Efficacy and Safety of Subcutaneous Secukinumab for Moder... | NCT01365455 | Trialant
NCT01365455
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Jan 5, 2021Actual
Enrollment
738Actual
Phase
Phase 3
Conditions
Moderate to Severe Plaque-type Psoriasis
Interventions
secukinumab 150 mg
placebo to secukinumab 150 mg
Countries
United States
Argentina
Canada
Colombia
Estonia
Iceland
Israel
Japan
Latvia
Lithuania
Mexico
Taiwan
Protocol Section
Identification Module
NCT ID
NCT01365455
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CAIN457A2302
Secondary IDs
ID
Type
Description
Link
2010-023512-13
EudraCT Number
Brief Title
Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year
Official Title
A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Acronym
ERASURE
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Mar 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 2011
Primary Completion Date
Apr 2013Actual
Completion Date
Apr 2013Actual
First Submitted Date
Jun 1, 2011
First Submission Date that Met QC Criteria
Jun 2, 2011
First Posted Date
Jun 3, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 16, 2015
Results First Submitted that Met QC Criteria
May 7, 2015
Results First Posted Date
May 29, 2015Estimated
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
Dec 9, 2020
Last Update Posted Date
Jan 5, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This study will assess the safety and efficacy of secukinumab compared to placebo in patients that have moderate to severe, chronic, plaque-type psoriasis.
Detailed Description
Not provided
Conditions Module
Conditions
Moderate to Severe Plaque-type Psoriasis
Keywords
Psoriasis
plaque
plaque-type psoriasis
IL-17 blocker
subcutaneous
psoriatic arthritis
injection
AIN457
AIN457A
secukinumab
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
738Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
AIN457 150 mg
Experimental
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
Drug: secukinumab 150 mg
Drug: placebo to secukinumab 150 mg
AIN457 300 mg
Experimental
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
Drug: secukinumab 150 mg
Drug: placebo to secukinumab 150 mg
placebo
Placebo Comparator
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Drug: placebo to secukinumab 150 mg
AIN457 150mg from Placebo
Experimental
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
secukinumab 150 mg
Drug
secukinumab (AIN457) 150mg or 300mg subcutaneous
AIN457 150 mg
AIN457 150mg from Placebo
AIN457 300 mg
AIN457 300mg from Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Achieved >75 or Higher (Psoriasis Area and Severity Index) PASI Score at 12 Weeks
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. 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).
12 weeks
Percentage of Participants Who Achieved (Investigator's Global Assessment) IGA Score of 0 or 1
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. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1. IGA score of 0 or 1 as an indicator of efficacy.
12 weeks
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Achieved a PASI (Psoriasis Area and Severity Index) Score of 90 or Better at Week 12
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 90 was defined as participants who achievied ≥ 90% improvement from baseline.
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.
Subjects not willing to limit UV light exposure during the study 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.
Not all patients that completed Maintenance Period continued in the follow-up Period. Many patients from Maintence rolled into CAIN457A2302E1 study
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Drug: secukinumab 150 mg
Drug: placebo to secukinumab 150 mg
placebo to secukinumab 150 mg
Drug
Placebo to Match secukinumab (AIN457) 150mg or 300mg subcutaneous
AIN457 150 mg
AIN457 150mg from Placebo
AIN457 300 mg
AIN457 300mg from Placebo
placebo
12 weeks
Number of Participants That Maintained the Psoriasis Area and Severity Index (PASI) 75 Response at 52 Weeks of Treatment for Participants Who Were PASI 75 Responders at Week 12
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).
12 and 52 weeks
Number of Participants That Maintained the IGA Mod 2011 0 or 1 Response at 52 Weeks of Treatment for Participants Who Were IGA Mod 2011 0 or 1 Responders at Week 12
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. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
12 and 52 weeks
Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
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 (max). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Week 1,2,3,4,8,12,
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to 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 (max). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Week 13,14,15,16,20,24,28,32,36,40,44,48,52
Mean Percent Change From Baseline in PASI Scores up to Week 12 - Induction Period
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.
Baseline, Week 1,2,3,4,8,12,
Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to 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). A negative mean percentage change indicates improvement.
Week 13,14,15,16,20,24,28,32,36,40,44,48,52
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
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.
Baseline, Week 1,2,3,4,8,12,
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
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 13,14,15,16,20,24,28,32,36,40,44,48,52
Time to PASI 75 Response up to 12 Weeks
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 (max). 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 75 was defined as participants achieving ≥ 75% improvement from baseline.
