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Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens (SCULPTURE)

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ClinicalTrials.gov Identifier: NCT01406938
Recruitment Status : Completed
First Posted : August 1, 2011
Results First Posted : May 19, 2015
Last Update Posted : May 19, 2015
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: AIN457 150mg
Drug: AIN457 300mg
Enrollment 967
Recruitment Details 966 patients randomized to two groups, induction secukinumab 150 mg or secukinumab 300 mg. Most randomized patients, 928/966 completed the 12-week induction period. 928 completed the induction period, a total of 843 were re-randomized to the maintenance period to either fixed interval dosing or start of relapse dosing at their respective dose level
Pre-assignment Details  
Arm/Group Title AIN457150 mg- Induction Period Only(IPO) AIN457 300 mg - IPO AIN457 150 mg - Fixed Interval (FI) AIN457 300 mg FI AIN457 150 mg- Start of Relapse (SoR) AIN457 300 mg- SoR
Hide Arm/Group Description secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO) secukinumab- 2 x 150mg injections per dose 1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection 2 s.c. secukinumab 150 mg injections 1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection 2 s.c. secukinumab 150 mg injections
Period Title: Induction Period
Started 482 484 0 0 0 0
FAS:Patients Assigned Study Treatment 482 483 0 0 0 0
Completed 464 464 0 0 0 0
Not Completed 18 20 0 0 0 0
Reason Not Completed
Subject/guardian decision             6             8             0             0             0             0
Protocol deviation             1             0             0             0             0             0
Adverse Event             8             9             0             0             0             0
Lack of Efficacy             1             0             0             0             0             0
Lost to Follow-up             2             3             0             0             0             0
Period Title: Maintenance Period
Started 0 0 203 217 206 217
FAS: Patients Assigned Treatment Drug 0 0 203 216 206 217
Completed 0 0 186 199 181 201
Not Completed 0 0 17 18 25 16
Reason Not Completed
Adverse Event             0             0             2             8             4             2
Death             0             0             0             0             1             0
Subject/guardian decision             0             0             11             7             10             7
Protocol Violation             0             0             2             2             2             2
Pregnancy             0             0             0             0             1             0
Lost to Follow-up             0             0             0             0             4             0
Lack of Efficacy             0             0             2             1             3             5
Period Title: Follow up
Started 26 23 40 39 40 35
Completed 18 18 32 36 31 32
Not Completed 8 5 8 3 9 3
Reason Not Completed
Lack of Efficacy             3             2             1             0             0             0
Patient/guardian decision             4             2             4             2             4             1
Protocol Violation             0             0             1             0             0             0
Physician Decision             0             0             2             0             3             1
Lost to Follow-up             1             1             0             1             2             1
Arm/Group Title AIN457150 mg- Induction Period Only(IPO) AIN457 300 mg - IPO Total
Hide Arm/Group Description secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO) secukinumab- 2 x 150mg injections per dose Total of all reporting groups
Overall Number of Baseline Participants 482 484 966
Hide Baseline Analysis Population Description
The Full analysis set (FAS) was comprised of all patients to whom study treatment had been assigned.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 482 participants 484 participants 966 participants
45.3  (12.83) 46.7  (12.83) 46.0  (12.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 482 participants 484 participants 966 participants
Female
177
  36.7%
151
  31.2%
328
  34.0%
Male
305
  63.3%
333
  68.8%
638
  66.0%
1.Primary Outcome
Title For the Fixed Interval Group and the Start of Relapse (SoR) Group, the Percentage of Participants (Who Responded to Treatment at Week 12) Maintaining a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52
Hide Description PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)
Time Frame Week 40 , week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - All patients to whom study treatment was assigned.
Arm/Group Title AIN457150 mg- Induction Period Only(IPO) AIN457 300 mg - IPO AIN457 150 mg - Fixed Interval (FI) AIN457 300 mg FI AIN457 150 mg- Start of Relapse (SoR) AIN457 300 mg- SoR
Hide Arm/Group Description:
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
secukinumab- 2 x 150mg injections per dose
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
2 s.c. secukinumab 150 mg injections
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
2 s.c. secukinumab 150 mg injections
Overall Number of Participants Analyzed 0 0 203 216 206 217
Measure Type: Number
Unit of Measure: Percent of participants
62.1 78.2 52.4 67.7
2.Secondary Outcome
Title Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12
Hide Description PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)
Time Frame Baseline, week 2, 3 , 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - All patients to whom study treatment was assigned
Arm/Group Title AIN457150 mg- Induction Period Only(IPO) AIN457 300 mg - IPO AIN457 150 mg - Fixed Interval (FI) AIN457 300 mg FI AIN457 150 mg- Start of Relapse (SoR) AIN457 300 mg- SoR
Hide Arm/Group Description:
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
secukinumab- 2 x 150mg injections per dose
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
2 s.c. secukinumab 150 mg injections
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
2 s.c. secukinumab 150 mg injections
Overall Number of Participants Analyzed 482 483 0 0 0 0
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 2 -7.46  (6.338) -9.28  (6.752)
Week 3 -11.13  (7.826) -12.97  (7.826)
Week 4 -14.18  (8.956) -15.90  (8.838)
Week 8 -18.69  (10.147) -19.56  (9.356)
Week 12 -20.71  (10.804) -20.89  (9.584)
3.Secondary Outcome
Title Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52
Hide Description PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)
