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Plaque Psoriasis Efficacy and Safety With Secukinumab (OPTIMISE)

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ClinicalTrials.gov Identifier: NCT02409667
Recruitment Status : Completed
First Posted : April 7, 2015
Results First Posted : May 13, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Intervention Biological: Secukinumab
Enrollment 16487
Recruitment Details  
Pre-assignment Details The screening period was up to 4 weeks and rescreening was allowed for an unlimited number of times. At the Screening Visit, every patient was registered in an Interactive Response Technology and the Investigator ensured that the patient fulfilled all the inclusion/exclusion criteria
Arm/Group Title Treatment Period 1: All Participants Treatment Period 2: Group 1 Treatment Period 2: Group 2 Treatment Period 2: Group 3 Treatment Period 2: Group 4
Hide Arm/Group Description Participants received secukinumab 300 mg subcutaneous (s.c.) every 4 weeks for 24 weeks. Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks. Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks. Participants with moderate to severe plaque psoriasis who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks. Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.
Period Title: Treatment Period 1, Baseline to Week 24
Started 1647 0 0 0 0
Completed 1526 0 0 0 0
Not Completed 121 0 0 0 0
Reason Not Completed
Withdrawal of informed consent             6             0             0             0             0
Withdrawal by Subject             6             0             0             0             0
Protocol deviation             20             0             0             0             0
Pregnancy             1             0             0             0             0
Physician Decision             4             0             0             0             0
Non-compliance with study treatment             5             0             0             0             0
Lost to Follow-up             6             0             0             0             0
Lack of Efficacy             48             0             0             0             0
Adverse Event             25             0             0             0             0
Period Title: Treatment Period 2, Week 24 to Week 52)
Started 0 644 662 114 93
Completed 0 621 641 106 90
Not Completed 0 23 21 8 3
Reason Not Completed
Lost to Follow-up             0             7             4             3             0
Lack of Efficacy             0             0             0             2             0
Adverse Event             0             7             4             1             2
Withdrawal of informed consent             0             5             4             0             0
Withdrawal by Subject             0             4             5             2             0
Pregnancy             0             0             1             0             1
Protocol deviation             0             0             3             0             0
Arm/Group Title Treatment Period 1: All Participants
Hide Arm/Group Description Participants received secukinumab 300 mg subcutaneous (s.c.) every 4 weeks for 24 weeks.
Overall Number of Baseline Participants 1647
Hide Baseline Analysis Population Description
The safety set for Treatment Period 1 includes all subjects who took at least one dose of study treatment during this treatment period.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1647 participants
43.1  (13.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1647 participants
Female
476
  28.9%
Male
1171
  71.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1647 participants
American Indian or Alaska Native
0
   0.0%
Asian
16
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
   0.2%
White
1597
  97.0%
More than one race
0
   0.0%
Unknown or Not Reported
30
   1.8%
1.Primary Outcome
Title Maintenance of PASI 90 Response at Week 52 in Participants With a PASI 90 Response at Week 24
Hide Description PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set for Treatment Period 2 of PASI 90 responders (FAS-P90R): The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
Arm/Group Title Treatment Period 2: Group 1 Treatment Period 2: Group 2
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
Overall Number of Participants Analyzed 644 662
Measure Type: Count of Participants
Unit of Measure: Participants
552
  85.7%
496
  74.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 1, Treatment Period 2: Group 2
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The statistical null-hypothesis to be rejected in the primary analysis was that the odds ratio of maintaining a PASI 90 response for patients with secukinumab 4-weekly dosing versus patients on secukinumab 6-weekly dosing exceeds the non-inferiority margin of 1+δ.
Statistical Test of Hypothesis P-Value 0.1499
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.91
Confidence Interval (2-Sided) 95%
1.44 to 2.55
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Key Secondary: PASI 90 Response Rate at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24
Hide Description PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS for Treatment Period 2 of PASI 75 responders who did not achieve a PASI 90 response (FAS-P75R): All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at the Week 24 visit, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after visit Week 24.
Arm/Group Title Treatment Period 2: Group 3 Treatment Period 2: Group 4
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.
Overall Number of Participants Analyzed 114 92
Measure Type: Count of Participants
Unit of Measure: Participants
53
  46.5%
52
  56.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 3, Treatment Period 2: Group 4
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1013
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.35 to 1.10
Estimation Comments [Not Specified]
3.Secondary Outcome
Title PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI 90 Response at Week 24
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
Only participants from the FAS-P90R with evaluable data were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
Arm/Group Title Treatment Period 2: Group 1 Treatment Period 2: Group 2
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
Overall Number of Participants Analyzed 644 662
Measure Type: Count of Participants
Unit of Measure: Participants
PASI 50 Number Analyzed 610 participants 629 participants
608
  99.7%
624
  99.2%
PASI 75 Number Analyzed 610 participants 629 participants
597
  97.9%
588
  93.5%
PASI 90 Number Analyzed 610 participants 629 participants
553
  90.7%
496
  78.9%
PASI 100 Number Analyzed 610 participants 629 participants
378
  62.0%
305
  48.5%
IGA mod 2011 Number Analyzed 609 participants 628 participants
564
  92.6%
529
  84.2%
4.Secondary Outcome
Title PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24
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
Only participants from the FAS-P75R with evaluable data were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at the Week 24 visit, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after visit Week 24.
