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Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year (ERASURE)

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ClinicalTrials.gov Identifier: NCT01365455
Recruitment Status : Completed
First Posted : June 3, 2011
Results First Posted : May 29, 2015
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Moderate to Severe Plaque-type Psoriasis
Interventions Drug: secukinumab 150 mg
Drug: placebo to secukinumab 150 mg
Enrollment 738

Recruitment Details Not all patients that completed Maintenance Period continued in the follow-up Period. Many patients from Maintence rolled into CAIN457A2302E1 study
Pre-assignment Details  
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo AIN457 150mg From Placebo AIN457 300mg From Placebo
Hide Arm/Group Description AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48. Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48. Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Period Title: Induction Period
Started 245 245 248 0 0
Completed 230 238 232 0 0
Not Completed 15 7 16 0 0
Reason Not Completed
Adverse Event             5             3             4             0             0
Lack of Efficacy             1             1             0             0             0
Pregnancy             0             1             0             0             0
Protocol deviation             0             1             1             0             0
Subject/guardian decision             9             1             8             0             0
Lost to Follow-up             0             0             3             0             0
Period Title: Maintenance Period
Started 230 238 18 109 105
Completed 201 215 15 100 92
Not Completed 29 23 3 9 13
Reason Not Completed
Adverse Event             12             5             1             2             4
Lack of Efficacy             10             2             0             2             2
Lost to Follow-up             2             4             0             0             3
Non-compliance with study treatment             0             0             0             1             0
Physician Decision             0             1             0             0             1
Pregnancy             0             4             0             0             2
Protocol deviation             1             1             0             0             0
Subject/guardian decision             4             6             2             4             1
Period Title: Follow-up Period
Started 58 47 18 0 0
Completed 58 47 18 0 0
Not Completed 0 0 0 0 0
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo Total
Hide Arm/Group Description AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48. Total of all reporting groups
Overall Number of Baseline Participants 245 245 248 738
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 245 participants 245 participants 248 participants 738 participants
44.9  (13.33) 44.9  (13.46) 45.4  (12.63) 45.1  (13.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 245 participants 245 participants 248 participants 738 participants
Female
77
  31.4%
76
  31.0%
76
  30.6%
229
  31.0%
Male
168
  68.6%
169
  69.0%
172
  69.4%
509
  69.0%
1.Primary Outcome
Title Percentage of Participants Who Achieved >75 or Higher (Psoriasis Area and Severity Index) PASI Score at 12 Weeks
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. 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).
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo
Hide Arm/Group Description:
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Overall Number of Participants Analyzed 243 245 246
Measure Type: Number
Unit of Measure: Percentage of participants
71.6 81.6 4.5
2.Primary Outcome
Title Percentage of Participants Who Achieved (Investigator's Global Assessment) IGA Score of 0 or 1
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. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1. IGA score of 0 or 1 as an indicator of efficacy.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo
Hide Arm/Group Description:
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Overall Number of Participants Analyzed 244 245 246
Measure Type: Number
Unit of Measure: Percentage of Participants
51.2 65.3 2.4
3.Secondary Outcome
Title Percentage of Participants Who Achieved a PASI (Psoriasis Area and Severity Index) Score of 90 or Better at Week 12
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 90 was defined as participants who achievied ≥ 90% improvement from baseline.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo
Hide Arm/Group Description:
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Overall Number of Participants Analyzed 243 245 246
Measure Type: Number
Unit of Measure: Percentage of Participants
39.1 59.2 1.2
4.Secondary Outcome
Title Number of Participants That Maintained the Psoriasis Area and Severity Index (PASI) 75 Response at 52 Weeks of Treatment for Participants Who Were PASI 75 Responders at Week 12
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).
Time Frame 12 and 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo
Hide Arm/Group Description:
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Overall Number of Participants Analyzed 245 245 248
Measure Type: Number
Unit of Measure: number of participants
PASI 75 response at Week 12 (n=243, 245, 246) 174 200 11
Maintained PASI 75 response at Wk 52(n=174,200,11) 126 161 NA [1] 
[1]
After W12: Efficacy was not focus for PBO group and therefore no data was provided at Week 52
5.Secondary Outcome
Title Number of Participants That Maintained the IGA Mod 2011 0 or 1 Response at 52 Weeks of Treatment for Participants Who Were IGA Mod 2011 0 or 1 Responders at Week 12
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. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
Time Frame 12 and 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo
Hide Arm/Group Description:
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Overall Number of Participants Analyzed 245 245 248
Measure Type: Number
Unit of Measure: number of participants
IGA mod2011 0or1 response at Wk 12(n=244,245,246) 125 160 6
Maintained IGAmod2011 0or1 resp atWk52 n=125,160,6 74 119 NA [1] 
[1]
After W12: Efficacy was not focus for PBO group and therefore no data was provided at Week 52
6.Secondary Outcome
Title Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo
Hide Description The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. A reduction in score from baseline shows efficacy. Each question has a score of 0 (no symptoms) up to 10 (Severe symptoms)
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo
Hide Arm/Group Description:
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Overall Number of Participants Analyzed 245 245 248
Mean (Standard Error)
Unit of Measure: Scores on a Scale
itching (n=86,79,84) -4.86  (0.299) -545  (0.276) -0.22  (0.260)
pain (n=86,79,84) -3.92  (0.337) -4.59  (0.322) 0.06  (0.246)