Week 12
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Induction Period
The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.
Baseline, Week 4,8, 12
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Maintenance Period
The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.
Week 12, 24, 36, 52
Percentage Changes in the Dermatology Life Quality Index (DLQI) During Induction Period
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Baseline, Week 4, 8 & 12
Percentage Changes in the Dermatology Life Quality Index (DLQI) During Maintenance Period
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Week 12,24, 36 & 52
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Induction Period
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Week 4, 8, 12
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Maintenance Period
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Week 12,24,36, & 52
Percentage of Participants Achieving PASI 75, PASI 90 and IGA Mod 2011 0 or 1 Response at Week 12 by Previous Exposure to Biologic Systemic Therapy or Anti-TNF-α Therapy and Failed to Respond to a Previous Biologic or Anti-TNF-α Therapy Psoriasis Therapy
PASI is an assessment of lesion severity & affected area into a single score:0(no disease)to 72(max. disease).Body is divided into 4 areas for scoring(head,arms,trunk,legs)each area is scored separately & then added for final PASI.For each area, % of skin involved is estimated:0(0%)to 6(90-100%)& severity is estimated by clinical signs, erythema,induration & desquamation;scale 0(none) to 4(max). 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 75, 90 is patients achieving≥75%or90% improvement from baseline.The IGA mod 2011 scale is static, exclusively to the patients disease at assessment,& not with any of the patient's previous disease states at other visits.The scores are:0=clear,1=almost clear,2= mild,3=moderate&4=severe.Response variables PASI 75,90, IGA mod 2011 0 or 1 response at wk 12 was scored versus previous psoriasis systemic therapy & response to previous biologic systemic therapy by treatment
Week 12
Number of Participants Who Developed Anti-secukinumab Antibodies
The development of anti-secunimubab anti-bodies would decrease a participant's ability to respond to secukinumab treatment.
Week 12
Birmingham
Alabama
35233
United States
Novartis Investigative Site
Phoenix
Arizona
85032
United States
Novartis Investigative Site
Los Angeles
California
90045
United States
Novartis Investigative Site
Oceanside
California
92056
United States
Novartis Investigative Site
Pasadena
California
91105
United States
Novartis Investigative Site
San Diego
California
92123
United States
Novartis Investigative Site
Colorado Springs
Colorado
80915
United States
Novartis Investigative Site
Boca Raton
Florida
33486
United States
Novartis Investigative Site
Snellville
Georgia
30078
United States
Novartis Investigative Site
Evansville
Indiana
47713
United States
Novartis Investigative Site
Topeka
Kansas
66606
United States
Novartis Investigative Site
Louisville
Kentucky
40202
United States
Novartis Investigative Site
Louisville
Kentucky
40291
United States
Novartis Investigative Site
Ann Arbor
Michigan
48103
United States
Novartis Investigative Site
Ann Arbor
Michigan
48109
United States
Novartis Investigative Site
Omaha
Nebraska
68144
United States
Novartis Investigative Site
New York
New York
10029
United States
Novartis Investigative Site
Rochester
New York
14623
United States
Novartis Investigative Site
Oregon City
Oregon
97045
United States
Novartis Investigative Site
Portland
Oregon
97210
United States
Novartis Investigative Site
Portland
Oregon
97223
United States
Novartis Investigative Site
Duncansville
Pennsylvania
16635
United States
Novartis Investigative Site
Philadelphia
Pennsylvania
19104
United States
Novartis Investigative Site
Charleston
South Carolina
29407
United States
Novartis Investigative Site
Nashville
Tennessee
37203
United States
Novartis Investigative Site
Austin
Texas
78759
United States