Arm/Group Title Treatment Period 2: Group 3 Treatment Period 2: Group 4
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.
Overall Number of Participants Analyzed 104 90
Measure Type: Count of Participants
Unit of Measure: Participants
PASI 50
98
  94.2%
88
  97.8%
PASI 75
74
  71.2%
80
  88.9%
PASI 90
53
  51.0%
52
  57.8%
PASI 100
12
  11.5%
13
  14.4%
IGA mod 2011 0 or 1
64
  61.5%
72
  80.0%
5.Secondary Outcome
Title Change From Baseline in PASI in Participants With a PASI 90 Response at Week 24
Hide Description PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative change from baseline indicates improvement.
Time Frame Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants from the FAS-P90R, who had evaluable data at both baseline and the post-baseline time point, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
Arm/Group Title Treatment Period 2: Group 1 Treatment Period 2: Group 2
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
Overall Number of Participants Analyzed 644 662
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 28 Number Analyzed 642 participants 656 participants
-20.7  (8.471) -19.9  (8.511)
Week 32 Number Analyzed 638 participants 655 participants
-20.7  (8.581) -19.8  (8.474)
Week 36 Number Analyzed 638 participants 650 participants
-20.6  (8.439) -19.7  (8.563)
Week 40 Number Analyzed 632 participants 649 participants
-20.5  (8.392) -19.6  (8.393)
Week 44 Number Analyzed 623 participants 639 participants
-20.5  (8.384) -19.6  (8.484)
Week 48 Number Analyzed 625 participants 638 participants
-20.5  (8.472) -19.2  (8.509)
Week 52 Number Analyzed 610 participants 629 participants
-20.4  (8.301) -19.2  (8.513)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 1, Treatment Period 2: Group 2
Comments Week 28
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0489
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean (LSM) estimate
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.18 to -0.00
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 1, Treatment Period 2: Group 2
Comments Week 32
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1073
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.19 to 0.02
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 1, Treatment Period 2: Group 2
Comments Week 36
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.37 to -0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 1, Treatment Period 2: Group 2
Comments Week 40
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-0.38 to -0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 1, Treatment Period 2: Group 2
Comments Week 44
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value -0.30
Confidence Interval (2-Sided) 95%
-0.45 to -0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 1, Treatment Period 2: Group 2
Comments Week 48
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0000
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-0.70 to -0.27
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 1, Treatment Period 2: Group 2
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0000
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM mean
Estimated Value -0.59
Confidence Interval (2-Sided) 95%
-0.81 to -0.36
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in PASI in Participants With a PASI Response of ≥75 to <90 at Week 24
Hide Description PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative change from baseline indicates improvement.
Time Frame Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the FAS-P75R, who had evaluable data at both baseline and the post-baseline time point, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.
Arm/Group Title Treatment Period 2: Group 3 Treatment Period 2: Group 4
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.
Overall Number of Participants Analyzed 114 92
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 28 Number Analyzed 114 participants 92 participants
-16.1  (6.160) -16.3  (8.029)
Week 32 Number Analyzed 112 participants 91 participants
-15.9  (6.002) -16.6  (7.941)
Week 36 Number Analyzed 111 participants 92 participants
-16.1  (6.356) -16.6  (7.996)
Week 40 Number Analyzed 111 participants 90 participants
-16.1  (6.908) -16.8  (8.170)
Week 44 Number Analyzed 108 participants 89 participants
-16.1  (6.553) -16.6  (8.259)
Week 48 Number Analyzed 109 participants 90 participants
-15.6  (6.246) -16.8  (8.307)
Week 52 Number Analyzed 104 participants 90 participants
-15.5  (6.371) -16.6  (8.011)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 3, Treatment Period 2: Group 4
Comments Week 28
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1740
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
-0.18 to 0.99
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 3, Treatment Period 2: Group 4
Comments Week 32
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0287
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.08 to 1.50
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 3, Treatment Period 2: Group 4
Comments Week 36
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1202
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
-0.16 to 1.41
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 3, Treatment Period 2: Group 4
Comments Week 40
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1157
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
-0.19 to 1.68
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 3, Treatment Period 2: Group 4
Comments Week 44
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3189
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value 0.54
Confidence Interval (2-Sided) 95%
-0.52 to 1.59
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 3, Treatment Period 2: Group 4
Comments Week 48
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0240
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.16 to 2.18
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 3, Treatment Period 2: Group 4
Comments Week 52
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0090
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value 1.47
Confidence Interval (2-Sided) 95%
0.37 to 2.57
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in DLQI in Participants With a PASI 90 Response at Week 24
Hide Description The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
Arm/Group Title Treatment Period 2: Group 1 Treatment Period 2: Group 2
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
Overall Number of Participants Analyzed 605 624
Mean (Standard Deviation)
Unit of Measure: score on a scale
-12.7  (7.325) -11.4  (7.480)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 1, Treatment Period 2: Group 2
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-0.93 to -0.31
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in DLQI in Participants With a PASI Response of ≥75 to <90 at Week 24
Hide Description The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.
