

Subjects were administered with placebo up to 12 weeks.

Reporting group title

Secukinumab (300 mg) after Week 12

Reporting group description

Subjects 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).

Reporting group title

Secukinumab (150 mg) after Week 12

Reporting group description

Subjects 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).

Reporting group title

Placebo followed by secukinumab (300 mg) after Week 12

Reporting group description

Reporting group title

Placebo followed by secukinumab (150 mg) after Week 12

Reporting group description

Serious adverse events	Secukinumab (300 mg) up to Week 12	Secukinumab (150 mg) up to Week 12	Placebo up to Week 12	Secukinumab (300 mg) after Week 12	Secukinumab (150 mg) after Week 12	Placebo followed by secukinumab (300 mg) after Week 12	Placebo followed by secukinumab (150 mg) after Week 12
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 48 (2.08%)	0 / 54 (0.00%)	2 / 49 (4.08%)	6 / 48 (12.50%)	6 / 54 (11.11%)	0 / 26 (0.00%)	1 / 23 (4.35%)
number of deaths (all causes)	0	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN CANCER
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	1 / 54 (1.85%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	1 / 54 (1.85%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
JOINT DISLOCATION
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
CEREBRAL INFARCTION
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	1 / 54 (1.85%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
TRANSIENT ISCHAEMIC ATTACK
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	1 / 54 (1.85%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
VESTIBULAR DISORDER
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
COLITIS
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	1 / 54 (1.85%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
DUODENAL ULCER
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
GASTRIC ULCER
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
GASTRITIS EROSIVE
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
UTERINE POLYP
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 49 (2.04%)	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
PSORIASIS
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	1 / 54 (1.85%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
BACK PAIN
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
HAEMARTHROSIS
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 49 (2.04%)	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
RHEUMATOID ARTHRITIS
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 26 (0.00%)	1 / 23 (4.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
VERTEBRAL FORAMINAL STENOSIS
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	1 / 54 (1.85%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
ANAL ABSCESS
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
ERYSIPELAS
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
HELICOBACTER INFECTION
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PNEUMONIA BACTERIAL
subjects affected / exposed	1 / 48 (2.08%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 3%

