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Clinical Trial Results:
A randomized, double-blind, placebo controlled, multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate efficacy after twelve weeks of treatment, and to assess the safety, tolerability, usability and long-term efficacy in patients with chronic plaque-type psoriasis

Summary
EudraCT number	2011-006057-28
Trial protocol	EE DE
Global end of trial date	24 Oct 2016

Results information
Results version number	v1(current)
This version publication date	08 Nov 2017
First version publication date	08 Nov 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

CAIN457A2308

ISRCTN number

US NCT number

NCT01555125

WHO universal trial number (UTN)

Sponsor organisation name

Novartis Pharma AG

Sponsor organisation address

CH-4002, Basel, Switzerland,

Public contact

Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,

Scientific contact

Clinical Disclosure Office, Novartis Pharma AG, 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

24 Oct 2016

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

24 Oct 2016

Was the trial ended prematurely?

Main objective of the trial

The primary objective was to demonstrate the efficacy of secukinumab (150 mg and 300 mg) in patients with moderate to severe chronic plaque-type psoriasis with respect to both PASI 75 and IGA 0 or 1 response (co-primary endpoints) at Week 12 compared to placebo.

Protection of trial subjects

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

Background therapy

Evidence for comparator

Actual start date of recruitment

08 May 2012

Long term follow-up planned

Yes

Long term follow-up rationale

Safety, Efficacy

Long term follow-up duration

2 Months

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 19

Country: Number of subjects enrolled

Estonia: 32

Country: Number of subjects enrolled

France: 30

Country: Number of subjects enrolled

Germany: 15

Country: Number of subjects enrolled

United States: 81

Worldwide total number of subjects

177

EEA total number of subjects

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)

162

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

"Study terminated by Sponsor" refers to the fact that - as per protocol – patients had to stop participating in the study in a given country where Secukinumab became available following approval.

Screening details

This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in patients with moderate to severe chronic, plaque-type psoriasis. There were 177 patients who were randomized and treated.

Period 1 title

Induction Period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

AIN457 150 mg

Arm description

Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing

Arm type

Experimental

Investigational medicinal product name

secukinumab 150 mg

Investigational medicinal product code

AIN457

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

150mg

AIN457 300 mg

Arm description

Patients received two secukinumab 150 mg s.c. injections at each dosing

Arm type

Experimental

Investigational medicinal product name

secukinumab 300 mg

Investigational medicinal product code

AIN457

Other name

secukinumab

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

300mg

Placebo

Arm description

Patients received placebo secukinumab (2 s.c. injections) at each dosing

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

AIN457

Other name

Placebo

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo

Number of subjects in period 1	AIN457 150 mg	AIN457 300 mg	Placebo
Started	59	59	59
Completed	58	56	56
Not completed	1	3	3
Adverse event, serious fatal	1	-	-
Adverse event, non-fatal	-	1	1
Lost to follow-up	-	2	-
Subject/guardian decision	-	-	2

Period 2 title

Maintenance Period

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

AIN457 150 mg

Arm description

Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing

Arm type

Experimental

Investigational medicinal product name

secukinumab 150 mg

Investigational medicinal product code

AIN457

Other name

Secukinumab

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

secukinumab 150 mg

AIN457 300 mg

Arm description

Patients received two secukinumab 150 mg s.c. injections at each dosing

Arm type

Experimental

Investigational medicinal product name

secukinumab 300 mg

Investigational medicinal product code

AIN457

Other name

Secukinumab

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

300mg

Placebo - AIN457 150mg

Arm description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re- randomized to AIN457 150 mg for the remainder of the study

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

AIN457

Other name

Placebo

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

150mg

Placebo - AIN457 300mg

Arm description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re- randomized to AIN457 300 mg for the remainder of the study

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

AIN457

Other name

Placebo

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

300mg

Number of subjects in period 2	AIN457 150 mg	AIN457 300 mg	Placebo - AIN457 150mg	Placebo - AIN457 300mg
Started	58	56	29	27
Completed	48	52	25	25
Not completed	10	4	4	2
Adverse event, serious fatal	-	-	-	1
Physician decision	-	-	1	-
Adverse event, non-fatal	1	1	-	-
Lost to follow-up	2	-	-	1
Subject/guardian decision	1	2	-	-
Lack of efficacy	6	1	3	-

Period 3 title

Extension

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

AIN457 150 mg

Arm description

Secukinumab 150 mg regimen group administered secukinumab 150 mg s.c. injection plus a placebo secukinumab s.c. injection at each dosing

Arm type

Experimental

Investigational medicinal product name

secukinumab 150 mg

Investigational medicinal product code

AIN457

Other name

secukinumab 150 mg

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

150mg

AIN457 300 mg

Arm description

Secukinumab 300 mg regimen group administered secukinumab 300 mg as 2 s.c. injections of the 150 mg dose at each dosing

Arm type

Experimental

Investigational medicinal product name

secukinumab 300 mg

Investigational medicinal product code

AIN457

Other name

secukinumab 300 mg

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

300mg

Placebo - AIN457 150mg

Arm description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re- randomized to AIN457 150 mg for the remainder of the study

Arm type

Placebo

Investigational medicinal product name

Placebo - AIN457 150mg

Investigational medicinal product code

AIN457

Other name

Placebo - AIN457 150mg

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

150

Placebo - AIN457 300mg

Arm description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study

Arm type

Placebo

Investigational medicinal product name

Placebo - AIN457 300mg

Investigational medicinal product code

AIN457

Other name

Placebo - AIN457 300mg

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

300

Number of subjects in period 3 ^[1]	AIN457 150 mg	AIN457 300 mg	Placebo - AIN457 150mg	Placebo - AIN457 300mg
Started	46	51	23	23
Completed	1	0	0	1
Not completed	45	51	23	22
Adverse event, non-fatal	1	2	1	1
Protocol deviation	1	-	-	-
Technical Problems	1	-	-	1
Study terminated by sponsor	32	33	16	20
Lost to follow-up	2	1	2	-
Subject/guardian decision	1	9	1	-
Lack of efficacy	7	6	3	-

Notes
[1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: The number of subjects reported is correct

Period 4 title

Follow-Up Period

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

AIN457 150 mg

Arm description

Secukinumab 150 mg regimen group administered secukinumab 150 mg s.c. injection plus a placebo secukinumab s.c. injection at each dosing

Arm type

Experimental

Investigational medicinal product name

secukinumab 150 mg

Investigational medicinal product code

AIN457

Other name

secukinumab 150 mg

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

150mg

AIN457 300 mg

Arm description

Secukinumab 300 mg regimen group administered secukinumab 300 mg as 2 s.c. injections of the 150 mg dose at each dosing

Arm type

Experimental

Investigational medicinal product name

secukinumab 300 mg

Investigational medicinal product code

AIN457

Other name

secukinumab 300 mg

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

300mg

Placebo - AIN457 150mg

Arm description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re- randomized to AIN457 150 mg for the remainder of the study

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

AIN457

Other name

Placebo

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo 150mg

Placebo - AIN457 300mg

Arm description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study

Arm type

Placebo

Investigational medicinal product name

Placebo 300mg

Investigational medicinal product code

AIN457

Other name

Placebo 300mg

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

300mg

Number of subjects in period 4	AIN457 150 mg	AIN457 300 mg	Placebo - AIN457 150mg	Placebo - AIN457 300mg
Started	36	31	19	18
Completed	32	30	18	17
Not completed	4	1	1	1
Lost to follow-up	1	-	-	-
Subject/guardian decision	3	1	1	1

