First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks (FEATURE)

• ClinicalTrials.gov Identifier: NCT01555125
• Recruitment Status: Completed
• First Posted: March 15, 2012
• Results First Posted: August 8, 2018
• Last Update Posted: August 8, 2018
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Moderate to Severe Plaque-type Psoriasis
• Interventions: Drug: secukinumab 150 mg; Drug: secukinumab 300 mg; Drug: placebo
• Enrollment: 177

Participant Flow

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.
Pre-assignment Details

Arm/Group Title	AIN457 150 mg	AIN457 300 mg	Placebo - AIN457 150mg	Placebo - AIN457 300mg	Placebo
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	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	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	Patients received placebo secukinumab (2 s.c. injections) at each dosing
Period Title: Induction Period
Started	59	59	0	0	59
Completed	58	56	0	0	56
Not Completed	1	3	0	0	3
Reason Not Completed
Lost to Follow-up	0	2	0	0	0
Adverse Event	0	1	0	0	1
Subject / guardian decision	0	0	0	0	2
Death	1	0	0	0	0
Period Title: Maintenance Period
Started	58	56	29	27	0
Completed	48	52	25	25	0
Not Completed	10	4	4	2	0
Reason Not Completed
Adverse Event	1	1	0	0	0
Subject / guardian decision	1	2	0	0	0
Lost to Follow-up	2	0	0	1	0
Lack of Efficacy	6	1	3	0	0
Physician Decision	0	0	1	0	0
Death	0	0	0	1	0
Period Title: Extension
Started	46	51	23	23	0
Completed	1	0	0	1	0
Not Completed	45	51	23	22	0
Reason Not Completed
Adverse Event	1	2	1	1	0
Protocol deviation	1	0	0	0	0
Lack of Efficacy	7	6	3	0	0
Lost to Follow-up	2	1	2	0	0
Study terminated by sponsor	32	33	16	20	0
Subject/guardian decision	1	9	1	0	0
Technical Problems	1	0	0	1	0
Period Title: Follow-Up Period
Started	36	31	19	18	0
Completed	32	30	18	17	0
Not Completed	4	1	1	1	0
Reason Not Completed
Lost to Follow-up	1	0	0	0	0
Subject / guardian decision	3	1	1	1	0

Baseline Characteristics

Arm/Group Title		AIN457 150 mg	AIN457 300 mg	Placebo	Total
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	Patients received placebo secukinumab (2 s.c. injections) at each dosing	Total of all reporting groups
Overall Number of Baseline Participants		59	59	59	177
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	59 participants	59 participants	59 participants	177 participants
		46 (15.09)	45.1 (12.57)	46.5 (14.14)	45.9 (13.91)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	59 participants	59 participants	59 participants	177 participants
	Female	19 32.2%	21 35.6%	20 33.9%	60 33.9%
	Male	40 67.8%	38 64.4%	39 66.1%	117 66.1%

Outcome Measures

1. Primary Outcome

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.
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
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AIN457 150 mg	AIN457 300 mg	Placebo
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	Patients received placebo secukinumab (2 s.c. injections) at each dosing
Overall Number of Participants Analyzed	59	58	59
Measure Type: Number; Unit of Measure: Percentage of participants
	69.5	75.9	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AIN457 150 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	AIN457 300 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

2. Primary Outcome

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
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
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AIN457 150 mg	AIN457 300 mg	Placebo
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	Patients received placebo secukinumab (2 s.c. injections) at each dosing
Overall Number of Participants Analyzed	59	58	59
Measure Type: Number; Unit of Measure: Percentage of Participants
	52.5	69	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AIN457 150 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	AIN457 300 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

3. Secondary Outcome

Title	Absolute Change From Baseline in Self Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12
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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were analyzed according to treatment received

Arm/Group Title	AIN457 150 mg	AIN457 300 mg	Placebo
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	Patients received placebo secukinumab (2 s.c. injections) at each dosing
Overall Number of Participants Analyzed	59	59	59
Mean (Standard Deviation); Unit of Measure: Score
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)

4. Secondary Outcome

Title	Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48
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.
Time Frame	Baseline, week 48

Outcome Measure Data

Analysis Population Description

Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were analyzed according to treatment received.