scaling (n=86,79,84) -4.74  (0.307) -5.49  (0.289) -0.11  (0.248)
7.Secondary Outcome
Title Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
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 (max). 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. 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 1,2,3,4,8,12,
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo
Hide Arm/Group Description:
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Overall Number of Participants Analyzed 245 245 247
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 IGA 0/1 (n=244,245,246) 0.0 0.0 0.0
Week 1 PASI 75 (n=243,245,246) 0.0 0.0 0.0
Week 1 PASI 50 (n=243,245,246) 2.1 4.5 0.4
Week 1 PASI 90 (n=243,245,246) 0.0 0.0 0.0
Week 1 PASI 100 (n=243,245,246) 0.0 0.0 0.0
Week 2 IGA 0/1 n=244,245,246) 1.2 4.5 0.0
Week 2 PASI 75 (n=243,245,246) 0.8 4.1 0.0
Week 2 PASI 50 (n=243,245,246) 18.5 28.2 3.3
Week 2 PASI 90 (n=243,245,246) 0.0 0.8 0.0
Week 2 PASI 100 (n=243,245,246) 0.0 0.0 0.0
Week 3 IGA 0/1( n=244,245,246) 6.6 11.0 0.4
Week 3 PASI 75 (n=243,245,246) 8.2 15.5 1.2
Week 3 PASI 50 (n=243,245,246) 41.2 53.1 4.9
Week 3 PASI 90 (n=243,245,246) 0.8 2.9 0.0
Week 3 PASI 100 (n=243,245,246) 0.0 0.8 0.0
Week 4 IGA 0/1( n=244,245,246) 17.2 26.1 1.2
Week 4 PASI 75 (n=243,245,246) 24.3 38.0 0.8
Week 4 PASI 50 (n=243,245,246) 63.0 74.7 7.3
Week 4 PASI 90 (n=243,245,246) 5.8 10.6 0.4
Week 4 PASI 100 (n=243,245,246) 0.8 3.7 0.0
Week 8 IGA 0/1( n=244,245,246) 42.2 60.0 1.6
Week 8 PASI 75 (n=243,245,246) 61.7 76.7 2.8
Week 8 PASI 50 (n=243,245,246) 88.5 92.2 9.3
Week 8 PASI 90 (n=243,245,246) 28.8 47.8 1.2
Week 8 PASI 100 (n=243,245,246) 8.2 16.7 0.0
Week 12 IGA 0/1( n=244,245,246) 51.2 65.3 2.4
Week 12 PASI 75 (n=243,245,246) 71.6 81.6 4.5
Week 12 PASI 50 (n=243,245,246) 83.5 90.6 8.9
Week 12 PASI 90 (n=243,245,246) 39.1 59.2 1.2
Week 12 PASI 100 (n=243,245,246) 12.8 28.6 0.8
8.Secondary Outcome
Title Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to 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 (max). 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. 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 13,14,15,16,20,24,28,32,36,40,44,48,52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo AIN457 150mg From Placebo AIN457 300mg From Placebo
Hide Arm/Group Description:
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Overall Number of Participants Analyzed 245 245 18 108 105
Measure Type: Number
Unit of Measure: Percentage of participants
Week 13 IGA 0/1 (n=244,245,18, 108, 104) 51.6 66.9 33.3 0.9 1.9
Week 13 PASI 75 (n=243,245,18, 108, 104) 70.8 79.6 55.6 2.8 0.0
Week 13 PASI 50 (n=243,245,18, 108, 104) 81.5 87.3 77.8 12.0 13.5
Week 13 PASI 90 (n=243,245,18, 108, 104) 44.9 60.8 22.2 0.9 0.0
Week 13 PASI 100 (n=243,245,18, 108, 104) 14.0 30.2 11.1 0.0 0.0
Week 14 IGA 0/1 (n=244,245,18, 108, 104) 55.3 74.7 33.3 4.6 10.6
Week 14 PASI 75 (n=243,245,18, 108, 104) 72.0 86.1 55.6 7.4 14.4
Week 14 PASI 50 (n=243,245,18, 108, 104) 83.1 91.4 83.3 34.3 38.5
Week 14 PASI 90 (n=243,245,18, 108, 104) 48.6 68.2 27.8 0.9 0.0
Week 14 PASI 100 (n=243,245,18, 108, 104) 16.5 35.5 11.1 0.0 0.0
Week 15 IGA 0/1 (n=244,245,18, 108, 104) 57.4 75.1 33.3 13.0 19.2
Week 15 PASI 75 (n=243,245,18, 108, 104) 75.3 87.8 55.6 13.9 26.9
Week 15 PASI 50 (n=243,245,18, 108, 104) 86.4 92.2 72.2 55.6 66.3
Week 15 PASI 90 (n=243,245,18, 108, 104) 51.0 68.6 27.8 2.8 6.7
Week 15 PASI 100 (n=243,245,18, 108, 104) 19.8 40.8 11.1 0.0 0.0
Week 16 IGA 0/1 (n=244,245,18, 108, 104) 58.2 73.5 38.9 25.9 30.8
Week 16 PASI 75 (n=243,245,18, 108, 104) 77.4 86.1 61.1 33.3 47.1
Week 16 PASI 50 (n=243,245,18, 108, 104) 87.2 91.4 77.8 68.5 81.7
Week 16 PASI 90 (n=243,245,18, 108, 104) 53.5 69.8 33.3 10.2 15.4
Week 16 PASI 100 (n=243,245,18, 108, 104) 21.0 41.6 22.2 0.9 4.8
Week 20 IGA 0/1 (n=244,245,18, 108, 104) 57.4 74.7 38.9 51.9 55.8
Week 20 PASI 75 (n=243,245,18, 108, 104) 77.0 86.9 72.2 66.7 75.0
Week 20 PASI 50 (n=243,245,18, 108, 104) 89.3 92.7 88.9 87.0 91.3
Week 20 PASI 90 (n=243,245,18, 108, 104) 51.9 69.8 38.9 38.0 50.0
Week 20 PASI 100 (n=243,245,18, 108, 104) 21.8 43.3 16.7 5.6 19.2
Week 24 IGA 0/1 (n=244,245,18, 108, 104) 58.2 71.4 50.0 57.4 72.1
Week 24 PASI 75 (n=243,245,18, 108, 104) 77.8 85.7 66.7 76.9 81.7
Week 24 PASI 50 (n=243,245,18, 108, 104) 86.8 91.0 88.9 91.7 93.3
Week 24 PASI 90 (n=243,245,18, 108, 104) 54.7 70.2 38.9 50.9 62.5
Week 24 PASI 100 (n=243,245,18, 108, 104) 23.9 42.4 16.7 16.7 26.0
Week 28 IGA 0/1 (n=244,245,18, 108, 104) 53.7 68.6 50.0 61.1 76.0
Week 28 PASI 75 (n=243,245,18, 108, 104) 72.4 82.9 72.2 74.1 87.5
Week 28 PASI 50 (n=243,245,18, 108, 104) 84.4 90.2 83.3 91.7 93.3
Week 28 PASI 90 (n=243,245,18, 108, 104) 53.1 68.6 50.0 50.0 71.2
Week 28 PASI 100 (n=243,245,18, 108, 104) 24.3 43.3 16.7 24.1 33.7
Week 32 IGA 0/1 (n=244,245,18, 108, 104) 50.8 68.2 44.4 57.4 76.0
Week 32 PASI 75 (n=243,245,18, 108, 104) 72.0 81.2 61.1 75.0 89.4
Week 32 PASI 50 (n=243,245,18, 108, 104) 86.4 88.6 77.8 88.9 94.2
Week 32 PASI 90 (n=243,245,18, 108, 104) 48.1 68.2 44.4 50.9 70.2
Week 32 PASI 100 (n=243,245,18, 108, 104) 22.2 43.7 16.7 22.2 39.4
Week 36 IGA 0/1 (n=244,245,18, 108, 104) 48.0 66.9 38.9 60.2 70.2
Week 36 PASI 75 (n=243,245,18, 108, 104) 67.5 79.2 61.1 73.1 86.5
Week 36 PASI 50 (n=243,245,18, 108, 104) 80.2 86.9 88.9 88.9 89.4
Week 36 PASI 90 (n=243,245,18, 108, 104) 44.4 67.3 44.4 52.8 64.4
Week 36 PASI 100 (n=243,245,18, 108, 104) 22.2 42.4 16.7 25.0 43.3
Week 40 IGA 0/1 (n=244,245,18, 108, 104) 47.1 64.9 44.4 57.4 69.2
Week 40 PASI 75 (n=243,245,18, 108, 104) 65.4 76.7 66.7 69.4 81.7
Week 40 PASI 50 (n=243,245,18, 108, 104) 78.6 84.9 83.3 88.0 88.5
Week 40 PASI 90 (n=243,245,18, 108, 104) 44.0 64.9 44.4 50.9 65.4
Week 40 PASI 100 (n=243,245,18, 108, 104) 21.0 40.8 27.8 24.1 42.3
Week 44 IGA 0/1 (n=244,245,18, 108, 104) 44.3 60.4 44.4 57.4 72.1
Week 44 PASI 75 (n=243,245,18, 108, 104) 63.4 79.2 61.1 68.5 79.8
Week 44 PASI 50 (n=243,245,18, 108, 104) 77.4 84.5 83.3 89.8 89.4
Week 44 PASI 90 (n=243,245,18, 108, 104) 42.8 61.2 38.9 47.2 66.3
Week 44 PASI 100 (n=243,245,18, 108, 104) 21.8 37.1 11.1 23.1 38.5
Week 48 IGA 0/1 (n=244,245,18, 108, 104) 41.4 62.9 27.8 50.0 69.2
Week 48 PASI 75 (n=243,245,18, 108, 104) 62.1 77.6 66.7 68.5 76.9
Week 48 PASI 50 (n=243,245,18, 108, 104) 77.4 84.9 83.3 86.1 83.7
Week 48 PASI 90 (n=243,245,18, 108, 104) 39.5 63.7 38.9 45.4 63.5
Week 48 PASI 100 (n=243,245,18, 108, 104) 22.2 40.4 11.1 20.4 37.5
Week 52 IGA 0/1 (n=244,245,18, 108, 104) 73.4 87.3 38.9 76.9 66.3
Week 52 PASI 75 (n=243,245,18, 108, 104) 86.8 94.3 66.7 88.0 73.1
Week 52 PASI 50(n=243,245,18, 108, 104) 91.8 95.9 83.3 96.3 81.7
Week 52 PASI 90 (n=243,245,18, 108, 104) 73.3 84.5 33.3 66.7 62.5
Week 52 PASI 100 (n=243,245,18, 108, 104) 41.2 62.0 11.1 36.1 43.3
9.Secondary Outcome
Title Mean Percent Change From Baseline in PASI Scores up to Week 12 - Induction Period
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). A negative mean percentage change indicates improvement.