Baseline characteristics

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Reporting group title

AIN457 150 mg

Reporting group description

Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing

Reporting group title

AIN457 300 mg

Reporting group description

Patients received two secukinumab 150 mg s.c. injections at each dosing

Reporting group title

Placebo

Reporting group description

Patients received placebo secukinumab (2 s.c. injections) at each dosing

Reporting group values	AIN457 150 mg	AIN457 300 mg	Placebo	Total
Number of subjects	59	59	59	177
Age categorical
Units: Subjects
In utero	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0
Newborns (0-27 days)	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0
Children (2-11 years)	0	0	0	0
Adolescents (12-17 years)	0	0	0	0
Adults (18-64 years)	51	58	53	162
From 65-84 years	8	1	6	15
85 years and over	0	0	0	0
Age Continuous
Units: Years
arithmetic mean (standard deviation)	46 ( 15.09 )	45.1 ( 12.57 )	46.5 ( 14.14 )	-
Gender, Male/Female
Units: Subjects
Female	19	21	20	60
Male	40	38	39	117

End points

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Reporting group title

AIN457 150 mg

Reporting group description

Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing

Reporting group title

AIN457 300 mg

Reporting group description

Patients received two secukinumab 150 mg s.c. injections at each dosing

Reporting group title

Placebo

Reporting group description

Patients received placebo secukinumab (2 s.c. injections) at each dosing

Reporting group title

AIN457 150 mg

Reporting group description

Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing

Reporting group title

AIN457 300 mg

Reporting group description

Patients received two secukinumab 150 mg s.c. injections at each dosing

Reporting group title

Placebo - AIN457 150mg

Reporting group description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re- randomized to AIN457 150 mg for the remainder of the study

Reporting group title

Placebo - AIN457 300mg

Reporting group description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re- randomized to AIN457 300 mg for the remainder of the study

Reporting group title

AIN457 150 mg

Reporting group description

Secukinumab 150 mg regimen group administered secukinumab 150 mg s.c. injection plus a placebo secukinumab s.c. injection at each dosing

Reporting group title

AIN457 300 mg

Reporting group description

Secukinumab 300 mg regimen group administered secukinumab 300 mg as 2 s.c. injections of the 150 mg dose at each dosing

Reporting group title

Placebo - AIN457 150mg

Reporting group description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re- randomized to AIN457 150 mg for the remainder of the study

Reporting group title

Placebo - AIN457 300mg

Reporting group description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study

Reporting group title

AIN457 150 mg

Reporting group description

Secukinumab 150 mg regimen group administered secukinumab 150 mg s.c. injection plus a placebo secukinumab s.c. injection at each dosing

Reporting group title

AIN457 300 mg

Reporting group description

Secukinumab 300 mg regimen group administered secukinumab 300 mg as 2 s.c. injections of the 150 mg dose at each dosing

Reporting group title

Placebo - AIN457 150mg

Reporting group description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re- randomized to AIN457 150 mg for the remainder of the study

Reporting group title

Placebo - AIN457 300mg

Reporting group description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study

Subject analysis set title

placebo

Subject analysis set type

Full analysis

Subject analysis set description

placebo secukinumab (2 s.c. injections) at each dosing

Subject analysis set title

placebo-AIN457 150mg

Subject analysis set type

Full analysis

Subject analysis set description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re- randomized to AIN457 150 mg for the remainder of the study

Subject analysis set title

Placebo-AIN457 300mg

Subject analysis set type

Full analysis

Subject analysis set description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study

Subject analysis set title

Placebo - AIN457 300 mg

Subject analysis set type

Full analysis

Subject analysis set description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study

Subject analysis set title

Placebo-AIN457 300mg

Subject analysis set type

Full analysis

Subject analysis set description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study

Subject analysis set title

placebo

Subject analysis set type

Full analysis

Subject analysis set description

placebo secukinumab (2 s.c. injections) at each dosing

Subject analysis set title

placebo

Subject analysis set type

Full analysis

Subject analysis set description

placebo secukinumab (2 s.c. injections) at each dosing

Subject analysis set title

Placebo-AIN457 300mg

Subject analysis set type

Full analysis

Subject analysis set description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study

Subject analysis set title

placebo

Subject analysis set type

Full analysis

Subject analysis set description

placebo secukinumab (2 s.c. injections) at each dosing

Subject analysis set title

Placebo - AIN457 300 mg

Subject analysis set type

Full analysis

Subject analysis set description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study

Subject analysis set title

Placebo-AIN457 300mg

Subject analysis set type

Full analysis

Subject analysis set description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study

Subject analysis set title

Full analysis set

Subject analysis set type

Full analysis

Subject analysis set description

Full analysis set (FAS) - All patients to whom study treatment was assigned

Primary: Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis at week 12 Measure: PASI 75 (psoriasis area and severity index) response"

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End point title

Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis at week 12 Measure: PASI 75 (psoriasis area and severity index) response" ^[1]

End point description

A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis

End point type

Primary

End point timeframe

12 weeks

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: All arms do not apply to this end point

End point values	AIN457 150 mg	AIN457 300 mg	placebo
Number of subjects analysed	59	58	59
Units: Percentage of participants
number (not applicable)	69.5	75.9	0

secukinumab 150 mg

Comparison groups

AIN457 150 mg v placebo

Number of subjects included in analysis

118

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Fisher exact

Confidence interval

secukinumab 300 mg, placebo

Comparison groups

AIN457 300 mg v placebo

Number of subjects included in analysis

117

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Fisher exact

Confidence interval

Primary: Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis Measure:IGA (investigator’s global assessment) with a 0 or 1 response at Week 12

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End point title

Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis Measure:IGA (investigator’s global assessment) with a 0 or 1 response at Week 12 ^[2]

End point description

The IGA scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA used in this study is static, i.e. it refers exclusively to the subject’s disease state at the time of the assessments, and does not attempt a comparison with any of the subject’s previous disease states, whether at baseline or at a previous visit. IGA has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe

End point type

Primary

End point timeframe

12 weeks

Notes
[2] - 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: All arms do not apply to this end point

End point values	AIN457 150 mg	AIN457 300 mg	placebo
Number of subjects analysed	59	58	59
Units: Percentage of Participants
number (not applicable)	52.5	69	0

Efficacy of secukinumab compared to placebo

Comparison groups

AIN457 150 mg v placebo

Number of subjects included in analysis

118

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Fisher exact

Confidence interval

Efficacy of secukinumab compared to placebo

Comparison groups

AIN457 300 mg v placebo

Number of subjects included in analysis

117

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Fisher exact

Confidence interval

Secondary: Absolute change from baseline in Self Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12

Top of page

End point title

Absolute change from baseline in Self Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 ^[3]

End point description

The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.

End point type

Secondary

End point timeframe

Week 12

Notes
[3] - 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: All arms do not apply to this end point

End point values	AIN457 150 mg	AIN457 300 mg	placebo
Number of subjects analysed	59	59	59
Units: Score
arithmetic mean (standard deviation)
Feelings about injections	1.07 ( 1.912 )	0.85 ( 1.685 )	0.57 ( 1.509 )
Self confidence	1.10 ( 2.331 )	1.08 ( 2.197 )	1.26 ( 2.009 )
Satisfaction with self-injection	1.64 ( 2.163 )	1.62 ( 2.667 )	1.32 ( 2.629 )

No statistical analyses for this end point

Secondary: Absolute change from baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at week 48

Top of page

End point title

Absolute change from baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at week 48 ^[4]

End point description

To measure subject satisfaction with the secukinumab PFS" Pre Filled Syringes. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.

