First Study of Secukinumab in Pre-filled Syringes in Subj... | NCT01555125 | Trialant
NCT01555125
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Aug 8, 2018Actual
Enrollment
177Actual
Phase
Phase 3
Conditions
Moderate to Severe Plaque-type Psoriasis
Interventions
secukinumab 150 mg
secukinumab 300 mg
placebo
Countries
United States
Canada
Estonia
France
Germany
Protocol Section
Identification Module
NCT ID
NCT01555125
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CAIN457A2308
Secondary IDs
ID
Type
Description
Link
2011-006057-28
EudraCT Number
Brief Title
First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks
Official Title
A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, Usability and Long-term Efficacy in Subjects With Chronic Plaque-type Psoriasis
Acronym
FEATURE
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Aug 2018
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
May 8, 2012Actual
Primary Completion Date
Oct 24, 2016Actual
Completion Date
Oct 24, 2016Actual
First Submitted Date
Mar 13, 2012
First Submission Date that Met QC Criteria
Mar 14, 2012
First Posted Date
Mar 15, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 20, 2017
Results First Submitted that Met QC Criteria
Aug 7, 2018
Results First Posted Date
Aug 8, 2018Actual
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
Aug 7, 2018
Last Update Posted Date
Aug 8, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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
The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.
Detailed Description
Not provided
Conditions Module
Conditions
Moderate to Severe Plaque-type Psoriasis
Keywords
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
177Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
secukinumab 150 mg
Experimental
Drug
Drug: secukinumab 150 mg
secukinumab 300 mg
Experimental
Drug
Drug: secukinumab 300 mg
placebo
Placebo Comparator
Drug: placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
secukinumab 150 mg
Drug
After the data base lock of week 52 data has been performed, subjects will receive secukinumab 150 mg treatment as open label for the remainder of the extension treatment period
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis at Week 12 Measure: PASI 75 (Psoriasis Area and Severity Index) Response.
A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis
12 weeks
Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) With a 0 or 1 Response at Week 12
The IGA scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit. IGA has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe
12 weeks
Secondary Outcomes
Measure
Description
Time Frame
Absolute Change From Baseline in Self Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12
The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
Severity of psoriasis disease meeting all of the following three criteria:
Psoriasis Area and Severity Index (PASI) score of 12 or greater, Investigator's Global Assessment (IGA) score of 3 or greater, Total body surface area (BSA) affected of 10% or greater.
-Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.
Exclusion criteria:
Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
Current drug-induced psoriasis.
Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
Hematological abnormalities.
History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
Pregnant or nursing (lactating) women. Other protocol-defined inclusion/exclusion criteria may apply
Sticherling M, Nikkels AF, Hamza AM, Kwong P, Szepietowski JC, El Sayed M, Ghislain PD, Khotko AA, Patekar M, Ortmann CE, Forrer P, Papanastasiou P, Keefe D. Secukinumab in Pediatric Patients with Plaque Psoriasis: Pooled Safety Analysis from Two Phase 3 Randomized Clinical Trials. Am J Clin Dermatol. 2023 Sep;24(5):821-835. doi: 10.1007/s40257-023-00782-8. Epub 2023 Jun 21.
"Study terminated by Sponsor" refers to the fact that - as per protocol - patients had to stop participating in the study in a given country where Secukinumab became available following approval.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
FG001
AIN457 300 mg
Periods
Title
Milestones
Reasons Not Completed
Induction Period
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
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
secukinumab 150 mg
secukinumab 300 mg
Drug
After the data base lock of week 52 data has been performed, subjects will receive secukinumab 300 mg treatment as open label for the remainder of the extension treatment period
secukinumab 300 mg
placebo
Drug
Subjects who were on placebo at Week 52 cannot continue in the extension treatment period
placebo
Week 12
Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48
The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Baseline, week 48
Number of Subjects With Potential Use Related Hazards at Week 1
To assess potential use-related hazards with the secukinumab PFS for the subject
Week 1
Percentage of Subjects With Successful Self Administration of Study Drug at Week 1
To assess the subject's ability to follow instructions for use with the secukinumab PFS
Week 1
Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Induction) With Non-responder Imputation
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.
Week 12
Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data)
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.
