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4 Year Extension Study of Efficacy and Safety of Secukinumab in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01640951
Recruitment Status : Completed
First Posted : July 16, 2012
Results First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Moderate to Severe Chronic Plaque-Type Psoriasis
Interventions Drug: AIN457 150 mg
Drug: AIN457 300 mg
Drug: Placebo
Enrollment 675
Recruitment Details 675 subjects from the core studies (CAIN457A2304 and CAIN457A2307) were enrolled at 112 sites. Subjects enrolled in the secukinumab 300 mg Open-Label (OL) arm came only from the CAIN457A2307 study, as such they were partial responders at Week 12, while all other subjects in the extension were PASI 75 responders at Week 12 in the core study.
Pre-assignment Details At Week 156, subjects who rolled over from the CAIN457A2304 study were unblinded and provided an option to switch to one of the treatment options described below upon investigator judgment; subjects from the CAIN457A2307 study could administer study drug at home every 4 weeks, but were required to come for office visits every 12-16 weeks.
Arm/Group Title AIN150FI AIN150 FI_AIN300 FI AIN300 FI AIN150 SoR AIN150 SOR_AIN300 FI AIN300 SoR AIN300 SoR _ AIN300 FI AIN300 OL
Hide Arm/Group Description AIN457 150 mg - Fixed Interval (FI) AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW) AIN457 300 mg - Fixed Interval (FI) AIN457 150 mg - Start of Relapse (SoR) AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW) AIN457 300 mg - Start of Relapse (SoR) AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW) AIN457 300 mg Open-label (OL)
Period Title: Overall Study
Started [1] 77 75 168 55 95 60 112 33
Completed 31 60 126 10 82 13 94 17
Not Completed 46 15 42 45 13 47 18 16
Reason Not Completed
Adverse Event             8             3             10             6             1             11             1             3
Lack of Efficacy             20             1             7             14             0             6             5             6
Lost to Follow-up             1             0             6             2             2             3             1             1
Non-compliance with study treatment             0             0             1             1             1             4             1             0
Physician Decision             2             5             2             2             2             3             3             0
Pregnancy             3             0             0             4             0             0             2             0
Protocol Deviation             0             1             2             1             0             1             0             0
Subject/Guardian decision             12             4             13             15             7             19             5             4
Death             0             1             1             0             0             0             0             2
[1]
All randomized patients (Full Analysis Set and Safety Set)
Arm/Group Title AIN150FI AIN150 FI_AIN300 FI AIN300 FI AIN150 SoR AIN150 SOR_AIN300 FI AIN300 SoR AIN300 SoR _ AIN300 FI AIN300 OL Total
Hide Arm/Group Description AIN457 150 mg - Fixed Interval (FI) AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW) AIN457 300 mg - Fixed Interval (FI) AIN457 150 mg - Start of Relapse (SoR) AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW) AIN457 300 mg - Start of Relapse (SoR) AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW) AIN457 300 mg Open-label (OL) Total of all reporting groups
Overall Number of Baseline Participants 77 75 168 55 95 60 112 33 675
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 77 participants 75 participants 168 participants 55 participants 95 participants 60 participants 112 participants 33 participants 675 participants
42.3  (13.24) 46.0  (12.03) 48.5  (12.54) 42.7  (12.23) 48.0  (12.13) 45.2  (12.08) 44.6  (13.09) 46.5  (13.99) 45.9  (12.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 75 participants 168 participants 55 participants 95 participants 60 participants 112 participants 33 participants 675 participants
Female
38
  49.4%
25
  33.3%
50
  29.8%
25
  45.5%
28
  29.5%
18
  30.0%
35
  31.3%
12
  36.4%
231
  34.2%
Male
39
  50.6%
50
  66.7%
118
  70.2%
30
  54.5%
67
  70.5%
42
  70.0%
77
  68.8%
21
  63.6%
444
  65.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 75 participants 168 participants 55 participants 95 participants 60 participants 112 participants 33 participants 675 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
2
   1.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.3%
Asian
13
  16.9%
14
  18.7%
31
  18.5%
5
   9.1%
21
  22.1%
9
  15.0%
26
  23.2%
4
  12.1%
123
  18.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
1
   0.1%
Black or African American
2
   2.6%
1
   1.3%
2
   1.2%
0
   0.0%
3
   3.2%
3
   5.0%
1
   0.9%
0
   0.0%
12
   1.8%
White
62
  80.5%
60
  80.0%
132
  78.6%
48
  87.3%
68
  71.6%
45
  75.0%
84
  75.0%
29
  87.9%
528
  78.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   0.6%
2
   3.6%
3
   3.2%
2
   3.3%
1
   0.9%
0
   0.0%
9
   1.3%
1.Primary Outcome
Title Long-term Safety and Tolerability of Secukinumab
Hide Description Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC)
Time Frame Week 268
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set. All subjects who took at least one dose of study treatment during the extension treatment period. A subject with multiple adverse events within a primary system organ class was counted only once in the total row. Deaths up to 28 days after the last dose are included. Only descriptive analysis done.
Arm/Group Title AIN150FI AIN150 FI_AIN300 FI AIN300 FI AIN150 SoR AIN150 SOR_AIN300 FI AIN300 SoR AIN300 SoR _ AIN300 FI AIN300 OL
Hide Arm/Group Description:
AIN457 150 mg - Fixed Interval (FI)
AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
AIN457 300 mg - Fixed Interval (FI)
AIN457 150 mg - Start of Relapse (SoR)
AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
AIN457 300 mg - Start of Relapse (SoR)
AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
AIN457 300 mg Open-label (OL)
Overall Number of Participants Analyzed 77 75 168 55 95 60 112 33
Measure Type: Number
Unit of Measure: Percentage of participants
AEs by Primary System Organ Class (SOC) 88.3 92.0 92.9 78.2 87.4 80.0 94.6 93.9
SAEs by Primary System Organ Class (SOC) 20.8 24.0 23.8 16.4 20.0 18.3 17.0 36.4
Deaths by Primary System Organ Class (SOC) 0.0 1.3 0.6 0.0 0.0 0.0 0.0 6.1
2.Secondary Outcome
Title Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Score of 75 at Weeks 52, 104, 156, 208 and 260
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 52, Week 104, Week 156, Week 208, Week 260
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.
