Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab
Official Title
A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Palmoplantar Pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 Weeks of Treatment, Compared to Placebo, and to Assess Long-term Safety, Tolerability, and Efficacy in Subjects With Moderate to Severe Chronic Palmoplantar Pustular Psoriasis - Amended With an Optional Extension Treatment Period of up to a Total of 148 Weeks
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jan 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 26, 2013Actual
Primary Completion Date
Nov 24, 2014Actual
Completion Date
May 31, 2017Actual
First Submitted Date
Dec 8, 2013
First Submission Date that Met QC Criteria
Dec 8, 2013
First Posted Date
Dec 11, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
May 31, 2018
Results First Submitted that Met QC Criteria
Jan 1, 2019
Results First Posted Date
Jan 4, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 1, 2019
Last Update Posted Date
Jan 4, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
A one year study assessing the efficacy and safety of secukinumab compared with placebo in adult patients with moderate to severe palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks
Detailed Description
Not provided
Conditions Module
Conditions
Palmoplantar Pustular Psoriasis
Keywords
palmoplantar, pustular, psoriasis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
237Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Secukinumab 300mg
Experimental
Secukinumab 300mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48.
In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19.
For extension period: Secukinumab 300mg at 4-weekly intervals starting Week 52 up to Week 148.
Biological: Secukinumab 300mg
Biological: Placebo
Secukinumab 150mg
Experimental
Secukinumab 150mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48.
In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19.
For extension period: Secukinumab 150mg at 4-weekly intervals starting Week 52 up to Week 148.
Biological: Secukinumab 150mg
Biological: Placebo
Placebo
Placebo Comparator
Placebo once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 12. Patients who achieved ppPASI 75 at Week 16 remained on placebo treatment Until week 48 and were not eligible to enter the extension. Patients who did not achieve ppPASI 75 at Week 16 were re-randomized to receive Secukinumab 150mg or Secukinumab 300mg from Week 16 onwards up to Week 148.
Biological: Secukinumab 300mg
Biological: Secukinumab 150mg
Biological: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Secukinumab 300mg
Biological
Secukinumab was used as 150 mg pre-filled syringes (PFS) in a double-blinded fashion. Secukinumab 300 mg s.c. (two PFS injections of the 150 mg dose) self-administered
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With ppPASI 75 Response at Week 16 (Period 1)
The primary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Baseline to Week 16
Secondary Outcomes
Measure
Description
Time Frame
ppPASI: Absolute Change From Baseline to Week 16
A secondary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI). The mean change of ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Palmoplantar pustular psoriasis for at least 6 months before Randomization
Moderate to severe palmoplantar pustular psoriasis as defined at Baseline by:
ppPASI score of ≥ 12 and
DLQI ≥ 10
Candidate for systemic therapy, defined as having palmoplantar pustular psoriasis inadequately controlled by:
Topical treatment, and/or
Phototherapy, and/or
Previous systemic therapy
Exclusion Criteria:
Forms of psoriasis other than chronic plaque psoriasis and pustular palmoplantar psoriasis (e.g., erythrodermic, guttate, or generalized pustular psoriasis)
Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors, or lithium) or history of proven contact dermatitis
Patients not willing to limit UV light exposure (e.g. sunbathing and/or the use of tanning devices) during the course of the study
Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy). Washout periods detailed in the protocol have to be adhered to
Previous exposure to any biologic drug directly targeting IL-17 or IL-17 Receptor (e.g., secukinumab, ixekizumab, or brodalumab)
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment and for 16 weeks after stopping treatment
Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy
Use of any other investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer
Other protocol-defined inclusion/exclusion criteria may apply.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Novartis Investigative Site
Feldkirch
A-6807
Austria
Novartis Investigative Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Undecided
Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
At baseline patients were randomized at 61 study centers to one of the three treatment groups in a 1:1:1 ratio.
Recruitment Details
A total of 337 patients were screened, and 237 of these patients completed the screening phase and were randomized to treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
AIN457 150mg
Secukinumab 150mg at each dosing.
FG001
AIN457 300mg
Secukinumab 300mg at each dosing.