Non-serious adverse events	Secukinumab (300 mg) up to Week 12	Secukinumab (150 mg) up to Week 12	Placebo up to Week 12	Secukinumab (300 mg) after Week 12	Secukinumab (150 mg) after Week 12	Placebo followed by secukinumab (300 mg) after Week 12	Placebo followed by secukinumab (150 mg) after Week 12
Total subjects affected by non serious adverse events
subjects affected / exposed	29 / 48 (60.42%)	36 / 54 (66.67%)	35 / 49 (71.43%)	36 / 48 (75.00%)	43 / 54 (79.63%)	21 / 26 (80.77%)	19 / 23 (82.61%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PYOGENIC GRANULOMA
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 26 (0.00%)	1 / 23 (4.35%)
occurrences all number	0	0	0	0	0	0	1
SKIN PAPILLOMA
subjects affected / exposed	2 / 48 (4.17%)	0 / 54 (0.00%)	0 / 49 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)	1 / 26 (3.85%)	1 / 23 (4.35%)
occurrences all number	2	0	0	1	0	1	1
Vascular disorders
HYPERTENSION
subjects affected / exposed	1 / 48 (2.08%)	1 / 54 (1.85%)	1 / 49 (2.04%)	1 / 48 (2.08%)	2 / 54 (3.70%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	1	1	1	1	2	1	0
General disorders and administration site conditions
FATIGUE
subjects affected / exposed	0 / 48 (0.00%)	2 / 54 (3.70%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	2	0	0	0	1	0
INJECTION SITE PAIN
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 49 (2.04%)	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 26 (0.00%)	1 / 23 (4.35%)
occurrences all number	0	0	1	0	0	0	1
OEDEMA PERIPHERAL
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	1 / 54 (1.85%)	0 / 26 (0.00%)	1 / 23 (4.35%)
occurrences all number	0	0	0	0	1	0	1
Reproductive system and breast disorders
DYSMENORRHOEA
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	0	0	1	0
MENOPAUSAL SYMPTOMS
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Respiratory, thoracic and mediastinal disorders
COUGH
subjects affected / exposed	2 / 48 (4.17%)	0 / 54 (0.00%)	3 / 49 (6.12%)	2 / 48 (4.17%)	4 / 54 (7.41%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	2	0	3	2	4	1	0
NASAL INFLAMMATION
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	0	0	1	0
OROPHARYNGEAL PAIN
subjects affected / exposed	1 / 48 (2.08%)	0 / 54 (0.00%)	1 / 49 (2.04%)	1 / 48 (2.08%)	3 / 54 (5.56%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	1	0	1	1	3	1	0
RHINITIS ALLERGIC
subjects affected / exposed	0 / 48 (0.00%)	1 / 54 (1.85%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	2 / 26 (7.69%)	0 / 23 (0.00%)
occurrences all number	0	1	0	0	0	2	0
Injury, poisoning and procedural complications
ARTHROPOD BITE
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	2 / 48 (4.17%)	1 / 54 (1.85%)	1 / 26 (3.85%)	1 / 23 (4.35%)
occurrences all number	0	0	0	2	1	1	1
BURNS FIRST DEGREE
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	0	0	1	0
BURSA INJURY
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 26 (0.00%)	1 / 23 (4.35%)
occurrences all number	0	0	0	0	0	0	1
CONTUSION
subjects affected / exposed	0 / 48 (0.00%)	2 / 54 (3.70%)	1 / 49 (2.04%)	1 / 48 (2.08%)	0 / 54 (0.00%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences all number	0	2	1	1	0	0	0
LACERATION
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	3 / 48 (6.25%)	0 / 54 (0.00%)	1 / 26 (3.85%)	1 / 23 (4.35%)
occurrences all number	0	0	0	3	0	1	1
MUSCLE RUPTURE
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	0	0	2	0
THERMAL BURN
subjects affected / exposed	0 / 48 (0.00%)	1 / 54 (1.85%)	0 / 49 (0.00%)	2 / 48 (4.17%)	0 / 54 (0.00%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences all number	0	1	0	2	0	0	0
Nervous system disorders
DIZZINESS
subjects affected / exposed	1 / 48 (2.08%)	1 / 54 (1.85%)	1 / 49 (2.04%)	0 / 48 (0.00%)	1 / 54 (1.85%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	1	1	1	0	1	1	0
HEADACHE
subjects affected / exposed	4 / 48 (8.33%)	6 / 54 (11.11%)	2 / 49 (4.08%)	7 / 48 (14.58%)	7 / 54 (12.96%)	2 / 26 (7.69%)	0 / 23 (0.00%)
occurrences all number	5	6	2	8	13	2	0
PARAESTHESIA
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 26 (0.00%)	1 / 23 (4.35%)
occurrences all number	0	0	0	0	0	0	1
Blood and lymphatic system disorders
LYMPHADENOPATHY
subjects affected / exposed	1 / 48 (2.08%)	2 / 54 (3.70%)	1 / 49 (2.04%)	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences all number	1	2	2	0	0	0	0
NEUTROPENIA
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Eye disorders
CONJUNCTIVITIS ALLERGIC
subjects affected / exposed	0 / 48 (0.00%)	2 / 54 (3.70%)	0 / 49 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences all number	0	2	0	1	0	0	0
DRY EYE
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	0	0	1	0
EYE SWELLING
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