Arm/Group Title		AIN457 150 mg	AIN457 300 mg	Placebo-AIN457 150mg	Placebo-AIN457 300mg
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	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	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
Overall Number of Participants Analyzed		58	56	29	27
Mean (Standard Deviation); Unit of Measure: Score
Feelings about injections	Number Analyzed	45 participants	52 participants	25 participants	24 participants
		0.93 (1.752)	1.01 (2.103)	0.63 (1.449)	0.76 (1.321)
Self-confidence	Number Analyzed	45 participants	51 participants	25 participants	24 participants
		1.63 (3.173)	1.24 (2.400)	0.97 (1.811)	0.94 (1.521)
Satisfaction, self-injection	Number Analyzed	43 participants	50 participants	25 participants	23 participants
		1.92 (2.239)	2.15 (2.673)	1.90 (3.250)	0.54 (1.840)

5. Secondary Outcome

Title	Number of Subjects With Potential Use Related Hazards at Week 1
Description	To assess potential use-related hazards with the secukinumab PFS for the subject
Time Frame	Week 1

Outcome Measure Data

Analysis Population Description

Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were analyzed according to treatment received

Arm/Group Title		AIN457 150 mg	AIN457 300 mg	Placebo
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	Patients received placebo secukinumab (2 s.c. injections) at each dosing
Overall Number of Participants Analyzed		59	59	59
Measure Type: Number; Unit of Measure: Number of participants
Needle stick in a critical area	Number Analyzed	58 participants	57 participants	59 participants
		0	0	0
Needle stick in non-critical area	Number Analyzed	58 participants	57 participants	59 participants
		0	0	1
Any part of the device swallowed	Number Analyzed	58 participants	57 participants	59 participants
		0	0	0
Allergic reaction to device material	Number Analyzed	58 participants	57 participants	59 participants
		0	0	0
Pain due to bent needle	Number Analyzed	58 participants	57 participants	59 participants
		0	0	0
Any breakage of the device	Number Analyzed	58 participants	57 participants	59 participants
		0	0	0
Swallowing of material debris observed	Number Analyzed	58 participants	57 participants	59 participants
		0	0	0
Any other problem	Number Analyzed	58 participants	57 participants	59 participants
		1	0	0
Less than full dose administered	Number Analyzed	58 participants	57 participants	59 participants
		1	0	0

6. Secondary Outcome

Title	Percentage of Subjects With Successful Self Administration of Study Drug at Week 1
Description	To assess the subject's ability to follow instructions for use with the secukinumab PFS
Time Frame	Week 1

Outcome Measure Data

Analysis Population Description

Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were analyzed according to treatment received

Arm/Group Title	AIN457 150 mg	AIN457 300 mg	Placebo
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	Patients received placebo secukinumab (2 s.c. injections) at each dosing
Overall Number of Participants Analyzed	58	57	59
Measure Type: Number; Unit of Measure: Percentage of participants
	100	100	100

7. Secondary Outcome

Title	Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Induction) With Non-responder Imputation
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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AIN457 150 mg	AIN457 300 mg	Placebo
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	Patients received placebo secukinumab (2 s.c. injections) at each dosing
Overall Number of Participants Analyzed	59	59	59
Measure Type: Number; Unit of Measure: Percentage of participants
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

8. Secondary Outcome

Title	Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data)
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.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AIN457 150 mg	AIN457 300 mg	Placebo-AIN457 150mg	Placebo - AIN457 300 mg
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	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	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
Overall Number of Participants Analyzed	59	58	29	27
Measure Type: Number; Unit of Measure: Percentage of participants
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

9. Secondary Outcome

Title	Percent of Responders With Investigator's Global Assessment (IGA) Mod 2011 Score of 0 or 1, (Maintenance; Observed Data)
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.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AIN457 150 mg	AIN457 300 mg	Placebo-AIN457 150mg	Placebo - AIN457 300 mg
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	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	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
Overall Number of Participants Analyzed	59	59	29	27
Measure Type: Number; Unit of Measure: Percentage of participants
	51	71.2	72	92

10. Secondary Outcome

Title	Absolute Change From Baseline for PASI Score at Week 12, (Induction)
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)
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AIN457 150 mg	AIN457 300 mg	Placebo
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	Patients received placebo secukinumab (2 s.c. injections) at each dosing
Overall Number of Participants Analyzed	59	59	59
Mean (Standard Deviation); Unit of Measure: Units on a scale
	-16.33 (8.49)	-17.90 (8.74)	0.50 (7.22)

11. Secondary Outcome

Title	Absolute Change From Baseline for PASI Score Over Time up to Week 52, (Maintenance; Observed Data)
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)
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AIN457 150 mg	AIN457 300 mg	Placebo-AIN457 150mg	Placebo - AIN457 300 mg
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	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	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
Overall Number of Participants Analyzed	59	58	29	27
Mean (Standard Deviation); Unit of Measure: Units on a scale
	-16.9 (8.27)	-18.7 (8.48)	-15.2 (5.38)	-20 (7.96)