Time Frame Baseline, week 12,16,20,24,28,32,36,40,44,48 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - All patients to whom study treatment was assigned
Arm/Group Title AIN457150 mg- Induction Period Only(IPO) AIN457 300 mg - IPO AIN457 150 mg - Fixed Interval (FI) AIN457 300 mg FI AIN457 150 mg- Start of Relapse (SoR) AIN457 300 mg- SoR
Hide Arm/Group Description:
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
secukinumab- 2 x 150mg injections per dose
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
2 s.c. secukinumab 150 mg injections
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
2 s.c. secukinumab 150 mg injections
Overall Number of Participants Analyzed 0 0 203 216 206 217
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 12 -21.52  (9.553) -22.32  (8.943) -23.19  (11.063) -21.58  (9.448)
Week 16 -21.23  (9.676) -22.61  (9.310) -23.26  (11.158) -21.58  (9.626)
Week 20 -20.79  (9.739) -22.47  (9.237) -22.28  (11.548) -20.97  (9.787)
Week 24 -20.61  (9.745) -22.30  (9.262) -21.36  (11.938) -20.09  (9.904)
Week 28 -20.29  (9.730) -22.13  (9.244) -20.53  (11.754) -19.27  (9.844)
Week 32 -20.11  (9.847) -21.98  (9.195) -19.41  (10.962) -18.68  (9.983)
Week 36 -19.82  (9.908) -21.79  (9.324) -18.86  (10.625) -18.14  (9.352)
Week 40 -19.51  (9.821) -21.71  (9.369) -18.30  (10.660) -17.89  (9.837)
Week 44 -19.40  (9.691) -21.58  (9.398) -17.73  (11.041) -17.03  (9.876)
Week 48 -19.04  (10.093) -21.34  (9.681) -17.48  (10.638) -16.58  (9.040)
Week 52 -18.79  (9.904) 21.47  (9.402) -17.40  (10.719) -16.33  (8.322)
4.Secondary Outcome
Title Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
Hide Description PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. 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 2, 4, 6, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - All patients to whom study treatment was assigned
Arm/Group Title AIN457150 mg- Induction Period Only(IPO) AIN457 300 mg - IPO AIN457 150 mg - Fixed Interval (FI) AIN457 300 mg FI AIN457 150 mg- Start of Relapse (SoR) AIN457 300 mg- SoR
Hide Arm/Group Description:
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
secukinumab- 2 x 150mg injections per dose
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
2 s.c. secukinumab 150 mg injections
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
2 s.c. secukinumab 150 mg injections
Overall Number of Participants Analyzed 482 483 0 0 0 0
Measure Type: Number
Unit of Measure: Percent of participant
Week 2 IGA 0/1 1.2 3.1
Week 2 PASI 75 1.9 5.2
Week 2 PASI 50 20.2 32.9
Week 2 PASI 90 0 0.2
Week 2 PASI 100 0 0.2
Week 3 IGA 0/1 5.2 9.3
Week 3 PASI 75 11 19.3
Week 3 PASI 50 43 63.6
Week 3 PASI 90 1.5 3.1
Week 3 PASI 100 0 0.6
Week 4 IGA 0/1 15.6 25.5
Week 4 PASI 75 27.9 42.9
Week 4 PASI 50 66.3 81.8
Week 4 PASI 90 6.7 13.7
Week 4 PASI 100 0.4 2.3
Week 8 IGA 0/1 47.8 59.4
Week 8 PASI 75 63.8 76.8
Week 8 PASI 50 88.4 93
Week 8 PASI 90 32.4 45.8
Week 8 PASI 100 8.3 13.9
Week 12 IGA 0/1 62.8 76
Week 12 PASI 75 84.4 90.1
Week 12 PASI 50 93.1 96.1
Week 12 PASI 90 49.3 64.2
Week 12 PASI 100 16.2 25.7
5.Secondary Outcome
Title Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
Hide Description The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant's disease state at the time of the assessments and does not attempt a comparison to any of the participant's previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe. The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe
Time Frame Baseline, week 16,20,24,28,32,36,40,44,48, and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - All patients to whom study treatment was assigned
Arm/Group Title AIN457150 mg- Induction Period Only(IPO) AIN457 300 mg - IPO AIN457 150 mg - Fixed Interval (FI) AIN457 300 mg FI AIN457 150 mg- Start of Relapse (SoR) AIN457 300 mg- SoR
Hide Arm/Group Description:
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
secukinumab- 2 x 150mg injections per dose
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
2 s.c. secukinumab 150 mg injections
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
2 s.c. secukinumab 150 mg injections
Overall Number of Participants Analyzed 0 0 203 216 206 217
Measure Type: Number
Unit of Measure: Percent of participants
Week 16 IGA 0/1 70.9 82.4 74.8 83.4
Week 16 PASI 75 90.1 92.1 92.7 94.9
Week 16 PASI 50 96.1 97.7 98.1 98.2
Week 16 PASI 90 59.1 75.5 68.4 76.5
Week 16 PASI 100 27.6 31.5 22.3 38.2
Week 20 IGA 0/1 69 75.5 64.6 77
Week 20 PASI 75 85.7 90.3 81.6 87.1
Week 20 PASI 50 94.6 97.7 92.2 97.2
Week 20 PASI 90 62.6 74.5 55.8 72.8
Week 20 PASI 100 29.1 35.6 24.8 35.5
Week 24 IGA 0/1 67.5 76.9 56.3 65.9
Week 24 PASI 75 80.3 88 72.3 77.9
Week 24 PASI 50 93.1 94.9 89.3 94
Week 24 PASI 90 66.5 74.1 51.5 59.9
Week 24 PASI 100 29.1 36.1 19.9 26.3
Week 28 IGA 0/1 65.5 72.7 44.7 52.5
Week 28 PASI 75 77.3 85.6 65 71.4
Week 28 PASI 50 92.6 93.5 87.4 94
Week 28 PASI 90 60.6 70.4 40.8 50.2
Week 28 PASI 100 29.6 38 15.5 23
Week 32 IGA 0/1 64 74.1 33.5 46.1
Week 32 PASI 75 74.9 84.3 50.5 63.1
Week 32 PASI 50 91.1 92.6 82 90.3
Week 32 PASI 90 58.6 74.1 32.5 41.5
Week 32 PASI 100 30.5 38.9 10.7 15.7
Week 36 IGA 0/1 59.6 70.4 27.2 33.6
Week 36 PASI 75 71.4 82.9 45.1 58.1
Week 36 PASI 50 87.7 91.2 78.6 94
Week 36 PASI 90 54.7 68.1 24.8 35.5
Week 36 PASI 100 28.6 38.9 2.9 7.4
Week 40 IGA 0/1 53.2 68.5 26.2 35.5
Week 40 PASI 75 68 81.5 42.2 58.5
Week 40 PASI 50 87.7 90.7 74.8 88.9
Week 40 PASI 90 52.2 68.5 18.9 26.7
Week 40 PASI 100 26.1 38 1.9 7.4
Week 44 IGA 0/1 52.7 64.8 20.4 27.6
Week 44 PASI 75 66 80.1 37.4 51.2
Week 44 PASI 50 84.2 92.1 72.8 82.5
Week 44 PASI 90 49.8 66.2 16.5 22.1
Week 44 PASI 100 22.7 39.8 1.5 4.6
Week 48 IGA 0/1 51.7 64.8 20.4 21.7
Week 48 PASI 75 65.5 78.7 33 45.6
Week 48 PASI 50 83.3 89.8 74.8 82
Week 48 PASI 90 49.8 62.5 12.6 14.7
Week 48 PASI 100 21.2 38.4 1 3.7
Week 52 IGA 0/1 47.3 59.3 18 20.3
Week 52 PASI 75 62.1 78.2 35 41
Week 52 PASI 50 83.7 87.5 73.8 81.1
Week 52 PASI 90 45.8 59.7 11.2 13.8
Week 52 PASI 100 21.2 36.6 2.4 5.1
6.Secondary Outcome
Title Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Induction)
Hide Description ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)
Time Frame Baseline to week 2, 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - All patients to whom study treatment was assigned
Arm/Group Title AIN457150 mg- Induction Period Only(IPO) AIN457 300 mg - IPO AIN457 150 mg - Fixed Interval (FI) AIN457 300 mg FI AIN457 150 mg- Start of Relapse (SoR) AIN457 300 mg- SoR
Hide Arm/Group Description:
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
secukinumab- 2 x 150mg injections per dose
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
2 s.c. secukinumab 150 mg injections
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
2 s.c. secukinumab 150 mg injections
