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

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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:
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
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
Hide 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
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo Total
Hide 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
Hide 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%
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.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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]
Show Statistical Analysis 2 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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]
Show Statistical Analysis 2 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description To assess potential use-related hazards with the secukinumab PFS for the subject
Time Frame Week 1
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description To assess the subject’s ability to follow instructions for use with the secukinumab PFS
Time Frame Week 1
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo-AIN457 150mg Placebo-AIN457 300mg Placebo
Hide 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
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
Hide 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   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide 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)
Show Other (Not Including Serious) Adverse Events Hide 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)
Since most patients were discontinued from study once secukinumab was commercially available in the respective countries, results beyond week 172 cannot be interpreted meaningfully.
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
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01555125     History of Changes
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