Periods
Title
Milestones
Reasons Not Completed
Period 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
2
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Placebo
Secukinumab 300mg
Secukinumab 150mg
Biological
secukinumab 150 mg s.c. (one PFS injection of the 150 mg dose + one PFS injection of placebo) self-administered
Placebo
Secukinumab 150mg
Placebo
Biological
secukinumab placebo s.c. (two PFS injections of placebo) self-administered
Placebo
Secukinumab 150mg
Secukinumab 300mg
Baseline to Week 16
Percentage of Participants With ppPASI 75 Response Over Time (Period 1)
A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Baseline to Week 16
Percentage of Participants With ppPASI 75 Response Over Time (Period 2)
A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Week 16 to Week 52
Percentage of Participants With ppPASI 75 Response Over Time (Extension Period)
A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to each post-baseline visit was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Week 52 to Week 148
Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety)
Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Baseline to Week 16 (Period 1)
Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)
Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Week 16 to Week 52 (Period 2)
Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety)
Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Week 52 to Week 148 (extension period)
Graz
8036
Austria
Novartis Investigative Site
Linz
A-4020
Austria
Novartis Investigative Site
Vienna
1090
Austria
Novartis Investigative Site
Vienna
A-1090
Austria
Novartis Investigative Site
Brussels
1200
Belgium
Novartis Investigative Site
Ghent
9000
Belgium
Novartis Investigative Site
Leuven
3000
Belgium
Novartis Investigative Site
Liège
4000
Belgium
Novartis Investigative Site
Limoges
Haute Vienne
87000
France
Novartis Investigative Site
Bordeaux
33075
France
Novartis Investigative Site
Clermont-Ferrand
63003
France
Novartis Investigative Site
Martigues
13500
France
Novartis Investigative Site
Nice
06202
France
Novartis Investigative Site
Paris
75010
France
Novartis Investigative Site
Paris
75014
France
Novartis Investigative Site
Poitiers
86021
France
Novartis Investigative Site
Rouen
76031
France
Novartis Investigative Site
Toulouse
31400
France
Novartis Investigative Site
Berlin
10827
Germany
Novartis Investigative Site
Bochum
44803
Germany
Novartis Investigative Site
Dresden
01307
Germany
Novartis Investigative Site
Düsseldorf
D 40225
Germany
Novartis Investigative Site
Freiburg im Breisgau
79104
Germany
Novartis Investigative Site
Gera
07548
Germany
Novartis Investigative Site
Göttingen
37075
Germany
Novartis Investigative Site
Greifswald
17475
Germany
Novartis Investigative Site
Hamburg
20354
Germany
Novartis Investigative Site
Hamburg
22391
Germany
Novartis Investigative Site
Hanau
63450
Germany
Novartis Investigative Site
Kiel
24105
Germany
Novartis Investigative Site
Lübeck
23538
Germany
Novartis Investigative Site
Mahlow
15831
Germany
Novartis Investigative Site
Münster
48149
Germany
Novartis Investigative Site
Plauen
08529
Germany
Novartis Investigative Site
Recklinghausen
45657
Germany
Novartis Investigative Site
Schwerin
19055
Germany
Novartis Investigative Site
Bologna
BO
40138
Italy
Novartis Investigative Site
Brescia
BS
25123
Italy
Novartis Investigative Site
Bydgoszcz
85-094
Poland
Novartis Investigative Site
Gdansk
80-803
Poland
Novartis Investigative Site
Olsztyn
10-045
Poland
Novartis Investigative Site
Zabrze
41-800
Poland
Novartis Investigative Site
Moscow
107076
Russia
Novartis Investigative Site
Rostov on Don Region
346880
Russia
Novartis Investigative Site
Ryazan
390046
Russia
Novartis Investigative Site
Saratov
410012
Russia
Novartis Investigative Site
San Cristóbal de La Laguna
Santa Cruz De Tenerife
38320
Spain
Novartis Investigative Site
Valencia
Valencia
46014
Spain
Novartis Investigative Site
A Coruña
15001
Spain
Novartis Investigative Site
Barcelona
08041
Spain
Novartis Investigative Site
Madrid
28006
Spain
Novartis Investigative Site
Madrid
28031
Spain
Novartis Investigative Site
Gothenburg
Västra Götaland County
SE-413 45
Sweden
Novartis Investigative Site
Jönköping
551 85
Sweden
Novartis Investigative Site
Malmö
SE-205 02
Sweden
Novartis Investigative Site
Stockholm
171 76
Sweden
Novartis Investigative Site
Uppsala
751 85
Sweden
Novartis Investigative Site
Leytonstone
London
E11 1NR
United Kingdom
Novartis Investigative Site
Salford
Manchester
M6 8HD
United Kingdom
Novartis Investigative Site
Dundee
Perthshire
DD1 9SY
United Kingdom
Novartis Investigative Site
Dudley
West Midlands
DY1 2HQ
United Kingdom
Novartis Investigative Site
Glasgow
G11 6NT
United Kingdom
Novartis Investigative Site
Liverpool
L14 3PE
United Kingdom
Novartis Investigative Site
Newport
NP20 4SZ
United Kingdom
Novartis Investigative Site
Portsmouth
PO6 6AD
United Kingdom
Novartis Investigative Site
Wolverhampton
WV10 0QP
United Kingdom
Novartis Investigative Site
York
YO31 8HE
United Kingdom
FG002
Placebo
Placebo at each dosing.