Week 52
Percent of Responders With Investigator's Global Assessment (IGA) Mod 2011 Score of 0 or 1, (Maintenance; Observed Data)
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.
Week 52
Absolute Change From Baseline for PASI Score at Week 12, (Induction)
PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)
Week 12
Absolute Change From Baseline for PASI Score Over Time up to Week 52, (Maintenance; Observed Data)
PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)
Week 52
Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction)
The IGA mod 2011 category 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
Week 12
Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data)
The IGA mod 2011 category 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.
Week 52
Change From Baseline in EQ-5D at Week 12 (Induction)
ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)
Week 12
Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Over Time up to Week 52, (Maintenance)
ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)
Week 52
Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score, (Induction)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. This result was reflected in the percentage change from baseline at Week 12, higher reductions (improvements) in DLQI scores (median treatment difference).
Baseline and week 12
Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52, (Maintenance)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. This result was reflected in the percentage change from baseline at Week 12, higher reductions (improvements) in DLQI scores (median treatment difference).
Baseline and week 52
Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12, (Induction)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Week 12
Percentage of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52, (Maintenance)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Week 52
Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52
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.
Week 172
Absolute Change From Baseline for PASI Score After Week 52, (Observed Data)
PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)
Week 172
Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data)
The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant's disease state at the time of the assessments and does not attempt a comparison to any of the participant's previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe. The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe
Week 172
Number of Participants Developing Treatment Emergent Anti-secukinumab Antibodies, Immunogenicity
The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to 8 weeks after last treatment
Baseline and at Week 12, 24, 52, 100, 148, and 196, 204
Mobile
Alabama
36608
United States
Novartis Investigative Site
Glendale
Arizona
85308
United States
Novartis Investigative Site
Hot Springs
Arkansas
71913
United States
Novartis Investigative Site
Los Angeles
California
90045
United States
Novartis Investigative Site
Atlanta
Georgia
30342
United States
Novartis Investigative Site
Newnan
Georgia
30263
United States
Novartis Investigative Site
Skokie
Illinois
60077
United States
Novartis Investigative Site
Boston
Massachusetts
02111
United States
Novartis Investigative Site
Fridley
Minnesota
55432
United States
Novartis Investigative Site
Omaha
Nebraska
68131
United States
Novartis Investigative Site
Lake Oswego
Oregon
97035
United States
Novartis Investigative Site
Portland
Oregon
97223
United States
Novartis Investigative Site
Charleston
South Carolina
29407
United States
Novartis Investigative Site
Goodlettsville
Tennessee
37072-2301
United States
Novartis Investigative Site
Austin
Texas
78759
United States
Novartis Investigative Site
Bryan
Texas
77802
United States
Novartis Investigative Site
Houston
Texas
77030
United States
Novartis Investigative Site
Hamilton
Ontario
L8N 1V6
Canada
Novartis Investigative Site
North Bay
Ontario
P1B 3Z7
Canada
Novartis Investigative Site
Waterloo
Ontario
N2J 1C4
Canada
Novartis Investigative Site
Québec
G1V 4X7
Canada
Novartis Investigative Site
Tallinn
13419
Estonia
Novartis Investigative Site
Tartu
51014
Estonia
Novartis Investigative Site
Martigues
13500
France
Novartis Investigative Site
Nice
06202
France
Novartis Investigative Site
Rouen
76031
France
Novartis Investigative Site
Toulouse
31400
France
Novartis Investigative Site
Regensburg
Bavaria
93053
Germany
Novartis Investigative Site
Gera
07548
Germany
Novartis Investigative Site
Hamburg
20354
Germany
Novartis Investigative Site
Leipzig
04103
Germany
Novartis Investigative Site
Osnabrück
49074
Germany
Derived
Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.
Houghton K, Patil D, Gomez B, Feldman SR. Correlation Between Change in Psoriasis Area and Severity Index and Dermatology Life Quality Index in Patients with Psoriasis: Pooled Analysis from Four Phase 3 Clinical Trials of Secukinumab. Dermatol Ther (Heidelb). 2021 Aug;11(4):1373-1384. doi: 10.1007/s13555-021-00564-2. Epub 2021 Jun 10.
Menter A, Cather JC, Jarratt M, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab on Moderate-to-severe Plaque Psoriasis Affecting Different Body Regions: a Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):639-647. doi: 10.1007/s13555-016-0140-7. Epub 2016 Aug 30.