12. Secondary Outcome

Title	Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction)
Description	The IGA mod 2011 category 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
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AIN457 150 mg	AIN457 300 mg	Placebo
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	Patients received placebo secukinumab (2 s.c. injections) at each dosing
Overall Number of Participants Analyzed	59	58	59
Measure Type: Number; Unit of Measure: Number of participants
clear	6	26	0
almost clear	26	17	0
mild	12	9	1
moderate	14	5	34
severe	1	1	24

13. Secondary Outcome

Title	Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data)
Description	The IGA mod 2011 category 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.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AIN457 150 mg	AIN457 300 mg	Placebo-AIN457 150mg	Placebo - AIN457 300 mg
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	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	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
Overall Number of Participants Analyzed	59	59	29	27
Measure Type: Number; Unit of Measure: Percentage of participants
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

14. Secondary Outcome

Title	Change From Baseline in EQ-5D at Week 12 (Induction)
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)
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AIN457 150 mg	AIN457 300 mg	Placebo
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	Patients received placebo secukinumab (2 s.c. injections) at each dosing
Overall Number of Participants Analyzed	59	59	59
Mean (Standard Deviation); Unit of Measure: Units on a scale
	12.1 (24.03)	11.2 (18.02)	0.8 (16.12)

15. Secondary Outcome

Title	Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Over Time up to Week 52, (Maintenance)
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)
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AIN457 150 mg	AIN457 300 mg	Placebo-AIN457 150mg	Placebo-AIN457 300mg
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	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	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
Overall Number of Participants Analyzed	57	57	29	26
Mean (Standard Deviation); Unit of Measure: Units on a scale
	11.4 (24.79)	13.5 (15.69)	12.2 (15.05)	19.7 (17.16)

16. Secondary Outcome

Title	Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score, (Induction)
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. This result was reflected in the percentage change from baseline at Week 12, higher reductions (improvements) in DLQI scores (median treatment difference).
Time Frame	Baseline and week 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AIN457 150 mg	AIN457 300 mg	Placebo
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	Patients received placebo secukinumab (2 s.c. injections) at each dosing
Overall Number of Participants Analyzed	56	53	54
Median (95% Confidence Interval); Unit of Measure: Percent change
	-78.6; (-85.9 to -67.5)	-85.0; (-90.9 to -77.7)	-16.7; (-25.3 to -3.0)

17. Secondary Outcome

Title	Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52, (Maintenance)
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. This result was reflected in the percentage change from baseline at Week 12, higher reductions (improvements) in DLQI scores (median treatment difference).
Time Frame	Baseline and week 52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AIN457 150 mg	AIN457 300 mg	Placebo-AIN457 150mg	Placebo-AIN457 300mg
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	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	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
Overall Number of Participants Analyzed	57	56	29	26
Median (95% Confidence Interval); Unit of Measure: Percent change
	-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)

18. Secondary Outcome

Title	Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12, (Induction)
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
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AIN457 150 mg	AIN457 300 mg	Placebo
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	Patients received placebo secukinumab (2 s.c. injections) at each dosing
Overall Number of Participants Analyzed	57	53	54
Measure Type: Number; Unit of Measure: Percentage of participants
	54.4	54.7	7.4

19. Secondary Outcome

Title	Percentage of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52, (Maintenance)
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
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AIN457 150 mg	AIN457 300 mg	Placebo-AIN457 150 mg	Placebo-AIN457 300mg
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	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	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
Overall Number of Participants Analyzed	28	35	18	20
Measure Type: Number; Unit of Measure: Percentage of participants
	48.3	62.5	62.1	76.9

20. Secondary Outcome

Title	Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52
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.
Time Frame	Week 172

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) - All patients to whom study treatment was assigned. Results after Week 172 and beyond cannot be interpreted meaningfully due to low number of evaluable patients at these visits.

Arm/Group Title		AIN457 150 mg	AIN457 300 mg	Placebo-AIN457 150mg	Placebo - AIN457 300 mg
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	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	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
Overall Number of Participants Analyzed		59	59	29	27
Measure Type: Number; Unit of Measure: Number of participants
Week 172 PASI 75	Number Analyzed	27 participants	32 participants	13 participants	19 participants
		26	25	9	17
Week 172 PASI 50	Number Analyzed	27 participants	32 participants	13 participants	19 participants
		27	32	12	18
Week 172 PASI 90	Number Analyzed	27 participants	32 participants	13 participants	19 participants
		14	21	9	11
Week 172 PASI 100	Number Analyzed	27 participants	32 participants	13 participants	19 participants
		6	16	6	7

21. Secondary Outcome

Title	Absolute Change From Baseline for PASI Score After Week 52, (Observed Data)
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)
Time Frame	Week 172

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AIN457 150 mg	AIN457 300 mg	Placebo-AIN457 150mg	Placebo - AIN457 300 mg
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	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	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
Overall Number of Participants Analyzed	27	32	13	19
Mean (Standard Deviation); Unit of Measure: Units on a scale
	-18 (6.97)	-18.7 (8.36)	-14.7 (5.97)	-19.4 (9.02)

22. Secondary Outcome

Title	Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data)
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
Time Frame	Week 172

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) - All patients to whom study treatment was assigned. Results after Week 172 and beyond cannot be interpreted meaningfully due to low number of evaluable patients at these visits.