Overall Number of Participants Analyzed 482 483 0 0 0 0
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 2 5.9  (14.64) 7.6  (12.86)
Week 4 10.8  (17.79) 13.6  (18.63)
Week 8 17.5  (20.79) 18.3  (21.51)
Week 12 20.2  (23.47) 21.2  (24.08)
7.Secondary Outcome
Title Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)
Hide Description ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)
Time Frame Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - All patients to whom study treatment was assigned
Arm/Group Title AIN457150 mg- Induction Period Only(IPO) AIN457 300 mg - IPO AIN457 150 mg - Fixed Interval (FI) AIN457 300 mg FI AIN457 150 mg- Start of Relapse (SoR) AIN457 300 mg- SoR
Hide Arm/Group Description:
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
secukinumab- 2 x 150mg injections per dose
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
2 s.c. secukinumab 150 mg injections
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
2 s.c. secukinumab 150 mg injections
Overall Number of Participants Analyzed 0 0 203 216 206 217
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 16 21.4  (25.11) 23  (22.44) 23.4  (25.31) 23.9  (26.09)
Week 20 20.6  (25.07) 23  (23.27) 22.1  (26.04) 22.4  (27.45)
Week 24 20.6  (25.05) 22.9  (23.32) 20  (26.66) 22.3  (26.47)
Week 28 19.4  (26.46) 23  (22.71) 19.3  (25.07) 20.4  (26.26)
Week 32 20.4  (24.95) 22.8  (23.22) 17.9  (24.97) 18.8  (25.90)
Week 36 19.6  (25.79) 23  (22.67) 17.4  (24.30) 17.7  (26.15)
Week 40 19.8  (25.39) 22.8  (22.69) 16.3  (23.53) 16.4  (26.38)
Week 44 19.8  (25.53) 22.3  (23.10) 15.4  (23.70) 14.9  (26.81)
Week 48 19.7  (25.33) 22.7  (22.85) 16.2  (23.17) 13.4  (26.65)
Week 52 18.3  (25.63) 23  (22.40) 16.7  (23.30) 13.4  (25.68)
8.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Induction)
Hide Description The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Time Frame Baseline to week 2, 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - All patients to whom study treatment was assigned
Arm/Group Title AIN457150 mg- Induction Period Only(IPO) AIN457 300 mg - IPO AIN457 150 mg - Fixed Interval (FI) AIN457 300 mg FI AIN457 150 mg- Start of Relapse (SoR) AIN457 300 mg- SoR
Hide Arm/Group Description:
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
secukinumab- 2 x 150mg injections per dose
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
2 s.c. secukinumab 150 mg injections
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
2 s.c. secukinumab 150 mg injections
Overall Number of Participants Analyzed 482 483 0 0 0 0
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 2 DLQI total score -5.5  (5.02) -6  (5.10)
Week 4 DLQI total score -8.2  (6.11) -8.7  (6.29)
Week 8 DLQI total score -10.2  (6.40) -10.3  (6.73)
Week 12 DLQI total score -10.8  (6.75) -11  (7.01)
9.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)
Hide Description The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Time Frame Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - All patients to whom study treatment was assigned
Arm/Group Title AIN457150 mg- Induction Period Only(IPO) AIN457 300 mg - IPO AIN457 150 mg - Fixed Interval (FI) AIN457 300 mg FI AIN457 150 mg- Start of Relapse (SoR) AIN457 300 mg- SoR
Hide Arm/Group Description:
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
secukinumab- 2 x 150mg injections per dose
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
2 s.c. secukinumab 150 mg injections
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
2 s.c. secukinumab 150 mg injections
Overall Number of Participants Analyzed 0 0 203 216 206 217
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 16 -11  (6.63) -11.4  (7.12) -11.4  (6.98) -11.3  (7.58)
Week 20 -10.6  (6.50) -11  (7.18) -10.6  (7.55) -11  (7.64)
Week 24 -10.5  (6.67) -11.1  (7.39) -10.1  (7.65) -10.3  (7.71)
Week 28 -10.5  (6.68) -11  (7.22) -9.7  (7.39) -9.5  (7.46)
Week 32 -10.5  (6.76) -10.9  (7.17) -8.6  (7.66) -8.9  (7.61)
Week 36 -10.2  (6.94) -10.9  (7.30) -8.6  (7.55) -8.5  (7.79)
Week 40 -10.1  (6.83) -10.8  (7.33) -8.4  (7.22) -8.5  (7.59)
Week 44 -10.2  (6.72) -10.8  (7.46) -8.4  (7.07) -8.6  (7.29)
Week 48 -10  (6.57) -10.8  (7.38) -8.6  (7.41) 7.9  (7.02)
Week 52 -9.8  (7.06) -10.9  (7.31) -8.4  (7.46) -7.6  (7.14)
10.Secondary Outcome
Title % of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Induction)
Hide Description The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Time Frame Baseline to week 2, 4, 6, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - All patients to whom study treatment was assigned
Arm/Group Title AIN457150 mg- Induction Period Only(IPO) AIN457 300 mg - IPO AIN457 150 mg - Fixed Interval (FI) AIN457 300 mg FI AIN457 150 mg- Start of Relapse (SoR) AIN457 300 mg- SoR
Hide Arm/Group Description:
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
secukinumab- 2 x 150mg injections per dose
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
2 s.c. secukinumab 150 mg injections
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
2 s.c. secukinumab 150 mg injections
Overall Number of Participants Analyzed 482 484 0 0 0 0
Measure Type: Number
Unit of Measure: Percent of participants
Week 2 (n=463,471) 9.5 13.8
Week 4 (n=479,482) 23.2 33.2
Week 8 (n=479,482) 44.7 52.1
Week 12 (n=479,482) 53.4 63.1
11.Secondary Outcome
Title % of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).
Hide Description The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Time Frame Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - All patients to whom study treatment was assigned
Arm/Group Title AIN457150 mg- Induction Period Only(IPO) AIN457 300 mg - IPO AIN457 150 mg - Fixed Interval (FI) AIN457 300 mg FI AIN457 150 mg- Start of Relapse (SoR) AIN457 300 mg- SoR
Hide Arm/Group Description:
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
secukinumab- 2 x 150mg injections per dose
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
2 s.c. secukinumab 150 mg injections
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
2 s.c. secukinumab 150 mg injections
Overall Number of Participants Analyzed 0 0 203 216 206 217
Measure Type: Number
Unit of Measure: Percent of participant
Week 16 (n=199,209,202,215) 59.8 66.5 58.4 72.1
Week 20 (n=202,213,205,217) 57.4 67.6 58 69.6
Week 24 (n=202,214,206,217) 58.4 68.7 53.9 65.4
Week 28 (n=202,214,206,217) 57.9 70.1 47.6 51.6
Week 32 (n=202,214,206,217) 57.9 67.8 37.9 47.5
Week 36 (n=202,214,206,217) 58.4 65 39.8 39.6
Week 40 (n=202,214,206,217) 55 66.4 35 42.4
Week 44 (n=202,214,206,217) 59.9 68.7 31.6 43.3
Week 48 (n=202,214,206,217) 54 67.3 32 40.6
Week 52 (n=202,214,206,217) 56.4 69.2 31.1 37.3
12.Secondary Outcome
Title Median Time to Relapse (Weeks) From Week 12.