Kircik L, Fowler J, Weiss J, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab for Moderate-to-Severe Head and Neck Psoriasis Over 52 Weeks: Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):627-638. doi: 10.1007/s13555-016-0139-0. Epub 2016 Aug 30.
Patients received two secukinumab 150 mg s.c. injections at each dosing
FG002
Placebo - AIN457 150mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re- randomized to AIN457 150 mg for the remainder of the study
FG003
Placebo - AIN457 300mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study
FG004
Placebo
Patients received placebo secukinumab (2 s.c. injections) at each dosing
FG00059 subjects
FG00159 subjects
FG0020 subjects
FG0030 subjects
FG00459 subjects
COMPLETED
FG00058 subjects
FG00156 subjects
FG0020 subjects
FG0030 subjects
FG00456 subjects
NOT COMPLETED
FG0001 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG0043 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Subject / guardian decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Maintenance Period
Type
Comment
Milestone Data
STARTED
FG00058 subjects
FG00156 subjects
FG00229 subjects
FG00327 subjects
FG0040 subjects
COMPLETED
FG00048 subjects
FG00152 subjects
FG00225 subjects
FG00325 subjects
FG004
NOT COMPLETED
FG00010 subjects
FG0014 subjects
FG0024 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG003
Extension
Type
Comment
Milestone Data
STARTED
FG00046 subjects
FG00151 subjects
FG00223 subjects
FG00323 subjects
FG0040 subjects
COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
NOT COMPLETED
FG00045 subjects
FG00151 subjects
FG00223 subjects
FG00322 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG003
Follow-Up Period
Type
Comment
Milestone Data
STARTED
FG00036 subjects
FG00131 subjects
FG00219 subjects
FG00318 subjects
FG0040 subjects
COMPLETED
FG00032 subjects
FG00130 subjects
FG00218 subjects
FG00317 subjects
FG004
NOT COMPLETED
FG0004 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
BG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
BG002
Placebo
Patients received placebo secukinumab (2 s.c. injections) at each dosing
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00059
BG00159
BG00259
BG003177
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00046± 15.09
BG00145.1± 12.57
BG00246.5± 14.14
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00019
BG00121
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
Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis at Week 12 Measure: PASI 75 (Psoriasis Area and Severity Index) Response.
A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Number
Percentage of participants
12 weeks
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
OG002
Placebo
Patients received placebo secukinumab (2 s.c. injections) at each dosing
Units
Counts
Participants
OG00059
OG00158
OG00259
Title
Denominators
Categories
Title
Measurements
OG00069.5
OG00175.9
OG0020
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
Fisher Exact
<0.0001
Superiority or Other
OG001
OG002
Fisher Exact
<0.0001
Primary
Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) With a 0 or 1 Response at Week 12
The IGA scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit. IGA has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Number
Percentage of Participants
12 weeks
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
Secondary
Absolute Change From Baseline in Self Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12
The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were analyzed according to treatment received
Posted
Mean
Standard Deviation
Score
Week 12
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
OG002
Placebo
Patients received placebo secukinumab (2 s.c. injections) at each dosing
Secondary
Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48
The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were analyzed according to treatment received.
Posted
Mean
Standard Deviation
Score
Baseline, week 48
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
OG002
Placebo-AIN457 150mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re- randomized to AIN457 150 mg for the remainder of the study
Secondary
Number of Subjects With Potential Use Related Hazards at Week 1
To assess potential use-related hazards with the secukinumab PFS for the subject
Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were analyzed according to treatment received
Posted
Number
Number of participants
Week 1
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
OG002
Placebo
Patients received placebo secukinumab (2 s.c. injections) at each dosing
Units
Counts
Participants
Secondary
Percentage of Subjects With Successful Self Administration of Study Drug at Week 1
To assess the subject's ability to follow instructions for use with the secukinumab PFS
Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were analyzed according to treatment received
Posted
Number
Percentage of participants
Week 1
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
OG002
Placebo
Patients received placebo secukinumab (2 s.c. injections) at each dosing
Units
Counts
Participants
Secondary
Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Induction) With Non-responder Imputation
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.
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
OG002
Secondary
Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data)
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.