Arm/Group Title		AIN457 150 mg	AIN457 300 mg	Placebo-AIN457 150mg	Placebo - AIN457 300 mg
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	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	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
Overall Number of Participants Analyzed		59	59	29	27
Measure Type: Number; Unit of Measure: Number of participants
Clear	Number Analyzed	27 participants	32 participants	13 participants	19 participants
		7	15	7	7
Almost clear	Number Analyzed	27 participants	32 participants	13 participants	19 participants
		3	4	1	2
Mild	Number Analyzed	27 participants	32 participants	13 participants	19 participants
		16	6	3	6
Moderate	Number Analyzed	27 participants	32 participants	13 participants	19 participants
		1	7	1	4
Severe	Number Analyzed	27 participants	32 participants	13 participants	19 participants
		0	0	1	0

23. Secondary Outcome

Title	Number of Participants Developing Treatment Emergent Anti-secukinumab Antibodies, Immunogenicity
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
Time Frame	Baseline and at Week 12, 24, 52, 100, 148, and 196, 204

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AIN457 150 mg	AIN457 300 mg	Placebo-AIN457 150mg	Placebo-AIN457 300mg	Placebo
Arm/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	Patients received two secukinumab 150 mg s.c. injections at each dosing	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	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	Patients received placebo secukinumab (2 s.c. injections) at each dosing
Overall Number of Participants Analyzed	59	59	29	27	3
Measure Type: Number; Unit of Measure: Number of participants
	3	0	0	0	0