Hide Description Median time to relapse (weeks) from week 12. Relapse is defined as greater than 50% loss of the maximal PASI improvement from baseline. 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 12 to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - All patients to whom study treatment was assigned
Arm/Group Title AIN457150 mg- Induction Period Only(IPO) AIN457 300 mg - IPO AIN457 150 mg - Fixed Interval (FI) AIN457 300 mg FI AIN457 150 mg- Start of Relapse (SoR) AIN457 300 mg- SoR
Hide Arm/Group Description:
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
secukinumab- 2 x 150mg injections per dose
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
2 s.c. secukinumab 150 mg injections
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
2 s.c. secukinumab 150 mg injections
Overall Number of Participants Analyzed 0 0 203 216 206 217
Median (95% Confidence Interval)
Unit of Measure: Number of weeks
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
302 [1] 
(302 to NA)
[1]
not estimable due to insufficient events at the time of analysis
13.Secondary Outcome
Title Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy
Hide Description PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. 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 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - All patients to whom study treatment was assigned, only participants with evaluable data were included
Arm/Group Title AIN457150 mg- Induction Period Only(IPO) AIN457 300 mg - IPO AIN457 150 mg - Fixed Interval (FI) AIN457 300 mg FI AIN457 150 mg- Start of Relapse (SoR) AIN457 300 mg- SoR
Hide Arm/Group Description:
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
secukinumab- 2 x 150mg injections per dose
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
2 s.c. secukinumab 150 mg injections
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
2 s.c. secukinumab 150 mg injections
Overall Number of Participants Analyzed 64 74 0 0 0 0
Measure Type: Number
Unit of Measure: Percent of participants
Week 12 IGA 0/1 42.2 62.2
Week 12 PASI 50 87.5 90.5
Week 12 PASI 75 68.8 86.5
Week 12 PASI 90 26.6 56.8
Week 12 PASI 100 6.3 21.6
14.Secondary Outcome
Title Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy
Hide Description PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - All patients to whom study treatment was assigned, only participants with evaluable data were included
Arm/Group Title AIN457150 mg- Induction Period Only(IPO) AIN457 300 mg - IPO AIN457 150 mg - Fixed Interval (FI) AIN457 300 mg FI AIN457 150 mg- Start of Relapse (SoR) AIN457 300 mg- SoR
Hide Arm/Group Description:
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
secukinumab- 2 x 150mg injections per dose
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
2 s.c. secukinumab 150 mg injections
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
2 s.c. secukinumab 150 mg injections
Overall Number of Participants Analyzed 0 0 21 36 23 28
Measure Type: Number
Unit of Measure: Percent of participants
Week 52 IGA 0/1 42.9 66.7 4.3 14.3
Week 52 PASI 50 81 86.1 60.9 75
Week 52 PASI 75 47.6 77.8 21.7 32.1
Week 52 PASI 90 33.3 66.7 13 7.1
Week 52 PASI 100 28.6 52.8 0 3.6
15.Secondary Outcome
Title Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
Hide Description PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. 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 16, 20, 24,28,32,36,40,44,48,and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - All patients to whom study treatment was assigned
Arm/Group Title AIN457150 mg- Induction Period Only(IPO) AIN457 300 mg - IPO AIN457 150 mg - Fixed Interval (FI) AIN457 300 mg FI AIN457 150 mg- Start of Relapse (SoR) AIN457 300 mg- SoR
Hide Arm/Group Description:
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
secukinumab- 2 x 150mg injections per dose
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
2 s.c. secukinumab 150 mg injections
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
2 s.c. secukinumab 150 mg injections
Overall Number of Participants Analyzed 0 0 203 216 206 217
Measure Type: Number
Unit of Measure: Percent of participants
PASI 50 Visit 0 1.5 0.9 0.5 0.5
PASI 50 Visit 1 1 0.5 1.5 0.5
PASI 50 Visit 2 2.5 0.5 3.4 0.5
PASI 50 Visit 3 0.5 1.9 3.4 0.5
PASI 50 Visit 4 1.5 2.8 4.4 1.8
PASI 50 Visit 5 3.4 0.5 2.4 1.8
PASI 50 Visit 6 2.5 0.5 4.9 0.9
PASI 50 Visit 7 3 3.2 6.8 5.5
PASI 50 Visit 8 3 1.9 10.2 12.4
PASI 50 Visit 9 8.4 7.9 8.7 16.6
PASI 50 Visit 10 72.9 79.6 53.9 59
PASI 75 Visit 0 4.9 3.2 3.9 2.8
PASI 75 Visit 1 5.9 2.8 6.8 2.3
PASI 75 Visit 2 5.4 2.8 8.3 4.1
PASI 75 Visit 3 3 3.2 7.8 6.9
PASI 75 Visit 4 4.9 1.9 11.2 8.3
PASI 75 Visit 5 3.4 1.9 10.7 10.6
PASI 75 Visit 6 4.9 1.9 11.7 8.3
PASI 75 Visit 7 4.4 3.7 9.2 11.1
PASI 75 Visit 8 2.5 4.2 9.7 18.4
PASI 75 Visit 9 7.4 8.8 10.7 15.2
PASI 75 Visit 10 53.2 65.7 10.2 12
PASI 90 Visit 0 24.6 12 23.8 15.7
PASI 90 Visit 1 4.4 5.1 15 7.8
PASI 90 Visit 2 2.5 3.7 8.3 12
PASI 90 Visit 3 5.4 4.2 6.8 11.1
PASI 90 Visit 4 4.4 2.3 11.2 11.1
PASI 90 Visit 5 3.9 1.4 8.7 6.5
PASI 90 Visit 6 3.4 5.1 9.7 8.8
PASI 90 Visit 7 3.9 4.6 7.3 10.6
PASI 90 Visit 8 5.4 6.5 2.9 8.3
PASI 90 Visit 9 13.8 13.4 2.9 3.7
PASI 90 Visit 10 28.1 41.7 3.4 4.6
PASI 100 Visit 0 53.2 41.2 65 51.2
PASI 100 Visit 1 5.9 6.5 9.7 7.8
PASI 100 Visit 2 5.9 4.2 6.3 12.4
PASI 100 Visit 3 3.4 4.6 7.3 8.8
PASI 100 Visit 4 3.4 2.3 6.3 6.9
PASI 100 Visit 5 3 5.6 2.9 6.5
PASI 100 Visit 6 4.9 5.1 1 1.8
PASI 100 Visit 7 4.4 3.7 0.5 2.3
PASI 100 Visit 8 2.5 5.6 0 0.9
PASI 100 Visit 9 4.4 7.9 0 0.5
PASI 100 Visit 10 8.9 13.4 1 0.9
IGA mod 2011 0 or 1 response Visit 0 19.2 11.6 20.4 12
IGA mod 2011 0 or 1 response Visit 1 5.4 3.7 10.2 6.5
IGA mod 2011 0 or 1 response Visit 2 2 3.7 9.7 7.4
IGA mod 2011 0 or 1 response Visit 3 5.4 5.1 9.2 10.6
IGA mod 2011 0 or 1 response Visit 4 3.9 3.2 8.3 12
IGA mod 2011 0 or 1 response Visit 5 3.4 1.9 10.2 13.8
IGA mod 2011 0 or 1 response Visit 6 6.4 4.6 9.2 7.8
IGA mod 2011 0 or 1 response Visit 7 6.4 3.7 7.8 10.1
IGA mod 2011 0 or 1 response Visit 8 5.9 2.8 5.8 8.3
IGA mod 2011 0 or 1 response Visit 9 6.4 12.5 3.9 6
IGA mod 2011 0 or 1 response Visit 10 35.5 47.2 5.3 5.5
16.Secondary Outcome
Title Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
Hide Description The number of secukinumab injections needed for participants to regain PASI 75 response from the start of relapse after week 12
Time Frame week 16, 20, 24,28,32,36,40,44,48,and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - All patients to whom study treatment was assigned
Arm/Group Title AIN457150 mg- Induction Period Only(IPO) AIN457 300 mg - IPO AIN457 150 mg - Fixed Interval (FI) AIN457 300 mg FI AIN457 150 mg- Start of Relapse (SoR) AIN457 300 mg- SoR
Hide Arm/Group Description:
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
secukinumab- 2 x 150mg injections per dose
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
2 s.c. secukinumab 150 mg injections
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
2 s.c. secukinumab 150 mg injections
Overall Number of Participants Analyzed 0 0 0 0 176 185
Measure Type: Number
Unit of Measure: percent of participants