End point type

Secondary

End point timeframe

Baseline, Week 48

Notes
[4] - 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: All arms do not apply to this end point

End point values	AIN457 150 mg	AIN457 300 mg	placebo-AIN457 150mg	Placebo-AIN457 300mg
Number of subjects analysed	58	56	29	27
Units: Score
arithmetic mean (standard deviation)
Feelings about injections (n=45, 52, 25, 24)	0.93 ( 1.752 )	1.01 ( 2.103 )	0.63 ( 1.449 )	0.76 ( 1.321 )
Self-confidence (n=45, 51, 25, 24)	1.63 ( 3.173 )	1.24 ( 2.400 )	0.97 ( 1.811 )	0.94 ( 1.521 )
Satisfaction, self-injection (n=43, 50, 25, 23)	1.92 ( 2.239 )	2.15 ( 2.673 )	1.90 ( 3.250 )	0.54 ( 1.840 )

No statistical analyses for this end point

Secondary: Percentage of subjects with potential use related hazards at week 1

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End point title

Percentage of subjects with potential use related hazards at week 1 ^[5]

End point description

To assess potential use-related hazards with the secukinumab PFS for the subject

End point type

Secondary

End point timeframe

Week 1

Notes
[5] - 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: All arms do not apply to this end point

End point values	AIN457 150 mg	AIN457 300 mg	placebo
Number of subjects analysed	59	59	59
Units: Percentage of participants
number (not applicable)
Needle stick in a critical area (n=0,0,0)	0	0	0
Needle stick in non-critical area (n=0,0,1)	0	0	1.7
Any part of the device swallowed (n=0,0,0)	0	0	0
Allergic reaction to devise material (n=0,0,0)	0	0	0
Pain due to bent needle (n=0,0,0)	0	0	0
Any breakage of the devise (0,0,0)	0	0	0
Swallowing of material debris observed (n=0,0,0)	0	0	0
Any other problem (n=1,0,0)	1.7	0	0
Less than full dose administered (n=1,0,0)	1.7	0	0

No statistical analyses for this end point

Secondary: Percentage of subjects with successful self administration of study drug at week 1

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End point title

Percentage of subjects with successful self administration of study drug at week 1 ^[6]

End point description

To assess the subject’s ability to follow instructions for use with the secukinumab PFS

End point type

Secondary

End point timeframe

Week 1

Notes
[6] - 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: All arms do not apply to this end point

End point values	AIN457 150 mg	AIN457 300 mg	placebo
Number of subjects analysed	58	57	59
Units: Percentage of participants	100	100	100

No statistical analyses for this end point

Secondary: Percent of Responders with PASI equal to or greater than 50, PASI 75, PASI 90, PASI 100, (induction) with non-responder imputation

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End point title

Percent of Responders with PASI equal to or greater than 50, PASI 75, PASI 90, PASI 100, (induction) with non-responder imputation ^[7]

End point description

PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline.

End point type

Secondary

End point timeframe

Week 12

Notes
[7] - 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: All arms do not apply to this end point

End point values	AIN457 150 mg	AIN457 300 mg	placebo
Number of subjects analysed	59	59	59
Units: Percentage of participants
number (not applicable)
Week 12 PASI 75	69.5	75.9	0.0
Week 12 PASI 50	86.4	87.9	5.1
Week 12 PASI 90	45.8	60.3	0
Week 12 PASI 100	8.5	43.1	0

No statistical analyses for this end point

Secondary: Percent of Responders with PASI equal to or greater than 50, PASI 75, PASI 90, PASI 100, (Maintenance, observed data)

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End point title

Percent of Responders with PASI equal to or greater than 50, PASI 75, PASI 90, PASI 100, (Maintenance, observed data) ^[8]

End point description

End point type

Secondary

End point timeframe

Week 52

Notes
[8] - 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: All arms do not apply to this end point

End point values	AIN457 150 mg	AIN457 300 mg	placebo-AIN457 150mg	Placebo - AIN457 300 mg
Number of subjects analysed	59	58	29	27
Units: Percentage of participants
number (not applicable)
Week 52 PASI 75	71.4	84.6	72.0	96.0
Week 52 PASI 50	89.8	96.2	84.0	100.0
Week 52 PASI 90	59.2	69.2	64.0	76.0
Week 52 PASI 100	36.7	48.1	52.0	44.0

No statistical analyses for this end point

Secondary: Percent of responders with IGA mod 2011 score of 0 or 1, (Maintenance; observed data)

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End point title

Percent of responders with IGA mod 2011 score of 0 or 1, (Maintenance; observed data) ^[9]

End point description

The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.

End point type

Secondary

End point timeframe

Week 52

Notes
[9] - 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: All arms do not apply to this end point

End point values	AIN457 150 mg	AIN457 300 mg	placebo-AIN457 150mg	Placebo - AIN457 300 mg
Number of subjects analysed	59	59	29	27
Units: Percentage of participants
number (not applicable)	51	71.2	72	92

No statistical analyses for this end point

Secondary: Absolute change from baseline for PASI score at Week 12, (induction)

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End point title

Absolute change from baseline for PASI score at Week 12, (induction) ^[10]

End point description

PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)

End point type

Secondary

End point timeframe

Week 12

Notes
[10] - 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: All arms do not apply to this end point

End point values	AIN457 150 mg	AIN457 300 mg	placebo
Number of subjects analysed	59	59	59
Units: Units on a scale
arithmetic mean (standard deviation)	-16.33 ( 8.49 )	-17.90 ( 8.74 )	0.50 ( 7.22 )

No statistical analyses for this end point

Secondary: Absolute change from baseline for PASI score over time up to week 52, (Maintenance; observed data)

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End point title

Absolute change from baseline for PASI score over time up to week 52, (Maintenance; observed data) ^[11]

End point description

End point type

Secondary

End point timeframe

Week 52

Notes
[11] - 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: All arms do not apply to this end point

End point values	AIN457 150 mg	AIN457 300 mg	placebo-AIN457 150mg	Placebo - AIN457 300 mg
Number of subjects analysed	59	58	29	27
Units: Units on a scale
arithmetic mean (standard deviation)	-16.9 ( 8.27 )	-18.7 ( 8.48 )	-15.2 ( 5.38 )	-20 ( 7.96 )

No statistical analyses for this end point

Secondary: Percentage of participants in each IGA mod 2011 category at Week 12, (induction)

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End point title

Percentage of participants in each IGA mod 2011 category at Week 12, (induction) ^[12]

End point description

End point type

Secondary

End point timeframe

Week 12

Notes
[12] - 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: All arms do not apply to this end point

End point values	AIN457 150 mg	AIN457 300 mg	placebo
Number of subjects analysed	59	58	59
Units: Percentage of participants
number (not applicable)
clear (n=6, 26, 0)	10.2	44.8	0.0
almost clear (n=26, 17, 0)	44.1	29.3	0.0
mild (n=12, 9,1)	20.3	15.5	1.7
moderate (n=14, 5, 34)	23.7	8.6	57.6
severe (n=1,1, 24)	1.7	1.7	40.7

No statistical analyses for this end point

Secondary: Percentage of participants in each IGA mod 2011 category over time up to week 52, (Maintenance; observed data)