Arm/Group Title Treatment Period 2: Group 3 Treatment Period 2: Group 4
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.
Overall Number of Participants Analyzed 105 89
Mean (Standard Deviation)
Unit of Measure: score on a scale
-10.0  (6.605) -9.72  (6.880)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 3, Treatment Period 2: Group 4
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0675
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
-0.09 to 2.42
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Psoriasis (WPAI-PSO) Score in Participants With a PASI 90 Response at Week 24
Hide Description The WPAI-PSO is a self-administered questionnaire comprised of 6 questions about effects of psoriasis on the patient’s ability to work and perform regular activities based on the previous 7 days. The questionnaire quantifies the number of hours the respondent was unable to work and evaluates how much the respondent’s psoriasis affected productivity while working. For respondents who were not in paid employment, the questionnaire evaluated how much the respondent’s psoriasis affects their ability to perform regular daily activities. Four outcomes were generated from the WPAI-PSO: % Absenteeism: percent work time missed due to health; % Presenteism: percent impairment while working due to health; % Total work productivity impairment: percent overall work impairment due to health; % Total activity impairment: percent activity impairment due to health for all respondents. First 3 outcomes applied to employed participants only. A negative change from baseline indicates improvement.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
Arm/Group Title Treatment Period 2: Group 1 Treatment Period 2: Group 2
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
Overall Number of Participants Analyzed 644 662
Mean (Standard Deviation)
Unit of Measure: score on a scale
Absenteeism Number Analyzed 360 participants 356 participants
-4.70  (19.590) -1.99  (19.759)
Presenteeism Number Analyzed 361 participants 348 participants
-23.1  (25.968) -23.0  (26.522)
Total activity impairment Number Analyzed 320 participants 312 participants
-24.3  (27.850) -23.2  (29.861)
Work productivity loss Number Analyzed 546 participants 550 participants
-31.9  (29.392) -28.6  (27.996)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 1, Treatment Period 2: Group 2
Comments Absenteeism
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2101
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value -0.97
Confidence Interval (2-Sided) 95%
-2.48 to 0.55
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 1, Treatment Period 2: Group 2
Comments Presenteeism
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2971
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value -0.67
Confidence Interval (2-Sided) 95%
-1.93 to 0.59
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 1, Treatment Period 2: Group 2
Comments Total activity impairment
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5499
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-2.59 to 1.38
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 1, Treatment Period 2: Group 2
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0758
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value -1.08
Confidence Interval (2-Sided) 95%
-2.28 to 0.11
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in WPAI-PSO Score in Participants With a PASI Response of ≥75 to <90 at Week 24
Hide Description The WPAI-PSO is a self-administered questionnaire comprised of 6 questions about effects of psoriasis on the patient’s ability to work and perform regular activities based on the previous 7 days. The questionnaire quantifies the number of hours the respondent was unable to work and evaluates how much the respondent’s psoriasis affected productivity while working. For respondents who were not in paid employment, the questionnaire evaluated how much the respondent’s psoriasis affects their ability to perform regular daily activities. Four outcomes were generated from the WPAI-PSO: % Absenteeism: percent work time missed due to health; % Presenteism: percent impairment while working due to health; % Total work productivity impairment: percent overall work impairment due to health; % Total activity impairment: percent activity impairment due to health for all respondents. First 3 outcomes applied to employed participants only. A negative change from baseline indicates improvement.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.
Arm/Group Title Treatment Period 2: Group 3 Treatment Period 2: Group 4
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.