SoR: one, Regain PASI 75 Injection 0 (n=97,128) 4.1 0.8
SoR: one, Regain PASI 75 Injection 1 (n=97,128) 40.2 0
SoR: one, Regain PASI 75 Injection 2 (n=97,128) 27.8 45.3
SoR: one, Regain PASI 75 Injection 3 (n=97,128) 11.3 0
SoR: one, Regain PASI 75 Injection 4 (n=97,128) 6.2 31.3
SoR: one, Regain PASI 75 Injection 5 (n=97,128) 4.1 0
SoR: one, Regain PASI 75 Injection 6 (n=97,128) 4.1 14.1
SoR: one, Regain PASI 75 Injection 7 (n=97,128) 1 0
SoR: one, Regain PASI 75 Injection 8 (n=97,128) 1 3.1
SoR: one, Regain PASI 75 Injection 10 (n=97,128) 0 3.9
SoR: one, Regain PASI 75 Injection 12 (n=97,128) 0 1.6
SoR: Two, Regain PASI 75 Injection 0 (n=21,36) 0 5.6
SoR: Two, Regain PASI 75 Injection 1 (n=21,36) 47.6 0
SoR: Two, Regain PASI 75 Injection 2 (n=21,36) 42.9 58.3
SoR: Two, Regain PASI 75 Injection 3 (n=21,36) 4.8 0
SoR: Two, Regain PASI 75 Injection 4 (n=21,36) 0 19.4
SoR: Two, Regain PASI 75 Injection 6 (n=21,36) 4.8 8.3
SoR: Two, Regain PASI 75 Injection 8 (n=21,36) 0 8.3
SoR: Three, Regain PASI 75 Injection 2 (n=0,4) NA [1]  100
[1]
No evaluable participants
17.Secondary Outcome
Title Number of Participants Developing Anti-secukinumab Antibodies
Hide Description The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to week 12, 24, 52 and 8 weeks after treatment at week 60
Time Frame Baseline, weeks 12, 24, 52 and 60
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - All patients to whom study treatment was assigned
Arm/Group Title AIN457150 mg- Induction Period Only(IPO) AIN457 300 mg - IPO AIN457 150 mg - Fixed Interval (FI) AIN457 300 mg FI AIN457 150 mg- Start of Relapse (SoR) AIN457 300 mg- SoR
Hide Arm/Group Description:
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
secukinumab- 2 x 150mg injections per dose
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
2 s.c. secukinumab 150 mg injections
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
2 s.c. secukinumab 150 mg injections
Overall Number of Participants Analyzed 0 0 203 216 206 217
Measure Type: Number
Unit of Measure: Number of participants
2 1 1 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title INDUCTION-AIN457 150mg INDUCTION-AIN457 300mg ENTIRE-AIN457 150mg ENTIRE-AIN457 300mg ENTIRE-AIN457 150 mg SoR ENTIRE-AIN457 300 mg SoR FOLLOW UP-AIN457 150mg IPO FOLLOW UP-AIN457 300mg IPO FOLLOW UP-AIN457 150 mg FOLLOW UP-AIN457 300 mg FOLLOW UP-AIN457 150 mg SoR FOLLOW UP-AIN457 300 mg SoR
Hide Arm/Group Description INDUCTION-AIN457 150mg INDUCTION-AIN457 300mg ENTIRE-AIN457 150mg ENTIRE-AIN457 300mg ENTIRE-AIN457 150 mg SoR ENTIRE-AIN457 300 mg SoR FOLLOW UP-AIN457 150mg IPO FOLLOW UP-AIN457 300mg IPO FOLLOW UP-AIN457 150 mg FOLLOW UP-AIN457 300 mg FOLLOW UP-AIN457 150 mg SoR FOLLOW UP-AIN457 300 mg SoR
All-Cause Mortality
INDUCTION-AIN457 150mg INDUCTION-AIN457 300mg ENTIRE-AIN457 150mg ENTIRE-AIN457 300mg ENTIRE-AIN457 150 mg SoR ENTIRE-AIN457 300 mg SoR FOLLOW UP-AIN457 150mg IPO FOLLOW UP-AIN457 300mg IPO FOLLOW UP-AIN457 150 mg FOLLOW UP-AIN457 300 mg FOLLOW UP-AIN457 150 mg SoR FOLLOW UP-AIN457 300 mg SoR
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 (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
INDUCTION-AIN457 150mg INDUCTION-AIN457 300mg ENTIRE-AIN457 150mg ENTIRE-AIN457 300mg ENTIRE-AIN457 150 mg SoR ENTIRE-AIN457 300 mg SoR FOLLOW UP-AIN457 150mg IPO FOLLOW UP-AIN457 300mg IPO FOLLOW UP-AIN457 150 mg FOLLOW UP-AIN457 300 mg FOLLOW UP-AIN457 150 mg SoR FOLLOW UP-AIN457 300 mg SoR
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 (%) Affected / at Risk (%)
Total   8/482 (1.66%)   10/484 (2.07%)   12/203 (5.91%)   18/217 (8.29%)   12/205 (5.85%)   14/217 (6.45%)   1/27 (3.70%)   0/23 (0.00%)   2/40 (5.00%)   1/39 (2.56%)   1/39 (2.56%)   0/35 (0.00%) 
Cardiac disorders                         
ACUTE MYOCARDIAL INFARCTION  1  0/482 (0.00%)  1/484 (0.21%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
ANGINA PECTORIS  1  1/482 (0.21%)  0/484 (0.00%)  1/203 (0.49%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
AORTIC VALVE INCOMPETENCE  1  0/482 (0.00%)  0/484 (0.00%)  1/203 (0.49%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
ATRIAL FIBRILLATION  1  0/482 (0.00%)  1/484 (0.21%)  1/203 (0.49%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
CORONARY ARTERY STENOSIS  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
MYOCARDIAL ISCHAEMIA  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/39 (2.56%)  0/35 (0.00%) 
PALPITATIONS  1  1/482 (0.21%)  0/484 (0.00%)  1/203 (0.49%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Congenital, familial and genetic disorders                         
FIBROUS DYSPLASIA OF BONE  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
HYDROCELE  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  1/39 (2.56%)  0/39 (0.00%)  0/35 (0.00%) 
Ear and labyrinth disorders                         
VESTIBULAR DISORDER  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Gastrointestinal disorders                         
ABDOMINAL PAIN  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
ABDOMINAL PAIN LOWER  1  1/482 (0.21%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
ABDOMINAL PAIN UPPER  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
CROHN'S DISEASE  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  0/482 (0.00%)  1/484 (0.21%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
ILEUS  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
NAUSEA  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
PANCREATITIS  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
VOMITING  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
General disorders                         
GENERALISED OEDEMA  1  1/482 (0.21%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Hepatobiliary disorders                         
CHOLECYSTITIS ACUTE  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
CHOLELITHIASIS  1  0/482 (0.00%)  0/484 (0.00%)  1/203 (0.49%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
HEPATIC CIRRHOSIS  1  1/482 (0.21%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
HEPATIC STEATOSIS  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
HEPATITIS  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
HEPATOTOXICITY  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
LIVER INJURY  1  0/482 (0.00%)  1/484 (0.21%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
PORTAL HYPERTENSION  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Infections and infestations                         
ABSCESS BACTERIAL  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
ABSCESS OF SALIVARY GLAND  1  0/482 (0.00%)  0/484 (0.00%)  1/203 (0.49%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
APPENDICITIS  1  1/482 (0.21%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
CELLULITIS  1  0/482 (0.00%)  0/484 (0.00%)  1/203 (0.49%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  1/40 (2.50%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
CHRONIC TONSILLITIS  1  0/482 (0.00%)  1/484 (0.21%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
GROIN ABSCESS  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
HELICOBACTER GASTRITIS  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