Time Frame Baseline, Week 1,2,3,4,8,12,
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Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo
Hide Arm/Group Description:
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Overall Number of Participants Analyzed 245 245 247
Mean (Standard Deviation)
Unit of Measure: Percent Change
Week 1 (n=243,243,242) -12.08  (19.225) -17.50  (17.317) -3.70  (14.756)
Week 2 (n=243,245,243) -28.61  (21.982) -36.51  (21.850) -5.63  (23.616)
Week 3 (n=243,245,243) -42.79  (23.695) -51.59  (22.415) -8.62  (25.785)
Week 4 (n=243,245,245) -55.73  (24.252) -64.61  (22.080) -8.89  (28.165)
Week 8 (n=243,245,245) -76.35  (20.427) -82.98  (19.331) -8.15  (32.755)
Week 12 (n=243,245,245) -80.87  (20.512) -87.72  (17.729) -5.89  (36.606)
10.Secondary Outcome
Title Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to 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). A negative mean percentage change indicates improvement.
Time Frame Week 13,14,15,16,20,24,28,32,36,40,44,48,52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo AIN457 150mg From Placebo AIN457 300mg From Placebo
Hide Arm/Group Description:
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Overall Number of Participants Analyzed 245 245 18 108 105
Mean (Standard Deviation)
Unit of Measure: Percent change
Week 13 (n=243,245,18,102,96) -83.12  (19.313) -89.55  (15.935) -63.10  (36.827) -21.03  (28.240) -21.66  (29.891)
Week 14 (n=243,245,18,107,102) -84.47  (18.832) -90.83  (15.013) -68.74  (30.225) -39.20  (26.228) -41.97  (28.809)
Week 15 (n=243,245,18,107,103) -84.67  (19.407) -91.40  (14.769) -67.15  (32.972) -51.78  (23.561) -57.77  (23.166)
Week 16 (n=243,245,18,107,103) -85.20  (19.213) -91.37  (15.367) -73.38  (28.051) -62.19  (23.591) -70.15  (20.686)
Week 20 (n=243,245,18,107,103) -85.75  (17.904) -90.86  (16.263) -80.57  (22.454) -77.75  (20.587) -84.53  (16.030)
Week 24 (n=243,245,18,107,103) -85.46  (20.240) -90.83  (16.652) -78.06  (25.062) -83.19  (18.635) -89.20  (13.969)
Week 28 (n=243,245,18,107,103) -84.72  (20.417) -90.15  (17.600) -79.55  (23.943) -84.07  (19.819) -91.24  (11.849)
Week 32 (n=243,245,18,107,103) -83.98  (21.887) -89.90  (17.775) -75.94  (25.879) -84.26  (20.622) -91.09  (13.240)
Week 36(n=243,245,18,107,103) -81.87  (25.048) -90.04  (17.981) -78.37  (24.608) -83.68  (20.328) -89.97  (16.373)
Week 40(n=243,245,18,107,103) -81.37  (25.395) -89.62  (17.385) -78.32  (24.770) -82.83  (20.762) -89.76  (17.029)
Week 44 (n=243,245,18,107,103) -80.81  (25.651) -88.97  (17.804) -79.96  (22.354) -83.44  (18.277) -89.37  (17.176)
Week 48(n=243,245,18,107,103) -79.78  (26.471) -89.35  (17.281) -79.54  (21.506) -83.40  (18.736) -88.44  (18.083)
Week 52 (n=243,245,18,107,103) -79.74  (26.524) -88.42  (19.132) -79.64  (22.169) -82.14  (18.554) -87.66  (20.615)
11.Secondary Outcome
Title Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
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 Baseline, Week 1,2,3,4,8,12,
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo
Hide Arm/Group Description:
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Overall Number of Participants Analyzed 245 245 247
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 (n=244,243,243) clear 0.0 0.0 0.0
Week 1 (n=244,243,243) almost clear 0.0 0.0 0.0
Week 1 (n=244,243,243) mild 6.6 9.1 4.1
Week 1 (n=244,243,243) moderate 66.4 68.7 60.9
Week 1 (n=244,243,243) severe 27.0 22.2 35.0
Week 2 (n=244,245,244) clear 0.0 0.0 0.0
Week 2 (n=244,245,244) almost clear 1.2 4.5 0.0
Week 2 (n=244,245,244) mild 23.0 27.8 5.3
Week 2 (n=244,245,244) moderate 57.0 55.5 59.8
Week 2 (n=244,245,244) severe 18.9 12.2 34.8
Week 3 (n=244,245,244) clear 0.0 1.2 0.0
Week 3 (n=244,245,244) almost clear 6.6 9.8 0.4
Week 3 (n=244,245,244) mild 34.0 43.3 7.0
Week 3 (n=244,245,244) moderate 49.2 40.4 58.6
Week 3 (n=244,245,244) severe 10.2 5.3 34.0
Week 4 (n=244,245,246) clear 0.4 3.7 0.0
Week 4 (n=244,245,246) almost clear 16.8 22.9 1.6
Week 4 (n=244,245,246) mild 40.2 43.7 7.3
Week 4 (n=244,245,246) moderate 37.3 26.5 58.1
Week 4 (n=244,245,246) severe 5.3 3.3 32.9
Week 8 (n=244,245,246) clear 10.2 20.4 0.0
Week 8 (n=244,245,246) almost clear 32.0 39.6 1.6
Week 8 (n=244,245,246) mild 38.9 29.0 8.1
Week 8 (n=244,245,246) moderate 16.4 10.2 53.3
Week 8 (n=244,245,246) severe 2.5 0.8 37.0
Week 12 (n=244,245,246) clear 16.4 32.2 0.8
Week 12 (n=244,245,246) almost clear 38.5 36.3 1.6
Week 12 (n=244,245,246) mild 29.1 23.3 6.5
Week 12 (n=244,245,246) moderate 14.8 6.9 55.3
Week 12 (n=244,245,246) severe 1.2 1.2 35.8
12.Secondary Outcome
Title Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
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 13,14,15,16,20,24,28,32,36,40,44,48,52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo AIN457 150mg From Placebo AIN457 300mg From Placebo
Hide Arm/Group Description:
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Overall Number of Participants Analyzed 245 245 18 108 105