FG003
Placebo - AIN457 150 mg
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.
FG004
Placebo - AIN457 300 mg
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.
FG00080 subjects
FG00179 subjects
FG00278 subjects
FG0030 subjects
FG0040 subjects
COMPLETED
FG00065 subjects
FG00164 subjects
FG00266 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG00015 subjects
FG00115 subjects
FG00212 subjects
FG0030 subjects
FG0040 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0007 subjects
FG0017 subjects
FG0025 subjects
FG0030 subjects
FG0040 subjects
Pregnancy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Adverse Event
FG0006 subjects
FG0018 subjects
FG0026 subjects
FG0030 subjects
FG004
Period 2
Type
Comment
Milestone Data
STARTED
FG00065 subjects
FG00164 subjects
FG00210 subjects
FG00327 subjects
FG00428 subjects
COMPLETED
FG00038 subjects
FG00149 subjects
FG0029 subjects
FG00313 subjects
FG004
NOT COMPLETED
FG00027 subjects
FG00115 subjects
FG0021 subjects
FG00314 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG00012 subjects
FG0017 subjects
FG0020 subjects
FG003
Extension Period
Type
Comment
Milestone Data
STARTED
FG00031 subjects
FG00136 subjects
FG0020 subjects
FG00310 subjects
FG00417 subjects
COMPLETED
FG00026 subjects
FG00131 subjects
FG0020 subjects
FG0036 subjects
FG004
NOT COMPLETED
FG0005 subjects
FG0015 subjects
FG0020 subjects
FG0034 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0003 subjects
FG0012 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
AIN457 150mg
Secukinumab 150mg at each dosing in period 1.
BG001
AIN457 300mg
Secukinumab 300mg at each dosing in period 1.
BG002
Placebo
Placebo at each dosing in period 1.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00080
BG00179
BG00278
BG003237
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Randomized (Started)
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00050.7± 13.68
BG00150.6± 14.77
BG00252.9± 11.33
BG003
Sex: Female, Male
Randomized (Started)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00063
BG00164
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Black
Title
Measurements
BG0001
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With ppPASI 75 Response at Week 16 (Period 1)
The primary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Full Analysis Set (FAS = Started). A patient with a missing ppPASI assessment at Week 16 was considered as a responder if he/she has met the response criterion already at the time of drop-out. Otherwise he/she was considered as a non-responder.
Posted
Number
percentage of participants
Baseline to Week 16
ID
Title
Description
OG000
AIN457 150mg
Secukinumab 150mg at each dosing.
OG001
AIN457 300mg
Secukinumab 300mg at each dosing
OG002
Placebo
Placebo at each dosing.
Units
Counts
Participants
OG00080
OG00179
OG00278
Title
Denominators
Categories
Title
Measurements
OG00017.5
OG00126.6
OG00214.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Regression, Logistic
with factors treatment, country, body weight at baseline visit (> 90 kg or >= 90kg) and presence of plaque-type psoriasis
0.5722
Odds Ratio (OR)
1.33
2-Sided
95
0.50
3.53
Superiority
OG001
OG002
Regression, Logistic
Secondary
ppPASI: Absolute Change From Baseline to Week 16
A secondary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI). The mean change of ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
FAS - Including only Patients with ppPASI Scores at Baseline and Week 16
Posted
Mean
Standard Deviation
units on a scale
Baseline to Week 16
ID
Title
Description
OG000
AIN457 150mg
Secukinumab 150mg at each dosing.
OG001
AIN457 300mg
Secukinumab 300mg at each dosing
OG002
Placebo
Placebo at each dosing.