Overall Number of Participants Analyzed 114 92
Mean (Standard Deviation)
Unit of Measure: score on a scale
Absenteeism Number Analyzed 54 participants 49 participants
-2.36  (12.990) -3.45  (18.698)
Presenteeism Number Analyzed 52 participants 48 participants
-22.9  (28.377) -22.1  (26.333)
Total activity impairment Number Analyzed 46 participants 43 participants
-23.1  (28.657) -21.7  (29.905)
Work productivity loss Number Analyzed 89 participants 77 participants
-18.2  (28.824) -22.5  (25.192)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 3, Treatment Period 2: Group 4
Comments Absenteeism
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4156
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value 1.20
Confidence Interval (2-Sided) 95%
-1.71 to 4.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 3, Treatment Period 2: Group 4
Comments Presenteeism
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8619
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value 0.63
Confidence Interval (2-Sided) 95%
-6.59 to 7.85
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 3, Treatment Period 2: Group 4
Comments Total activity impairment
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6139
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-6.31 to 10.61
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 3, Treatment Period 2: Group 4
Comments Work productivity loss
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5674
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value 1.70
Confidence Interval (2-Sided) 95%
-4.16 to 7.56
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Pain, Itching and Scaling Score in Participants With a PASI 90 Response at Week 24
Hide Description Self-administered, 11-point numeric rating scales (NRS, 0-10) were used to evaluate the patients’ assessment of their current pain, itching and scaling. Respondents answered the following questions for the assessment: Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours?; Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours?; and Scaling: Overall, how severe was your psoriasis-related scaling over the past 24 hours? Patients had to rate their pain, itching, and scaling from 0 to 10 (11-point scale), with the understanding that the 0 represents the absence or null end of the pain, itching, or scale intensity (i.e. no pain, itching or scaling) and the 10 represents the other extreme of pain, itching, or scaling intensity (i.e. pain, itching or scaling as bad as it could be). The number that the patient selected represents his or her intensity score in the respective category. A negative change from baseline indicates improvement
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
Arm/Group Title Treatment Period 2: Group 1 Treatment Period 2: Group 2
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
Overall Number of Participants Analyzed 644 662
Mean (Standard Deviation)
Unit of Measure: score on a scale
Pain Number Analyzed 495 participants 478 participants
-4.56  (2.771) -4.17  (2.2727)
Itching Number Analyzed 590 participants 608 participants
-5.59  (2.885) -5.20  (2.985)
Scaling Number Analyzed 598 participants 610 participants
-6.05  (2.659) -5.73  (2.757)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 1, Treatment Period 2: Group 2
Comments Pain
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1219
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-0.30 to 0.04
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 1, Treatment Period 2: Group 2
Comments Itching
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value -0.38
Confidence Interval (2-Sided) 95%
-0.57 to -0.18
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 1, Treatment Period 2: Group 2
Comments Scaling
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value -0.31
Confidence Interval (2-Sided) 95%
-0.48 to -0.14
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Pain, Itching and Scaling Score in Participants With a PASI Response of ≥75 to <90 at Week 24
Hide Description Self-administered, 11-point numeric rating scales (NRS, 0-10) were used to evaluate the patients’ assessment of their current pain, itching and scaling. Respondents answered the following questions for the assessment: Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours?; Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours?; and Scaling: Overall, how severe was your psoriasis-related scaling over the past 24 hours? Patients had to rate their pain, itching, and scaling from 0 to 10 (11-point scale), with the understanding that the 0 represents the absence or null end of the pain, itching, or scale intensity (i.e. no pain, itching or scaling) and the 10 represents the other extreme of pain, itching, or scaling intensity (i.e. pain, itching or scaling as bad as it could be). The number that the patient selected represents his or her intensity score in the respective category. A negative change from baseline indicates improvement
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.
Arm/Group Title Treatment Period 2: Group 3 Treatment Period 2: Group 4
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.
Overall Number of Participants Analyzed 114 92
Mean (Standard Deviation)
Unit of Measure: score on a scale
Pain Number Analyzed 80 participants 68 participants
-3.59  (2.754) -3.68  (3.049)
Itching Number Analyzed 101 participants 83 participants
-4.13  (2.883) -4.49  (3.129)
Scaling Number Analyzed 102 participants 89 participants
-4.66  (2.960) -5.40  (2.899)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 3, Treatment Period 2: Group 4
Comments Pain
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6457
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
-0.57 to 0.92
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 3, Treatment Period 2: Group 4
Comments Itching
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6136
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
-0.56 to 0.94
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 3, Treatment Period 2: Group 4
Comments Scaling
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0203
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.12 to 1.39
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in the European Quality of Life - 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) in Participants With a PASI 90 Response at Week 24
Hide Description A visual analogue scale (VAS) was used within the EQ-5D. This scale recorded the respondent’s self-rated health on a vertical 20-cm VAS where the endpoints were labeled “best imaginable health state” and “worst imaginable health state.” This resulted in a numeric value set ranging from 0 (=”worst imaginable health state”) up to 100 (=”best imaginable health state”). A positive change from baseline indicates improvement.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
Arm/Group Title Treatment Period 2: Group 1 Treatment Period 2: Group 2
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
Overall Number of Participants Analyzed 603 620
Mean (Standard Deviation)
Unit of Measure: score on a scale
24.34  (23.296) 21.24  (22.074)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 1, Treatment Period 2: Group 2
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0027
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value 2.22
Confidence Interval (2-Sided) 95%
0.77 to 3.68
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in the EQ-5D VAS in Participants With a PASI Response of ≥75 to <90 at Week 24
Hide Description A visual analogue scale (VAS) was used within the EQ-5D. This scale recorded the respondent’s self-rated health on a vertical 20-cm VAS where the endpoints were labeled “best imaginable health state” and “worst imaginable health state.” This resulted in a numeric value set ranging from 0 (=”worst imaginable health state”) up to 100 (=”best imaginable health state”).
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.