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End point title

Percentage of participants in each IGA mod 2011 category over time up to week 52, (Maintenance; observed data) ^[13]

End point description

End point type

Secondary

End point timeframe

Week 52

Notes
[13] - 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: All arms do not apply to this end point

End point values	AIN457 150 mg	AIN457 300 mg	placebo-AIN457 150mg	Placebo - AIN457 300 mg
Number of subjects analysed	59	59	29	27
Units: Percentage of participants
number (not applicable)
Clear	36.7	48.1	52	44
Almost clear	14.3	23.1	20	48
Mild	18.4	19.2	4	4
Moderate	26.5	9.6	20	4
Severe	4.1	0	4	0

No statistical analyses for this end point

Secondary: Change from baseline in EQ-5D at week 12 (induction)

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End point title

Change from baseline in EQ-5D at week 12 (induction) ^[14]

End point description

ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example “confined to bed”) A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)

End point type

Secondary

End point timeframe

Week 12

Notes
[14] - 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: All arms do not apply to this end point

End point values	AIN457 150 mg	AIN457 300 mg	placebo
Number of subjects analysed	59	59	59
Units: Units on a scale
arithmetic mean (standard deviation)	12.1 ( 24.03 )	11.2 ( 18.02 )	0.8 ( 16.12 )

No statistical analyses for this end point

Secondary: Change from baseline in EQ-5D at week 12 and over time up to week 52, (Maintenance)

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End point title

Change from baseline in EQ-5D at week 12 and over time up to week 52, (Maintenance) ^[15]

End point description

End point type

Secondary

End point timeframe

Week 52

Notes
[15] - 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: All arms do not apply to this end point

End point values	AIN457 150 mg	AIN457 300 mg	placebo-AIN457 150mg	Placebo-AIN457 300mg
Number of subjects analysed	57	57	29	26
Units: Units on a scale
arithmetic mean (standard deviation)	11.4 ( 24.79 )	13.5 ( 15.69 )	12.2 ( 15.05 )	19.7 ( 17.16 )

No statistical analyses for this end point

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) total score, (Induction)

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End point title

Change from Baseline in Dermatology Life Quality Index (DLQI) total score, (Induction) ^[16]

End point description

The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions

End point type

Secondary

End point timeframe

Week 12

Notes
[16] - 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: All arms do not apply to this end point

End point values	AIN457 150 mg	AIN457 300 mg	placebo
Number of subjects analysed	56	53	54
Units: Units on a scale
median (confidence interval 95%)	-78.6 (-85.9 to -67.5)	-85.0 (-90.9 to -77.7)	-16.7 (-25.3 to -3.0)

No statistical analyses for this end point

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) score over time up to week 52, (Maintenance)

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End point title

Change from Baseline in Dermatology Life Quality Index (DLQI) score over time up to week 52, (Maintenance) ^[17]

End point description

End point type

Secondary

End point timeframe

Week 52

Notes
[17] - 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: All arms do not apply to this end point

End point values	AIN457 150 mg	AIN457 300 mg	placebo-AIN457 150mg	Placebo-AIN457 300mg
Number of subjects analysed	57	56	29	26
Units: Units on a scale
median (confidence interval 95%)	-71.4 (-83.3 to -61.9)	-90.5 (-95.7 to -84.2)	-91.7 (-100 to -81.7)	-97.2 (-100 to -83.3)

No statistical analyses for this end point

Secondary: Percentage of participants achieving a DLQI score of 0 or 1 at week 12, (Induction)

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End point title

Percentage of participants achieving a DLQI score of 0 or 1 at week 12, (Induction) ^[18]

End point description

End point type

Secondary

End point timeframe

Week 12

Notes
[18] - 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: All arms do not apply to this end point

End point values	AIN457 150 mg	AIN457 300 mg	placebo
Number of subjects analysed	57	53	54
Units: Percentage of participants
number (not applicable)	54.4	54.7	7.4

No statistical analyses for this end point

Secondary: Percentage of participants achieving a DLQI score of 0 or 1 over time up to week 52, (Maintenance)

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End point title

Percentage of participants achieving a DLQI score of 0 or 1 over time up to week 52, (Maintenance) ^[19]

End point description

End point type

Secondary

End point timeframe

Week 52

Notes
[19] - 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: All arms do not apply to this end point

End point values	AIN457 150 mg	AIN457 300 mg	placebo-AIN457 150mg	Placebo-AIN457 300mg
Number of subjects analysed	28	35	18	20
Units: Percentage of participants
number (not applicable)	48.3	62.5	62.1	76.9

No statistical analyses for this end point

Secondary: Percent of Responders with PASI equal to or greater than 50, PASI 75, PASI 90, PASI 100 after week 52

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End point title

Percent of Responders with PASI equal to or greater than 50, PASI 75, PASI 90, PASI 100 after week 52 ^[20]

End point description

End point type

Secondary

End point timeframe

Week 172

Notes
[20] - 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: All arms do not apply to this end point

End point values	AIN457 150 mg	AIN457 300 mg	placebo-AIN457 150mg	Placebo - AIN457 300 mg
Number of subjects analysed	27	32	13	19
Units: Percentage of participants
number (not applicable)
Week 172 PASI 75 (n=26, 25, 9, 17)	96.3	78.1	69.2	89.5
Week 172 PASI 50 (n=27, 32, 12, 18)	100	100	92.3	94.7
Week 172 PASI 90 (14, 21, 9, 11)	51.9	65.6	69.2	57.9
Week 172 PASI 100 (n=6, 16, 6, 7)	22.2	50.0	46.2	36.8

No statistical analyses for this end point

Secondary: Absolute change from baseline for PASI score after Week 52, (observed data)

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End point title

Absolute change from baseline for PASI score after Week 52, (observed data) ^[21]

End point description

End point type

Secondary

End point timeframe

Week 172

Notes
[21] - 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: All arms do not apply to this end point

End point values	AIN457 150 mg	AIN457 300 mg	placebo-AIN457 150mg	Placebo - AIN457 300 mg
Number of subjects analysed	27	32	13	19
Units: Units on a scale
arithmetic mean (standard deviation)	-18 ( 6.97 )	-18.7 ( 8.36 )	-14.7 ( 5.97 )	-19.4 ( 9.02 )

No statistical analyses for this end point

Secondary: Percent of participants in each IGA mod 2011 category after Week 52 (observed data)

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End point title

Percent of participants in each IGA mod 2011 category after Week 52 (observed data) ^[22]

End point description

The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant’s disease state at the time of the assessments and does not attempt a comparison to any of the participant’s previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe. The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe

End point type

Secondary

End point timeframe

Week 172

Notes
[22] - 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: All arms do not apply to this end point

End point values	AIN457 150 mg	AIN457 300 mg	placebo-AIN457 150mg	Placebo - AIN457 300 mg
Number of subjects analysed	27	32	13	19
Units: Percentage of participants
number (not applicable)
Clear (7, 15, 7, 7)	25.9	46.9	53.8	36.8
Almost clear (n=3,4,1,2)	11.1	12.5	7.7	10.5
Mild (n=16,6,3,6)	59.3	18.8	23.1	31.6
Moderate (n=1,7,1,4)	3.7	21.9	7.7	21.1
Severe (n=0,0,1,0)	0.0	0.0	7.7	0.0

No statistical analyses for this end point

Secondary: Number of participants developing treatment emergent anti-secukinumab antibodies, immunogenicity