Arm/Group Title AIN150FI AIN150 FI_AIN300 FI AIN150FI (NSW+SW) AIN300 FI AIN150 SoR AIN150 SOR_AIN300 FI AIN300 SoR AIN300 SoR _ AIN300 FI AIN300 OL
Hide Arm/Group Description:
AIN457 150 mg - Fixed Interval (FI)
AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
AIN457 150 mg - Fixed Interval combined non-switch and switch
AIN457 300 mg - Fixed Interval (FI)
AIN457 150 mg - Start of Relapse (SoR)
AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
AIN457 300 mg - Start of Relapse (SoR)
AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
AIN457 300 mg Open-label (OL)
Overall Number of Participants Analyzed 77 75 152 168 55 95 60 112 33
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 52 Number Analyzed 76 participants 75 participants 151 participants 162 participants 55 participants 95 participants 58 participants 111 participants 33 participants
69.7 65.3 67.5 88.9 38.2 38.9 51.7 39.6 63.6
Week 104 Number Analyzed 60 participants 73 participants 133 participants 152 participants 30 participants 94 participants 34 participants 110 participants 30 participants
63.3 54.8 58.6 80.9 40.0 39.4 55.9 44.5 63.3
Week 156 Number Analyzed 40 participants 75 participants 115 participants 139 participants 16 participants 94 participants 20 participants 111 participants 21 participants
85.0 49.3 61.7 78.4 62.5 35.1 65.0 41.4 57.1
Week 208 Number Analyzed 35 participants 69 participants 104 participants 132 participants 11 participants 87 participants 12 participants 100 participants 21 participants
80.0 78.3 78.8 87.9 63.6 87.4 41.7 79.0 61.9
Week 260 Number Analyzed 29 participants 56 participants 85 participants 122 participants 10 participants 79 participants 13 participants 87 participants 16 participants
89.7 71.4 77.6 88.5 50.0 86.1 53.8 81.6 75.0
3.Secondary Outcome
Title Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260
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 52, Week 104, Week 156, Week 208, Week 260
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.
Arm/Group Title AIN150FI AIN150 FI_AIN300 FI AIN150FI (NSW+SW) AIN300 FI AIN150 SoR AIN150 SOR_AIN300 FI AIN300 SoR AIN300 SoR _ AIN300 FI AIN300 OL
Hide Arm/Group Description:
AIN457 150 mg - Fixed Interval (FI)
AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
AIN457 150 mg - Fixed Interval combined non-switch and switch
AIN457 300 mg - Fixed Interval (FI)
AIN457 150 mg - Start of Relapse (SoR)
AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
AIN457 300 mg - Start of Relapse (SoR)
AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
AIN457 300 mg Open-label (OL)
Overall Number of Participants Analyzed 77 75 152 168 55 95 60 112 33
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 52 / PASI 50 Number Analyzed 76 participants 75 participants 151 participants 162 participants 55 participants 95 participants 58 participants 111 participants 33 participants
89.5 98.7 94.0 98.8 80.0 86.3 91.4 88.3 93.9
Week 52 / PASI 90 Number Analyzed 76 participants 75 participants 151 participants 162 participants 55 participants 95 participants 58 participants 111 participants 33 participants
61.8 38.7 50.3 68.5 12.7 11.6 19.0 12.6 39.4
Week 52 / PASI 100 Number Analyzed 76 participants 75 participants 151 participants 162 participants 55 participants 95 participants 58 participants 111 participants 33 participants
31.6 16.0 23.8 43.8 3.6 2.1 8.6 3.6 9.1
Week 104 / PASI 50 Number Analyzed 60 participants 73 participants 133 participants 152 participants 30 participants 94 participants 34 participants 110 participants 30 participants
88.3 84.9 86.5 96.7 80.0 87.2 88.2 85.5 86.7
Week 104 / PASI 90 Number Analyzed 60 participants 73 participants 133 participants 152 participants 30 participants 94 participants 34 participants 110 participants 30 participants
46.7 23.3 33.8 64.5 16.7 9.6 14.7 18.2 26.7
Week 104 / PASI 100 Number Analyzed 60 participants 73 participants 133 participants 152 participants 30 participants 94 participants 34 participants 110 participants 30 participants
28.3 6.8 16.5 43.4 10.0 1.1 5.9 4.5 13.3
Week 156 / PASI 50 Number Analyzed 40 participants 75 participants 115 participants 139 participants 16 participants 94 participants 20 participants 111 participants 21 participants
100.0 86.7 91.3 97.1 93.8 88.3 85.0 90.1 90.5
Week 156 / PASI 90 Number Analyzed 40 participants 75 participants 115 participants 139 participants 16 participants 94 participants 20 participants 111 participants 21 participants
60.0 17.3 32.2 61.9 31.3 10.6 30.0 10.8 28.6
Week 156 / PASI 100 Number Analyzed 40 participants 75 participants 115 participants 139 participants 16 participants 94 participants 20 participants 111 participants 21 participants
45.0 8.0 20.9 41.7 6.3 4.3 0.0 3.6 19.0
Week 208 / PASI 50 Number Analyzed 35 participants 69 participants 104 participants 132 participants 11 participants 87 participants 12 participants 100 participants 21 participants
100.0 97.1 98.1 97.0 72.7 98.9 100.0 95.0 95.2
Week 208 / PASI 90 Number Analyzed 35 participants 69 participants 104 participants 132 participants 11 participants 87 participants 12 participants 100 participants 21 participants
51.4 49.3 50.0 65.9 27.3 64.4 16.7 53.0 23.8
Week 208 / PASI 100 Number Analyzed 35 participants 69 participants 104 participants 132 participants 11 participants 87 participants 12 participants 100 participants 21 participants
28.6 20.3 23.1 43.2 9.1 23.0 0.0 24.0 23.8
Week 260 / PASI 50 Number Analyzed 29 participants 56 participants 85 participants 122 participants 10 participants 79 participants 13 participants 87 participants 16 participants
100.0 96.4 97.6 97.5 100.0 97.5 100.0 93.1 87.5
Week 260 / PASI 90 Number Analyzed 29 participants 56 participants 85 participants 122 participants 10 participants 79 participants 13 participants 87 participants 16 participants
51.7 46.4 48.2 66.4 30.0 57.0 7.7 54.0 43.8
Week 260 / PASI 100 Number Analyzed 29 participants 56 participants 85 participants 122 participants 10 participants 79 participants 13 participants 87 participants 16 participants
31.0 17.9 22.4 41.0 10.0 29.1 7.7 18.4 25.0
4.Secondary Outcome
Title Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 52, 104, 156, 208 and 260
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 Baseline, Week 52, Week 104, Week 156, Week 208, Week 260
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.