Secondary
Percentage of Participants With ppPASI 75 Response Over Time (Period 1)
A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
FAS
Posted
Number
percentage of participants
Baseline to Week 16
ID
Title
Description
OG000
AIN457 150mg
Secukinumab 150mg at each dosing.
OG001
AIN457 300mg
Secukinumab 300mg at each dosing
OG002
Placebo
Placebo at each dosing.
Secondary
Percentage of Participants With ppPASI 75 Response Over Time (Period 2)
A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
FAS - Including only patients entering period 2
Posted
Number
percentage of participants
Week 16 to Week 52
ID
Title
Description
OG000
AIN457 150mg
Secukinumab 150mg at each dosing.
OG001
AIN457 300mg
Secukinumab 300mg at each dosing
OG002
Placebo
Placebo at each dosing.
OG003
Secondary
Percentage of Participants With ppPASI 75 Response Over Time (Extension Period)
A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to each post-baseline visit was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
FAS - Including only patients entering extension period (Placebo Week 16 responders not eligible)
Posted
Number
percentage of participants
Week 52 to Week 148
ID
Title
Description
OG000
AIN457 150mg
Secukinumab 150mg at each dosing.
OG001
AIN457 300mg
Secukinumab 300mg at each dosing
OG002
Placebo - AIN457 150 mg
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.
Secondary
Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety)
Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Safety Set
Posted
Number
percentage of participants
Baseline to Week 16 (Period 1)
ID
Title
Description
OG000
AIN457 150mg
Secukinumab 150mg at each dosing.
OG001
AIN457 300mg
Secukinumab 300mg at each dosing
OG002
Placebo
Placebo at each dosing.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)
Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Safety Set - Including only patients entering period 2
Posted
Number
percentage of participants
Week 16 to Week 52 (Period 2)
ID
Title
Description
OG000
AIN457 150mg
Secukinumab 150mg at each dosing.
OG001
AIN457 300mg
Secukinumab 300mg at each dosing
OG002
Placebo
Placebo at each dosing.
OG003
Placebo - AIN457 150 mg
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.
OG004
Placebo - AIN457 300 mg
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.
Secondary
Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety)
Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Safety Set - including only patients entering the extension period
Posted
Number
percentage of participants
Week 52 to Week 148 (extension period)
ID
Title
Description
OG000
AIN457 150mg
Secukinumab 150mg at each dosing.
OG001
AIN457 300mg
Secukinumab 300mg at each dosing
Units
Counts
Participants
OG000
Time Frame
Baseline to Week 148
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Initial AIN457 150 mg
AEs for patients randomized to Secukinumab 150 mg at start of study.
0
80
9
80
73
80
EG001
Initial AIN457 300 mg
AEs for patients randomized to Secukinumab 300 mg at start of study.
0
79
13
79
73
79
EG002
Placebo
AEs for patients randomized to Placebo at start of study while treated with Placebo (AEs that occurred after re-randomization to Secukinumab are not counted in this group).
0
78
5
78
53
78
EG003
AIN457 150 mg in Any Period
AEs for patients initially randomized to AIN457 150mg and placebo non-responder re-randomized to AIN457 150 mg at Week 16
0
107
11
107
92
107
EG004
AIN457 300 mg in Any Period
AEs for patients initially randomized to AIN457 300mg and placebo non-responder re-randomized to AIN457 300 mg at Week 16
0
107
17
107
94
107
EG005
Any AIN457
Any Secukinumab
0
214
28
214
186
214
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Arrhythmia
Cardiac disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected79 at risk
EG0020 affected78 at risk
EG0030 affected107 at risk
EG0041 affected107 at risk
EG0051 affected214 at risk
Atrial thrombosis
Cardiac disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected79 at risk
EG0020 affected78 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected79 at risk
EG0021 affected78 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected79 at risk
EG0020 affected78 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0011 affected79 at risk
EG0020 affected78 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected79 at risk
EG0020 affected78 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Abdominal mass
Gastrointestinal disorders
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Drug ineffective
General disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected79 at risk
EG0020 affected78 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected79 at risk
EG0021 affected78 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected79 at risk
EG0020 affected78 at risk
EG003
Erysipelas
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected79 at risk
EG0021 affected78 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Peritonsillar abscess
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected79 at risk
EG0020 affected78 at risk
EG003
Rash pustular
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Superinfection bacterial
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected79 at risk
EG0020 affected78 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected79 at risk