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Number
Percentage of participants
Week 52
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
OG002
Secondary
Percent of Responders With Investigator's Global Assessment (IGA) Mod 2011 Score of 0 or 1, (Maintenance; Observed Data)
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.
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Number
Percentage of participants
Week 52
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
OG002
Placebo-AIN457 150mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re- randomized to AIN457 150 mg for the remainder of the study
OG003
Secondary
Absolute Change From Baseline for PASI Score at Week 12, (Induction)
PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Mean
Standard Deviation
Units on a scale
Week 12
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
OG002
Placebo
Patients received placebo secukinumab (2 s.c. injections) at each dosing
Secondary
Absolute Change From Baseline for PASI Score Over Time up to Week 52, (Maintenance; Observed Data)
PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Mean
Standard Deviation
Units on a scale
Week 52
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
OG002
Placebo-AIN457 150mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re- randomized to AIN457 150 mg for the remainder of the study
Secondary
Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction)
The IGA mod 2011 category 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
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Number
Number of participants
Week 12
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
OG002
Placebo
Patients received placebo secukinumab (2 s.c. injections) at each dosing
Secondary
Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data)
The IGA mod 2011 category 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.
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Number
Percentage of participants
Week 52
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
OG002
Placebo-AIN457 150mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re- randomized to AIN457 150 mg for the remainder of the study
Secondary
Change From Baseline in EQ-5D at Week 12 (Induction)
ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Mean
Standard Deviation
Units on a scale
Week 12
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
OG002
Placebo
Patients received placebo secukinumab (2 s.c. injections) at each dosing
Secondary
Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Over Time up to Week 52, (Maintenance)
ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Mean
Standard Deviation
Units on a scale
Week 52
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
OG002
Placebo-AIN457 150mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re- randomized to AIN457 150 mg for the remainder of the study
Secondary
Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score, (Induction)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. This result was reflected in the percentage change from baseline at Week 12, higher reductions (improvements) in DLQI scores (median treatment difference).
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Median
95% Confidence Interval
Percent change
Baseline and week 12
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
OG002
Placebo
Secondary
Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52, (Maintenance)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. This result was reflected in the percentage change from baseline at Week 12, higher reductions (improvements) in DLQI scores (median treatment difference).
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Median
95% Confidence Interval
Percent change
Baseline and week 52
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
OG002
Placebo-AIN457 150mg
Secondary
Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12, (Induction)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
OG002
Placebo
Patients received placebo secukinumab (2 s.c. injections) at each dosing
Secondary
Percentage of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52, (Maintenance)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Number
Percentage of participants
Week 52
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
OG002
Placebo-AIN457 150 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study
Secondary
Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52
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.
Full analysis set (FAS) - All patients to whom study treatment was assigned. Results after Week 172 and beyond cannot be interpreted meaningfully due to low number of evaluable patients at these visits.
Posted
Number
Number of participants
Week 172
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
Secondary
Absolute Change From Baseline for PASI Score After Week 52, (Observed Data)
PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Mean
Standard Deviation
Units on a scale
Week 172
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
OG002
Placebo-AIN457 150mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re- randomized to AIN457 150 mg for the remainder of the study
Secondary
Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data)
The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant's disease state at the time of the assessments and does not attempt a comparison to any of the participant's previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe. The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe
Full analysis set (FAS) - All patients to whom study treatment was assigned. Results after Week 172 and beyond cannot be interpreted meaningfully due to low number of evaluable patients at these visits.