Arm/Group Title AIN150FI AIN150 FI_AIN300 FI AIN150FI (NSW+SW) AIN300 FI AIN150 SoR AIN150 SOR_AIN300 FI AIN300 SoR AIN300 SoR _ AIN300 FI AIN300 OL
Hide Arm/Group Description:
AIN457 150 mg - Fixed Interval (FI)
AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
AIN457 150 mg - Fixed Interval combined non-switch and switch
AIN457 300 mg - Fixed Interval (FI)
AIN457 150 mg - Start of Relapse (SoR)
AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
AIN457 300 mg - Start of Relapse (SoR)
AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
AIN457 300 mg Open-label (OL)
Overall Number of Participants Analyzed 77 75 152 168 55 95 60 112 33
Mean (Standard Deviation)
Unit of Measure: Percent change
Week 52 Number Analyzed 76 participants 75 participants 151 participants 162 participants 55 participants 95 participants 58 participants 111 participants 33 participants
-83.54  (21.744) -81.47  (16.179) -82.51  (19.147) -91.14  (13.377) -65.13  (23.452) -67.91  (21.521) -75.63  (16.970) -69.13  (18.976) -79.75  (17.045)
Week 104 Number Analyzed 60 participants 73 participants 133 participants 152 participants 30 participants 94 participants 34 participants 110 participants 30 participants
-78.13  (26.278) -72.47  (24.099) -75.02  (25.168) -88.48  (16.273) -63.17  (28.596) -68.40  (18.057) -67.62  (40.039) -70.98  (19.720) -76.10  (19.342)
Week 156 Number Analyzed 40 participants 75 participants 115 participants 139 participants 16 participants 94 participants 20 participants 111 participants 21 participants
-90.27  (11.543) -71.48  (19.892) -78.02  (19.576) -88.34  (15.555) -78.97  (16.709) -68.71  (18.094) -77.40  (18.714) -69.77  (18.586) -76.12  (20.437)
Week 208 Number Analyzed 35 participants 69 participants 104 participants 132 participants 11 participants 87 participants 12 participants 100 participants 21 participants
-87.60  (12.296) -85.06  (14.082) -85.91  (13.501) -90.46  (14.116) -72.64  (24.394) -89.36  (12.978) -74.38  (13.817) -85.25  (17.018) -79.12  (16.827)
Week 260 Number Analyzed 29 participants 56 participants 85 participants 122 participants 10 participants 79 participants 13 participants 87 participants 16 participants
-88.75  (10.928) -84.10  (15.012) -85.68  (13.867) -90.06  (14.639) -76.20  (17.418) -89.40  (12.763) -78.13  (10.197) -85.48  (17.116) -81.47  (21.335)
5.Secondary Outcome
Title Percentage of Participants Achieving Investigator’s Global Assessment Modified 2011 (IGA) 2011 Score of 0 or 1 Over Time at Weeks 52, 104, 156, 208 and 260
Hide Description The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant’s disease state at the time of the assessments and does not attempt a comparison to any of the participant’s previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe). The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe.
Time Frame Week 52, Week 104, Week 156, Week 208, Week 260
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.
Arm/Group Title AIN150FI AIN150 FI_AIN300 FI AIN150FI (NSW+SW) AIN300 FI AIN150 SoR AIN150 SOR_AIN300 FI AIN300 SoR AIN300 SoR _ AIN300 FI AIN300 OL
Hide Arm/Group Description:
AIN457 150 mg - Fixed Interval (FI)
AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
AIN457 150 mg - Fixed Interval combined non-switch and switch
AIN457 300 mg - Fixed Interval (FI)
AIN457 150 mg - Start of Relapse (SoR)
AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
AIN457 300 mg - Start of Relapse (SoR)
AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
AIN457 300 mg Open-label (OL)
Overall Number of Participants Analyzed 77 75 152 168 55 95 60 112 33
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 52 / IGA 0/1 Number Analyzed 76 participants 75 participants 151 participants 165 participants 55 participants 95 participants 60 participants 111 participants 33 participants
59.2 50.7 55.0 69.1 20.0 20.0 28.3 19.8 42.4
Week 104 / IGA 0/1 Number Analyzed 60 participants 73 participants 133 participants 152 participants 30 participants 94 participants 34 participants 110 participants 30 participants
51.7 30.1 39.8 66.4 20.0 16.0 17.6 17.3 23.3
Week 156 / IGA 0/1 Number Analyzed 40 participants 75 participants 115 participants 139 participants 16 participants 94 participants 20 participants 111 participants 21 participants
62.5 21.3 35.7 56.8 37.5 14.9 25.0 15.3 28.6
Week 208 / IGA 0/1 Number Analyzed 35 participants 68 participants 103 participants 132 participants 12 participants 87 participants 12 participants 100 participants 21 participants
57.1 47.1 50.5 62.1 41.7 63.2 8.3 52.0 23.8
Week 260 / IGA 0/1 Number Analyzed 29 participants 56 participants 85 participants 120 participants 10 participants 79 participants 13 participants 87 participants 16 participants
55.2 48.2 50.6 65.0 40.0 58.2 30.8 54.0 37.5
6.Secondary Outcome
Title Percentage Change From Baseline in Dermatology Life Quality Index (DLQI©) Response at Weeks 52, 104, 156, 208 and 260
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, Week 52, Week 104, Week 156, Week 208, Week 260
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.