Measure Type: Number
Unit of Measure: Percentage of participants
Week 13 (n=244,245,18,103,96) clear 17.6 38.0 11.1 0.0 0.0
Week 13 (n=244,245,18,103,96) almost clear 40.6 35.9 22.2 1.0 2.1
Week 13 (n=244,245,18,103,96) mild 27.0 19.2 27.8 15.5 14.6
Week 13 (n=244,245,18,103,96) moderate 12.7 6.5 27.8 61.2 59.4
Week 13 (n=244,245,18,103,96) severe 2.0 0.4 11.1 22.3 24.0
Week 14 (n=244,245,18,108,102) clear 19.3 41.6 16.7 0.0 0.0
Week 14 (n=244,245,18,108,102)almost clear 42.3 36.7 16.7 4.6 10.8
Week 14 (n=244,245,18,108,102) mild 25.0 13.5 33.3 30.6 27.5
Week 14 (n=244,245,18,108,102)moderate 12.3 7.3 22.2 56.5 50.0
Week 14 (n=244,245,18,108,102)severe 1.2 0.8 11.1 8.3 11.8
Week 15 (n=244,245,18,108,103) clear 22.1 45.3 11.1 0.0 1.9
Week 15 (n=244,245,18,108,103) almost clear 38.9 33.9 22.2 13.9 17.5
Week 15 (n=244,245,18,108,103) mild 27.5 14.7 33.3 38.9 39.8
Week 15 (n=244,245,18,108,103) moderate 10.2 5.3 22.2 42.6 35.9
Week 15 (n=244,245,18,108,103) severe 1.2 0.8 11.1 4.6 4.9
Week 16 (n=244,245,18,108,103) clear 23.8 47.3 22.2 0.0 6.8
Week 16 (n=244,245,18,108,103) almost clear 37.7 30.6 16.7 0.0 24.3
Week 16 (n=244,245,18,108,103) mild 26.6 15.9 27.8 7.4 39.8
Week 16 (n=244,245,18,108,103) moderate 10.7 5.3 22.2 57.4 26.2
Week 16 (n=244,245,18,108,103) severe 1.2 0.8 11.1 35.2 2.9
Week 20 (n=244,245,18,108,103) clear 23.8 46.1 16.7 0.0 26.2
Week 20 (n=244,245,18,108,103) almost clear 37.3 31.8 22.2 1.0 31.1
Week 20 (n=244,245,18,108,103) mild 26.2 14.3 33.3 15.5 32.0
Week 20 (n=244,245,18,108,103) moderate 11.5 7.3 16.7 61.2 10.7
Week 20 (n=244,245,18,108,103) severe 1.2 0.4 11.1 22.3 0.0
Week 24 (n=244,245,18,108,103) clear 27.0 46.5 16.7 0.0 32.0
Week 24 (n=244,245,18,108,103) almost clear 35.7 29.0 33.3 4.6 41.7
Week 24 (n=244,245,18,108,103) mild 24.6 15.1 22.2 30.6 20.4
Week 24 (n=244,245,18,108,103) moderate 10.7 7.8 16.7 56.5 5.8
Week 24 (n=244,245,18,108,103) severe 2.0 1.6 11.1 8.3 0.0
Week 28 (n=244,245,18,108,103) clear 26.6 46.5 11.1 0.0 38.8
Week 28 (n=244,245,18,108,103) almost clear 32.8 26.5 38.9 13.9 40.8
Week 28 (n=244,245,18,108,103) mild 25.8 16.7 16.7 38.9 14.6
Week 28 (n=244,245,18,108,103) moderate 12.7 9.4 27.8 42.6 5.8
Week 28 (n=244,245,18,108,103) severe 2.0 0.8 5.6 4.6 0.0
Week 32 (n=244,245,18,108,103) clear 26.2 46.5 16.7 29.6 42.7
Week 32 (n=244,245,18,108,103) almost clear 30.3 26.5 27.8 30.6 35.9
Week 32 (n=244,245,18,108,103) mild 27.0 16.7 27.8 22.2 13.6
Week 32 (n=244,245,18,108,103) moderate 14.3 9.0 22.2 14.8 7.8
Week 32 (n=244,245,18,108,103) severe 2.0 1.2 5.6 2.8 0.0
Week 36 (n=244,245,18,108,103) clear 28.3 46.5 11.1 28.7 45.6
Week 36 (n=244,245,18,108,103) almost clear 27.0 26.9 27.8 33.3 29.1
Week 36 (n=244,245,18,108,103) mild 25.4 16.7 33.3 18.5 16.5
Week 36 (n=244,245,18,108,103) moderate 16.8 8.2 16.7 16.7 8.7
Week 36 (n=244,245,18,108,103) severe 2.5 1.6 11.1 2.8 0.0
Week 40 (n=244,245,18,108,103) clear 28.7 46.1 22.2 25.9 44.7
Week 40 (n=244,245,18,108,103) almost clear 25.8 25.3 22.2 34.3 31.1
Week 40 (n=244,245,18,108,103) mild 25.0 17.1 27.8 21.3 11.7
Week 40 (n=244,245,18,108,103) moderate 18.4 10.2 16.7 15.7 11.7
Week 40 (n=244,245,18,108,103) severe 2.0 1.2 11.1 2.8 1.0
Week 44 (n=244,245,18,108,103) clear 27.5 42.9 5.6 25.9 40.8
Week 44 (n=244,245,18,108,103) almost clear 25.0 24.1 38.9 33.3 36.9
Week 44 (n=244,245,18,108,103) mild 25.4 20.4 22.2 20.4 8.7
Week 44 (n=244,245,18,108,103) moderate 20.1 11.8 27.8 17.6 11.7
Week 44 (n=244,245,18,108,103) severe 2.0 0.8 5.6 2.8 1.9
Week 48 (n=244,245,18,108,103) clear 27.0 44.5 11.1 25.9 43.7
Week 48 (n=244,245,18,108,103) almost clear 22.1 25.3 16.7 28.7 34.0
Week 48 (n=244,245,18,108,103) mild 27.9 16.3 50.0 27.8 9.7
Week 48 (n=244,245,18,108,103) moderate 20.1 12.7 16.7 14.8 11.7
Week 48 (n=244,245,18,108,103) severe 2.9 1.2 5.6 2.8 1.0
Week 52 (n=244,245,18,108,103) clear 25.8 43.3 11.1 21.3 44.7
Week 52 (n=244,245,18,108,103) almost clear 24.2 24.1 27.8 31.5 29.1
Week 52 (n=244,245,18,108,103) mild 29.1 19.6 27.8 28.7 12.6
Week 52 (n=244,245,18,108,103) moderate 16.0 11.4 27.8 15.7 11.7
Week 52 (n=244,245,18,108,103) severe 4.9 1.6 5.6 2.8 1.9
13.Secondary Outcome
Title Time to PASI 75 Response up to 12 Weeks
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 (max). 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 75 was defined as participants achieving ≥ 75% improvement from baseline.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo
Hide Arm/Group Description:
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Overall Number of Participants Analyzed 245 245 247
Median (Inter-Quartile Range)
Unit of Measure: days
57
(55 to 85)
57
(29 to 59)
NA [1] 
(NA to NA)
[1]
median could not be calculated because less than 50% of the participants achieved PASI 75
14.Secondary Outcome
Title Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Induction Period
Hide Description The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.