EG0020 affected78 at risk
EG003
Subarachnoid haemorrhage
Injury, poisoning and procedural complications
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected79 at risk
EG0021 affected78 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Transaminases increased
Investigations
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected79 at risk
EG0021 affected78 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected79 at risk
EG0020 affected78 at risk
EG003
Cervical spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected79 at risk
EG0020 affected78 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Tonsil cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected79 at risk
EG0021 affected78 at risk
EG003
Endometrial hyperplasia
Reproductive system and breast disorders
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected79 at risk
EG0020 affected78 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Pustular psoriasis
Skin and subcutaneous tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0014 affected79 at risk
EG0020 affected78 at risk
EG003
Hip arthroplasty
Surgical and medical procedures
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected79 at risk
EG0020 affected78 at risk
EG003
Hypotension
Vascular disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Bradycardia
Cardiac disorders
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0012 affected79 at risk
EG0020 affected78 at risk
EG0031 affected107 at risk
EG0043 affected107 at risk
EG0054 affected214 at risk
Tachycardia
Cardiac disorders
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0012 affected79 at risk
EG0021 affected78 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0010 affected79 at risk
EG0021 affected78 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0012 affected79 at risk
EG0020 affected78 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0012 affected79 at risk
EG0020 affected78 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (20.0)
Systematic Assessment
EG0003 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0012 affected79 at risk
EG0020 affected78 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (20.0)
Systematic Assessment
EG0005 affected80 at risk
EG0018 affected79 at risk
EG0024 affected78 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (20.0)
Systematic Assessment
EG0003 affected80 at risk
EG0016 affected79 at risk
EG0020 affected78 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0012 affected79 at risk
EG0020 affected78 at risk
EG003
Asthenia
General disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0012 affected79 at risk
EG0021 affected78 at risk
EG003
Chest pain
General disorders
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0011 affected79 at risk
EG0021 affected78 at risk
EG003
Fatigue
General disorders
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0013 affected79 at risk
EG0023 affected78 at risk
EG003
Feeling hot
General disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected79 at risk
EG0022 affected78 at risk
EG003
Injection site urticaria
General disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0012 affected79 at risk
EG0020 affected78 at risk
EG003
Pyrexia
General disorders
MedDRA (20.0)
Systematic Assessment
EG0004 affected80 at risk
EG0011 affected79 at risk
EG0020 affected78 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0012 affected79 at risk
EG0020 affected78 at risk
EG003
Bacterial vaginosis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0005 affected80 at risk
EG0016 affected79 at risk
EG0021 affected78 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0012 affected79 at risk
EG0020 affected78 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0004 affected80 at risk
EG0013 affected79 at risk
EG0020 affected78 at risk
EG003
Cystitis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0003 affected80 at risk
EG0011 affected79 at risk
EG0021 affected78 at risk
EG003
Ear infection
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Eczema impetiginous
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Erysipelas
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0012 affected79 at risk
EG0020 affected78 at risk
EG003
Folliculitis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0005 affected80 at risk
EG0018 affected79 at risk
EG0021 affected78 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0012 affected79 at risk
EG0021 affected78 at risk
EG003
Furuncle
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0012 affected79 at risk
EG0021 affected78 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0013 affected79 at risk
EG0020 affected78 at risk
EG003
Impetigo
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0012 affected79 at risk
EG0020 affected78 at risk
EG003
Influenza
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0005 affected80 at risk
EG0013 affected79 at risk
EG0022 affected78 at risk
EG003
Laryngitis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected79 at risk
EG0022 affected78 at risk
EG003
Localised infection
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0013 affected79 at risk
EG0020 affected78 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0012 affected79 at risk
EG0020 affected78 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0015 affected79 at risk