Arm/Group Title AIN150FI AIN150 FI_AIN300 FI AIN150FI (NSW+SW) AIN300 FI AIN150 SoR AIN150 SOR_AIN300 FI AIN300 SoR AIN300 SoR _ AIN300 FI AIN300 OL
Hide Arm/Group Description:
AIN457 150 mg - Fixed Interval (FI)
AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
AIN457 150 mg - Fixed Interval combined non-switch and switch
AIN457 300 mg - Fixed Interval (FI)
AIN457 150 mg - Start of Relapse (SoR)
AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
AIN457 300 mg - Start of Relapse (SoR)
AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
AIN457 300 mg Open-label (OL)
Overall Number of Participants Analyzed 77 75 152 168 55 95 60 112 33
Median (95% Confidence Interval)
Unit of Measure: Percent change
Week 52 Number Analyzed 77 participants 74 participants 151 participants 164 participants 54 participants 95 participants 60 participants 108 participants 33 participants
-77.3
(-87.5 to -68.3)
-85.7
(-90.0 to -77.8)
-81.8
(-87.5 to -75.0)
-93.3
(-95.5 to -90.3)
-65.0
(-74.7 to -55.6)
-68.2
(-75.0 to -61.0)
-66.7
(-75.0 to -52.9)
-72.8
(-79.0 to -65.0)
-79.2
(-89.6 to -65.0)
Week 104 Number Analyzed 66 participants 71 participants 137 participants 152 participants 33 participants 91 participants 40 participants 103 participants 29 participants
-70.8
(-83.3 to -63.3)
-73.8
(-80.4 to -65.9)
-73.3
(-78.1 to -67.3)
-87.5
(-93.3 to -83.3)
-71.9
(-80.2 to -58.6)
-63.6
(-70.8 to -56.3)
-68.8
(-78.9 to -51.8)
-74.9
(-81.2 to -66.7)
-77.2
(-88.9 to -62.0)
Week 156 Number Analyzed 39 participants 74 participants 113 participants 137 participants 15 participants 93 participants 21 participants 107 participants 22 participants
-89.3
(-97.4 to -81.0)
-67.9
(-75.0 to -60.0)
-75.0
(-80.0 to -69.3)
-91.7
(-93.8 to -86.4)
-79.6
(-91.7 to -58.3)
-60.6
(-67.7 to -53.3)
-73.9
(-84.6 to -62.5)
-66.7
(-74.2 to -59.4)
-80.0
(-90.5 to -61.5)
Week 208 Number Analyzed 37 participants 69 participants 106 participants 131 participants 12 participants 88 participants 14 participants 98 participants 21 participants
-87.5
(-97.4 to -82.1)
-81.3
(-88.9 to -72.4)
-83.3
(-89.3 to -78.2)
-92.1
(-96.0 to -88.3)
-75.0
(-86.1 to -56.5)
-85.7
(-90.5 to -80.1)
-74.1
(-85.6 to -55.4)
-84.6
(-88.1 to -78.9)
-81.7
(-90.5 to -66.7)
Week 260 Number Analyzed 29 participants 56 participants 85 participants 118 participants 9 participants 79 participants 13 participants 85 participants 16 participants
-90.9
(-95.5 to -76.2)
-84.8
(-91.7 to -76.2)
-86.1
(-91.7 to -78.3)
-92.3
(-95.0 to -83.3)
-75.0
(-100.0 to -44.9)
-82.3
(-90.6 to -74.3)
-63.9
(-78.4 to -44.4)
-83.3
(-89.1 to -76.2)
-80.0
(-95.0 to -59.3)
7.Secondary Outcome
Title Percentage of Participants With Dermatology Life Quality Index (DLQI©) Response (DLQI 0 or 1) Over Time at Weeks 52, 104, 156, 208 and 260
Hide Description The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Time Frame Week 52, Week 104, Week 156, Week 208, Week 260
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.
Arm/Group Title AIN150FI AIN150 FI_AIN300 FI AIN150FI (NSW+SW) AIN300 FI AIN150 SoR AIN150 SOR_AIN300 FI AIN300 SoR AIN300 SoR _ AIN300 FI AIN300 OL
Hide Arm/Group Description:
AIN457 150 mg - Fixed Interval (FI)
AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
AIN457 150 mg - Fixed Interval combined non-switch and switch
AIN457 300 mg - Fixed Interval (FI)
AIN457 150 mg - Start of Relapse (SoR)
AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
AIN457 300 mg - Start of Relapse (SoR)
AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
AIN457 300 mg Open-label (OL)
Overall Number of Participants Analyzed 77 75 152 168 55 95 60 112 33
Measure Type: Number
Unit of Measure: Percentage of participants
Week 52 Number Analyzed 77 participants 75 participants 152 participants 165 participants 55 participants 95 participants 60 participants 111 participants 33 participants
59.7 57.3 58.6 72.7 32.7 34.7 28.3 41.4 54.5
Week 104 Number Analyzed 66 participants 72 participants 138 participants 153 participants 34 participants 91 participants 40 participants 106 participants 30 participants
54.5 47.2 50.7 64.7 41.2 33.0 32.5 41.5 36.7
Week 156 Number Analyzed 39 participants 75 participants 114 participants 138 participants 16 participants 93 participants 21 participants 109 participants 22 participants
66.7 37.3 47.4 67.4 43.8 35.5 38.1 38.5 50.0
Week 208 Number Analyzed 37 participants 70 participants 107 participants 132 participants 13 participants 88 participants 14 participants 100 participants 21 participants
62.2 52.9 56.1 70.5 30.8 62.5 42.9 59.0 52.4
Week 260 Number Analyzed 29 participants 57 participants 86 participants 119 participants 10 participants 79 participants 13 participants 87 participants 16 participants
55.2 54.4 54.7 65.5 60.0 55.7 15.6 56.3 50.0
8.Secondary Outcome
Title EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D©) Score and Percent Change From Baseline at Weeks 52, 104 and 156
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, Week 52, Week 104, Week 156
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.
Arm/Group Title AIN150FI AIN150 FI_AIN300 FI AIN150FI (NSW+SW) AIN300 FI AIN150 SoR AIN150 SOR_AIN300 FI AIN300 SoR AIN300 SoR _ AIN300 FI AIN300 OL
Hide Arm/Group Description:
AIN457 150 mg - Fixed Interval (FI)
AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
AIN457 150 mg - Fixed Interval combined non-switch and switch
AIN457 300 mg - Fixed Interval (FI)
AIN457 150 mg - Start of Relapse (SoR)
AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
AIN457 300 mg - Start of Relapse (SoR)
AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
AIN457 300 mg Open-label (OL)
Overall Number of Participants Analyzed 77 75 152 168 55 95 60 112 33
Mean (Standard Deviation)
Unit of Measure: Percent change
Week 52 Number Analyzed 76 participants 75 participants 151 participants 165 participants 54 participants 93 participants 58 participants 110 participants 33 participants
68.8  (137.47) 57.0  (137.79) 63.0  (137.30) 115.8  (666.41) 40.2  (94.91) 76.9  (222.97) 41.3  (140.42) 98.8  (359.93) 60.9  (74.18)
Week 104 Number Analyzed 65 participants 72 participants 137 participants 153 participants 33 participants 89 participants 40 participants 106 participants 30 participants
58.6  (122.96) 62.4  (156.21) 60.6  (140.91) 118.5  (689.52) 29.5  (70.63) 152.9  (902.21) 46.7  (142.85) 77.2  (150.86) 54.3  (84.82)
Week 156 Number Analyzed 39 participants 75 participants 114 participants 138 participants 14 participants 91 participants 21 participants 107 participants 22 participants
61.0  (114.81) 52.1  (115.04) 55.2  (114.53) 125.3  (677.23) 45.1  (102.64) 140.3  (778.86) 13.7  (25.16) 109.5  (373.51) 68.1  (96.22)
9.Secondary Outcome
Title Number of Participants With Treatment Emergent Anti-drug Antibodies (ADA)
Hide Description The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment.