Time Frame Baseline, Week 4,8, 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo
Hide Arm/Group Description:
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Overall Number of Participants Analyzed 245 245 247
Mean (Standard Deviation)
Unit of Measure: percent change
Week 4 (238, 236,235) 38.1  (95.93) 57.1  (234.10) 6.3  (59.30)
Week 8 (241, 242,241) 52.3  (142.28) 72.7  (306.36) 6.3  (65.47)
Week 12 (242, 242,242) 58.5  (158.66) 76.3  (281.48) 5.4  (67.60)
15.Secondary Outcome
Title Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Maintenance Period
Hide Description The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.
Time Frame Week 12, 24, 36, 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo AIN457 150mg From Placebo AIN457 300mg From Placebo
Hide Arm/Group Description:
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Overall Number of Participants Analyzed 245 245 18 108 105
Mean (Standard Deviation)
Unit of Measure: Percent Change
Week 12 (242, 242,18, 108, 104) 58.5  (158.66) 76.3  (281.48) 37.7  (83.41) -0.1  (38.95) 3.3  (79.45)
Week 24 (242, 242,18, 108, 97) 55.8  (140.46) 78.0  (299.91) 48.1  (92.06) 28.1  (55.71) 39.7  (80.03)
Week 36 (242, 242,18, 108, 100) 55.1  (129.87) 80.5  (300.89) 45.3  (77.11) 28.5  (60.39) 43.8  (100.57)
Week 52 (242, 242,18, 108,100) 54.3  (128.86) 76.9  (299.07) 43.9  (81.50) 28.3  (60.68) 41.3  (95.90)
16.Secondary Outcome
Title Percentage Changes in the Dermatology Life Quality Index (DLQI) During Induction Period
Hide Description The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Time Frame Baseline, Week 4, 8 & 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo
Hide Arm/Group Description:
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Overall Number of Participants Analyzed 245 245 247
Median (95% Confidence Interval)
Unit of Measure: Percent Change
Week 4 (n=237,236,232)
-55.0
(-58.9 to -50.7)
-62.5
(-66.7 to -58.6)
-5.0
(-10.1 to 0.0)
Week 8 (n=241,242,239)
-73.1
(-76.7 to -69.2)
-81.5
(-84.4 to -79.0)
-8.3
(-13.3 to -2.6)
Week 12 (n=242,242,240)
-77.8
(-81.3 to -75.0)
-86.4
(-88.9 to -83.3)
-9.1
(-15.6 to -3.3)
17.Secondary Outcome
Title Percentage Changes in the Dermatology Life Quality Index (DLQI) During Maintenance Period
Hide Description The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Time Frame Week 12,24, 36 & 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo AIN457 150mg From Placebo AIN457 300mg From Placebo
Hide Arm/Group Description:
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Overall Number of Participants Analyzed 245 245 18 108 105
Median (95% Confidence Interval)
Unit of Measure: Percent Change
Week 12 (242,242,17,108,104)
-77.8
(-81.3 to -75.0)
-86.4
(-88.9 to -83.3)
-58.3
(-80.0 to -41.7)
-7.1
(-16.7 to 3.4)
-4.4
(-13.9 to 3.4)
Week 24 (242,242,17,108,97)
-83.3
(-87.5 to -79.4)
-89.6
(-92.5 to -86.0)
-76.6
(-88.9 to -59.6)
-83.3
(-87.5 to -76.7)
-83.3
(-89.9 to -76.6)
Week 36 (242,242,17,108,100)
-78.6
(-83.3 to -75.0)
-91.7
(-94.2 to -88.9)
-77.9
(-93.3 to -47.2)
-78.5
(-85.7 to -66.7)
-90.0
(-93.3 to -82.7)
Week 52 (242,242,17,108,100)
-76.5
(-80.6 to -72.3)
-88.9
(-92.3 to -85.7)
-64.4
(-83.3 to -12.5)
-75.0
(-82.8 to -66.2)
-88.9
(-92.9 to -82.9)
18.Secondary Outcome
Title Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Induction Period
Hide Description The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Time Frame Week 4, 8, 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo
Hide Arm/Group Description:
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Overall Number of Participants Analyzed 245 245 247
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 4 (238, 237, 235) 17.6 23.6 6.4
Week 8 (242,243,241) 39.7 48.1 10.0
Week 12 (243,243,243) 46.1 58.8 10.3
19.Secondary Outcome
Title Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Maintenance Period
Hide Description The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Time Frame Week 12,24,36, & 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo AIN457 150mg From Placebo AIN457 300mg From Placebo
Hide Arm/Group Description:
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Overall Number of Participants Analyzed 245 245 18 108 105
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 12 (243,243,18,108,105) 46.1 58.8 27.8 10.2 8.6
Week 24 (243,243,18,108,98) 54.7 64.6 50.0 53.7 67.3
Week 36 (243,243,18,108,101) 51.9 68.7 50.0 56.5 69.3
Week 52 (243,243,18,108,101) 48.6 66.3 22.2 52.8 67.3
20.Secondary Outcome
Title Percentage of Participants Achieving PASI 75, PASI 90 and IGA Mod 2011 0 or 1 Response at Week 12 by Previous Exposure to Biologic Systemic Therapy or Anti-TNF-α Therapy and Failed to Respond to a Previous Biologic or Anti-TNF-α Therapy Psoriasis Therapy
Hide Description PASI is an assessment of lesion severity & affected area into a single score:0(no disease)to 72(max. disease).Body is divided into 4 areas for scoring(head,arms,trunk,legs)each area is scored separately & then added for final PASI.For each area, % of skin involved is estimated:0(0%)to 6(90-100%)& severity is estimated by clinical signs, erythema,induration & desquamation;scale 0(none) to 4(max). 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 75, 90 is patients achieving≥75%or90% improvement from baseline.The IGA mod 2011 scale is static, exclusively to the patients disease at assessment,& not with any of the patient's previous disease states at other visits.The scores are:0=clear,1=almost clear,2= mild,3=moderate&4=severe.Response variables PASI 75,90, IGA mod 2011 0 or 1 response at wk 12 was scored versus previous psoriasis systemic therapy & response to previous biologic systemic therapy by treatment
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo
Hide Arm/Group Description:
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Overall Number of Participants Analyzed 245 245 247
Measure Type: Number
Unit of Measure: Percentage of participants
IGA 0/1 biologic (29, 19, 24) 41.4 57.9 4.2
PASI 75 biologic (29, 19, 24) 48.3 57.9 12.5
PASI 90 biologic (29, 19, 24) 24.1 31.6 4.2
IGA 0/1 anti-TNF-α therapy (18,17,21) 50.0 64.7 4.8
PASI 75 anti-TNF-α therapy (18,17,21) 55.6 64.7 14.3
PASI 90 anti-TNF-α therapy (18,17,21) 33.3 35.3 4.8
21.Secondary Outcome
Title Number of Participants Who Developed Anti-secukinumab Antibodies
Hide Description The development of anti-secunimubab anti-bodies would decrease a participant’s ability to respond to secukinumab treatment.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo
Hide Arm/Group Description:
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Overall Number of Participants Analyzed 245 245 247