Arm/Group Title Treatment Period 2: Group 3 Treatment Period 2: Group 4
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.
Overall Number of Participants Analyzed 103 88
Mean (Standard Deviation)
Unit of Measure: score on a scale
15.86  (20.099) 18.92  (19.855)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 3, Treatment Period 2: Group 4
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2823
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value -2.31
Confidence Interval (2-Sided) 95%
-6.55 to 1.92
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in the EQ-5D Utility Index (Germany, United Kingdom (UK)) in Participants With a PASI 90 Response at Week 24
Hide Description

The EQ-5D quantifies the health state of a patient for the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort & anxiety/depression. In this study the EQ-5D-5L version has been used which evaluates each of these dimensions using the following 5 labels: no problems, slight problems, moderate problems, severe problems & unable to/extreme problems. Based on the 5 dimensions, a summary score (utility index) was derived using country specific value sets evaluating the patient condition described by the outcome in the single dimensions. The EQ-5D-5L (in this trail) utility index based on the crosswalk value sets available from the EuroQol for Germany & UK (https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/) was calculated. A positive change from baseline indicates improvement.

A visual analogue scale was used within the EQ-5D measuring the health state of the patients, ranging from 0 (worst imaginable health state) up to 100 (best imaginable health state).

Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
Arm/Group Title Treatment Period 2: Group 1 Treatment Period 2: Group 2
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
Overall Number of Participants Analyzed 605 623
Mean (Standard Deviation)
Unit of Measure: score on a scale
Germany 0.17  (0.200) 0.13  (0.182)
UK 0.28  (0.250) 0.22  (0.230)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 1, Treatment Period 2: Group 2
Comments Germany
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0861
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.00 to 0.02
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 1, Treatment Period 2: Group 2
Comments UK
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0117
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
0.00 to 0.04
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in the EQ-5D Utility Index (Germany, UK) in Participants With a PASI Response of ≥75 to <90 at Week 24
Hide Description

The EQ-5D quantifies the health state of a patient for the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. In the current study the EQ-5D-5L version has been used which evaluates each of these dimensions using the following five labels: “no problems”, “slight problems”, “moderate problems”, “severe problems” and “unable to/extreme problems”.

Based on the five dimensions, a summary score (utility index) was derived using country specific value sets evaluating the patient condition described by the outcome in the single dimensions. For this trial, the EQ-5D-5L utility index based on the crosswalk value sets available from the EuroQol for Germany and for UK (https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/) was calculated.

A visual analogue scale (VAS) was used within the EQ-5D measuring the health state of the patients, ranging from 0 (=”worst imaginable health state”) up to 100 (=”best imaginable health state”).

Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.
Arm/Group Title Treatment Period 2: Group 3 Treatment Period 2: Group 4
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.
Overall Number of Participants Analyzed 103 89
Mean (Standard Deviation)
Unit of Measure: score on a scale
Germany 0.11  (0.164) 0.13  (0.164)
UK 0.18  (0.206) 0.21  (0.204)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 3, Treatment Period 2: Group 4
Comments Germany
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1852
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.05 to 0.01
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treatment Period 2: Group 3, Treatment Period 2: Group 4
Comments UK
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2203
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM estimate
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.07 to 0.02
Estimation Comments [Not Specified]
Time Frame Week 52
Adverse Event Reporting Description The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
 
Arm/Group Title Treatment Period 1: All Participants Treatment Period 2: Group 1 Treatment Period 2: Group 2 Treatment Period 2: Group 3 Treatment Period 2: Group 4
Hide Arm/Group Description Participants received secukinumab 300 mg subcutaneous (s.c.) every 4 weeks for 24 weeks. Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks. Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks. Participants with moderate to severe plaque psoriasis who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks. Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.