subjects affected / exposed	0 / 48 (0.00%)	1 / 54 (1.85%)	1 / 49 (2.04%)	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 26 (0.00%)	1 / 23 (4.35%)
occurrences all number	0	1	1	0	0	0	1
BURNING MOUTH SYNDROME
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 26 (0.00%)	1 / 23 (4.35%)
occurrences all number	0	0	0	0	0	0	1
CONSTIPATION
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	1	0	1	0
DIARRHOEA
subjects affected / exposed	2 / 48 (4.17%)	2 / 54 (3.70%)	1 / 49 (2.04%)	0 / 48 (0.00%)	3 / 54 (5.56%)	3 / 26 (11.54%)	1 / 23 (4.35%)
occurrences all number	2	2	1	0	4	4	3
DYSPEPSIA
subjects affected / exposed	0 / 48 (0.00%)	1 / 54 (1.85%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	1	0	0	0	1	0
DYSPHAGIA
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	2 / 48 (4.17%)	0 / 54 (0.00%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences all number	0	0	0	2	0	0	0
GASTRITIS
subjects affected / exposed	1 / 48 (2.08%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	2 / 54 (3.70%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences all number	1	0	0	0	2	0	0
GASTROOESOPHAGEAL REFLUX DISEASE
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	2 / 48 (4.17%)	0 / 54 (0.00%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences all number	0	0	0	2	0	0	0
GLOSSITIS
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	0	0	1	0
HAEMORRHOIDS
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	2 / 48 (4.17%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	2	0	1	0
NAUSEA
subjects affected / exposed	1 / 48 (2.08%)	2 / 54 (3.70%)	0 / 49 (0.00%)	1 / 48 (2.08%)	1 / 54 (1.85%)	1 / 26 (3.85%)	1 / 23 (4.35%)
occurrences all number	1	2	0	1	1	1	2
STOMATITIS
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	1	0	1	0
TOOTHACHE
subjects affected / exposed	1 / 48 (2.08%)	0 / 54 (0.00%)	0 / 49 (0.00%)	2 / 48 (4.17%)	1 / 54 (1.85%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	1	0	0	2	1	1	0
Skin and subcutaneous tissue disorders
ALOPECIA
subjects affected / exposed	0 / 48 (0.00%)	2 / 54 (3.70%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	2	0	0	0	1	0
DERMATITIS ATOPIC
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	0	0	1	0
DERMATITIS
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	1 / 48 (2.08%)	1 / 54 (1.85%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	1	1	1	0
ECZEMA
subjects affected / exposed	1 / 48 (2.08%)	2 / 54 (3.70%)	0 / 49 (0.00%)	1 / 48 (2.08%)	1 / 54 (1.85%)	0 / 26 (0.00%)	1 / 23 (4.35%)
occurrences all number	1	2	0	1	1	0	1
ERYTHEMA
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	1	0	1	0
INTERTRIGO
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	1 / 54 (1.85%)	1 / 26 (3.85%)	1 / 23 (4.35%)
occurrences all number	0	0	0	0	1	1	1
PAPULE
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	1 / 54 (1.85%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	0	1	1	0
PRURITUS
subjects affected / exposed	2 / 48 (4.17%)	0 / 54 (0.00%)	2 / 49 (4.08%)	2 / 48 (4.17%)	2 / 54 (3.70%)	1 / 26 (3.85%)	1 / 23 (4.35%)
occurrences all number	2	0	2	2	2	1	2
PSORIASIS
subjects affected / exposed	2 / 48 (4.17%)	0 / 54 (0.00%)	1 / 49 (2.04%)	2 / 48 (4.17%)	1 / 54 (1.85%)	0 / 26 (0.00%)	1 / 23 (4.35%)
occurrences all number	2	0	1	2	1	0	1
SEBORRHOEIC DERMATITIS
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	2 / 49 (4.08%)	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences all number	0	0	2	0	0	0	0
SKIN FISSURES
subjects affected / exposed	1 / 48 (2.08%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	1	0	0	0	0	1	0
SKIN REACTION
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 26 (0.00%)	1 / 23 (4.35%)
occurrences all number	0	0	0	0	0	0	1
Renal and urinary disorders
HAEMATURIA
subjects affected / exposed	2 / 48 (4.17%)	2 / 54 (3.70%)	0 / 49 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)	2 / 26 (7.69%)	0 / 23 (0.00%)
occurrences all number	2	2	0	1	0	2	0
NEPHROLITHIASIS
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Musculoskeletal and connective tissue disorders
ARTHRALGIA
subjects affected / exposed	1 / 48 (2.08%)	2 / 54 (3.70%)	5 / 49 (10.20%)	5 / 48 (10.42%)	3 / 54 (5.56%)	0 / 26 (0.00%)	3 / 23 (13.04%)
occurrences all number	1	2	5	5	3	0	6
BACK PAIN
subjects affected / exposed	2 / 48 (4.17%)	2 / 54 (3.70%)	1 / 49 (2.04%)	4 / 48 (8.33%)	4 / 54 (7.41%)	5 / 26 (19.23%)	1 / 23 (4.35%)
occurrences all number	2	2	1	4	4	6	3
MUSCLE SPASMS
subjects affected / exposed	1 / 48 (2.08%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	1	0	0	0	0	1	0
MUSCULOSKELETAL PAIN
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	2 / 48 (4.17%)	1 / 54 (1.85%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	2	1	1	0
PAIN IN EXTREMITY
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	3 / 48 (6.25%)	2 / 54 (3.70%)	1 / 26 (3.85%)	1 / 23 (4.35%)