Measure Type: Number
Unit of Measure: participants
2 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title INDUCTION-AIN457 150mg INDUCTION-AIN457 300mg INDUCTION-Placebo ENTIRE-AIN457 150mg ENTIRE-AIN457 300mg ENTIRE-Any AIN457 150mg ENTIRE-Any AIN457 300mg ENTIRE-Placebo FOLLOW UP-Any AIN457 150mg FOLLOW UP-Any AIN457 300mg FOLLOW UP-Placebo
Hide Arm/Group Description INDUCTION-AIN457 150mg INDUCTION-AIN457 300mg INDUCTION-Placebo ENTIRE-AIN457 150mg ENTIRE-AIN457 300mg ENTIRE-Any AIN457 150mg ENTIRE-Any AIN457 300mg ENTIRE-Placebo FOLLOW UP-Any AIN457 150mg FOLLOW UP-Any AIN457 300mg FOLLOW UP-Placebo
All-Cause Mortality
INDUCTION-AIN457 150mg INDUCTION-AIN457 300mg INDUCTION-Placebo ENTIRE-AIN457 150mg ENTIRE-AIN457 300mg ENTIRE-Any AIN457 150mg ENTIRE-Any AIN457 300mg ENTIRE-Placebo FOLLOW UP-Any AIN457 150mg FOLLOW UP-Any AIN457 300mg FOLLOW UP-Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) 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 150mg INDUCTION-AIN457 300mg INDUCTION-Placebo ENTIRE-AIN457 150mg ENTIRE-AIN457 300mg ENTIRE-Any AIN457 150mg ENTIRE-Any AIN457 300mg ENTIRE-Placebo FOLLOW UP-Any AIN457 150mg FOLLOW UP-Any AIN457 300mg FOLLOW UP-Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/245 (1.63%)   6/245 (2.45%)   4/247 (1.62%)   15/245 (6.12%)   17/245 (6.94%)   19/353 (5.38%)   19/349 (5.44%)   5/247 (2.02%)   1/58 (1.72%)   1/47 (2.13%)   0/18 (0.00%) 
Blood and lymphatic system disorders                       
HAEMORRHAGIC ANAEMIA  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
LYMPHADENOPATHY  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
Cardiac disorders                       
ANGINA UNSTABLE  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  1/245 (0.41%)  1/353 (0.28%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
ARRHYTHMIA  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
CARDIAC FAILURE  1  1/245 (0.41%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  1/245 (0.41%)  1/353 (0.28%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
CORONARY ARTERY DISEASE  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  1/245 (0.41%)  1/353 (0.28%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
MYOCARDIAL INFARCTION  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
Ear and labyrinth disorders                       
SUDDEN HEARING LOSS  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
Gastrointestinal disorders                       
ABDOMINAL HERNIA OBSTRUCTIVE  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
COLITIS ULCERATIVE  1  0/245 (0.00%)  1/245 (0.41%)  0/247 (0.00%)  1/245 (0.41%)  1/245 (0.41%)  1/353 (0.28%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
GASTRITIS  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
INTESTINAL HAEMORRHAGE  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
PANCREATITIS  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
General disorders                       
ASTHENIA  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
HERNIA  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
NON-CARDIAC CHEST PAIN  1  0/245 (0.00%)  0/245 (0.00%)  1/247 (0.40%)  0/245 (0.00%)  0/245 (0.00%)  0/353 (0.00%)  0/349 (0.00%)  1/247 (0.40%)  1/58 (1.72%)  0/47 (0.00%)  0/18 (0.00%) 
Hepatobiliary disorders                       
CHOLECYSTITIS  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
CHOLELITHIASIS  1  0/245 (0.00%)  1/245 (0.41%)  0/247 (0.00%)  1/245 (0.41%)  1/245 (0.41%)  1/353 (0.28%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
Infections and infestations                       
BACTERAEMIA  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
CELLULITIS  1  0/245 (0.00%)  0/245 (0.00%)  1/247 (0.40%)  0/245 (0.00%)  0/245 (0.00%)  0/353 (0.00%)  0/349 (0.00%)  1/247 (0.40%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
GASTROENTERITIS  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
PNEUMONIA  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  2/245 (0.82%)  0/353 (0.00%)  2/349 (0.57%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
PYELONEPHRITIS  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
UROSEPSIS  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
Injury, poisoning and procedural complications                       
COMMINUTED FRACTURE  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
CONCUSSION  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
CONTUSION  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
LARYNGEAL INJURY  1  0/245 (0.00%)  1/245 (0.41%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
MULTIPLE INJURIES  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
PELVIC FRACTURE  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
PULMONARY CONTUSION  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
RADIUS FRACTURE  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
RIB FRACTURE  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
TOXICITY TO VARIOUS AGENTS  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
WOUND  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
Metabolism and nutrition disorders                       
ELECTROLYTE IMBALANCE  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
HYPOALBUMINAEMIA  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
HYPOPROTEINAEMIA  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
TYPE 2 DIABETES MELLITUS  1  1/245 (0.41%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders                       
BURSITIS  1  0/245 (0.00%)  1/245 (0.41%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                       
BASAL CELL CARCINOMA  1  1/245 (0.41%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
BENIGN NEOPLASM OF SKIN  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  0/245 (0.00%)  0/353 (0.00%)  0/349 (0.00%)  1/247 (0.40%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
BLADDER CANCER  1  1/245 (0.41%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
FOLLICULAR THYROID CANCER  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
THYROID CANCER  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
UTERINE LEIOMYOMA  1  0/245 (0.00%)  1/245 (0.41%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
Nervous system disorders                       
CAROTID ARTERY DISSECTION  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  0/245 (0.00%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
CEREBROVASCULAR ACCIDENT  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  0/245 (0.00%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