Adverse Events

Time Frame	Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
Adverse Event Reporting Description	AE additional description
Arm/Group Title	Induction AIN457 150 mg	Induction AIN457 300 mg	Induction Placebo	Entire Any AIN457 150 mg	Entire Any AIN457 300 mg
Arm/Group Description	Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing	Patients received two secukinumab 150 mg s.c. injections at each dosing	placebo secukinumab (2 s.c. injections) at each dosing	Includes all patients in the AIN457 150 mg and in the placebo- AIN457 150 mg treatment groups	Includes all patients in the AIN457 300 mg and in the placebo- AIN457 300 mg treatment groups
All-Cause Mortality
	Induction AIN457 150 mg	Induction AIN457 300 mg	Induction Placebo	Entire Any AIN457 150 mg	Entire Any AIN457 300 mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--	--/--	--/--
Serious Adverse Events
	Induction AIN457 150 mg	Induction AIN457 300 mg	Induction Placebo	Entire Any AIN457 150 mg	Entire Any AIN457 300 mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	1/59 (1.69%)	3/59 (5.08%)	1/59 (1.69%)	10/88 (11.36%)	10/86 (11.63%)
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION † 1	0/59 (0.00%)	1/59 (1.69%)	0/59 (0.00%)	0/88 (0.00%)	1/86 (1.16%)
CARDIAC FAILURE CONGESTIVE † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	0/86 (0.00%)
CARDIO-RESPIRATORY ARREST † 1	1/59 (1.69%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	0/86 (0.00%)
CORONARY ARTERY DISEASE † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	1/86 (1.16%)
TACHYCARDIA † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	0/86 (0.00%)
Ear and labyrinth disorders
VERTIGO † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	1/86 (1.16%)
Gastrointestinal disorders
CROHN'S DISEASE † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	1/86 (1.16%)
RECTAL HAEMORRHAGE † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	0/86 (0.00%)
General disorders
COMPLICATION ASSOCIATED WITH DEVICE † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	0/86 (0.00%)
Infections and infestations
CELLULITIS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	0/86 (0.00%)
PNEUMONIA † 1	1/59 (1.69%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	0/86 (0.00%)
PNEUMONIA INFLUENZAL † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	0/86 (0.00%)
SEPSIS † 1	1/59 (1.69%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	0/86 (0.00%)
SEPTIC VASCULITIS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	0/86 (0.00%)
Injury, poisoning and procedural complications
ALCOHOL POISONING † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	1/86 (1.16%)
HIP FRACTURE † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	1/86 (1.16%)
PERIORBITAL HAEMATOMA † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	1/86 (1.16%)
Metabolism and nutrition disorders
DIABETES MELLITUS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	0/86 (0.00%)
Musculoskeletal and connective tissue disorders
BACK PAIN † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	0/86 (0.00%)
INTERVERTEBRAL DISC PROTRUSION † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	2/86 (2.33%)
LUMBAR SPINAL STENOSIS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	1/86 (1.16%)
OSTEOARTHRITIS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	0/86 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOSQUAMOUS CELL LUNG CANCER † 1	1/59 (1.69%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	0/86 (0.00%)
BASAL CELL CARCINOMA † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	0/86 (0.00%)
BLADDER CANCER † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	1/86 (1.16%)
LYMPHOPROLIFERATIVE DISORDER † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	1/86 (1.16%)
Nervous system disorders
CEREBROVASCULAR ACCIDENT † 1	0/59 (0.00%)	1/59 (1.69%)	0/59 (0.00%)	0/88 (0.00%)	1/86 (1.16%)
DIZZINESS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	1/86 (1.16%)
LOSS OF CONSCIOUSNESS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	1/86 (1.16%)
SCIATICA † 1	0/59 (0.00%)	1/59 (1.69%)	0/59 (0.00%)	0/88 (0.00%)	1/86 (1.16%)
Psychiatric disorders
DEPRESSION † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	0/86 (0.00%)
Reproductive system and breast disorders
POSTMENOPAUSAL HAEMORRHAGE † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	0/86 (0.00%)
VAGINAL HAEMORRHAGE † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	0/86 (0.00%)
Skin and subcutaneous tissue disorders