EG0022 affected78 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0004 affected80 at risk
EG0013 affected79 at risk
EG0020 affected78 at risk
EG003
Otitis externa
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Paronychia
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0011 affected79 at risk
EG0020 affected78 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0003 affected80 at risk
EG0011 affected79 at risk
EG0020 affected78 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0012 affected79 at risk
EG0020 affected78 at risk
EG003
Rash pustular
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0003 affected80 at risk
EG0011 affected79 at risk
EG0020 affected78 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0013 affected79 at risk
EG0021 affected78 at risk
EG003
Skin bacterial infection
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0003 affected80 at risk
EG0013 affected79 at risk
EG0021 affected78 at risk
EG003
Skin infection
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0012 affected79 at risk
EG0021 affected78 at risk
EG003
Staphylococcal skin infection
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0003 affected80 at risk
EG0011 affected79 at risk
EG0020 affected78 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0013 affected79 at risk
EG0020 affected78 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0003 affected80 at risk
EG0013 affected79 at risk
EG0020 affected78 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0012 affected79 at risk
EG0020 affected78 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0004 affected80 at risk
EG0017 affected79 at risk
EG0024 affected78 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0005 affected80 at risk
EG0015 affected79 at risk
EG0023 affected78 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG00017 affected80 at risk
EG00131 affected79 at risk
EG00212 affected78 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0013 affected79 at risk
EG0021 affected78 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0012 affected79 at risk
EG0020 affected78 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0012 affected79 at risk
EG0021 affected78 at risk
EG003
Blood pressure increased
Investigations
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0012 affected79 at risk
EG0020 affected78 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0012 affected79 at risk
EG0022 affected78 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA (20.0)
Systematic Assessment
EG0004 affected80 at risk
EG0011 affected79 at risk
EG0023 affected78 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0012 affected79 at risk
EG0020 affected78 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0005 affected80 at risk
EG0014 affected79 at risk
EG0025 affected78 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0004 affected80 at risk
EG0017 affected79 at risk
EG0024 affected78 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0003 affected80 at risk
EG0011 affected79 at risk
EG0021 affected78 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0017 affected79 at risk
EG0026 affected78 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0010 affected79 at risk
EG0022 affected78 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0012 affected79 at risk
EG0020 affected78 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0012 affected79 at risk
EG0020 affected78 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected79 at risk
EG0022 affected78 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0011 affected79 at risk
EG0022 affected78 at risk
EG003
Headache
Nervous system disorders
MedDRA (20.0)
Systematic Assessment
EG0007 affected80 at risk
EG00112 affected79 at risk
EG00210 affected78 at risk
EG003
Migraine
Nervous system disorders
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0011 affected79 at risk
EG0020 affected78 at risk
EG003
Sciatica
Nervous system disorders
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0013 affected79 at risk
EG0022 affected78 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected79 at risk
EG0020 affected78 at risk
EG003
Depression
Psychiatric disorders
MedDRA (20.0)
Systematic Assessment
EG0003 affected80 at risk
EG0011 affected79 at risk
EG0022 affected78 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0012 affected79 at risk
EG0022 affected78 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0012 affected79 at risk
EG0021 affected78 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (20.0)
Systematic Assessment
EG0005 affected80 at risk
EG0018 affected79 at risk
EG0020 affected78 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0014 affected79 at risk
EG0022 affected78 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0014 affected79 at risk
EG0021 affected78 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0003 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Dermatitis psoriasiform
Skin and subcutaneous tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0011 affected79 at risk
EG0020 affected78 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Dyshidrotic eczema
Skin and subcutaneous tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0003 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0003 affected80 at risk
EG0017 affected79 at risk