Time Frame Week 268
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only descriptive analysis done.
Arm/Group Title AIN150FI AIN150 FI_AIN300 FI AIN300 FI AIN150 SoR AIN150 SOR_AIN300 FI AIN300 SoR AIN300 SoR _ AIN300 FI AIN300 OL
Hide Arm/Group Description:
AIN457 150 mg - Fixed Interval (FI)
AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
AIN457 300 mg - Fixed Interval (FI)
AIN457 150 mg - Start of Relapse (SoR)
AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
AIN457 300 mg - Start of Relapse (SoR)
AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
AIN457 300 mg Open-label (OL)
Overall Number of Participants Analyzed 77 75 168 55 95 60 112 33
Measure Type: Number
Unit of Measure: Participants
2 1 3 0 4 0 4 2
10.Secondary Outcome
Title Percentage of Patients With Experiencing a Relapse
Hide Description

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 260
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.
Arm/Group Title AIN150FI AIN150 FI_AIN300 FI AIN300 FI AIN150 SoR AIN150 SOR_AIN300 FI AIN300 SoR AIN300 SoR _ AIN300 FI AIN300 OL
Hide Arm/Group Description:
AIN457 150 mg - Fixed Interval (FI)
AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
AIN457 300 mg - Fixed Interval (FI)
AIN457 150 mg - Start of Relapse (SoR)
AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
AIN457 300 mg - Start of Relapse (SoR)
AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
AIN457 300 mg Open-label (OL)
Overall Number of Participants Analyzed 77 75 168 55 95 60 112 33
Measure Type: Number
Unit of Measure: Percentage of Participants
31.2 40.0 19.6 61.8 52.6 43.3 56.3 36.4
11.Secondary Outcome
Title Percentage of Patients With Experiencing a Rebound
Hide Description

Rebound of disease is defined as a worsening of PASI of > 125% of the value at baseline (core study), or new pustular, erythrodermic or more inflammatory psoriasis occurring within 8 weeks of stopping therapy (i.e., if this definition was fulfilled at more than 8 weeks after last study treatment administration, this was defined as rebound like event).

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 Up to Week 264 (8 weeks post last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.
Arm/Group Title AIN150FI AIN150 FI_AIN300 FI AIN300 FI AIN150 SoR AIN150 SOR_AIN300 FI AIN300 SoR AIN300 SoR _ AIN300 FI AIN300 OL
Hide Arm/Group Description:
AIN457 150 mg - Fixed Interval (FI)
AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
AIN457 300 mg - Fixed Interval (FI)
AIN457 150 mg - Start of Relapse (SoR)
AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
AIN457 300 mg - Start of Relapse (SoR)
AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)
AIN457 300 mg Open-label (OL)
Overall Number of Participants Analyzed 77 75 168 55 95 60 112 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
11.5
(5.1 to 22.8)
5.8
(1.9 to 14.9)
5.0
(2.2 to 10.3)
9.4
(2.5 to 26.2)
1.1
(0.1 to 7.0)
6.9
(1.2 to 24.2)
10.6
(5.7 to 18.5)
13.0
(3.4 to 34.7)
Time Frame Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months.
Adverse Event Reporting Description Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
 
Arm/Group Title Any AIN457 150 mg Any AIN457 300 mg Any AIN457 Dose
Hide Arm/Group Description Any AIN457 150 mg Any AIN457 300 mg Any AIN457 dose
All-Cause Mortality
Any AIN457 150 mg Any AIN457 300 mg Any AIN457 Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/132 (0.00%)   4/543 (0.74%)   4/675 (0.59%) 
Show Serious Adverse Events Hide Serious Adverse Events
Any AIN457 150 mg Any AIN457 300 mg Any AIN457 Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/132 (18.94%)   119/543 (21.92%)   144/675 (21.33%) 
Blood and lymphatic system disorders       
AUTOIMMUNE HAEMOLYTIC ANAEMIA  1  1/132 (0.76%)  0/543 (0.00%)  1/675 (0.15%) 
LYMPHOID TISSUE HYPERPLASIA  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
Cardiac disorders       
ACUTE MYOCARDIAL INFARCTION  1  0/132 (0.00%)  3/543 (0.55%)  3/675 (0.44%) 
ANGINA UNSTABLE  1  0/132 (0.00%)  2/543 (0.37%)  2/675 (0.30%) 
AORTIC VALVE DISEASE  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
ARRHYTHMIA  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
ARRHYTHMIA SUPRAVENTRICULAR  1  1/132 (0.76%)  0/543 (0.00%)  1/675 (0.15%) 
ATRIAL FIBRILLATION  1  1/132 (0.76%)  4/543 (0.74%)  5/675 (0.74%) 
ATRIAL FLUTTER  1  1/132 (0.76%)  0/543 (0.00%)  1/675 (0.15%) 
ATRIOVENTRICULAR BLOCK COMPLETE  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
BRADYCARDIA  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
BUNDLE BRANCH BLOCK LEFT  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
CARDIAC FAILURE ACUTE  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
CARDIAC FAILURE CHRONIC  1  0/132 (0.00%)  2/543 (0.37%)  2/675 (0.30%) 
CONGESTIVE CARDIOMYOPATHY  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
CORONARY ARTERY DISEASE  1  0/132 (0.00%)  2/543 (0.37%)  2/675 (0.30%) 
CORONARY ARTERY OCCLUSION  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
CORONARY OSTIAL STENOSIS  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
LEFT VENTRICULAR DYSFUNCTION  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
LONG QT SYNDROME  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
MYOCARDIAL INFARCTION  1  0/132 (0.00%)  2/543 (0.37%)  2/675 (0.30%) 
MYOCARDIAL ISCHAEMIA  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
MYOCARDITIS  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
TACHYCARDIA  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
Ear and labyrinth disorders       