HEADACHE  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
ISCHAEMIC STROKE  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
SYNCOPE  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
Psychiatric disorders                       
ALCOHOL WITHDRAWAL SYNDROME  1  0/245 (0.00%)  0/245 (0.00%)  1/247 (0.40%)  0/245 (0.00%)  0/245 (0.00%)  0/353 (0.00%)  0/349 (0.00%)  1/247 (0.40%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
HALLUCINATION, AUDITORY  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
MENTAL STATUS CHANGES  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  1/245 (0.41%)  1/353 (0.28%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
PANIC ATTACK  1  0/245 (0.00%)  0/245 (0.00%)  1/247 (0.40%)  0/245 (0.00%)  0/245 (0.00%)  0/353 (0.00%)  0/349 (0.00%)  1/247 (0.40%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
Renal and urinary disorders                       
NEPHROLITHIASIS  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
OBSTRUCTIVE UROPATHY  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
RENAL FAILURE ACUTE  1  0/245 (0.00%)  1/245 (0.41%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders                       
PNEUMOTHORAX  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
PULMONARY MASS  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
PULMONARY OEDEMA  1  1/245 (0.41%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders                       
PSORIASIS  1  0/245 (0.00%)  0/245 (0.00%)  1/247 (0.40%)  0/245 (0.00%)  0/245 (0.00%)  0/353 (0.00%)  0/349 (0.00%)  1/247 (0.40%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
Surgical and medical procedures                       
ABORTION INDUCED  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  0/245 (0.00%)  0/353 (0.00%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  1/47 (2.13%)  0/18 (0.00%) 
Vascular disorders                       
AORTIC ANEURYSM  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
AORTIC THROMBOSIS  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
HYPERTENSION  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
HYPERTENSIVE CRISIS  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
INDUCTION-AIN457 150mg INDUCTION-AIN457 300mg INDUCTION-Placebo ENTIRE-AIN457 150mg ENTIRE-AIN457 300mg ENTIRE-Any AIN457 150mg ENTIRE-Any AIN457 300mg ENTIRE-Placebo FOLLOW UP-Any AIN457 150mg FOLLOW UP-Any AIN457 300mg FOLLOW UP-Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   108/245 (44.08%)   102/245 (41.63%)   77/247 (31.17%)   172/245 (70.20%)   161/245 (65.71%)   228/353 (64.59%)   229/349 (65.62%)   85/247 (34.41%)   8/58 (13.79%)   8/47 (17.02%)   5/18 (27.78%) 
Blood and lymphatic system disorders                       
LYMPHADENOPATHY  1  2/245 (0.82%)  3/245 (1.22%)  0/247 (0.00%)  6/245 (2.45%)  3/245 (1.22%)  6/353 (1.70%)  3/349 (0.86%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
Cardiac disorders                       
SUPRAVENTRICULAR TACHYCARDIA  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  0/245 (0.00%)  0/353 (0.00%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  1/18 (5.56%) 
Gastrointestinal disorders                       
CONSTIPATION  1  1/245 (0.41%)  1/245 (0.41%)  1/247 (0.40%)  4/245 (1.63%)  5/245 (2.04%)  4/353 (1.13%)  5/349 (1.43%)  1/247 (0.40%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
DIARRHOEA  1  4/245 (1.63%)  5/245 (2.04%)  3/247 (1.21%)  9/245 (3.67%)  11/245 (4.49%)  10/353 (2.83%)  16/349 (4.58%)  4/247 (1.62%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
DYSPEPSIA  1  1/245 (0.41%)  1/245 (0.41%)  0/247 (0.00%)  6/245 (2.45%)  2/245 (0.82%)  6/353 (1.70%)  4/349 (1.15%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  0/245 (0.00%)  3/245 (1.22%)  0/247 (0.00%)  1/245 (0.41%)  5/245 (2.04%)  3/353 (0.85%)  5/349 (1.43%)  1/247 (0.40%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
NAUSEA  1  6/245 (2.45%)  1/245 (0.41%)  6/247 (2.43%)  7/245 (2.86%)  2/245 (0.82%)  8/353 (2.27%)  3/349 (0.86%)  8/247 (3.24%)  0/58 (0.00%)  1/47 (2.13%)  0/18 (0.00%) 
TOOTHACHE  1  3/245 (1.22%)  2/245 (0.82%)  2/247 (0.81%)  8/245 (3.27%)  4/245 (1.63%)  8/353 (2.27%)  5/349 (1.43%)  2/247 (0.81%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
VOMITING  1  2/245 (0.82%)  5/245 (2.04%)  2/247 (0.81%)  3/245 (1.22%)  6/245 (2.45%)  4/353 (1.13%)  7/349 (2.01%)  4/247 (1.62%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
General disorders                       
FATIGUE  1  8/245 (3.27%)  2/245 (0.82%)  2/247 (0.81%)  9/245 (3.67%)  3/245 (1.22%)  10/353 (2.83%)  3/349 (0.86%)  2/247 (0.81%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
INFLUENZA LIKE ILLNESS  1  3/245 (1.22%)  5/245 (2.04%)  3/247 (1.21%)  15/245 (6.12%)  11/245 (4.49%)  17/353 (4.82%)  14/349 (4.01%)  3/247 (1.21%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
Infections and infestations                       
ABSCESS LIMB  1  1/245 (0.41%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  1/18 (5.56%) 
BRONCHITIS  1  2/245 (0.82%)  3/245 (1.22%)  1/247 (0.40%)  7/245 (2.86%)  11/245 (4.49%)  8/353 (2.27%)  17/349 (4.87%)  2/247 (0.81%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
FOLLICULITIS  1  4/245 (1.63%)  2/245 (0.82%)  2/247 (0.81%)  10/245 (4.08%)  6/245 (2.45%)  12/353 (3.40%)  9/349 (2.58%)  2/247 (0.81%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
FURUNCLE  1  1/245 (0.41%)  2/245 (0.82%)  0/247 (0.00%)  5/245 (2.04%)  4/245 (1.63%)  5/353 (1.42%)  4/349 (1.15%)  1/247 (0.40%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
GASTROENTERITIS  1  1/245 (0.41%)  2/245 (0.82%)  1/247 (0.40%)  6/245 (2.45%)  4/245 (1.63%)  7/353 (1.98%)  7/349 (2.01%)  1/247 (0.40%)  0/58 (0.00%)  0/47 (0.00%)  1/18 (5.56%) 
INFLUENZA  1  4/245 (1.63%)  1/245 (0.41%)  2/247 (0.81%)  8/245 (3.27%)  7/245 (2.86%)  8/353 (2.27%)  10/349 (2.87%)  3/247 (1.21%)  1/58 (1.72%)  1/47 (2.13%)  0/18 (0.00%) 
NASOPHARYNGITIS  1  23/245 (9.39%)  22/245 (8.98%)  19/247 (7.69%)  53/245 (21.63%)  45/245 (18.37%)  69/353 (19.55%)  57/349 (16.33%)  20/247 (8.10%)  1/58 (1.72%)  0/47 (0.00%)  0/18 (0.00%) 
ORAL HERPES  1  0/245 (0.00%)  3/245 (1.22%)  2/247 (0.81%)  4/245 (1.63%)  6/245 (2.45%)  6/353 (1.70%)  8/349 (2.29%)  2/247 (0.81%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
OTITIS MEDIA  1  0/245 (0.00%)  3/245 (1.22%)  1/247 (0.40%)  1/245 (0.41%)  6/245 (2.45%)  2/353 (0.57%)  6/349 (1.72%)  1/247 (0.40%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
PERIODONTITIS  1  2/245 (0.82%)  1/245 (0.41%)  1/247 (0.40%)  3/245 (1.22%)  5/245 (2.04%)  3/353 (0.85%)  7/349 (2.01%)  1/247 (0.40%)  0/58 (0.00%)  0/47 (0.00%)  1/18 (5.56%) 