HEPATITIS B  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  1/27 (3.70%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
INFLUENZA  1  0/482 (0.00%)  0/484 (0.00%)  1/203 (0.49%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
OOPHORITIS  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
PHARYNGEAL ABSCESS  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
PNEUMONIA  1  0/482 (0.00%)  0/484 (0.00%)  1/203 (0.49%)  1/217 (0.46%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
PNEUMONIA VIRAL  1  0/482 (0.00%)  0/484 (0.00%)  1/203 (0.49%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
POST PROCEDURAL INFECTION  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
SEPSIS  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/39 (2.56%)  0/35 (0.00%) 
TONSILLITIS BACTERIAL  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
VULVAL ABSCESS  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Injury, poisoning and procedural complications                         
CONCUSSION  1  0/482 (0.00%)  1/484 (0.21%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
FALL  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
FEMUR FRACTURE  1  0/482 (0.00%)  1/484 (0.21%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
HAND FRACTURE  1  0/482 (0.00%)  1/484 (0.21%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
LUMBAR VERTEBRAL FRACTURE  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
PANCREATIC INJURY  1  0/482 (0.00%)  1/484 (0.21%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
POST-TRAUMATIC PAIN  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
SPINAL CORD INJURY  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
TENDON RUPTURE  1  0/482 (0.00%)  1/484 (0.21%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  2/217 (0.92%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
THORACIC VERTEBRAL FRACTURE  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Investigations                         
URINE ANALYSIS ABNORMAL  1  1/482 (0.21%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Metabolism and nutrition disorders                         
GOUT  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Musculoskeletal and connective tissue disorders                         
CHONDROMALACIA  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
FRACTURE NONUNION  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
INTERVERTEBRAL DISC PROTRUSION  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
OSTEOARTHRITIS  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                         
BASAL CELL CARCINOMA  1  0/482 (0.00%)  1/484 (0.21%)  0/203 (0.00%)  2/217 (0.92%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
BENIGN BREAST NEOPLASM  1  0/482 (0.00%)  1/484 (0.21%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
PITUITARY TUMOUR BENIGN  1  0/482 (0.00%)  0/484 (0.00%)  1/203 (0.49%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Nervous system disorders                         
CENTRAL NERVOUS SYSTEM INFLAMMATION  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  1/40 (2.50%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
HAEMORRHAGIC STROKE  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
HYPOAESTHESIA  1  0/482 (0.00%)  0/484 (0.00%)  1/203 (0.49%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
LOSS OF CONSCIOUSNESS  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
MULTIPLE SCLEROSIS  1  0/482 (0.00%)  0/484 (0.00%)  1/203 (0.49%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
SCIATICA  1  0/482 (0.00%)  0/484 (0.00%)  1/203 (0.49%)  0/217 (0.00%)  0/205 (0.00%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
SYNCOPE  1  0/482 (0.00%)  1/484 (0.21%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
VASCULAR HEADACHE  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Psychiatric disorders                         
ALCOHOL ABUSE  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
ALCOHOL WITHDRAWAL SYNDROME  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
ALCOHOLISM  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
DEPRESSION  1  1/482 (0.21%)  0/484 (0.00%)  1/203 (0.49%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
PANIC ATTACK  1  1/482 (0.21%)  0/484 (0.00%)  1/203 (0.49%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Renal and urinary disorders                         
CALCULUS URETERIC  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
IGA NEPHROPATHY  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/39 (2.56%)  0/35 (0.00%) 
NEPHROLITHIASIS  1  0/482 (0.00%)  1/484 (0.21%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
RENAL COLIC  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
RENAL TUBULAR NECROSIS  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/39 (2.56%)  0/35 (0.00%) 
Reproductive system and breast disorders                         
BENIGN PROSTATIC HYPERPLASIA  1  0/482 (0.00%)  0/484 (0.00%)  1/203 (0.49%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
METRORRHAGIA  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
VARICOCELE  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  1/39 (2.56%)  0/39 (0.00%)  0/35 (0.00%) 
VULVA CYST  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Respiratory, thoracic and mediastinal disorders                         
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  0/482 (0.00%)  0/484 (0.00%)  1/203 (0.49%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
PLEURAL EFFUSION  1  1/482 (0.21%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
PLEURISY  1  0/482 (0.00%)  0/484 (0.00%)  1/203 (0.49%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
PNEUMONITIS  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/39 (2.56%)  0/35 (0.00%) 
SLEEP APNOEA SYNDROME  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Skin and subcutaneous tissue disorders                         
DERMAL CYST  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
DERMATITIS CONTACT  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
PEMPHIGUS  1  0/482 (0.00%)  1/484 (0.21%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
PHOTOSENSITIVITY REACTION  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
PSORIASIS  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
PUSTULAR PSORIASIS  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Vascular disorders                         
FEMORAL ARTERY OCCLUSION  1  1/482 (0.21%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
GRANULOMATOSIS WITH POLYANGIITIS  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
HYPERTENSION  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
PERIPHERAL ARTERY STENOSIS  1  1/482 (0.21%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
INDUCTION-AIN457 150mg INDUCTION-AIN457 300mg ENTIRE-AIN457 150mg ENTIRE-AIN457 300mg ENTIRE-AIN457 150 mg SoR ENTIRE-AIN457 300 mg SoR FOLLOW UP-AIN457 150mg IPO FOLLOW UP-AIN457 300mg IPO FOLLOW UP-AIN457 150 mg FOLLOW UP-AIN457 300 mg FOLLOW UP-AIN457 150 mg SoR FOLLOW UP-AIN457 300 mg SoR
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 (%) Affected / at Risk (%)