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End point title

Number of participants developing treatment emergent anti-secukinumab antibodies, immunogenicity

End point description

The development of anti-secunimubab anti-bodies will decrease a participant’s ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to 8 weeks after last treatment

End point type

Secondary

End point timeframe

Baseline and at Week 12, 24, 52, 100, 148, and 196, 204

End point values	AIN457 150 mg	AIN457 300 mg	Placebo	placebo-AIN457 150mg	Placebo-AIN457 300mg
Number of subjects analysed	59	59	3	29	27
Units: Number of participants	3	0	0	0	0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

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

Adverse event reporting additional description

Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

19.1

Reporting group title

Induction AIN457 150 mg

Reporting group description

Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing

Reporting group title

Induction Placebo

Reporting group description

placebo secukinumab (2 s.c. injections) at each dosing

Reporting group title

Induction AIN457 300 mg

Reporting group description

Patients received two secukinumab 150 mg s.c. injections at each dosing

Reporting group title

Entire Any AIN457 300 mg

Reporting group description

Includes all patients in the AIN457 300 mg and in the placebo- AIN457 300 mg treatment groups

Reporting group title

Entire Any AIN457 150 mg

Reporting group description

Includes all patients in the AIN457 150 mg and in the placebo- AIN457 150 mg treatment groups

Serious adverse events	Induction AIN457 150 mg	Induction Placebo	Induction AIN457 300 mg	Entire Any AIN457 300 mg	Entire Any AIN457 150 mg
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 59 (1.69%)	1 / 59 (1.69%)	3 / 59 (5.08%)	10 / 86 (11.63%)	10 / 88 (11.36%)
number of deaths (all causes)	1	1	0	1	1
number of deaths resulting from adverse events	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOSQUAMOUS CELL LUNG CANCER
subjects affected / exposed	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
BASAL CELL CARCINOMA
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	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
BLADDER CANCER
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
LYMPHOPROLIFERATIVE DISORDER
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
THROMBOSIS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	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
General disorders and administration site conditions
COMPLICATION ASSOCIATED WITH DEVICE
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	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
Reproductive system and breast disorders
POSTMENOPAUSAL HAEMORRHAGE
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	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
VAGINAL HAEMORRHAGE
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	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
Psychiatric disorders
DEPRESSION
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	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
Injury, poisoning and procedural complications
ALCOHOL POISONING
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
HIP FRACTURE
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PERIORBITAL HAEMATOMA
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	1 / 86 (1.16%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
CARDIAC FAILURE CONGESTIVE
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	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
CARDIO-RESPIRATORY ARREST
subjects affected / exposed	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
CORONARY ARTERY DISEASE
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
TACHYCARDIA
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	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
Nervous system disorders
CEREBROVASCULAR ACCIDENT
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	1 / 86 (1.16%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
DIZZINESS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
LOSS OF CONSCIOUSNESS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
SCIATICA
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	1 / 86 (1.16%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
VERTIGO
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
CROHN'S DISEASE
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
RECTAL HAEMORRHAGE
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	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
Skin and subcutaneous tissue disorders
DERMATITIS EXFOLIATIVE
subjects affected / exposed	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 86 (0.00%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	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
Musculoskeletal and connective tissue disorders
BACK PAIN
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
INTERVERTEBRAL DISC PROTRUSION
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
LUMBAR SPINAL STENOSIS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
OSTEOARTHRITIS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
CELLULITIS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	2 / 88 (2.27%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PNEUMONIA
subjects affected / exposed	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PNEUMONIA INFLUENZAL
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	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
SEPSIS
subjects affected / exposed	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
SEPTIC VASCULITIS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
DIABETES MELLITUS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	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