PHARYNGITIS  1  2/245 (0.82%)  3/245 (1.22%)  0/247 (0.00%)  8/245 (3.27%)  7/245 (2.86%)  9/353 (2.55%)  9/349 (2.58%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
RHINITIS  1  2/245 (0.82%)  2/245 (0.82%)  1/247 (0.40%)  3/245 (1.22%)  6/245 (2.45%)  4/353 (1.13%)  7/349 (2.01%)  1/247 (0.40%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
TINEA PEDIS  1  2/245 (0.82%)  2/245 (0.82%)  0/247 (0.00%)  4/245 (1.63%)  6/245 (2.45%)  8/353 (2.27%)  10/349 (2.87%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  10/245 (4.08%)  9/245 (3.67%)  0/247 (0.00%)  28/245 (11.43%)  26/245 (10.61%)  36/353 (10.20%)  32/349 (9.17%)  2/247 (0.81%)  1/58 (1.72%)  0/47 (0.00%)  0/18 (0.00%) 
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  2/245 (0.82%)  4/245 (1.63%)  2/247 (0.81%)  6/245 (2.45%)  8/245 (3.27%)  7/353 (1.98%)  11/349 (3.15%)  2/247 (0.81%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
VULVOVAGINAL MYCOTIC INFECTION  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  0/245 (0.00%)  1/245 (0.41%)  0/353 (0.00%)  1/349 (0.29%)  0/247 (0.00%)  0/58 (0.00%)  1/47 (2.13%)  0/18 (0.00%) 
Injury, poisoning and procedural complications                       
CONTUSION  1  2/245 (0.82%)  5/245 (2.04%)  1/247 (0.40%)  5/245 (2.04%)  5/245 (2.04%)  5/353 (1.42%)  7/349 (2.01%)  1/247 (0.40%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
EXCORIATION  1  2/245 (0.82%)  2/245 (0.82%)  0/247 (0.00%)  2/245 (0.82%)  5/245 (2.04%)  3/353 (0.85%)  7/349 (2.01%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
LIGAMENT SPRAIN  1  1/245 (0.41%)  1/245 (0.41%)  0/247 (0.00%)  2/245 (0.82%)  7/245 (2.86%)  3/353 (0.85%)  8/349 (2.29%)  1/247 (0.40%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
MUSCLE STRAIN  1  3/245 (1.22%)  4/245 (1.63%)  0/247 (0.00%)  7/245 (2.86%)  6/245 (2.45%)  8/353 (2.27%)  7/349 (2.01%)  1/247 (0.40%)  0/58 (0.00%)  1/47 (2.13%)  0/18 (0.00%) 
Investigations                       
BLOOD CREATININE INCREASED  1  0/245 (0.00%)  0/245 (0.00%)  1/247 (0.40%)  1/245 (0.41%)  0/245 (0.00%)  1/353 (0.28%)  1/349 (0.29%)  1/247 (0.40%)  0/58 (0.00%)  1/47 (2.13%)  0/18 (0.00%) 
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  5/245 (2.04%)  2/353 (0.57%)  5/349 (1.43%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
Metabolism and nutrition disorders                       
HYPERLIPIDAEMIA  1  1/245 (0.41%)  3/245 (1.22%)  2/247 (0.81%)  8/245 (3.27%)  6/245 (2.45%)  13/353 (3.68%)  9/349 (2.58%)  2/247 (0.81%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
HYPERTRIGLYCERIDAEMIA  1  0/245 (0.00%)  1/245 (0.41%)  0/247 (0.00%)  2/245 (0.82%)  5/245 (2.04%)  4/353 (1.13%)  7/349 (2.01%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders                       
ARTHRALGIA  1  6/245 (2.45%)  2/245 (0.82%)  7/247 (2.83%)  9/245 (3.67%)  9/245 (3.67%)  13/353 (3.68%)  14/349 (4.01%)  8/247 (3.24%)  0/58 (0.00%)  1/47 (2.13%)  0/18 (0.00%) 
BACK PAIN  1  3/245 (1.22%)  2/245 (0.82%)  4/247 (1.62%)  7/245 (2.86%)  7/245 (2.86%)  9/353 (2.55%)  9/349 (2.58%)  4/247 (1.62%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
INTERVERTEBRAL DISC PROTRUSION  1  0/245 (0.00%)  0/245 (0.00%)  0/247 (0.00%)  1/245 (0.41%)  0/245 (0.00%)  2/353 (0.57%)  0/349 (0.00%)  0/247 (0.00%)  0/58 (0.00%)  1/47 (2.13%)  0/18 (0.00%) 
MYALGIA  1  1/245 (0.41%)  1/245 (0.41%)  4/247 (1.62%)  4/245 (1.63%)  5/245 (2.04%)  5/353 (1.42%)  5/349 (1.43%)  4/247 (1.62%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
PAIN IN EXTREMITY  1  3/245 (1.22%)  4/245 (1.63%)  2/247 (0.81%)  6/245 (2.45%)  7/245 (2.86%)  8/353 (2.27%)  8/349 (2.29%)  3/247 (1.21%)  1/58 (1.72%)  0/47 (0.00%)  0/18 (0.00%) 
PSORIATIC ARTHROPATHY  1  1/245 (0.41%)  0/245 (0.00%)  3/247 (1.21%)  4/245 (1.63%)  6/245 (2.45%)  5/353 (1.42%)  7/349 (2.01%)  4/247 (1.62%)  2/58 (3.45%)  0/47 (0.00%)  0/18 (0.00%) 
Nervous system disorders                       
HEADACHE  1  13/245 (5.31%)  12/245 (4.90%)  7/247 (2.83%)  19/245 (7.76%)  22/245 (8.98%)  24/353 (6.80%)  30/349 (8.60%)  10/247 (4.05%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
Psychiatric disorders                       
DEPRESSION  1  0/245 (0.00%)  1/245 (0.41%)  0/247 (0.00%)  6/245 (2.45%)  1/245 (0.41%)  8/353 (2.27%)  2/349 (0.57%)  1/247 (0.40%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
INSOMNIA  1  3/245 (1.22%)  0/245 (0.00%)  0/247 (0.00%)  6/245 (2.45%)  0/245 (0.00%)  10/353 (2.83%)  2/349 (0.57%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders                       
COUGH  1  2/245 (0.82%)  4/245 (1.63%)  3/247 (1.21%)  3/245 (1.22%)  11/245 (4.49%)  5/353 (1.42%)  16/349 (4.58%)  3/247 (1.21%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
OROPHARYNGEAL PAIN  1  10/245 (4.08%)  4/245 (1.63%)  3/247 (1.21%)  11/245 (4.49%)  7/245 (2.86%)  12/353 (3.40%)  12/349 (3.44%)  3/247 (1.21%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
RHINITIS ALLERGIC  1  0/245 (0.00%)  3/245 (1.22%)  0/247 (0.00%)  2/245 (0.82%)  5/245 (2.04%)  2/353 (0.57%)  6/349 (1.72%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders                       
DERMATITIS CONTACT  1  0/245 (0.00%)  2/245 (0.82%)  1/247 (0.40%)  1/245 (0.41%)  7/245 (2.86%)  1/353 (0.28%)  11/349 (3.15%)  1/247 (0.40%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
ECZEMA  1  2/245 (0.82%)  3/245 (1.22%)  0/247 (0.00%)  7/245 (2.86%)  7/245 (2.86%)  11/353 (3.12%)  9/349 (2.58%)  0/247 (0.00%)  0/58 (0.00%)  1/47 (2.13%)  0/18 (0.00%) 
PRURITUS  1  9/245 (3.67%)  11/245 (4.49%)  6/247 (2.43%)  13/245 (5.31%)  14/245 (5.71%)  15/353 (4.25%)  19/349 (5.44%)  6/247 (2.43%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
PSORIASIS  1  4/245 (1.63%)  0/245 (0.00%)  7/247 (2.83%)  7/245 (2.86%)  1/245 (0.41%)  8/353 (2.27%)  3/349 (0.86%)  8/247 (3.24%)  2/58 (3.45%)  1/47 (2.13%)  0/18 (0.00%) 
URTICARIA  1  3/245 (1.22%)  3/245 (1.22%)  0/247 (0.00%)  8/245 (3.27%)  8/245 (3.27%)  9/353 (2.55%)  9/349 (2.58%)  0/247 (0.00%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
Vascular disorders                       
HYPERTENSION  1  9/245 (3.67%)  0/245 (0.00%)  3/247 (1.21%)  16/245 (6.53%)  11/245 (4.49%)  21/353 (5.95%)  15/349 (4.30%)  3/247 (1.21%)  0/58 (0.00%)  0/47 (0.00%)  0/18 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01365455     History of Changes
Other Study ID Numbers: CAIN457A2302
2010-023512-13 ( EudraCT Number )
First Submitted: June 1, 2011
First Posted: June 3, 2011
Results First Submitted: February 16, 2015
Results First Posted: May 29, 2015
Last Update Posted: February 17, 2016