DERMATITIS EXFOLIATIVE † 1	0/59 (0.00%)	0/59 (0.00%)	1/59 (1.69%)	0/88 (0.00%)	0/86 (0.00%)
Vascular disorders
THROMBOSIS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	0/86 (0.00%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA (19.1)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	2%
	Induction AIN457 150 mg	Induction AIN457 300 mg	Induction Placebo	Entire Any AIN457 150 mg	Entire Any AIN457 300 mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	29/59 (49.15%)	24/59 (40.68%)	22/59 (37.29%)	70/88 (79.55%)	74/86 (86.05%)
Blood and lymphatic system disorders
ANAEMIA † 1	2/59 (3.39%)	0/59 (0.00%)	0/59 (0.00%)	5/88 (5.68%)	0/86 (0.00%)
EOSINOPHILIA † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	1/86 (1.16%)
Cardiac disorders
ANGINA PECTORIS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	0/86 (0.00%)
Ear and labyrinth disorders
VERTIGO † 1	1/59 (1.69%)	1/59 (1.69%)	0/59 (0.00%)	2/88 (2.27%)	3/86 (3.49%)
Eye disorders
BLEPHARITIS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	0/86 (0.00%)
Gastrointestinal disorders
ABDOMINAL DISTENSION † 1	0/59 (0.00%)	1/59 (1.69%)	0/59 (0.00%)	0/88 (0.00%)	2/86 (2.33%)
ABDOMINAL PAIN † 1	0/59 (0.00%)	0/59 (0.00%)	1/59 (1.69%)	3/88 (3.41%)	2/86 (2.33%)
ABDOMINAL PAIN UPPER † 1	1/59 (1.69%)	1/59 (1.69%)	1/59 (1.69%)	1/88 (1.14%)	4/86 (4.65%)
COLITIS † 1	1/59 (1.69%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	1/86 (1.16%)
CONSTIPATION † 1	1/59 (1.69%)	0/59 (0.00%)	0/59 (0.00%)	5/88 (5.68%)	2/86 (2.33%)
DENTAL CARIES † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	2/86 (2.33%)
DIARRHOEA † 1	3/59 (5.08%)	5/59 (8.47%)	1/59 (1.69%)	10/88 (11.36%)	7/86 (8.14%)
DYSPEPSIA † 1	0/59 (0.00%)	0/59 (0.00%)	1/59 (1.69%)	2/88 (2.27%)	5/86 (5.81%)
FLATULENCE † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	3/86 (3.49%)
GASTROOESOPHAGEAL REFLUX DISEASE † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	5/88 (5.68%)	5/86 (5.81%)
NAUSEA † 1	0/59 (0.00%)	3/59 (5.08%)	1/59 (1.69%)	4/88 (4.55%)	5/86 (5.81%)
TOOTHACHE † 1	2/59 (3.39%)	0/59 (0.00%)	1/59 (1.69%)	10/88 (11.36%)	4/86 (4.65%)
VOMITING † 1	0/59 (0.00%)	2/59 (3.39%)	0/59 (0.00%)	4/88 (4.55%)	6/86 (6.98%)
General disorders
ASTHENIA † 1	2/59 (3.39%)	0/59 (0.00%)	0/59 (0.00%)	4/88 (4.55%)	1/86 (1.16%)
FATIGUE † 1	0/59 (0.00%)	0/59 (0.00%)	1/59 (1.69%)	0/88 (0.00%)	2/86 (2.33%)
INJECTION SITE OEDEMA † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	0/86 (0.00%)
INJECTION SITE PAIN † 1	1/59 (1.69%)	0/59 (0.00%)	1/59 (1.69%)	2/88 (2.27%)	1/86 (1.16%)
NON-CARDIAC CHEST PAIN † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	2/86 (2.33%)
OEDEMA PERIPHERAL † 1	1/59 (1.69%)	1/59 (1.69%)	0/59 (0.00%)	2/88 (2.27%)	1/86 (1.16%)
PYREXIA † 1	2/59 (3.39%)	2/59 (3.39%)	2/59 (3.39%)	6/88 (6.82%)	3/86 (3.49%)
Immune system disorders
SEASONAL ALLERGY † 1	0/59 (0.00%)	1/59 (1.69%)	0/59 (0.00%)	3/88 (3.41%)	5/86 (5.81%)
Infections and infestations
ABSCESS ORAL † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	2/86 (2.33%)
ACARODERMATITIS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	2/86 (2.33%)
BRONCHITIS † 1	0/59 (0.00%)	1/59 (1.69%)	1/59 (1.69%)	5/88 (5.68%)	4/86 (4.65%)
CELLULITIS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	2/86 (2.33%)
CONJUNCTIVITIS † 1	0/59 (0.00%)	1/59 (1.69%)	0/59 (0.00%)	2/88 (2.27%)	1/86 (1.16%)
CYSTITIS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	1/86 (1.16%)
EAR INFECTION † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	2/86 (2.33%)
FOLLICULITIS † 1	0/59 (0.00%)	0/59 (0.00%)	1/59 (1.69%)	2/88 (2.27%)	2/86 (2.33%)
GASTROENTERITIS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	5/88 (5.68%)	4/86 (4.65%)
GASTROENTERITIS VIRAL † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	0/86 (0.00%)
INFLUENZA † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	4/88 (4.55%)	6/86 (6.98%)
LABYRINTHITIS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	3/88 (3.41%)	1/86 (1.16%)
NASOPHARYNGITIS † 1	3/59 (5.08%)	3/59 (5.08%)	5/59 (8.47%)	21/88 (23.86%)	17/86 (19.77%)
ORAL CANDIDIASIS † 1	1/59 (1.69%)	1/59 (1.69%)	0/59 (0.00%)	1/88 (1.14%)	2/86 (2.33%)
ORAL HERPES † 1	0/59 (0.00%)	1/59 (1.69%)	0/59 (0.00%)	0/88 (0.00%)	5/86 (5.81%)
OTITIS MEDIA † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	2/86 (2.33%)
OTITIS MEDIA BACTERIAL † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	0/86 (0.00%)
PERIODONTITIS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	2/86 (2.33%)