VESTIBULAR DISORDER  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
Gastrointestinal disorders       
ABDOMINAL PAIN  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
ABDOMINAL PAIN UPPER  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
ANAL INCONTINENCE  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
GASTRIC ULCER HAEMORRHAGE  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
GASTRITIS  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
INTESTINAL OBSTRUCTION  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
LARGE INTESTINE POLYP  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
LEUKOPLAKIA ORAL  1  1/132 (0.76%)  0/543 (0.00%)  1/675 (0.15%) 
PANCREATITIS ACUTE  1  0/132 (0.00%)  2/543 (0.37%)  2/675 (0.30%) 
TOOTHACHE  1  1/132 (0.76%)  0/543 (0.00%)  1/675 (0.15%) 
UMBILICAL HERNIA  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
General disorders       
NON-CARDIAC CHEST PAIN  1  0/132 (0.00%)  3/543 (0.55%)  3/675 (0.44%) 
PERIPHERAL SWELLING  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
PYREXIA  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
Hepatobiliary disorders       
CHOLECYSTITIS ACUTE  1  3/132 (2.27%)  0/543 (0.00%)  3/675 (0.44%) 
CHOLELITHIASIS  1  0/132 (0.00%)  2/543 (0.37%)  2/675 (0.30%) 
HEPATIC CIRRHOSIS  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
HEPATIC STEATOSIS  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
HEPATITIS ALCOHOLIC  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
Infections and infestations       
ACUTE HEPATITIS B  1  1/132 (0.76%)  0/543 (0.00%)  1/675 (0.15%) 
ACUTE SINUSITIS  1  1/132 (0.76%)  0/543 (0.00%)  1/675 (0.15%) 
ANAL ABSCESS  1  1/132 (0.76%)  0/543 (0.00%)  1/675 (0.15%) 
APPENDICITIS  1  0/132 (0.00%)  2/543 (0.37%)  2/675 (0.30%) 
BURSITIS INFECTIVE STAPHYLOCOCCAL  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
CELLULITIS  1  0/132 (0.00%)  2/543 (0.37%)  2/675 (0.30%) 
CHRONIC TONSILLITIS  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
CLOSTRIDIUM DIFFICILE COLITIS  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
CYSTITIS  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
EPIDIDYMITIS  1  1/132 (0.76%)  0/543 (0.00%)  1/675 (0.15%) 
ERYSIPELAS  1  0/132 (0.00%)  3/543 (0.55%)  3/675 (0.44%) 
GASTROINTESTINAL INFECTION  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
HERPES ZOSTER  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
MENINGITIS STREPTOCOCCAL  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
ORCHITIS  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
OSTEOMYELITIS BACTERIAL  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
PERITONSILLITIS  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
PNEUMONIA  1  0/132 (0.00%)  6/543 (1.10%)  6/675 (0.89%) 
SEPSIS  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
SINUSITIS  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
STAPHYLOCOCCAL SEPSIS  1  0/132 (0.00%)  2/543 (0.37%)  2/675 (0.30%) 
URINARY TRACT INFECTION  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
URINARY TRACT INFECTION STAPHYLOCOCCAL  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
Injury, poisoning and procedural complications       
ALCOHOL POISONING  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
ANKLE FRACTURE  1  0/132 (0.00%)  3/543 (0.55%)  3/675 (0.44%) 
BRAIN CONTUSION  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
CONCUSSION  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
FACIAL BONES FRACTURE  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
FALL  1  1/132 (0.76%)  0/543 (0.00%)  1/675 (0.15%) 
FEMUR FRACTURE  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
HIP FRACTURE  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
JOINT DISLOCATION  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
LIGAMENT INJURY  1  1/132 (0.76%)  1/543 (0.18%)  2/675 (0.30%) 
LIMB CRUSHING INJURY  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
LOWER LIMB FRACTURE  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
MENISCUS INJURY  1  1/132 (0.76%)  1/543 (0.18%)  2/675 (0.30%) 
RIB FRACTURE  1  1/132 (0.76%)  0/543 (0.00%)  1/675 (0.15%) 
ROAD TRAFFIC ACCIDENT  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
SPLENIC INJURY  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
SUBARACHNOID HAEMORRHAGE  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
TENDON RUPTURE  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
TIBIA FRACTURE  1  0/132 (0.00%)  2/543 (0.37%)  2/675 (0.30%) 
UPPER LIMB FRACTURE  1  0/132 (0.00%)  3/543 (0.55%)  3/675 (0.44%) 
WRIST FRACTURE  1  0/132 (0.00%)  2/543 (0.37%)  2/675 (0.30%) 
Investigations       
ALANINE AMINOTRANSFERASE INCREASED  1  1/132 (0.76%)  2/543 (0.37%)  3/675 (0.44%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  0/132 (0.00%)  3/543 (0.55%)  3/675 (0.44%) 
BLOOD BILIRUBIN INCREASED  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  0/132 (0.00%)  2/543 (0.37%)  2/675 (0.30%) 
HEPATIC ENZYME INCREASED  1  1/132 (0.76%)  3/543 (0.55%)  4/675 (0.59%) 
LIVER FUNCTION TEST INCREASED  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
Metabolism and nutrition disorders       
DIABETES MELLITUS  1  0/132 (0.00%)  2/543 (0.37%)  2/675 (0.30%) 
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  1/132 (0.76%)  0/543 (0.00%)  1/675 (0.15%) 
FLANK PAIN  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
FOOT DEFORMITY  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
INTERVERTEBRAL DISC PROTRUSION  1  0/132 (0.00%)  3/543 (0.55%)  3/675 (0.44%) 