All-Cause Mortality
Treatment Period 1: All Participants Treatment Period 2: Group 1 Treatment Period 2: Group 2 Treatment Period 2: Group 3 Treatment Period 2: Group 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/1647 (0.06%)   0/644 (0.00%)   0/662 (0.00%)   0/114 (0.00%)   0/93 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Period 1: All Participants Treatment Period 2: Group 1 Treatment Period 2: Group 2 Treatment Period 2: Group 3 Treatment Period 2: Group 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   73/1647 (4.43%)   25/644 (3.88%)   25/662 (3.78%)   4/114 (3.51%)   3/93 (3.23%) 
Cardiac disorders           
Acute myocardial infarction  1  1/1647 (0.06%)  0/644 (0.00%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Angina pectoris  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  1/114 (0.88%)  0/93 (0.00%) 
Atrial fibrillation  1  0/1647 (0.00%)  0/644 (0.00%)  2/662 (0.30%)  0/114 (0.00%)  0/93 (0.00%) 
Atrial flutter  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Coronary artery disease  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Coronary artery stenosis  1  0/1647 (0.00%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Myocardial infarction  1  0/1647 (0.00%)  0/644 (0.00%)  0/662 (0.00%)  1/114 (0.88%)  0/93 (0.00%) 
Myocardial ischaemia  1  0/1647 (0.00%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Ear and labyrinth disorders           
Hypoacusis  1  0/1647 (0.00%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Tympanic membrane perforation  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Gastrointestinal disorders           
Abdominal pain upper  1  0/1647 (0.00%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Colitis ulcerative  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Crohn's disease  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Gastrointestinal disorder  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Haematochezia  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Haemorrhoids  1  0/1647 (0.00%)  0/644 (0.00%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Inguinal hernia  1  0/1647 (0.00%)  0/644 (0.00%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Intestinal polyp  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Pancreatitis  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
General disorders           
Asthenia  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Oedema peripheral  1  0/1647 (0.00%)  0/644 (0.00%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Hepatobiliary disorders           
Alcoholic liver disease  1  0/1647 (0.00%)  0/644 (0.00%)  0/662 (0.00%)  1/114 (0.88%)  0/93 (0.00%) 
Bile duct stone  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Biliary colic  1  0/1647 (0.00%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Cholecystitis acute  1  2/1647 (0.12%)  1/644 (0.16%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Cholelithiasis  1  1/1647 (0.06%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Hepatic function abnormal  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Hepatotoxicity  1  0/1647 (0.00%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Infections and infestations           
Abscess jaw  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Appendicitis  1  1/1647 (0.06%)  0/644 (0.00%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Bronchiolitis  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Endocarditis  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Erysipelas  1  2/1647 (0.12%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Gastroenteritis  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Giardiasis  1  0/1647 (0.00%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Herpes zoster  1  0/1647 (0.00%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Infectious mononucleosis  1  0/1647 (0.00%)  0/644 (0.00%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Osteomyelitis  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Pilonidal cyst  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Pneumonia  1  0/1647 (0.00%)  0/644 (0.00%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Pneumonia bacterial  1  0/1647 (0.00%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Pneumonia pseudomonal  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Respiratory tract infection  1  0/1647 (0.00%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  1/93 (1.08%) 
Staphylococcal bacteraemia  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Tonsillitis  1  0/1647 (0.00%)  0/644 (0.00%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Urinary tract infection  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  1/114 (0.88%)  0/93 (0.00%) 
Urosepsis  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Viral infection  1  0/1647 (0.00%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Injury, poisoning and procedural complications           
Alcohol poisoning  1  2/1647 (0.12%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Bone contusion  1  0/1647 (0.00%)  0/644 (0.00%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Clavicle fracture  1  0/1647 (0.00%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Fracture  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Joint dislocation  1  1/1647 (0.06%)  0/644 (0.00%)  2/662 (0.30%)  0/114 (0.00%)  0/93 (0.00%) 