Frequency threshold for reporting non-serious adverse events: 2%

Non-serious adverse events	Induction AIN457 150 mg	Induction Placebo	Induction AIN457 300 mg	Entire Any AIN457 300 mg	Entire Any AIN457 150 mg
Total subjects affected by non serious adverse events
subjects affected / exposed	29 / 59 (49.15%)	22 / 59 (37.29%)	24 / 59 (40.68%)	74 / 86 (86.05%)	70 / 88 (79.55%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MELANOCYTIC NAEVUS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	0 / 88 (0.00%)
occurrences all number	0	0	0	3	0
SKIN PAPILLOMA
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	1 / 88 (1.14%)
occurrences all number	0	0	0	2	1
SQUAMOUS CELL CARCINOMA
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	0 / 88 (0.00%)
occurrences all number	0	0	0	2	0
Vascular disorders
HAEMATOMA
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	3 / 86 (3.49%)	0 / 88 (0.00%)
occurrences all number	0	0	1	3	0
HYPERTENSION
subjects affected / exposed	2 / 59 (3.39%)	1 / 59 (1.69%)	1 / 59 (1.69%)	3 / 86 (3.49%)	3 / 88 (3.41%)
occurrences all number	2	1	1	3	3
General disorders and administration site conditions
ASTHENIA
subjects affected / exposed	2 / 59 (3.39%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	4 / 88 (4.55%)
occurrences all number	2	0	0	1	4
FATIGUE
subjects affected / exposed	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	2 / 86 (2.33%)	0 / 88 (0.00%)
occurrences all number	0	1	0	2	0
INJECTION SITE OEDEMA
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	2 / 88 (2.27%)
occurrences all number	0	0	0	0	2
INJECTION SITE PAIN
subjects affected / exposed	1 / 59 (1.69%)	1 / 59 (1.69%)	0 / 59 (0.00%)	1 / 86 (1.16%)	2 / 88 (2.27%)
occurrences all number	4	1	0	1	6
NON-CARDIAC CHEST PAIN
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	2 / 88 (2.27%)
occurrences all number	0	0	0	2	2
OEDEMA PERIPHERAL
subjects affected / exposed	1 / 59 (1.69%)	0 / 59 (0.00%)	1 / 59 (1.69%)	1 / 86 (1.16%)	2 / 88 (2.27%)
occurrences all number	1	0	1	1	2
PYREXIA
subjects affected / exposed	2 / 59 (3.39%)	2 / 59 (3.39%)	2 / 59 (3.39%)	3 / 86 (3.49%)	6 / 88 (6.82%)
occurrences all number	2	2	2	3	9
Immune system disorders
SEASONAL ALLERGY
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	5 / 86 (5.81%)	3 / 88 (3.41%)
occurrences all number	0	0	1	5	3
Reproductive system and breast disorders
DYSMENORRHOEA
subjects affected / exposed	0 / 59 (0.00%)	1 / 59 (1.69%)	2 / 59 (3.39%)	3 / 86 (3.49%)	0 / 88 (0.00%)
occurrences all number	0	2	3	12	0
Respiratory, thoracic and mediastinal disorders
COUGH
subjects affected / exposed	2 / 59 (3.39%)	0 / 59 (0.00%)	1 / 59 (1.69%)	9 / 86 (10.47%)	8 / 88 (9.09%)
occurrences all number	2	0	1	10	9
DYSPNOEA
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	0 / 88 (0.00%)
occurrences all number	0	0	0	2	0
NASAL CONGESTION
subjects affected / exposed	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	4 / 86 (4.65%)	3 / 88 (3.41%)
occurrences all number	0	1	0	4	3
OROPHARYNGEAL PAIN
subjects affected / exposed	2 / 59 (3.39%)	0 / 59 (0.00%)	1 / 59 (1.69%)	10 / 86 (11.63%)	5 / 88 (5.68%)
occurrences all number	2	0	1	13	5
SINUS CONGESTION
subjects affected / exposed	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	2 / 88 (2.27%)
occurrences all number	1	0	0	2	2
WHEEZING
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	2 / 88 (2.27%)
occurrences all number	0	0	0	2	2
Psychiatric disorders
ANXIETY
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	3 / 86 (3.49%)	3 / 88 (3.41%)
occurrences all number	0	0	0	3	4
DEPRESSION
subjects affected / exposed	2 / 59 (3.39%)	0 / 59 (0.00%)	1 / 59 (1.69%)	2 / 86 (2.33%)	6 / 88 (6.82%)
occurrences all number	2	0	1	2	6
INSOMNIA
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	1 / 86 (1.16%)	3 / 88 (3.41%)
occurrences all number	0	0	1	1	3
Investigations
ALANINE AMINOTRANSFERASE INCREASED
subjects affected / exposed	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	2 / 88 (2.27%)
occurrences all number	1	0	0	0	3
BLOOD PRESSURE INCREASED
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	2 / 88 (2.27%)
occurrences all number	0	0	0	0	3
BLOOD TRIGLYCERIDES INCREASED
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	2 / 88 (2.27%)
occurrences all number	0	0	0	1	3
C-REACTIVE PROTEIN INCREASED
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	0 / 88 (0.00%)
occurrences all number	0	0	0	2	0
GAMMA-GLUTAMYLTRANSFERASE INCREASED
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	0 / 88 (0.00%)
occurrences all number	0	0	0	2	0
HEPATIC ENZYME INCREASED
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	2 / 86 (2.33%)	0 / 88 (0.00%)
occurrences all number	0	0	1	3	0
VITAMIN D DECREASED
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	2 / 88 (2.27%)
occurrences all number	0	0	0	0	5
WEIGHT DECREASED
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	0 / 88 (0.00%)
occurrences all number	0	0	0	2	0
WEIGHT INCREASED
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	2 / 86 (2.33%)	0 / 88 (0.00%)
occurrences all number	0	0	1	2	0
Injury, poisoning and procedural complications
ARTHROPOD BITE
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	2 / 88 (2.27%)
occurrences all number	0	0	0	1	2
CONTUSION
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	4 / 88 (4.55%)
occurrences all number	0	0	0	1	4
FALL
subjects affected / exposed	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	1 / 88 (1.14%)
occurrences all number	1	0	0	2	1
LIGAMENT SPRAIN
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	2 / 88 (2.27%)
occurrences all number	0	0	0	1	2
LIMB INJURY
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	2 / 88 (2.27%)
occurrences all number	0	0	0	1	2
MUSCLE STRAIN
subjects affected / exposed	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	4 / 86 (4.65%)	2 / 88 (2.27%)
occurrences all number	0	1	0	4	2
ROAD TRAFFIC ACCIDENT
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	2 / 88 (2.27%)
occurrences all number	0	0	0	1	2
SKIN ABRASION
subjects affected / exposed	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	2 / 88 (2.27%)
occurrences all number	1	0	0	0	2
Cardiac disorders
ANGINA PECTORIS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	2 / 88 (2.27%)
occurrences all number	0	0	0	0	2
Nervous system disorders
HEADACHE
subjects affected / exposed	4 / 59 (6.78%)	4 / 59 (6.78%)	0 / 59 (0.00%)	6 / 86 (6.98%)	5 / 88 (5.68%)
occurrences all number	11	4	0	20	34
MIGRAINE
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	3 / 86 (3.49%)	1 / 88 (1.14%)
occurrences all number	0	0	0	3	1
SCIATICA
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	5 / 86 (5.81%)	0 / 88 (0.00%)
occurrences all number	0	0	1	5	0
SINUS HEADACHE
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	0 / 88 (0.00%)
occurrences all number	0	0	0	2	0
SYNCOPE
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	2 / 86 (2.33%)	0 / 88 (0.00%)
occurrences all number	0	0	1	2	0
Blood and lymphatic system disorders
ANAEMIA
subjects affected / exposed	2 / 59 (3.39%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	5 / 88 (5.68%)
occurrences all number	2	0	0	0	5
EOSINOPHILIA
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	2 / 88 (2.27%)
occurrences all number	0	0	0	1	3
Ear and labyrinth disorders
VERTIGO
subjects affected / exposed	1 / 59 (1.69%)	0 / 59 (0.00%)	1 / 59 (1.69%)	3 / 86 (3.49%)	2 / 88 (2.27%)
occurrences all number	1	0	1	3	3
Eye disorders
BLEPHARITIS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	2 / 88 (2.27%)
occurrences all number	0	0	0	0	3
Gastrointestinal disorders
ABDOMINAL DISTENSION
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	2 / 86 (2.33%)	0 / 88 (0.00%)
occurrences all number	0	0	1	2	0
ABDOMINAL PAIN
subjects affected / exposed	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	2 / 86 (2.33%)	3 / 88 (3.41%)
occurrences all number	0	1	0	9	4
ABDOMINAL PAIN UPPER
subjects affected / exposed	1 / 59 (1.69%)	1 / 59 (1.69%)	1 / 59 (1.69%)	4 / 86 (4.65%)	1 / 88 (1.14%)
occurrences all number	1	1	1	7	3
COLITIS
subjects affected / exposed	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	2 / 88 (2.27%)
occurrences all number	1	0	0	4	3
CONSTIPATION
subjects affected / exposed	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	5 / 88 (5.68%)
occurrences all number	1	0	0	2	5
DENTAL CARIES
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	1 / 88 (1.14%)
occurrences all number	0	0	0	2	1
DIARRHOEA
subjects affected / exposed	3 / 59 (5.08%)	1 / 59 (1.69%)	5 / 59 (8.47%)	7 / 86 (8.14%)	10 / 88 (11.36%)
occurrences all number	3	1	6	16	11
DYSPEPSIA
subjects affected / exposed	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	5 / 86 (5.81%)	2 / 88 (2.27%)
occurrences all number	0	1	0	12	2
FLATULENCE
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	3 / 86 (3.49%)	0 / 88 (0.00%)
occurrences all number	0	0	0	7	0
GASTROOESOPHAGEAL REFLUX DISEASE
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	5 / 86 (5.81%)	5 / 88 (5.68%)
occurrences all number	0	0	0	5	7
NAUSEA
subjects affected / exposed	0 / 59 (0.00%)	1 / 59 (1.69%)	3 / 59 (5.08%)	5 / 86 (5.81%)	4 / 88 (4.55%)