OSTEOARTHRITIS  1  2/132 (1.52%)  3/543 (0.55%)  5/675 (0.74%) 
PAIN IN EXTREMITY  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
PSORIATIC ARTHROPATHY  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
ROTATOR CUFF SYNDROME  1  1/132 (0.76%)  0/543 (0.00%)  1/675 (0.15%) 
SPINAL PAIN  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
TENOSYNOVITIS  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
BASAL CELL CARCINOMA  1  1/132 (0.76%)  3/543 (0.55%)  4/675 (0.59%) 
BENIGN LUNG NEOPLASM  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
BENIGN NEOPLASM OF THYROID GLAND  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
BLADDER ADENOCARCINOMA STAGE UNSPECIFIED  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
BREAST CANCER  1  1/132 (0.76%)  1/543 (0.18%)  2/675 (0.30%) 
CHOLANGIOCARCINOMA  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
COLON CANCER  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
DYSPLASTIC NAEVUS  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
ENDOMETRIAL ADENOCARCINOMA  1  1/132 (0.76%)  0/543 (0.00%)  1/675 (0.15%) 
INVASIVE DUCTAL BREAST CARCINOMA  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
MALIGNANT MELANOMA  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
PROSTATE CANCER  1  0/132 (0.00%)  2/543 (0.37%)  2/675 (0.30%) 
UTERINE LEIOMYOMA  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
Nervous system disorders       
ALTERED STATE OF CONSCIOUSNESS  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
CAROTID ARTERY STENOSIS  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
CARPAL TUNNEL SYNDROME  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
CAUDA EQUINA SYNDROME  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
CEREBROVASCULAR ACCIDENT  1  0/132 (0.00%)  2/543 (0.37%)  2/675 (0.30%) 
CERVICOBRACHIAL SYNDROME  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
CUBITAL TUNNEL SYNDROME  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
DIZZINESS  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
HEADACHE  1  0/132 (0.00%)  2/543 (0.37%)  2/675 (0.30%) 
INTRACRANIAL ANEURYSM  1  1/132 (0.76%)  0/543 (0.00%)  1/675 (0.15%) 
METABOLIC ENCEPHALOPATHY  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
NERVE COMPRESSION  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
PERONEAL NERVE PALSY  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
SCIATICA  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
SYNCOPE  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
TRANSIENT ISCHAEMIC ATTACK  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
Product Issues       
DEVICE MALFUNCTION  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
Psychiatric disorders       
ADJUSTMENT DISORDER  1  1/132 (0.76%)  0/543 (0.00%)  1/675 (0.15%) 
DELIRIUM  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
DEPRESSION  1  1/132 (0.76%)  1/543 (0.18%)  2/675 (0.30%) 
SUICIDE ATTEMPT  1  0/132 (0.00%)  2/543 (0.37%)  2/675 (0.30%) 
Renal and urinary disorders       
ACUTE KIDNEY INJURY  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
NEPHROLITHIASIS  1  1/132 (0.76%)  1/543 (0.18%)  2/675 (0.30%) 
RENAL INFARCT  1  1/132 (0.76%)  0/543 (0.00%)  1/675 (0.15%) 
RENAL INJURY  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
RENAL TUBULAR NECROSIS  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
URETEROLITHIASIS  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
URINARY INCONTINENCE  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
URINARY RETENTION  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
Reproductive system and breast disorders       
ENDOMETRIOSIS  1  1/132 (0.76%)  0/543 (0.00%)  1/675 (0.15%) 
MENOMETRORRHAGIA  1  1/132 (0.76%)  0/543 (0.00%)  1/675 (0.15%) 
PROSTATOMEGALY  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
UTERINE POLYP  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
VULVA CYST  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
Respiratory, thoracic and mediastinal disorders       
ACUTE RESPIRATORY FAILURE  1  0/132 (0.00%)  2/543 (0.37%)  2/675 (0.30%) 
LUNG DISORDER  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
PNEUMOTHORAX  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
PULMONARY CAVITATION  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
PULMONARY EMBOLISM  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
RESPIRATORY SYMPTOM  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
THORACIC HAEMORRHAGE  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
Skin and subcutaneous tissue disorders       
DERMAL CYST  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
DERMATITIS ALLERGIC  1  1/132 (0.76%)  0/543 (0.00%)  1/675 (0.15%) 
PSORIASIS  1  0/132 (0.00%)  3/543 (0.55%)  3/675 (0.44%) 
Social circumstances       
ALCOHOL USE  1  1/132 (0.76%)  0/543 (0.00%)  1/675 (0.15%) 
Vascular disorders       
AORTIC DILATATION  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
HYPERTENSION  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
PERIPHERAL ARTERY STENOSIS  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
VARICOSE VEIN  1  0/132 (0.00%)  1/543 (0.18%)  1/675 (0.15%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Any AIN457 150 mg Any AIN457 300 mg Any AIN457 Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   93/132 (70.45%)   449/543 (82.69%)   542/675 (80.30%) 
Cardiac disorders       
TACHYCARDIA  1  3/132 (2.27%)  1/543 (0.18%)  4/675 (0.59%) 
Endocrine disorders       
HYPERTHYROIDISM  1  3/132 (2.27%)  0/543 (0.00%)  3/675 (0.44%) 