PHARYNGITIS † 1	0/59 (0.00%)	1/59 (1.69%)	0/59 (0.00%)	3/88 (3.41%)	4/86 (4.65%)
PNEUMONIA † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	3/86 (3.49%)
RHINITIS † 1	2/59 (3.39%)	1/59 (1.69%)	0/59 (0.00%)	7/88 (7.95%)	5/86 (5.81%)
SINUSITIS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	7/88 (7.95%)	3/86 (3.49%)
SKIN BACTERIAL INFECTION † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	1/86 (1.16%)
STAPHYLOCOCCAL INFECTION † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	2/86 (2.33%)
TINEA PEDIS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	3/86 (3.49%)
TONGUE FUNGAL INFECTION † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	2/86 (2.33%)
TONSILLITIS † 1	0/59 (0.00%)	0/59 (0.00%)	1/59 (1.69%)	5/88 (5.68%)	2/86 (2.33%)
TOOTH ABSCESS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	2/86 (2.33%)
TOOTH INFECTION † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	3/88 (3.41%)	2/86 (2.33%)
UPPER RESPIRATORY TRACT INFECTION † 1	2/59 (3.39%)	0/59 (0.00%)	1/59 (1.69%)	16/88 (18.18%)	16/86 (18.60%)
URINARY TRACT INFECTION † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	5/88 (5.68%)	4/86 (4.65%)
VIRAL UPPER RESPIRATORY TRACT INFECTION † 1	1/59 (1.69%)	1/59 (1.69%)	0/59 (0.00%)	6/88 (6.82%)	3/86 (3.49%)
VULVOVAGINAL CANDIDIASIS † 1	1/59 (1.69%)	1/59 (1.69%)	0/59 (0.00%)	2/88 (2.27%)	5/86 (5.81%)
Injury, poisoning and procedural complications
ARTHROPOD BITE † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	1/86 (1.16%)
CONTUSION † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	4/88 (4.55%)	1/86 (1.16%)
FALL † 1	1/59 (1.69%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	2/86 (2.33%)
LIGAMENT SPRAIN † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	1/86 (1.16%)
LIMB INJURY † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	1/86 (1.16%)
MUSCLE STRAIN † 1	0/59 (0.00%)	0/59 (0.00%)	1/59 (1.69%)	2/88 (2.27%)	4/86 (4.65%)
ROAD TRAFFIC ACCIDENT † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	1/86 (1.16%)
SKIN ABRASION † 1	1/59 (1.69%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	0/86 (0.00%)
Investigations
ALANINE AMINOTRANSFERASE INCREASED † 1	1/59 (1.69%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	0/86 (0.00%)
BLOOD PRESSURE INCREASED † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	0/86 (0.00%)
BLOOD TRIGLYCERIDES INCREASED † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	1/86 (1.16%)
C-REACTIVE PROTEIN INCREASED † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	2/86 (2.33%)
GAMMA-GLUTAMYLTRANSFERASE INCREASED † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	2/86 (2.33%)
HEPATIC ENZYME INCREASED † 1	0/59 (0.00%)	1/59 (1.69%)	0/59 (0.00%)	0/88 (0.00%)	2/86 (2.33%)
VITAMIN D DECREASED † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	0/86 (0.00%)
WEIGHT DECREASED † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	2/86 (2.33%)
WEIGHT INCREASED † 1	0/59 (0.00%)	1/59 (1.69%)	0/59 (0.00%)	0/88 (0.00%)	2/86 (2.33%)
Metabolism and nutrition disorders
DIABETES MELLITUS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	3/88 (3.41%)	2/86 (2.33%)
HYPERCHOLESTEROLAEMIA † 1	2/59 (3.39%)	1/59 (1.69%)	1/59 (1.69%)	5/88 (5.68%)	2/86 (2.33%)
HYPERTRIGLYCERIDAEMIA † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	1/86 (1.16%)
HYPOKALAEMIA † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	0/86 (0.00%)
HYPOSIDERAEMIA † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	2/86 (2.33%)
TYPE 2 DIABETES MELLITUS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	2/86 (2.33%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA † 1	0/59 (0.00%)	1/59 (1.69%)	0/59 (0.00%)	7/88 (7.95%)	11/86 (12.79%)
BACK PAIN † 1	0/59 (0.00%)	3/59 (5.08%)	0/59 (0.00%)	4/88 (4.55%)	6/86 (6.98%)
BURSITIS † 1	1/59 (1.69%)	2/59 (3.39%)	0/59 (0.00%)	1/88 (1.14%)	3/86 (3.49%)
INTERVERTEBRAL DISC PROTRUSION † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	2/86 (2.33%)
MUSCLE SPASMS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	2/86 (2.33%)
MUSCULAR WEAKNESS † 1	1/59 (1.69%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	0/86 (0.00%)
MYALGIA † 1	1/59 (1.69%)	0/59 (0.00%)	0/59 (0.00%)	3/88 (3.41%)	2/86 (2.33%)
NECK PAIN † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	3/88 (3.41%)	1/86 (1.16%)
PAIN IN EXTREMITY † 1	1/59 (1.69%)	1/59 (1.69%)	0/59 (0.00%)	5/88 (5.68%)	6/86 (6.98%)
PSORIATIC ARTHROPATHY † 1	0/59 (0.00%)	0/59 (0.00%)	1/59 (1.69%)	2/88 (2.27%)	3/86 (3.49%)
SPINAL PAIN † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	3/86 (3.49%)