Posted
Number
Number of participants
Week 172
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
OG002
Placebo-AIN457 150mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re- randomized to AIN457 150 mg for the remainder of the study
Secondary
Number of Participants Developing Treatment Emergent Anti-secukinumab Antibodies, Immunogenicity
The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to 8 weeks after last treatment
Posted
Number
Number of participants
Baseline and at Week 12, 24, 52, 100, 148, and 196, 204
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
OG002
Placebo-AIN457 150mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re- randomized to AIN457 150 mg for the remainder of the study
OG003
Placebo-AIN457 300mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study
Time Frame
Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
Description
AE additional description
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
Induction AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing
1
59
29
59
EG001
Induction AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing
3
59
24
59
EG002
Induction Placebo
placebo secukinumab (2 s.c. injections) at each dosing
1
59
22
59
EG003
Entire Any AIN457 150 mg
Includes all patients in the AIN457 150 mg and in the placebo- AIN457 150 mg treatment groups
10
88
70
88
EG004
Entire Any AIN457 300 mg
Includes all patients in the AIN457 300 mg and in the placebo- AIN457 300 mg treatment groups
10
86
74
86
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ACUTE MYOCARDIAL INFARCTION
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG0030 affected88 at risk
EG0041 affected86 at risk
CARDIAC FAILURE CONGESTIVE
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
CARDIO-RESPIRATORY ARREST
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
CORONARY ARTERY DISEASE
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
TACHYCARDIA
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
VERTIGO
Ear and labyrinth disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
CROHN'S DISEASE
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
RECTAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
COMPLICATION ASSOCIATED WITH DEVICE
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
PNEUMONIA INFLUENZAL
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
SEPSIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
SEPTIC VASCULITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
ALCOHOL POISONING
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
HIP FRACTURE
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
PERIORBITAL HAEMATOMA
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
DIABETES MELLITUS
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
INTERVERTEBRAL DISC PROTRUSION
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
LUMBAR SPINAL STENOSIS
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
OSTEOARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
ADENOSQUAMOUS CELL LUNG CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
BASAL CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
BLADDER CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
LYMPHOPROLIFERATIVE DISORDER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
CEREBROVASCULAR ACCIDENT
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
LOSS OF CONSCIOUSNESS
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
SCIATICA
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
POSTMENOPAUSAL HAEMORRHAGE
Reproductive system and breast disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
VAGINAL HAEMORRHAGE
Reproductive system and breast disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
DERMATITIS EXFOLIATIVE
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0021 affected59 at risk
EG003
THROMBOSIS
Vascular disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA (19.1)
Systematic Assessment
EG0002 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG0035 affected88 at risk
EG0040 affected86 at risk
EOSINOPHILIA
Blood and lymphatic system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
ANGINA PECTORIS
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
VERTIGO
Ear and labyrinth disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
BLEPHARITIS
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0021 affected59 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected59 at risk
EG0011 affected59 at risk
EG0021 affected59 at risk
EG003
COLITIS
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
DENTAL CARIES
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0003 affected59 at risk
EG0015 affected59 at risk
EG0021 affected59 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0021 affected59 at risk
EG003
FLATULENCE
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0013 affected59 at risk
EG0021 affected59 at risk
EG003
TOOTHACHE
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0002 affected59 at risk
EG0010 affected59 at risk
EG0021 affected59 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0012 affected59 at risk
EG0020 affected59 at risk
EG003
ASTHENIA
General disorders
MedDRA (19.1)
Systematic Assessment
EG0002 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
FATIGUE
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0021 affected59 at risk
EG003
INJECTION SITE OEDEMA