Joint injury  1  2/1647 (0.12%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Ligament rupture  1  0/1647 (0.00%)  0/644 (0.00%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Ligament sprain  1  0/1647 (0.00%)  0/644 (0.00%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Meniscus injury  1  0/1647 (0.00%)  0/644 (0.00%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Radius fracture  1  0/1647 (0.00%)  1/644 (0.16%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Spinal column injury  1  0/1647 (0.00%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Subarachnoid haemorrhage  1  0/1647 (0.00%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Tendon rupture  1  0/1647 (0.00%)  0/644 (0.00%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Thermal burn  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Tibia fracture  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Investigations           
Alanine aminotransferase increased  1  9/1647 (0.55%)  1/644 (0.16%)  1/662 (0.15%)  1/114 (0.88%)  0/93 (0.00%) 
Aspartate aminotransferase increased  1  10/1647 (0.61%)  2/644 (0.31%)  1/662 (0.15%)  1/114 (0.88%)  0/93 (0.00%) 
Blood bilirubin increased  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Hepatic enzyme increased  1  3/1647 (0.18%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Liver function test increased  1  0/1647 (0.00%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Transaminases increased  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Metabolism and nutrition disorders           
Hypoglycaemia  1  2/1647 (0.12%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain  1  0/1647 (0.00%)  0/644 (0.00%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Bursitis  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Intervertebral disc protrusion  1  3/1647 (0.18%)  0/644 (0.00%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Osteoarthritis  1  0/1647 (0.00%)  0/644 (0.00%)  0/662 (0.00%)  1/114 (0.88%)  0/93 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Anogenital warts  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Basal cell carcinoma  1  2/1647 (0.12%)  1/644 (0.16%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Bowen's disease  1  2/1647 (0.12%)  0/644 (0.00%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Cholesteatoma  1  0/1647 (0.00%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Gastric cancer stage II  1  0/1647 (0.00%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Lung adenocarcinoma  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Malignant melanoma  1  0/1647 (0.00%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Malignant melanoma in situ  1  0/1647 (0.00%)  0/644 (0.00%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Oral fibroma  1  0/1647 (0.00%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Plasma cell myeloma  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Skin cancer  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Thyroid adenoma  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Nervous system disorders           
Burning sensation  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Cerebral ischaemia  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Cerebrovascular accident  1  2/1647 (0.12%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Epilepsy  1  1/1647 (0.06%)  1/644 (0.16%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Facial nerve disorder  1  0/1647 (0.00%)  0/644 (0.00%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Haemorrhagic stroke  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Monoplegia  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Peripheral sensorimotor neuropathy  1  0/1647 (0.00%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  1/93 (1.08%) 
Seizure  1  0/1647 (0.00%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Tension headache  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Pregnancy, puerperium and perinatal conditions           
Ectopic pregnancy  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Psychiatric disorders           
Alcohol abuse  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Anxiety disorder  1  1/1647 (0.06%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Confusional state  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Depression  1  2/1647 (0.12%)  0/644 (0.00%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Schizophrenia  1  1/1647 (0.06%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Renal and urinary disorders           
Calculus urethral  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Renal colic  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Renal failure  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Ureteric stenosis  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Reproductive system and breast disorders           
Breast enlargement  1  0/1647 (0.00%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Peyronie's disease  1  0/1647 (0.00%)  0/644 (0.00%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Prostatitis  1  0/1647 (0.00%)  0/644 (0.00%)  0/662 (0.00%)  1/114 (0.88%)  0/93 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Acute respiratory failure  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Nasal polyps  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Pulmonary embolism  1  0/1647 (0.00%)  0/644 (0.00%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Skin and subcutaneous tissue disorders           
Actinic keratosis  1  0/1647 (0.00%)  1/644 (0.16%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Dermatitis exfoliative  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Lichenoid keratosis  1  0/1647 (0.00%)  0/644 (0.00%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Skin exfoliation  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
Social circumstances           