occurrences all number	0	0	0	3	3	1	1
SPINAL PAIN
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 49 (2.04%)	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	1	0	0	1	0
Infections and infestations
BRONCHITIS
subjects affected / exposed	1 / 48 (2.08%)	1 / 54 (1.85%)	0 / 49 (0.00%)	3 / 48 (6.25%)	1 / 54 (1.85%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences all number	1	1	0	3	1	0	0
CANDIDA INFECTION
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	2 / 48 (4.17%)	0 / 54 (0.00%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences all number	0	0	0	2	0	0	0
CONJUNCTIVITIS
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	1 / 54 (1.85%)	2 / 26 (7.69%)	0 / 23 (0.00%)
occurrences all number	0	0	0	0	1	2	0
ECTHYMA
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	0	0	1	0
FUNGAL INFECTION
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	0	0	1	0
GASTROENTERITIS
subjects affected / exposed	2 / 48 (4.17%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	2 / 54 (3.70%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences all number	2	0	0	0	2	0	0
GASTROINTESTINAL CANDIDIASIS
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	0	0	1	0
GASTROINTESTINAL INFECTION
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 49 (2.04%)	2 / 48 (4.17%)	2 / 54 (3.70%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences all number	0	0	1	2	2	0	0
GINGIVITIS
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 49 (2.04%)	1 / 48 (2.08%)	0 / 54 (0.00%)	0 / 26 (0.00%)	1 / 23 (4.35%)
occurrences all number	0	0	2	1	0	0	1
HORDEOLUM
subjects affected / exposed	0 / 48 (0.00%)	2 / 54 (3.70%)	0 / 49 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences all number	0	2	0	1	0	0	0
IMPETIGO
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	1 / 54 (1.85%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	0	2	1	0
LARYNGITIS
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 26 (0.00%)	1 / 23 (4.35%)
occurrences all number	0	0	0	0	0	0	1
NASOPHARYNGITIS
subjects affected / exposed	10 / 48 (20.83%)	14 / 54 (25.93%)	18 / 49 (36.73%)	21 / 48 (43.75%)	25 / 54 (46.30%)	10 / 26 (38.46%)	10 / 23 (43.48%)
occurrences all number	10	17	19	29	36	13	19
ORAL CANDIDIASIS
subjects affected / exposed	1 / 48 (2.08%)	0 / 54 (0.00%)	0 / 49 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	1	0	0	2	0	1	0
ORAL HERPES
subjects affected / exposed	0 / 48 (0.00%)	2 / 54 (3.70%)	0 / 49 (0.00%)	2 / 48 (4.17%)	2 / 54 (3.70%)	1 / 26 (3.85%)	1 / 23 (4.35%)
occurrences all number	0	2	0	3	2	1	2
OTITIS EXTERNA
subjects affected / exposed	1 / 48 (2.08%)	0 / 54 (0.00%)	0 / 49 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	1	0	0	1	0	1	0
OTITIS MEDIA
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	2 / 54 (3.70%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences all number	0	0	0	0	2	0	0
PERIODONTITIS
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	1 / 48 (2.08%)	3 / 54 (5.56%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	1	3	1	0
PARONYCHIA
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 26 (0.00%)	1 / 23 (4.35%)
occurrences all number	0	0	0	0	0	0	1
PHARYNGITIS
subjects affected / exposed	0 / 48 (0.00%)	2 / 54 (3.70%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences all number	0	3	0	0	0	0	0
PULPITIS DENTAL
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 26 (0.00%)	1 / 23 (4.35%)
occurrences all number	0	0	0	0	0	0	1
RHINITIS
subjects affected / exposed	1 / 48 (2.08%)	0 / 54 (0.00%)	2 / 49 (4.08%)	2 / 48 (4.17%)	3 / 54 (5.56%)	1 / 26 (3.85%)	4 / 23 (17.39%)
occurrences all number	1	0	2	2	3	1	5
ROOT CANAL INFECTION
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	0	0	1	0
SINUSITIS
subjects affected / exposed	2 / 48 (4.17%)	1 / 54 (1.85%)	0 / 49 (0.00%)	0 / 48 (0.00%)	2 / 54 (3.70%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences all number	2	2	0	0	2	0	0
SKIN CANDIDA
subjects affected / exposed	0 / 48 (0.00%)	2 / 54 (3.70%)	0 / 49 (0.00%)	0 / 48 (0.00%)	1 / 54 (1.85%)	0 / 26 (0.00%)	0 / 23 (0.00%)
occurrences all number	0	2	0	0	1	0	0
UPPER RESPIRATORY TRACT INFECTION
subjects affected / exposed	0 / 48 (0.00%)	2 / 54 (3.70%)	1 / 49 (2.04%)	1 / 48 (2.08%)	0 / 54 (0.00%)	0 / 26 (0.00%)	1 / 23 (4.35%)
occurrences all number	0	2	1	1	0	0	1
URINARY TRACT INFECTION
subjects affected / exposed	0 / 48 (0.00%)	3 / 54 (5.56%)	1 / 49 (2.04%)	1 / 48 (2.08%)	1 / 54 (1.85%)	0 / 26 (0.00%)	1 / 23 (4.35%)
occurrences all number	0	3	1	1	1	0	2
Metabolism and nutrition disorders
DECREASED APPETITE
subjects affected / exposed	0 / 48 (0.00%)	0 / 54 (0.00%)	0 / 49 (0.00%)	0 / 48 (0.00%)	0 / 54 (0.00%)	1 / 26 (3.85%)	0 / 23 (0.00%)
occurrences all number	0	0	0	0	0	1	0