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
INJECTION SITE PAIN
General disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected59 at risk
EG0021 affected59 at risk
EG003
NON-CARDIAC CHEST PAIN
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
PYREXIA
General disorders
MedDRA (19.1)
Systematic Assessment
EG0002 affected59 at risk
EG0012 affected59 at risk
EG0022 affected59 at risk
EG003
SEASONAL ALLERGY
Immune system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
ABSCESS ORAL
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
ACARODERMATITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0011 affected59 at risk
EG0021 affected59 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
CONJUNCTIVITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
CYSTITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
EAR INFECTION
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
FOLLICULITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0021 affected59 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
GASTROENTERITIS VIRAL
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
LABYRINTHITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0003 affected59 at risk
EG0013 affected59 at risk
EG0025 affected59 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
ORAL HERPES
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
OTITIS MEDIA
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
OTITIS MEDIA BACTERIAL
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
PERIODONTITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
RHINITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0002 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
SKIN BACTERIAL INFECTION
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
STAPHYLOCOCCAL INFECTION
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
TINEA PEDIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
TONGUE FUNGAL INFECTION
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
TONSILLITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0021 affected59 at risk
EG003
TOOTH ABSCESS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
TOOTH INFECTION
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0002 affected59 at risk
EG0010 affected59 at risk
EG0021 affected59 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
VULVOVAGINAL CANDIDIASIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
ARTHROPOD BITE
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
LIGAMENT SPRAIN
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
LIMB INJURY
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
MUSCLE STRAIN
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0021 affected59 at risk
EG003
ROAD TRAFFIC ACCIDENT
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
SKIN ABRASION
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA (19.1)
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
BLOOD PRESSURE INCREASED
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
BLOOD TRIGLYCERIDES INCREASED
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
C-REACTIVE PROTEIN INCREASED
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
HEPATIC ENZYME INCREASED
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
VITAMIN D DECREASED
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
WEIGHT INCREASED
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
DIABETES MELLITUS
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
HYPERCHOLESTEROLAEMIA
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0002 affected59 at risk
EG0011 affected59 at risk
EG0021 affected59 at risk
EG003
HYPERTRIGLYCERIDAEMIA
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
HYPOSIDERAEMIA
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
TYPE 2 DIABETES MELLITUS
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0013 affected59 at risk
EG0020 affected59 at risk
EG003
BURSITIS
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected59 at risk
EG0012 affected59 at risk
EG0020 affected59 at risk
EG003
INTERVERTEBRAL DISC PROTRUSION
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
PSORIATIC ARTHROPATHY
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0021 affected59 at risk
EG003
SPINAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
TENDONITIS
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
MELANOCYTIC NAEVUS
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
SKIN PAPILLOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
SQUAMOUS CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0004 affected59 at risk
EG0010 affected59 at risk
EG0024 affected59 at risk
EG003
MIGRAINE
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
SCIATICA
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
SINUS HEADACHE
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA (19.1)
Systematic Assessment
EG0002 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
GLYCOSURIA
Renal and urinary disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
DYSMENORRHOEA
Reproductive system and breast disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0012 affected59 at risk
EG0021 affected59 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0002 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
NASAL CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0021 affected59 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0002 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