Alcohol use  1  0/1647 (0.00%)  0/644 (0.00%)  1/662 (0.15%)  0/114 (0.00%)  0/93 (0.00%) 
Vascular disorders           
Deep vein thrombosis  1  0/1647 (0.00%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  1/93 (1.08%) 
Iliac artery occlusion  1  1/1647 (0.06%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  0/93 (0.00%) 
1
Term from vocabulary, MedDRA (19.1)
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%
Treatment Period 1: All Participants Treatment Period 2: Group 1 Treatment Period 2: Group 2 Treatment Period 2: Group 3 Treatment Period 2: Group 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   884/1647 (53.67%)   272/644 (42.24%)   288/662 (43.50%)   64/114 (56.14%)   60/93 (64.52%) 
Ear and labyrinth disorders           
Vertigo  1  4/1647 (0.24%)  2/644 (0.31%)  2/662 (0.30%)  1/114 (0.88%)  2/93 (2.15%) 
Eye disorders           
Conjunctivitis allergic  1  6/1647 (0.36%)  3/644 (0.47%)  0/662 (0.00%)  1/114 (0.88%)  2/93 (2.15%) 
Eye pruritus  1  5/1647 (0.30%)  0/644 (0.00%)  0/662 (0.00%)  0/114 (0.00%)  3/93 (3.23%) 
Gastrointestinal disorders           
Diarrhoea  1  74/1647 (4.49%)  16/644 (2.48%)  22/662 (3.32%)  4/114 (3.51%)  0/93 (0.00%) 
Odynophagia  1  7/1647 (0.43%)  4/644 (0.62%)  6/662 (0.91%)  1/114 (0.88%)  3/93 (3.23%) 
Toothache  1  34/1647 (2.06%)  11/644 (1.71%)  11/662 (1.66%)  3/114 (2.63%)  1/93 (1.08%) 
General disorders           
Fatigue  1  41/1647 (2.49%)  5/644 (0.78%)  2/662 (0.30%)  0/114 (0.00%)  0/93 (0.00%) 
Injection site haematoma  1  18/1647 (1.09%)  2/644 (0.31%)  1/662 (0.15%)  0/114 (0.00%)  2/93 (2.15%) 
Pyrexia  1  36/1647 (2.19%)  10/644 (1.55%)  8/662 (1.21%)  2/114 (1.75%)  1/93 (1.08%) 
Infections and infestations           
Bronchitis  1  23/1647 (1.40%)  12/644 (1.86%)  6/662 (0.91%)  1/114 (0.88%)  3/93 (3.23%) 
Cystitis  1  12/1647 (0.73%)  3/644 (0.47%)  3/662 (0.45%)  0/114 (0.00%)  2/93 (2.15%) 
Folliculitis  1  31/1647 (1.88%)  8/644 (1.24%)  8/662 (1.21%)  1/114 (0.88%)  2/93 (2.15%) 
Gastroenteritis  1  22/1647 (1.34%)  10/644 (1.55%)  10/662 (1.51%)  3/114 (2.63%)  2/93 (2.15%) 
Influenza  1  36/1647 (2.19%)  17/644 (2.64%)  19/662 (2.87%)  4/114 (3.51%)  4/93 (4.30%) 
Nasopharyngitis  1  6/1647 (0.36%)  3/644 (0.47%)  6/662 (0.91%)  0/114 (0.00%)  2/93 (2.15%) 
Oral candidiasis  1  25/1647 (1.52%)  9/644 (1.40%)  14/662 (2.11%)  0/114 (0.00%)  3/93 (3.23%) 
Oral herpes  1  41/1647 (2.49%)  12/644 (1.86%)  8/662 (1.21%)  3/114 (2.63%)  0/93 (0.00%) 
Pulpitis dental  1  4/1647 (0.24%)  1/644 (0.16%)  2/662 (0.30%)  2/114 (1.75%)  2/93 (2.15%) 
Rhinitis  1  52/1647 (3.16%)  8/644 (1.24%)  12/662 (1.81%)  3/114 (2.63%)  0/93 (0.00%) 
Sinusitis  1  22/1647 (1.34%)  8/644 (1.24%)  6/662 (0.91%)  1/114 (0.88%)  2/93 (2.15%) 
Tonsillitis  1  34/1647 (2.06%)  8/644 (1.24%)  9/662 (1.36%)  2/114 (1.75%)  3/93 (3.23%) 
Upper respiratory tract infection  1  65/1647 (3.95%)  18/644 (2.80%)  16/662 (2.42%)  7/114 (6.14%)  5/93 (5.38%) 
Urinary tract infection  1  26/1647 (1.58%)  16/644 (2.48%)  8/662 (1.21%)  3/114 (2.63%)  3/93 (3.23%) 
Viral upper respiratory tract infection  1  368/1647 (22.34%)  94/644 (14.60%)  95/662 (14.35%)  23/114 (20.18%)  22/93 (23.66%) 
Injury, poisoning and procedural complications           
Arthropod bite  1  3/1647 (0.18%)  4/644 (0.62%)  4/662 (0.60%)  0/114 (0.00%)  2/93 (2.15%) 
Investigations           
Alanine aminotransferase increased  1  10/1647 (0.61%)  4/644 (0.62%)  6/662 (0.91%)  2/114 (1.75%)  4/93 (4.30%) 
Aspartate aminotransferase increased  1  8/1647 (0.49%)  4/644 (0.62%)  3/662 (0.45%)  1/114 (0.88%)  3/93 (3.23%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  50/1647 (3.04%)  16/644 (2.48%)  19/662 (2.87%)  3/114 (2.63%)  4/93 (4.30%) 
Arthritis  1  4/1647 (0.24%)  1/644 (0.16%)  1/662 (0.15%)  0/114 (0.00%)  2/93 (2.15%) 
Back pain  1  64/1647 (3.89%)  18/644 (2.80%)  28/662 (4.23%)  4/114 (3.51%)  1/93 (1.08%) 
Nervous system disorders           
Headache  1  141/1647 (8.56%)  31/644 (4.81%)  27/662 (4.08%)  6/114 (5.26%)  1/93 (1.08%) 
Migraine  1  9/1647 (0.55%)  1/644 (0.16%)  1/662 (0.15%)  0/114 (0.00%)  2/93 (2.15%) 
Respiratory, thoracic and mediastinal disorders           
Cough  1  61/1647 (3.70%)  11/644 (1.71%)  10/662 (1.51%)  3/114 (2.63%)  0/93 (0.00%) 
Oropharyngeal pain  1  46/1647 (2.79%)  13/644 (2.02%)  17/662 (2.57%)  3/114 (2.63%)  1/93 (1.08%) 
Skin and subcutaneous tissue disorders           
Dermatitis atopic  1  3/1647 (0.18%)  2/644 (0.31%)  1/662 (0.15%)  0/114 (0.00%)  2/93 (2.15%) 
Dermatitis contact  1  9/1647 (0.55%)  4/644 (0.62%)  1/662 (0.15%)  0/114 (0.00%)  3/93 (3.23%) 
Eczema  1  20/1647 (1.21%)  8/644 (1.24%)  14/662 (2.11%)  3/114 (2.63%)  1/93 (1.08%) 
Erythrodermic psoriasis  1  0/1647 (0.00%)  0/644 (0.00%)  0/662 (0.00%)  3/114 (2.63%)  1/93 (1.08%) 
Pruritus  1  65/1647 (3.95%)  9/644 (1.40%)  11/662 (1.66%)  2/114 (1.75%)  4/93 (4.30%) 
Psoriasis  1  21/1647 (1.28%)  12/644 (1.86%)  16/662 (2.42%)  11/114 (9.65%)  8/93 (8.60%) 
Vascular disorders           
Hypertension  1  55/1647 (3.34%)  7/644 (1.09%)  10/662 (1.51%)  4/114 (3.51%)  4/93 (4.30%) 
1
Term from vocabulary, MedDRA (19.1)
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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
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
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Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02409667     History of Changes
Other Study ID Numbers: CAIN457A3302
First Submitted: March 31, 2015
First Posted: April 7, 2015
Results First Submitted: May 4, 2018
Results First Posted: May 13, 2019
Last Update Posted: May 13, 2019