EG0023 affected78 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0012 affected79 at risk
EG0020 affected78 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0003 affected80 at risk
EG0012 affected79 at risk
EG0020 affected78 at risk
EG003
Lichen planus
Skin and subcutaneous tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0011 affected79 at risk
EG0020 affected78 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0006 affected80 at risk
EG00111 affected79 at risk
EG0024 affected78 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0012 affected79 at risk
EG0021 affected78 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0005 affected80 at risk
EG0017 affected79 at risk
EG0025 affected78 at risk
EG003
Pustular psoriasis
Skin and subcutaneous tissue disorders
MedDRA (20.0)
Systematic Assessment
EG00019 affected80 at risk
EG00116 affected79 at risk
EG0024 affected78 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0001 affected80 at risk
EG0015 affected79 at risk
EG0020 affected78 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0003 affected80 at risk
EG0010 affected79 at risk
EG0021 affected78 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0010 affected79 at risk
EG0020 affected78 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0013 affected79 at risk
EG0020 affected78 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0000 affected80 at risk
EG0014 affected79 at risk
EG0020 affected78 at risk
EG003
Hypertension
Vascular disorders
MedDRA (20.0)
Systematic Assessment
EG0002 affected80 at risk
EG0015 affected79 at risk
EG0023 affected78 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Novartis Pharmaceuticals
862-778-8300
Novartis.email@novartis.com
ID
Term
D011565
Psoriasis
Ancestor Terms
ID
Term
D017444
Skin Diseases, Papulosquamous
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C555450
secukinumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
0 subjects
0 subjects
20 subjects
8 subjects
5 subjects
FG0045 subjects
Withdrawal by Subject
FG00011 subjects
FG0018 subjects
FG0020 subjects
FG0037 subjects
FG0042 subjects
Physician Decision
FG0004 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0041 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
13 subjects
4 subjects
4 subjects
FG0042 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Adverse Event
FG0001 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG0042 subjects
51.4
± 13.33
59
BG003186
Male
BG00017
BG00115
BG00219
BG00351
1
BG0032
Caucasian
Title
Measurements
BG00078
BG00178
BG00276
BG003232
Missing
Title
Measurements
BG0001
BG0010
BG0021
BG0032
Other
Title
Measurements
BG0000
BG0011
BG0020
BG0031
with factors treatment, country, body weight at baseline visit (> 90 kg or >= 90kg) and presence of plaque-type psoriasis
0.0411
Odds Ratio (OR)
2.62
2-Sided
95
1.04
6.60
Superiority
Units
Counts
Participants
OG00068
OG00169
OG00270
Title
Denominators
Categories
Baseline
Title
Measurements
OG00021.79± 8.211
OG00123.01± 10.787
OG00223.10± 10.198
Change from Baseline to Week 16
Title
Measurements
OG000-6.99± 10.904
OG001-9.74± 12.130
OG002-6.73± 9.868
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Regression, Linear
with factors treatment, country, body weight at baseline visit (> 90 kg or >= 90kg) and presence of plaque-type psoriasis
0.9431
Mean Difference (Final Values)
-0.56
2-Sided
95
-4.59
3.47
Superiority
OG001
OG002
Regression, Linear
with factors treatment, country, body weight at baseline visit (> 90 kg or >= 90kg) and presence of plaque-type psoriasis
0.1576
Mean Difference (Final Values)
-3.13
2-Sided
95
-7.14
0.88
Superiority
Units
Counts
Participants
OG00080
OG00179
OG00278
Title
Denominators
Categories
Week 1
ParticipantsOG00079
ParticipantsOG00179
ParticipantsOG00275
Title
Measurements
OG0000
OG0011.3
OG0021.3
Week 2
ParticipantsOG00079
ParticipantsOG00178
ParticipantsOG00277
Title
Measurements
OG000
Week 3
ParticipantsOG00078
ParticipantsOG00174
ParticipantsOG00271
Title
Measurements
OG000
Week 4
ParticipantsOG00077
ParticipantsOG00177
ParticipantsOG00274
Title
Measurements
OG000
Week 8
ParticipantsOG00077
ParticipantsOG00175
ParticipantsOG00273
Title
Measurements
OG000
Week 12
ParticipantsOG00075
ParticipantsOG00171
ParticipantsOG00269
Title
Measurements
OG000
Week 16
ParticipantsOG00080
ParticipantsOG00179
ParticipantsOG00278
Title
Measurements
OG000
Placebo - AIN457 150 mg
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.
OG004
Placebo - AIN457 300 mg
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.
Units
Counts
Participants
OG00064
OG00164
OG00210
OG00327
OG00428
Title
Denominators
Categories
Week 16
ParticipantsOG00064
ParticipantsOG00164
ParticipantsOG00210
ParticipantsOG00327
ParticipantsOG00428
Title
Measurements
OG00018.8
OG00131.3
OG00290.0
OG003
Week 20
ParticipantsOG00064
ParticipantsOG00164
ParticipantsOG00210
ParticipantsOG00326
Week 24
ParticipantsOG00063
ParticipantsOG00164
ParticipantsOG00210
ParticipantsOG00326
Week 32
ParticipantsOG00055
ParticipantsOG00158
ParticipantsOG00210
ParticipantsOG00320
Week 40
ParticipantsOG00045
ParticipantsOG00155
ParticipantsOG00210
ParticipantsOG00316
Week 48
ParticipantsOG00042
ParticipantsOG00150
ParticipantsOG00210
ParticipantsOG00315
Week 52
ParticipantsOG00038
ParticipantsOG00151
ParticipantsOG0029
ParticipantsOG00314
OG003
Placebo - AIN457 300 mg
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.