SINUS CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
WHEEZING
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
ACNE
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
ACTINIC KERATOSIS
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0021 affected59 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0021 affected59 at risk
EG003
DERMAL CYST
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
DERMATITIS
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
DERMATITIS CONTACT
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0012 affected59 at risk
EG0020 affected59 at risk
EG003
ECZEMA
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0021 affected59 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0011 affected59 at risk
EG0021 affected59 at risk
EG003
PSORIASIS
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0021 affected59 at risk
EG003
URTICARIA PAPULAR
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected59 at risk
EG0020 affected59 at risk
EG003
HAEMATOMA
Vascular disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected59 at risk
EG0011 affected59 at risk
EG0020 affected59 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA (19.1)
Systematic Assessment
EG0002 affected59 at risk
EG0011 affected59 at risk
EG0021 affected59 at risk
EG003
Since most patients were discontinued from study once secukinumab was commercially available in the respective countries, results beyond week 172 cannot be interpreted meaningfully.
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
Clinical Disclosure Office
Novartis Pharmaceutical
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
1 subjects
2 subjects
0 subjects
0 subjects
0 subjects
0 subjects
FG0040 subjects
Subject / guardian decision
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
Lack of Efficacy
FG0006 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
FG0040 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
0 subjects
0 subjects
1 subjects
FG0040 subjects
Protocol deviation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Lack of Efficacy
FG0007 subjects
FG0016 subjects
FG0023 subjects
FG0030 subjects
FG0040 subjects
Lost to Follow-up
FG0002 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
Study terminated by sponsor
FG00032 subjects
FG00133 subjects
FG00216 subjects
FG00320 subjects
FG0040 subjects
Subject/guardian decision
FG0001 subjects
FG0019 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
Technical Problems
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
0 subjects
0 subjects
0 subjects
FG0040 subjects
Subject / guardian decision
FG0003 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
45.9
± 13.91
20
BG00360
Male
BG00040
BG00138
BG00239
BG003117
Superiority or Other
OG002
Placebo
Patients received placebo secukinumab (2 s.c. injections) at each dosing
Units
Counts
Participants
OG00059
OG00158
OG00259
Title
Denominators
Categories
Title
Measurements
OG00052.5
OG00169
OG0020
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
Fisher Exact
<0.0001
Superiority or Other
OG001
OG002
Fisher Exact
<0.0001
Superiority or Other
Units
Counts
Participants
OG00059
OG00159
OG00259
Title
Denominators
Categories
Feelings about injections
Title
Measurements
OG0001.07± 1.912
OG0010.85± 1.685
OG0020.57± 1.509
Self confidence
Title
Measurements
OG0001.10± 2.331
OG0011.08± 2.197
OG0021.26± 2.009
Satisfaction with self-injection
Title
Measurements
OG0001.64± 2.163
OG0011.62± 2.667
OG0021.32± 2.629
OG003
Placebo-AIN457 300mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study
Units
Counts
Participants
OG00058
OG00156
OG00229
OG00327
Title
Denominators
Categories
Feelings about injections
ParticipantsOG00045
ParticipantsOG00152
ParticipantsOG00225
ParticipantsOG00324
Title
Measurements
OG0000.93± 1.752
OG0011.01± 2.103
OG0020.63± 1.449
OG003
Self-confidence
ParticipantsOG00045
ParticipantsOG00151
ParticipantsOG00225
ParticipantsOG00324
Satisfaction, self-injection
ParticipantsOG00043
ParticipantsOG00150
ParticipantsOG00225
ParticipantsOG00323
OG00059
OG00159
OG00259
Title
Denominators
Categories
Needle stick in a critical area
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
Title
Measurements
OG0000
OG0010
OG0020
Needle stick in non-critical area
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
Title
Measurements
OG000
Any part of the device swallowed
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
Title
Measurements
OG000
Allergic reaction to device material
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
Title
Measurements
OG000
Pain due to bent needle
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
Title
Measurements
OG000
Any breakage of the device
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
Title
Measurements
OG000
Swallowing of material debris observed
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
Title
Measurements
OG000
Any other problem
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
Title
Measurements
OG000
Less than full dose administered
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00259
Title
Measurements
OG000
OG00058
OG00157
OG00259
Title
Denominators
Categories
Title
Measurements
OG000100
OG001100
OG002100
Placebo
Patients received placebo secukinumab (2 s.c. injections) at each dosing
Units
Counts
Participants
OG00059
OG00159
OG00259
Title
Denominators
Categories