Total   190/482 (39.42%)   178/484 (36.78%)   134/203 (66.01%)   137/217 (63.13%)   120/205 (58.54%)   126/217 (58.06%)   6/27 (22.22%)   6/23 (26.09%)   8/40 (20.00%)   7/39 (17.95%)   13/39 (33.33%)   9/35 (25.71%) 
Blood and lymphatic system disorders                         
IRON DEFICIENCY ANAEMIA  1  0/482 (0.00%)  0/484 (0.00%)  1/203 (0.49%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/39 (2.56%)  0/35 (0.00%) 
LYMPHADENOPATHY  1  0/482 (0.00%)  0/484 (0.00%)  1/203 (0.49%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  1/40 (2.50%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Eye disorders                         
CATARACT  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/39 (2.56%)  0/35 (0.00%) 
CONJUNCTIVITIS  1  0/482 (0.00%)  3/484 (0.62%)  3/203 (1.48%)  5/217 (2.30%)  3/205 (1.46%)  3/217 (1.38%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Gastrointestinal disorders                         
ABDOMINAL TENDERNESS  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  1/27 (3.70%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
APHTHOUS STOMATITIS  1  2/482 (0.41%)  1/484 (0.21%)  0/203 (0.00%)  2/217 (0.92%)  1/205 (0.49%)  0/217 (0.00%)  1/27 (3.70%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
CONSTIPATION  1  0/482 (0.00%)  2/484 (0.41%)  0/203 (0.00%)  3/217 (1.38%)  2/205 (0.98%)  0/217 (0.00%)  0/27 (0.00%)  1/23 (4.35%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
DIARRHOEA  1  7/482 (1.45%)  8/484 (1.65%)  6/203 (2.96%)  7/217 (3.23%)  8/205 (3.90%)  10/217 (4.61%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  2/482 (0.41%)  4/484 (0.83%)  5/203 (2.46%)  4/217 (1.84%)  0/205 (0.00%)  2/217 (0.92%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
HYPERCHLORHYDRIA  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/39 (2.56%)  0/35 (0.00%) 
NAUSEA  1  10/482 (2.07%)  4/484 (0.83%)  5/203 (2.46%)  3/217 (1.38%)  5/205 (2.44%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/39 (2.56%)  0/35 (0.00%) 
TOOTHACHE  1  3/482 (0.62%)  0/484 (0.00%)  4/203 (1.97%)  1/217 (0.46%)  4/205 (1.95%)  2/217 (0.92%)  0/27 (0.00%)  1/23 (4.35%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
VOMITING  1  2/482 (0.41%)  3/484 (0.62%)  2/203 (0.99%)  5/217 (2.30%)  1/205 (0.49%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
General disorders                         
ASTHENIA  1  1/482 (0.21%)  3/484 (0.62%)  1/203 (0.49%)  0/217 (0.00%)  2/205 (0.98%)  3/217 (1.38%)  0/27 (0.00%)  0/23 (0.00%)  1/40 (2.50%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
INFLUENZA LIKE ILLNESS  1  1/482 (0.21%)  0/484 (0.00%)  1/203 (0.49%)  0/217 (0.00%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  1/40 (2.50%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
INJECTION SITE PAIN  1  3/482 (0.62%)  4/484 (0.83%)  0/203 (0.00%)  4/217 (1.84%)  3/205 (1.46%)  5/217 (2.30%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
OEDEMA PERIPHERAL  1  4/482 (0.83%)  4/484 (0.83%)  4/203 (1.97%)  3/217 (1.38%)  2/205 (0.98%)  3/217 (1.38%)  1/27 (3.70%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
PYREXIA  1  3/482 (0.62%)  0/484 (0.00%)  4/203 (1.97%)  5/217 (2.30%)  5/205 (2.44%)  2/217 (0.92%)  0/27 (0.00%)  0/23 (0.00%)  2/40 (5.00%)  0/39 (0.00%)  3/39 (7.69%)  0/35 (0.00%) 
Infections and infestations                         
BRONCHITIS  1  3/482 (0.62%)  6/484 (1.24%)  11/203 (5.42%)  7/217 (3.23%)  1/205 (0.49%)  7/217 (3.23%)  1/27 (3.70%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
EAR INFECTION  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  2/217 (0.92%)  1/27 (3.70%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
FOLLICULITIS  1  3/482 (0.62%)  3/484 (0.62%)  2/203 (0.99%)  6/217 (2.76%)  3/205 (1.46%)  6/217 (2.76%)  1/27 (3.70%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
GASTROENTERITIS  1  5/482 (1.04%)  2/484 (0.41%)  7/203 (3.45%)  5/217 (2.30%)  4/205 (1.95%)  5/217 (2.30%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
HERPES ZOSTER  1  3/482 (0.62%)  1/484 (0.21%)  3/203 (1.48%)  1/217 (0.46%)  1/205 (0.49%)  2/217 (0.92%)  0/27 (0.00%)  1/23 (4.35%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
INFLUENZA  1  6/482 (1.24%)  6/484 (1.24%)  9/203 (4.43%)  6/217 (2.76%)  5/205 (2.44%)  8/217 (3.69%)  1/27 (3.70%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/39 (2.56%)  0/35 (0.00%) 
NASOPHARYNGITIS  1  48/482 (9.96%)  46/484 (9.50%)  37/203 (18.23%)  36/217 (16.59%)  32/205 (15.61%)  42/217 (19.35%)  0/27 (0.00%)  1/23 (4.35%)  1/40 (2.50%)  0/39 (0.00%)  0/39 (0.00%)  1/35 (2.86%) 
ORAL HERPES  1  3/482 (0.62%)  2/484 (0.41%)  2/203 (0.99%)  2/217 (0.92%)  4/205 (1.95%)  2/217 (0.92%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  1/39 (2.56%)  0/39 (0.00%)  0/35 (0.00%) 
PERIODONTITIS  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  2/205 (0.98%)  2/217 (0.92%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  1/35 (2.86%) 
PHARYNGITIS  1  4/482 (0.83%)  9/484 (1.86%)  8/203 (3.94%)  12/217 (5.53%)  2/205 (0.98%)  7/217 (3.23%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
PHARYNGITIS BACTERIAL  1  1/482 (0.21%)  1/484 (0.21%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  5/217 (2.30%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
RHINITIS  1  5/482 (1.04%)  3/484 (0.62%)  4/203 (1.97%)  6/217 (2.76%)  4/205 (1.95%)  4/217 (1.84%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
SINUSITIS  1  5/482 (1.04%)  3/484 (0.62%)  3/203 (1.48%)  6/217 (2.76%)  7/205 (3.41%)  4/217 (1.84%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  1/39 (2.56%)  0/39 (0.00%)  0/35 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  17/482 (3.53%)  17/484 (3.51%)  16/203 (7.88%)  16/217 (7.37%)  11/205 (5.37%)  14/217 (6.45%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  2/39 (5.13%)  0/39 (0.00%)  0/35 (0.00%) 
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  0/482 (0.00%)  3/484 (0.62%)  3/203 (1.48%)  4/217 (1.84%)  0/205 (0.00%)  5/217 (2.30%)  0/27 (0.00%)  0/23 (0.00%)  1/40 (2.50%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Injury, poisoning and procedural complications                         
JOINT DISLOCATION  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  1/40 (2.50%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
PROCEDURAL PAIN  1  2/482 (0.41%)  2/484 (0.41%)  1/203 (0.49%)  0/217 (0.00%)  1/205 (0.49%)  1/217 (0.46%)  0/27 (0.00%)  1/23 (4.35%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  1/35 (2.86%) 
Investigations                         
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  4/482 (0.83%)  3/484 (0.62%)  4/203 (1.97%)  1/217 (0.46%)  5/205 (2.44%)  3/217 (1.38%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Metabolism and nutrition disorders                         
DIABETES MELLITUS  1  5/482 (1.04%)  0/484 (0.00%)  3/203 (1.48%)  1/217 (0.46%)  4/205 (1.95%)  0/217 (0.00%)  0/27 (0.00%)  2/23 (8.70%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
DYSLIPIDAEMIA  1  5/482 (1.04%)  2/484 (0.41%)  2/203 (0.99%)  1/217 (0.46%)  6/205 (2.93%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