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A randomized, double-blind, placebo-controlled, multicenter, exploratory evaluation of surrogate markers of cardiovascular risk in patients with active chronic plaque-type psoriasis treated for 52 weeks with subcutaneous (s.c.) secukinumab (300 mg and 150 mg)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Flow Mediated Dilation (FMD) at Week 12 followed by secukinumab 300 mg vs pooled placebo treatment

Primary: Flow Mediated Dilation (FMD) at Week 12 followed by secukinumab 300 mg vs pooled placebo treatment

Secondary: Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52

Secondary: Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52

Secondary: Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52

Secondary: Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52

Secondary: Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52

Secondary: Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52

Secondary: Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12

Secondary: Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12

Secondary: Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52

Secondary: Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52

Secondary: Change from Baseline in High sensitivity C-reactive protein (hsCRP) at Week 4, 12, 24 and 52

Secondary: Change from Baseline in High sensitivity C-reactive protein (hsCRP) at Week 4, 12, 24 and 52

Secondary: Change from Baseline in S-100 protein B (total) at Week 4, 12, 24 and 52

Secondary: Change from Baseline in S-100 protein B (total) at Week 4, 12, 24 and 52

Secondary: Change from Baseline in Chemokine (c-c motif) ligand 5 (CCL5), Monocyte chemoattractant protein 1 (MCP-1) and Macrophage inflammatory proteins (MIP) 1 alpha and 1 beta at Week 4, 12, 24 and 52

Secondary: Change from Baseline in Chemokine (c-c motif) ligand 5 (CCL5), Monocyte chemoattractant protein 1 (MCP-1) and Macrophage inflammatory proteins (MIP) 1 alpha and 1 beta at Week 4, 12, 24 and 52

Secondary: Change from Baseline in Fasting plasma glucose (FPG) at Week 4, 12, 24 and 52

Secondary: Change from Baseline in Fasting plasma glucose (FPG) at Week 4, 12, 24 and 52

Secondary: Change from Baseline in Fasting Insulin at Week 4, 12, 24 and 52

Secondary: Change from Baseline in Fasting Insulin at Week 4, 12, 24 and 52

Secondary: Change from Baseline in Homeostatic Model Assessment (HOMA) beta-cell function at Week 4, 12, 24 and 52

Secondary: Change from Baseline in Homeostatic Model Assessment (HOMA) beta-cell function at Week 4, 12, 24 and 52

Secondary: Change from Baseline in Homeostatic Model Assessment (HOMA) insulin resistance at Week 4, 12, 24 and 52

Secondary: Change from Baseline in Homeostatic Model Assessment (HOMA) insulin resistance at Week 4, 12, 24 and 52

Secondary: Change from Baseline in Hemoglobin A1c (glycated hemoglobin) at Week 4, 12, 24 and 52

Secondary: Change from Baseline in Hemoglobin A1c (glycated hemoglobin) at Week 4, 12, 24 and 52

Secondary: Change from Baseline in Sex hormone-binding globulin (SHBG) at Week 4, 12, 24 and 52

Secondary: Change from Baseline in Sex hormone-binding globulin (SHBG) at Week 4, 12, 24 and 52

Secondary: Change from Baseline in Adiponectin at Week 4, 12, 24 and 52

Secondary: Change from Baseline in Adiponectin at Week 4, 12, 24 and 52

Secondary: Change from Baseline in Leptin at Week 4, 12, 24 and 52

Secondary: Change from Baseline in Leptin at Week 4, 12, 24 and 52

Secondary: Change from Baseline in Soluble biomarkers of impaired lipid metabolism at Week 4, 12, 24 and 52

Secondary: Change from Baseline in Soluble biomarkers of impaired lipid metabolism at Week 4, 12, 24 and 52

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A randomized, double-blind, placebo-controlled, multicenter, exploratory evaluation of surrogate markers of cardiovascular risk in patients with active chronic plaque-type psoriasis treated for 52 weeks with subcutaneous (s.c.) secukinumab (300 mg and 150 mg)