TENDONITIS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	3/86 (3.49%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MELANOCYTIC NAEVUS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	2/86 (2.33%)
SKIN PAPILLOMA † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	2/86 (2.33%)
SQUAMOUS CELL CARCINOMA † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	2/86 (2.33%)
Nervous system disorders
HEADACHE † 1	4/59 (6.78%)	0/59 (0.00%)	4/59 (6.78%)	5/88 (5.68%)	6/86 (6.98%)
MIGRAINE † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	1/88 (1.14%)	3/86 (3.49%)
SCIATICA † 1	0/59 (0.00%)	1/59 (1.69%)	0/59 (0.00%)	0/88 (0.00%)	5/86 (5.81%)
SINUS HEADACHE † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	2/86 (2.33%)
SYNCOPE † 1	0/59 (0.00%)	1/59 (1.69%)	0/59 (0.00%)	0/88 (0.00%)	2/86 (2.33%)
Psychiatric disorders
ANXIETY † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	3/88 (3.41%)	3/86 (3.49%)
DEPRESSION † 1	2/59 (3.39%)	1/59 (1.69%)	0/59 (0.00%)	6/88 (6.82%)	2/86 (2.33%)
INSOMNIA † 1	0/59 (0.00%)	1/59 (1.69%)	0/59 (0.00%)	3/88 (3.41%)	1/86 (1.16%)
Renal and urinary disorders
GLYCOSURIA † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	0/86 (0.00%)
HAEMATURIA † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	3/88 (3.41%)	2/86 (2.33%)
Reproductive system and breast disorders
DYSMENORRHOEA † 1	0/59 (0.00%)	2/59 (3.39%)	1/59 (1.69%)	0/88 (0.00%)	3/86 (3.49%)
Respiratory, thoracic and mediastinal disorders
COUGH † 1	2/59 (3.39%)	1/59 (1.69%)	0/59 (0.00%)	8/88 (9.09%)	9/86 (10.47%)
DYSPNOEA † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	2/86 (2.33%)
NASAL CONGESTION † 1	0/59 (0.00%)	0/59 (0.00%)	1/59 (1.69%)	3/88 (3.41%)	4/86 (4.65%)
OROPHARYNGEAL PAIN † 1	2/59 (3.39%)	1/59 (1.69%)	0/59 (0.00%)	5/88 (5.68%)	10/86 (11.63%)
SINUS CONGESTION † 1	1/59 (1.69%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	2/86 (2.33%)
WHEEZING † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	2/86 (2.33%)
Skin and subcutaneous tissue disorders
ACNE † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	3/88 (3.41%)	0/86 (0.00%)
ACTINIC KERATOSIS † 1	0/59 (0.00%)	0/59 (0.00%)	1/59 (1.69%)	1/88 (1.14%)	3/86 (3.49%)
ALOPECIA † 1	0/59 (0.00%)	0/59 (0.00%)	1/59 (1.69%)	0/88 (0.00%)	3/86 (3.49%)
DERMAL CYST † 1	1/59 (1.69%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	1/86 (1.16%)
DERMATITIS † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	2/88 (2.27%)	1/86 (1.16%)
DERMATITIS CONTACT † 1	0/59 (0.00%)	2/59 (3.39%)	0/59 (0.00%)	2/88 (2.27%)	5/86 (5.81%)
ECZEMA † 1	0/59 (0.00%)	0/59 (0.00%)	1/59 (1.69%)	3/88 (3.41%)	5/86 (5.81%)
PRURITUS † 1	0/59 (0.00%)	1/59 (1.69%)	1/59 (1.69%)	2/88 (2.27%)	3/86 (3.49%)
PSORIASIS † 1	0/59 (0.00%)	0/59 (0.00%)	1/59 (1.69%)	6/88 (6.82%)	3/86 (3.49%)
URTICARIA PAPULAR † 1	0/59 (0.00%)	0/59 (0.00%)	0/59 (0.00%)	0/88 (0.00%)	2/86 (2.33%)
Vascular disorders
HAEMATOMA † 1	0/59 (0.00%)	1/59 (1.69%)	0/59 (0.00%)	0/88 (0.00%)	3/86 (3.49%)
HYPERTENSION † 1	2/59 (3.39%)	1/59 (1.69%)	1/59 (1.69%)	3/88 (3.41%)	3/86 (3.49%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA (19.1)

Limitations and Caveats

Since most patients were discontinued from study once secukinumab was commercially available in the respective countries, results beyond week 172 cannot be interpreted meaningfully.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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

Results Point of Contact

• Name/Title: Clinical Disclosure Office
• Organization: Novartis Pharmaceutical
• Phone: 862-778-8300
• EMail: Novartis.email@novartis.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Menter A, Cather JC, Jarratt M, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab on Moderate-to-severe Plaque Psoriasis Affecting Different Body Regions: a Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):639-647. Epub 2016 Aug 30.

Kircik L, Fowler J, Weiss J, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab for Moderate-to-Severe Head and Neck Psoriasis Over 52 Weeks: Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):627-638. Epub 2016 Aug 30.

• Responsible Party: Novartis ( Novartis Pharmaceuticals )
• ClinicalTrials.gov Identifier: NCT01555125
• Other Study ID Numbers: CAIN457A2308; 2011-006057-28 ( EudraCT Number )
• First Submitted: March 13, 2012
• First Posted: March 15, 2012
• Results First Submitted: October 20, 2017
• Results First Posted: August 8, 2018
• Last Update Posted: August 8, 2018