occurrences all number	0	1	3	5	5
TOOTHACHE
subjects affected / exposed	2 / 59 (3.39%)	1 / 59 (1.69%)	0 / 59 (0.00%)	4 / 86 (4.65%)	10 / 88 (11.36%)
occurrences all number	2	2	0	4	12
VOMITING
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 59 (3.39%)	6 / 86 (6.98%)	4 / 88 (4.55%)
occurrences all number	0	0	2	6	4
Skin and subcutaneous tissue disorders
ACNE
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	3 / 88 (3.41%)
occurrences all number	0	0	0	0	3
ACTINIC KERATOSIS
subjects affected / exposed	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	3 / 86 (3.49%)	1 / 88 (1.14%)
occurrences all number	0	1	0	5	1
ALOPECIA
subjects affected / exposed	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	3 / 86 (3.49%)	0 / 88 (0.00%)
occurrences all number	0	1	0	3	0
DERMAL CYST
subjects affected / exposed	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	2 / 88 (2.27%)
occurrences all number	1	0	0	1	2
DERMATITIS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	2 / 88 (2.27%)
occurrences all number	0	0	0	2	2
DERMATITIS CONTACT
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 59 (3.39%)	5 / 86 (5.81%)	2 / 88 (2.27%)
occurrences all number	0	0	2	7	2
ECZEMA
subjects affected / exposed	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	5 / 86 (5.81%)	3 / 88 (3.41%)
occurrences all number	0	1	0	5	3
PRURITUS
subjects affected / exposed	0 / 59 (0.00%)	1 / 59 (1.69%)	1 / 59 (1.69%)	3 / 86 (3.49%)	2 / 88 (2.27%)
occurrences all number	0	1	1	3	2
PSORIASIS
subjects affected / exposed	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	3 / 86 (3.49%)	6 / 88 (6.82%)
occurrences all number	0	1	0	3	8
URTICARIA PAPULAR
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	0 / 88 (0.00%)
occurrences all number	0	0	0	2	0
Renal and urinary disorders
GLYCOSURIA
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	2 / 88 (2.27%)
occurrences all number	0	0	0	0	3
HAEMATURIA
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	3 / 88 (3.41%)
occurrences all number	0	0	0	2	4
Musculoskeletal and connective tissue disorders
ARTHRALGIA
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	11 / 86 (12.79%)	7 / 88 (7.95%)
occurrences all number	0	0	1	15	10
BACK PAIN
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	3 / 59 (5.08%)	6 / 86 (6.98%)	4 / 88 (4.55%)
occurrences all number	0	0	3	19	6
BURSITIS
subjects affected / exposed	1 / 59 (1.69%)	0 / 59 (0.00%)	2 / 59 (3.39%)	3 / 86 (3.49%)	1 / 88 (1.14%)
occurrences all number	1	0	2	3	1
INTERVERTEBRAL DISC PROTRUSION
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	0 / 88 (0.00%)
occurrences all number	0	0	0	2	0
MUSCLE SPASMS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	0 / 88 (0.00%)
occurrences all number	0	0	0	2	0
MUSCULAR WEAKNESS
subjects affected / exposed	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	2 / 88 (2.27%)
occurrences all number	1	0	0	0	2
MYALGIA
subjects affected / exposed	1 / 59 (1.69%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	3 / 88 (3.41%)
occurrences all number	1	0	0	2	3
NECK PAIN
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	3 / 88 (3.41%)
occurrences all number	0	0	0	1	3
PAIN IN EXTREMITY
subjects affected / exposed	1 / 59 (1.69%)	0 / 59 (0.00%)	1 / 59 (1.69%)	6 / 86 (6.98%)	5 / 88 (5.68%)
occurrences all number	1	0	1	7	5
PSORIATIC ARTHROPATHY
subjects affected / exposed	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	3 / 86 (3.49%)	2 / 88 (2.27%)
occurrences all number	0	1	0	3	2
SPINAL PAIN
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	3 / 86 (3.49%)	0 / 88 (0.00%)
occurrences all number	0	0	0	11	0
TENDONITIS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	3 / 86 (3.49%)	2 / 88 (2.27%)
occurrences all number	0	0	0	3	2
Infections and infestations
ABSCESS ORAL
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	0 / 88 (0.00%)
occurrences all number	0	0	0	2	0
ACARODERMATITIS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	0 / 88 (0.00%)
occurrences all number	0	0	0	2	0
BRONCHITIS
subjects affected / exposed	0 / 59 (0.00%)	1 / 59 (1.69%)	1 / 59 (1.69%)	4 / 86 (4.65%)	5 / 88 (5.68%)
occurrences all number	0	1	1	5	5
CELLULITIS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	0 / 88 (0.00%)
occurrences all number	0	0	0	2	0
CONJUNCTIVITIS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	1 / 86 (1.16%)	2 / 88 (2.27%)
occurrences all number	0	0	1	2	3
CYSTITIS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	2 / 88 (2.27%)
occurrences all number	0	0	0	1	2
EAR INFECTION
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	1 / 88 (1.14%)
occurrences all number	0	0	0	2	1
FOLLICULITIS
subjects affected / exposed	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	2 / 86 (2.33%)	2 / 88 (2.27%)
occurrences all number	0	1	0	2	3
GASTROENTERITIS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	4 / 86 (4.65%)	5 / 88 (5.68%)
occurrences all number	0	0	0	4	5
GASTROENTERITIS VIRAL
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	2 / 88 (2.27%)
occurrences all number	0	0	0	0	2
INFLUENZA
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	6 / 86 (6.98%)	4 / 88 (4.55%)
occurrences all number	0	0	0	6	5
LABYRINTHITIS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	3 / 88 (3.41%)
occurrences all number	0	0	0	1	3
NASOPHARYNGITIS
subjects affected / exposed	3 / 59 (5.08%)	5 / 59 (8.47%)	3 / 59 (5.08%)	17 / 86 (19.77%)	21 / 88 (23.86%)
occurrences all number	4	5	3	32	37
ORAL CANDIDIASIS
subjects affected / exposed	1 / 59 (1.69%)	0 / 59 (0.00%)	1 / 59 (1.69%)	2 / 86 (2.33%)	1 / 88 (1.14%)
occurrences all number	1	0	2	8	1
ORAL HERPES
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	5 / 86 (5.81%)	0 / 88 (0.00%)
occurrences all number	0	0	1	5	0
OTITIS MEDIA
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	1 / 88 (1.14%)
occurrences all number	0	0	0	2	2
OTITIS MEDIA BACTERIAL
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	2 / 88 (2.27%)
occurrences all number	0	0	0	0	3
PERIODONTITIS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	1 / 88 (1.14%)
occurrences all number	0	0	0	2	2
PHARYNGITIS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 59 (1.69%)	4 / 86 (4.65%)	3 / 88 (3.41%)
occurrences all number	0	0	1	9	3
PNEUMONIA
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	3 / 86 (3.49%)	0 / 88 (0.00%)
occurrences all number	0	0	0	3	0
RHINITIS
subjects affected / exposed	2 / 59 (3.39%)	0 / 59 (0.00%)	1 / 59 (1.69%)	5 / 86 (5.81%)	7 / 88 (7.95%)
occurrences all number	2	0	1	5	9
SINUSITIS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	3 / 86 (3.49%)	7 / 88 (7.95%)
occurrences all number	0	0	0	4	8
SKIN BACTERIAL INFECTION
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	2 / 88 (2.27%)
occurrences all number	0	0	0	1	2
STAPHYLOCOCCAL INFECTION
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	0 / 88 (0.00%)
occurrences all number	0	0	0	2	0
TINEA PEDIS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	3 / 86 (3.49%)	0 / 88 (0.00%)
occurrences all number	0	0	0	3	0
TONGUE FUNGAL INFECTION
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	0 / 88 (0.00%)
occurrences all number	0	0	0	2	0
TONSILLITIS
subjects affected / exposed	0 / 59 (0.00%)	1 / 59 (1.69%)	0 / 59 (0.00%)	2 / 86 (2.33%)	5 / 88 (5.68%)
occurrences all number	0	1	0	2	5
TOOTH ABSCESS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	2 / 88 (2.27%)
occurrences all number	0	0	0	2	2
TOOTH INFECTION
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	3 / 88 (3.41%)
occurrences all number	0	0	0	2	3
UPPER RESPIRATORY TRACT INFECTION
subjects affected / exposed	2 / 59 (3.39%)	1 / 59 (1.69%)	0 / 59 (0.00%)	16 / 86 (18.60%)	16 / 88 (18.18%)
occurrences all number	2	1	0	30	22
URINARY TRACT INFECTION
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	4 / 86 (4.65%)	5 / 88 (5.68%)
occurrences all number	0	0	0	4	9
VIRAL UPPER RESPIRATORY TRACT INFECTION
subjects affected / exposed	1 / 59 (1.69%)	0 / 59 (0.00%)	1 / 59 (1.69%)	3 / 86 (3.49%)	6 / 88 (6.82%)
occurrences all number	1	0	1	4	8
VULVOVAGINAL CANDIDIASIS
subjects affected / exposed	1 / 59 (1.69%)	0 / 59 (0.00%)	1 / 59 (1.69%)	5 / 86 (5.81%)	2 / 88 (2.27%)
occurrences all number	1	0	1	7	3
Metabolism and nutrition disorders
DIABETES MELLITUS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	3 / 88 (3.41%)
occurrences all number	0	0	0	2	3
HYPERCHOLESTEROLAEMIA
subjects affected / exposed	2 / 59 (3.39%)	1 / 59 (1.69%)	1 / 59 (1.69%)	2 / 86 (2.33%)	5 / 88 (5.68%)
occurrences all number	2	1	1	2	5
HYPERTRIGLYCERIDAEMIA
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	1 / 86 (1.16%)	2 / 88 (2.27%)
occurrences all number	0	0	0	1	2
HYPOKALAEMIA
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 86 (0.00%)	2 / 88 (2.27%)
occurrences all number	0	0	0	0	2
HYPOSIDERAEMIA
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	1 / 88 (1.14%)
occurrences all number	0	0	0	2	2
TYPE 2 DIABETES MELLITUS
subjects affected / exposed	0 / 59 (0.00%)	0 / 59 (0.00%)	0 / 59 (0.00%)	2 / 86 (2.33%)	0 / 88 (0.00%)
occurrences all number	0	0	0	2	0