Week 12 PASI 50
Title
Measurements
OG00086.4
OG00187.9
OG0025.1
Week 12 PASI 90
Title
Measurements
OG00045.8
OG00160.3
OG0020
Week 12 PASI 100
Title
Measurements
OG0008.5
OG00143.1
OG0020
Placebo-AIN457 150mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re- randomized to AIN457 150 mg for the remainder of the study
OG003
Placebo - AIN457 300 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study
Units
Counts
Participants
OG00059
OG00158
OG00229
OG00327
Title
Denominators
Categories
Week 52 PASI 75
Title
Measurements
OG00071.4
OG00184.6
OG00272.0
OG00396.0
Week 52 PASI 50
Title
Measurements
OG00089.8
OG00196.2
OG00284.0
OG003
Week 52 PASI 90
Title
Measurements
OG00059.2
OG00169.2
OG00264.0
OG003
Week 52 PASI 100
Title
Measurements
OG00036.7
OG00148.1
OG00252.0
OG003
Placebo - AIN457 300 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study
Units
Counts
Participants
OG00059
OG00159
OG00229
OG00327
Title
Denominators
Categories
Title
Measurements
OG00051
OG00171.2
OG00272
OG00392
Units
Counts
Participants
OG00059
OG00159
OG00259
Title
Denominators
Categories
Title
Measurements
OG000-16.33± 8.49
OG001-17.90± 8.74
OG0020.50± 7.22
OG003
Placebo - AIN457 300 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study
Units
Counts
Participants
OG00059
OG00158
OG00229
OG00327
Title
Denominators
Categories
Title
Measurements
OG000-16.9± 8.27
OG001-18.7± 8.48
OG002-15.2± 5.38
OG003-20± 7.96
Units
Counts
Participants
OG00059
OG00158
OG00259
Title
Denominators
Categories
clear
Title
Measurements
OG0006
OG00126
OG0020
almost clear
Title
Measurements
OG00026
OG00117
OG0020
mild
Title
Measurements
OG00012
OG0019
OG0021
moderate
Title
Measurements
OG00014
OG0015
OG00234
severe
Title
Measurements
OG0001
OG0011
OG00224
OG003
Placebo - AIN457 300 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study
Units
Counts
Participants
OG00059
OG00159
OG00229
OG00327
Title
Denominators
Categories
Clear
Title
Measurements
OG00036.7
OG00148.1
OG00252
OG00344
Almost clear
Title
Measurements
OG00014.3
OG00123.1
OG00220
OG003
Mild
Title
Measurements
OG00018.4
OG00119.2
OG0024
OG003
Moderate
Title
Measurements
OG00026.5
OG0019.6
OG00220
OG003
Severe
Title
Measurements
OG0004.1
OG0010
OG0024
OG003
Units
Counts
Participants
OG00059
OG00159
OG00259
Title
Denominators
Categories
Title
Measurements
OG00012.1± 24.03
OG00111.2± 18.02
OG0020.8± 16.12
OG003
Placebo-AIN457 300mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study
Units
Counts
Participants
OG00057
OG00157
OG00229
OG00326
Title
Denominators
Categories
Title
Measurements
OG00011.4± 24.79
OG00113.5± 15.69
OG00212.2± 15.05
OG00319.7± 17.16
Patients received placebo secukinumab (2 s.c. injections) at each dosing
Units
Counts
Participants
OG00056
OG00153
OG00254
Title
Denominators
Categories
Title
Measurements
OG000-78.6(-85.9 to -67.5)
OG001-85.0(-90.9 to -77.7)
OG002-16.7(-25.3 to -3.0)
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re- randomized to AIN457 150 mg for the remainder of the study
OG003
Placebo-AIN457 300mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study
Units
Counts
Participants
OG00057
OG00156
OG00229
OG00326
Title
Denominators
Categories
Title
Measurements
OG000-71.4(-83.3 to -61.9)
OG001-90.5(-95.7 to -84.2)
OG002-91.7(-100 to -81.7)
OG003-97.2(-100 to -83.3)
Units
Counts
Participants
OG00057
OG00153
OG00254
Title
Denominators
Categories
Title
Measurements
OG00054.4
OG00154.7
OG0027.4
OG003
Placebo-AIN457 300mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study
Units
Counts
Participants
OG00028
OG00135
OG00218
OG00320
Title
Denominators
Categories
Title
Measurements
OG00048.3
OG00162.5
OG00262.1
OG00376.9
OG002
Placebo-AIN457 150mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re- randomized to AIN457 150 mg for the remainder of the study
OG003
Placebo - AIN457 300 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study
Units
Counts
Participants
OG00059
OG00159
OG00229
OG00327
Title
Denominators
Categories
Week 172 PASI 75
ParticipantsOG00027
ParticipantsOG00132
ParticipantsOG00213
ParticipantsOG00319
Title
Measurements
OG00026
OG00125
OG0029
OG003
Week 172 PASI 50
ParticipantsOG00027
ParticipantsOG00132
ParticipantsOG00213
ParticipantsOG00319
Week 172 PASI 90
ParticipantsOG00027
ParticipantsOG00132
ParticipantsOG00213
ParticipantsOG00319
Week 172 PASI 100
ParticipantsOG00027
ParticipantsOG00132
ParticipantsOG00213
ParticipantsOG00319
OG003
Placebo - AIN457 300 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study
Units
Counts
Participants
OG00027
OG00132
OG00213
OG00319
Title
Denominators
Categories
Title
Measurements
OG000-18± 6.97
OG001-18.7± 8.36
OG002-14.7± 5.97
OG003-19.4± 9.02
OG003
Placebo - AIN457 300 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study
Units
Counts
Participants
OG00059
OG00159
OG00229
OG00327
Title
Denominators
Categories
Clear
ParticipantsOG00027
ParticipantsOG00132
ParticipantsOG00213
ParticipantsOG00319
Title
Measurements
OG0007
OG00115
OG0027
OG003
Almost clear
ParticipantsOG00027
ParticipantsOG00132
ParticipantsOG00213
ParticipantsOG00319
Mild
ParticipantsOG00027
ParticipantsOG00132
ParticipantsOG00213
ParticipantsOG00319
Moderate
ParticipantsOG00027
ParticipantsOG00132
ParticipantsOG00213
ParticipantsOG00319
Severe
ParticipantsOG00027
ParticipantsOG00132
ParticipantsOG00213
ParticipantsOG00319
OG004
Placebo
Patients received placebo secukinumab (2 s.c. injections) at each dosing