Gastrointestinal disorders       
ABDOMINAL PAIN  1  3/132 (2.27%)  11/543 (2.03%)  14/675 (2.07%) 
DENTAL CARIES  1  1/132 (0.76%)  11/543 (2.03%)  12/675 (1.78%) 
DIARRHOEA  1  8/132 (6.06%)  32/543 (5.89%)  40/675 (5.93%) 
GASTRITIS  1  4/132 (3.03%)  13/543 (2.39%)  17/675 (2.52%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  3/132 (2.27%)  12/543 (2.21%)  15/675 (2.22%) 
NAUSEA  1  8/132 (6.06%)  9/543 (1.66%)  17/675 (2.52%) 
TOOTHACHE  1  5/132 (3.79%)  21/543 (3.87%)  26/675 (3.85%) 
VOMITING  1  1/132 (0.76%)  16/543 (2.95%)  17/675 (2.52%) 
General disorders       
FATIGUE  1  5/132 (3.79%)  16/543 (2.95%)  21/675 (3.11%) 
NON-CARDIAC CHEST PAIN  1  4/132 (3.03%)  13/543 (2.39%)  17/675 (2.52%) 
OEDEMA PERIPHERAL  1  3/132 (2.27%)  17/543 (3.13%)  20/675 (2.96%) 
PYREXIA  1  3/132 (2.27%)  14/543 (2.58%)  17/675 (2.52%) 
Hepatobiliary disorders       
HEPATIC STEATOSIS  1  3/132 (2.27%)  9/543 (1.66%)  12/675 (1.78%) 
Immune system disorders       
SEASONAL ALLERGY  1  0/132 (0.00%)  16/543 (2.95%)  16/675 (2.37%) 
Infections and infestations       
BRONCHITIS  1  7/132 (5.30%)  51/543 (9.39%)  58/675 (8.59%) 
CELLULITIS  1  1/132 (0.76%)  15/543 (2.76%)  16/675 (2.37%) 
CONJUNCTIVITIS  1  3/132 (2.27%)  19/543 (3.50%)  22/675 (3.26%) 
FOLLICULITIS  1  3/132 (2.27%)  25/543 (4.60%)  28/675 (4.15%) 
FURUNCLE  1  2/132 (1.52%)  11/543 (2.03%)  13/675 (1.93%) 
GASTROENTERITIS  1  6/132 (4.55%)  23/543 (4.24%)  29/675 (4.30%) 
HERPES ZOSTER  1  6/132 (4.55%)  13/543 (2.39%)  19/675 (2.81%) 
INFLUENZA  1  12/132 (9.09%)  42/543 (7.73%)  54/675 (8.00%) 
NASOPHARYNGITIS  1  31/132 (23.48%)  185/543 (34.07%)  216/675 (32.00%) 
ORAL HERPES  1  1/132 (0.76%)  19/543 (3.50%)  20/675 (2.96%) 
PHARYNGITIS  1  5/132 (3.79%)  28/543 (5.16%)  33/675 (4.89%) 
RHINITIS  1  4/132 (3.03%)  22/543 (4.05%)  26/675 (3.85%) 
SINUSITIS  1  8/132 (6.06%)  30/543 (5.52%)  38/675 (5.63%) 
TINEA PEDIS  1  3/132 (2.27%)  12/543 (2.21%)  15/675 (2.22%) 
TONSILLITIS  1  5/132 (3.79%)  20/543 (3.68%)  25/675 (3.70%) 
TOOTH ABSCESS  1  2/132 (1.52%)  15/543 (2.76%)  17/675 (2.52%) 
UPPER RESPIRATORY TRACT INFECTION  1  13/132 (9.85%)  62/543 (11.42%)  75/675 (11.11%) 
URINARY TRACT INFECTION  1  4/132 (3.03%)  23/543 (4.24%)  27/675 (4.00%) 
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  0/132 (0.00%)  26/543 (4.79%)  26/675 (3.85%) 
Injury, poisoning and procedural complications       
ARTHROPOD BITE  1  1/132 (0.76%)  13/543 (2.39%)  14/675 (2.07%) 
CONTUSION  1  2/132 (1.52%)  22/543 (4.05%)  24/675 (3.56%) 
FALL  1  0/132 (0.00%)  11/543 (2.03%)  11/675 (1.63%) 
LIGAMENT SPRAIN  1  1/132 (0.76%)  12/543 (2.21%)  13/675 (1.93%) 
MUSCLE STRAIN  1  1/132 (0.76%)  19/543 (3.50%)  20/675 (2.96%) 
Investigations       
ALANINE AMINOTRANSFERASE INCREASED  1  3/132 (2.27%)  7/543 (1.29%)  10/675 (1.48%) 
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  2/132 (1.52%)  15/543 (2.76%)  17/675 (2.52%) 
HEPATIC ENZYME INCREASED  1  5/132 (3.79%)  10/543 (1.84%)  15/675 (2.22%) 
Metabolism and nutrition disorders       
DIABETES MELLITUS  1  1/132 (0.76%)  20/543 (3.68%)  21/675 (3.11%) 
DYSLIPIDAEMIA  1  3/132 (2.27%)  12/543 (2.21%)  15/675 (2.22%) 
GOUT  1  0/132 (0.00%)  11/543 (2.03%)  11/675 (1.63%) 
HYPERCHOLESTEROLAEMIA  1  1/132 (0.76%)  12/543 (2.21%)  13/675 (1.93%) 
HYPERGLYCAEMIA  1  0/132 (0.00%)  12/543 (2.21%)  12/675 (1.78%) 
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  9/132 (6.82%)  63/543 (11.60%)  72/675 (10.67%) 
BACK PAIN  1  9/132 (6.82%)  53/543 (9.76%)  62/675 (9.19%) 
BURSITIS  1  2/132 (1.52%)  11/543 (2.03%)  13/675 (1.93%) 
MUSCULOSKELETAL PAIN  1  2/132 (1.52%)  16/543 (2.95%)  18/675 (2.67%) 
MYALGIA  1  0/132 (0.00%)  15/543 (2.76%)  15/675 (2.22%) 
OSTEOARTHRITIS  1  4/132 (3.03%)  17/543 (3.13%)  21/675 (3.11%) 
PAIN IN EXTREMITY  1  8/132 (6.06%)  22/543 (4.05%)  30/675 (4.44%) 
PSORIATIC ARTHROPATHY  1  3/132 (2.27%)  20/543 (3.68%)  23/675 (3.41%) 
Nervous system disorders       
DIZZINESS  1  3/132 (2.27%)  12/543 (2.21%)  15/675 (2.22%) 
HEADACHE  1  11/132 (8.33%)  50/543 (9.21%)  61/675 (9.04%) 
Psychiatric disorders       
DEPRESSION  1  4/132 (3.03%)  13/543 (2.39%)  17/675 (2.52%) 
INSOMNIA  1  3/132 (2.27%)  14/543 (2.58%)  17/675 (2.52%) 
Renal and urinary disorders       
HAEMATURIA  1  5/132 (3.79%)  11/543 (2.03%)  16/675 (2.37%) 
Respiratory, thoracic and mediastinal disorders       
COUGH  1  4/132 (3.03%)  51/543 (9.39%)  55/675 (8.15%) 
DYSPNOEA  1  3/132 (2.27%)  6/543 (1.10%)  9/675 (1.33%) 
OROPHARYNGEAL PAIN  1  4/132 (3.03%)  31/543 (5.71%)  35/675 (5.19%) 
SINUS CONGESTION  1  0/132 (0.00%)  11/543 (2.03%)  11/675 (1.63%) 
Skin and subcutaneous tissue disorders       
ACNE  1  3/132 (2.27%)  3/543 (0.55%)  6/675 (0.89%) 
ACTINIC KERATOSIS  1  3/132 (2.27%)  6/543 (1.10%)  9/675 (1.33%) 
DERMATITIS CONTACT  1  1/132 (0.76%)  32/543 (5.89%)  33/675 (4.89%) 
ECZEMA  1  6/132 (4.55%)  25/543 (4.60%)  31/675 (4.59%) 
PRURITUS  1  9/132 (6.82%)  27/543 (4.97%)  36/675 (5.33%) 
PSORIASIS  1  7/132 (5.30%)  49/543 (9.02%)  56/675 (8.30%) 
Vascular disorders       
HYPERTENSION  1  8/132 (6.06%)  63/543 (11.60%)  71/675 (10.52%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: Novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01640951     History of Changes
Other Study ID Numbers: CAIN457A2304E1
2012-000985-39 ( EudraCT Number )
First Submitted: July 12, 2012
First Posted: July 16, 2012
Results First Submitted: April 23, 2018
Results First Posted: May 25, 2018
Last Update Posted: May 25, 2018