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Were there any global substantial amendments to the protocol? Yes

27 Mar 2012

The opportunity for the patient to enter an extension study instead of a non-treatment follow-up period upon completion of the core study treatment period was described  For permitted concomitant medications, the requirement of a stable dose for at least four weeks before Randomization was removed  Urine pregnancy testing was clarified as not required for post-menopausal women  Procedures at Screening for misrandomized patients were specified  Corrections and clarifications were made to the study protocol, including inclusion of immunogenicity and PK sample analysis method and procedures, blinding

20 Mar 2013

Provided continued treatment for another 156 weeks or until the drug is available in the country of participation for eligible patients who were on active therapy during the Maintenance period  Allowed for rescreening of patients, and specified rescreening procedures  Specified that at Week 52 the sites will become aware which patients received placebo during the Maintenance period. After the Week 52 data base lock, the study will be open label  Introduced home administration of study treatment for certain visits of the extension treatment period  Clarified that abnormalities in vital signs or laboratory evaluations did not require protocol specified actions, but actions to be determined by the Investigator  Provided instructions to report defects, malfunctions or product complaints of the prefilled syringe

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.

Efficacy results after Wk 172 can't be interpreted meaningfully due to low # of evaluable patients. As per protocol, availability of AIN457 in participating countries led to discontinuation of most patients before they reached the later visits.

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis at week 12 Measure: PASI 75 (psoriasis area and severity index) response"

Primary: Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis at week 12 Measure: PASI 75 (psoriasis area and severity index) response"

Primary: Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis Measure:IGA (investigator’s global assessment) with a 0 or 1 response at Week 12

Primary: Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis Measure:IGA (investigator’s global assessment) with a 0 or 1 response at Week 12

Secondary: Absolute change from baseline in Self Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12

Secondary: Absolute change from baseline in Self Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12

Secondary: Absolute change from baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at week 48

Secondary: Absolute change from baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at week 48

Secondary: Percentage of subjects with potential use related hazards at week 1

Secondary: Percentage of subjects with potential use related hazards at week 1

Secondary: Percentage of subjects with successful self administration of study drug at week 1

Secondary: Percentage of subjects with successful self administration of study drug at week 1

Secondary: Percent of Responders with PASI equal to or greater than 50, PASI 75, PASI 90, PASI 100, (induction) with non-responder imputation

Secondary: Percent of Responders with PASI equal to or greater than 50, PASI 75, PASI 90, PASI 100, (induction) with non-responder imputation

Secondary: Percent of Responders with PASI equal to or greater than 50, PASI 75, PASI 90, PASI 100, (Maintenance, observed data)

Secondary: Percent of Responders with PASI equal to or greater than 50, PASI 75, PASI 90, PASI 100, (Maintenance, observed data)

Secondary: Percent of responders with IGA mod 2011 score of 0 or 1, (Maintenance; observed data)

Secondary: Percent of responders with IGA mod 2011 score of 0 or 1, (Maintenance; observed data)

Secondary: Absolute change from baseline for PASI score at Week 12, (induction)

Secondary: Absolute change from baseline for PASI score at Week 12, (induction)

Secondary: Absolute change from baseline for PASI score over time up to week 52, (Maintenance; observed data)

Secondary: Absolute change from baseline for PASI score over time up to week 52, (Maintenance; observed data)

Secondary: Percentage of participants in each IGA mod 2011 category at Week 12, (induction)

Secondary: Percentage of participants in each IGA mod 2011 category at Week 12, (induction)

Secondary: Percentage of participants in each IGA mod 2011 category over time up to week 52, (Maintenance; observed data)

Secondary: Percentage of participants in each IGA mod 2011 category over time up to week 52, (Maintenance; observed data)

Secondary: Change from baseline in EQ-5D at week 12 (induction)

Secondary: Change from baseline in EQ-5D at week 12 (induction)

Secondary: Change from baseline in EQ-5D at week 12 and over time up to week 52, (Maintenance)

Secondary: Change from baseline in EQ-5D at week 12 and over time up to week 52, (Maintenance)

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) total score, (Induction)

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) total score, (Induction)

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) score over time up to week 52, (Maintenance)

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) score over time up to week 52, (Maintenance)

Secondary: Percentage of participants achieving a DLQI score of 0 or 1 at week 12, (Induction)

Secondary: Percentage of participants achieving a DLQI score of 0 or 1 at week 12, (Induction)

Secondary: Percentage of participants achieving a DLQI score of 0 or 1 over time up to week 52, (Maintenance)

Secondary: Percentage of participants achieving a DLQI score of 0 or 1 over time up to week 52, (Maintenance)

Secondary: Percent of Responders with PASI equal to or greater than 50, PASI 75, PASI 90, PASI 100 after week 52

Secondary: Percent of Responders with PASI equal to or greater than 50, PASI 75, PASI 90, PASI 100 after week 52

Secondary: Absolute change from baseline for PASI score after Week 52, (observed data)

Secondary: Absolute change from baseline for PASI score after Week 52, (observed data)

Secondary: Percent of participants in each IGA mod 2011 category after Week 52 (observed data)

Secondary: Percent of participants in each IGA mod 2011 category after Week 52 (observed data)

Secondary: Number of participants developing treatment emergent anti-secukinumab antibodies, immunogenicity

Secondary: Number of participants developing treatment emergent anti-secukinumab antibodies, immunogenicity

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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