HYPERCHOLESTEROLAEMIA  1  5/482 (1.04%)  5/484 (1.03%)  3/203 (1.48%)  5/217 (2.30%)  3/205 (1.46%)  2/217 (0.92%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
HYPERGLYCAEMIA  1  0/482 (0.00%)  0/484 (0.00%)  2/203 (0.99%)  1/217 (0.46%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  1/23 (4.35%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
HYPERLIPIDAEMIA  1  2/482 (0.41%)  2/484 (0.41%)  2/203 (0.99%)  6/217 (2.76%)  2/205 (0.98%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
HYPERTRIGLYCERIDAEMIA  1  2/482 (0.41%)  0/484 (0.00%)  2/203 (0.99%)  0/217 (0.00%)  3/205 (1.46%)  0/217 (0.00%)  0/27 (0.00%)  1/23 (4.35%)  0/40 (0.00%)  0/39 (0.00%)  1/39 (2.56%)  0/35 (0.00%) 
Musculoskeletal and connective tissue disorders                         
ARTHRALGIA  1  9/482 (1.87%)  9/484 (1.86%)  8/203 (3.94%)  11/217 (5.07%)  12/205 (5.85%)  13/217 (5.99%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/39 (2.56%)  0/35 (0.00%) 
BACK PAIN  1  10/482 (2.07%)  4/484 (0.83%)  12/203 (5.91%)  9/217 (4.15%)  9/205 (4.39%)  7/217 (3.23%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
INTERVERTEBRAL DISC PROTRUSION  1  1/482 (0.21%)  1/484 (0.21%)  3/203 (1.48%)  1/217 (0.46%)  3/205 (1.46%)  1/217 (0.46%)  0/27 (0.00%)  1/23 (4.35%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
PAIN IN EXTREMITY  1  6/482 (1.24%)  2/484 (0.41%)  5/203 (2.46%)  4/217 (1.84%)  6/205 (2.93%)  2/217 (0.92%)  0/27 (0.00%)  0/23 (0.00%)  1/40 (2.50%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
PSORIATIC ARTHROPATHY  1  4/482 (0.83%)  1/484 (0.21%)  5/203 (2.46%)  2/217 (0.92%)  6/205 (2.93%)  2/217 (0.92%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
SPINAL OSTEOARTHRITIS  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/39 (2.56%)  0/35 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                         
BASAL CELL CARCINOMA  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  1/217 (0.46%)  2/205 (0.98%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/39 (2.56%)  0/35 (0.00%) 
SEBORRHOEIC KERATOSIS  1  1/482 (0.21%)  0/484 (0.00%)  1/203 (0.49%)  0/217 (0.00%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  1/23 (4.35%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Nervous system disorders                         
HEADACHE  1  22/482 (4.56%)  17/484 (3.51%)  14/203 (6.90%)  11/217 (5.07%)  14/205 (6.83%)  11/217 (5.07%)  1/27 (3.70%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  1/35 (2.86%) 
PARAESTHESIA  1  1/482 (0.21%)  1/484 (0.21%)  2/203 (0.99%)  2/217 (0.92%)  1/205 (0.49%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  1/35 (2.86%) 
Psychiatric disorders                         
INSOMNIA  1  9/482 (1.87%)  1/484 (0.21%)  6/203 (2.96%)  1/217 (0.46%)  3/205 (1.46%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  1/40 (2.50%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Renal and urinary disorders                         
DYSURIA  1  1/482 (0.21%)  0/484 (0.00%)  1/203 (0.49%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/39 (2.56%)  0/35 (0.00%) 
GLYCOSURIA  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  1/23 (4.35%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
KETONURIA  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  1/23 (4.35%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Respiratory, thoracic and mediastinal disorders                         
COUGH  1  10/482 (2.07%)  10/484 (2.07%)  13/203 (6.40%)  11/217 (5.07%)  8/205 (3.90%)  8/217 (3.69%)  0/27 (0.00%)  0/23 (0.00%)  1/40 (2.50%)  0/39 (0.00%)  1/39 (2.56%)  0/35 (0.00%) 
OROPHARYNGEAL PAIN  1  3/482 (0.62%)  7/484 (1.45%)  3/203 (1.48%)  10/217 (4.61%)  3/205 (1.46%)  7/217 (3.23%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
SINUS CONGESTION  1  6/482 (1.24%)  3/484 (0.62%)  5/203 (2.46%)  1/217 (0.46%)  0/205 (0.00%)  3/217 (1.38%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Skin and subcutaneous tissue disorders                         
DERMATITIS  1  1/482 (0.21%)  3/484 (0.62%)  0/203 (0.00%)  5/217 (2.30%)  5/205 (2.44%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
DERMATITIS CONTACT  1  2/482 (0.41%)  1/484 (0.21%)  3/203 (1.48%)  5/217 (2.30%)  4/205 (1.95%)  3/217 (1.38%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
ECZEMA  1  1/482 (0.21%)  6/484 (1.24%)  0/203 (0.00%)  8/217 (3.69%)  1/205 (0.49%)  7/217 (3.23%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
ERYTHEMA  1  1/482 (0.21%)  2/484 (0.41%)  1/203 (0.49%)  2/217 (0.92%)  1/205 (0.49%)  2/217 (0.92%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/39 (2.56%)  0/35 (0.00%) 
ERYTHRODERMIC PSORIASIS  1  1/482 (0.21%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  1/205 (0.49%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  2/40 (5.00%)  3/39 (7.69%)  4/39 (10.26%)  5/35 (14.29%) 
PAIN OF SKIN  1  0/482 (0.00%)  1/484 (0.21%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/39 (2.56%)  0/35 (0.00%) 
PRURITUS  1  20/482 (4.15%)  12/484 (2.48%)  12/203 (5.91%)  13/217 (5.99%)  17/205 (8.29%)  6/217 (2.76%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  1/39 (2.56%)  2/39 (5.13%)  1/35 (2.86%) 
PSORIASIS  1  1/482 (0.21%)  7/484 (1.45%)  0/203 (0.00%)  3/217 (1.38%)  1/205 (0.49%)  6/217 (2.76%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  1/39 (2.56%)  1/39 (2.56%)  0/35 (0.00%) 
PUSTULAR PSORIASIS  1  0/482 (0.00%)  1/484 (0.21%)  0/203 (0.00%)  1/217 (0.46%)  0/205 (0.00%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  2/39 (5.13%)  0/39 (0.00%)  2/35 (5.71%) 
SEBORRHOEIC DERMATITIS  1  4/482 (0.83%)  2/484 (0.41%)  5/203 (2.46%)  6/217 (2.76%)  3/205 (1.46%)  1/217 (0.46%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
SKIN LESION  1  0/482 (0.00%)  0/484 (0.00%)  0/203 (0.00%)  0/217 (0.00%)  0/205 (0.00%)  0/217 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  1/39 (2.56%)  0/39 (0.00%)  0/35 (0.00%) 
URTICARIA  1  3/482 (0.62%)  4/484 (0.83%)  6/203 (2.96%)  2/217 (0.92%)  1/205 (0.49%)  4/217 (1.84%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Vascular disorders                         
HYPERTENSION  1  11/482 (2.28%)  11/484 (2.27%)  9/203 (4.43%)  17/217 (7.83%)  9/205 (4.39%)  12/217 (5.53%)  0/27 (0.00%)  0/23 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/35 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
A limitation of this study is the lack of a placebo group; however, because the placebo response is very low in psoriasis, it is inappropriate to maintain patients on placebo for 52 weeks. .
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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
Results Point of Contact
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Name/Title: Study Director
Organization: Novartis Pharmaceutical
Phone: 862-778-8300
EMail: trialandresults.registries@novartis.com
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Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01406938    
Other Study ID Numbers: CAIN457A2304
2011-000767-27 ( EudraCT Number )
First Submitted: July 12, 2011
First Posted: August 1, 2011
Results First Submitted: February 13, 2015
Results First Posted: May 19, 2015
Last Update Posted: May 19, 2015