Novartis Investigative Site
Bryan
Texas
77802
United States
Novartis Investigative Site
Dallas
Texas
75231
United States
Novartis Investigative Site
Dallas
Texas
75246-1613
United States
Novartis Investigative Site
Houston
Texas
77030
United States
Novartis Investigative Site
San Antonio
Texas
78229
United States
Novartis Investigative Site
Salt Lake City
Utah
84117
United States
Novartis Investigative Site
Norfolk
Virginia
23507
United States
Novartis Investigative Site
CABA
Buenos Aires
C1122AAF
Argentina
Novartis Investigative Site
CABA
Buenos Aires
C1181ACH
Argentina
Novartis Investigative Site
CABA
Buenos Aires
C1425AWC
Argentina
Novartis Investigative Site
Mendoza
M5502EZA
Argentina
Novartis Investigative Site
Moncton
New Brunswick
E1C 8X3
Canada
Novartis Investigative Site
Hamilton
Ontario
L8N 1V6
Canada
Novartis Investigative Site
Peterborough
Ontario
K9J 5K2
Canada
Novartis Investigative Site
Waterloo
Ontario
N2J 1C4
Canada
Novartis Investigative Site
Montreal
Quebec
H3H 1V4
Canada
Novartis Investigative Site
Barranquilla
Atlántico
Colombia
Novartis Investigative Site
Barranquilla
Colombia
Novartis Investigative Site
Bogotá
Colombia
Novartis Investigative Site
Bucaramanga
Colombia
Novartis Investigative Site
Tallinn
10138
Estonia
Novartis Investigative Site
Tallinn
10617
Estonia
Novartis Investigative Site
Tallinn
13419
Estonia
Novartis Investigative Site
Tartu
51014
Estonia
Novartis Investigative Site
Kopavogur
IS-201
Iceland
Novartis Investigative Site
Afula
18101
Israel
Novartis Investigative Site
Petah Tikva
49100
Israel
Novartis Investigative Site
Ramat Gan
52621
Israel
Novartis Investigative Site
Nagoya
Aichi-ken
467-8602
Japan
Novartis Investigative Site
Fukuoka
Fukuoka
814-0180
Japan
Novartis Investigative Site
Kurume
Fukuoka
830-0011
Japan
Novartis Investigative Site
Maebashi
Gunma
371-8511
Japan
Novartis Investigative Site
Asahikawa
Hokkaido
078-8510
Japan
Novartis Investigative Site
Sapporo
Hokkaido
060-0063
Japan
Novartis Investigative Site
Kobe
Hyōgo
654-0155
Japan
Novartis Investigative Site
Inashiki-gun
Ibaraki
300-0395
Japan
Novartis Investigative Site
Isehara
Kanagawa
259-1193
Japan
Novartis Investigative Site
Kawasaki
Kanagawa
213-8507
Japan
Novartis Investigative Site
Sagamihara
Kanagawa
228-8522
Japan
Novartis Investigative Site
Bunkyo-ku
Tokyo
113-8655
Japan
Novartis Investigative Site
Chiyoda-ku
Tokyo
102-8798
Japan
Novartis Investigative Site
Minato-ku
Tokyo
105-8471
Japan
Novartis Investigative Site
Shinagawa-ku
Tokyo
141-8625
Japan
Novartis Investigative Site
Shinjuku-ku
Tokyo
160-0023
Japan
Novartis Investigative Site
Shinjuku-ku
Tokyo
160-8582
Japan
Novartis Investigative Site
Kyoto
602-8566
Japan
Novartis Investigative Site
Daugavpils
LV-5404
Latvia
Novartis Investigative Site
Riga
1012
Latvia
Novartis Investigative Site
Riga
LV-1001
Latvia
Novartis Investigative Site
Ventspils
LV-3601
Latvia
Novartis Investigative Site
Kaunas
50009
Lithuania
Novartis Investigative Site
Klaipėda
92304
Lithuania
Novartis Investigative Site
Vilnius
LT-07195
Lithuania
Novartis Investigative Site
Vilnius
LT-08661
Lithuania
Novartis Investigative Site
Zapopan
Jalisco
45190
Mexico
Novartis Investigative Site
Mexico City
Mexico City
06780
Mexico
Novartis Investigative Site
Mexico City
Mexico City
14050
Mexico
Novartis Investigative Site
Monterrey
Nuevo León
64460
Mexico
Novartis Investigative Site
Hsinchu
Taiwan
Taiwan
Novartis Investigative Site
Taichung
40447
Taiwan
Novartis Investigative Site
Taipei
10002
Taiwan
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.
Dehlin M, Fasth AER, Reinhardt M, Jacobsson LTH. Impact of psoriasis disease activity and other risk factors on serum urate levels in patients with psoriasis and psoriatic arthritis-a post-hoc analysis of pooled data from three phase 3 trials with secukinumab. Rheumatol Adv Pract. 2021 Feb 18;5(1):rkab009. doi: 10.1093/rap/rkab009. eCollection 2021.
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.
Gottlieb AB, Langley RG, Philipp S, Sigurgeirsson B, Blauvelt A, Martin R, Papavassilis C, Mpofu S. Secukinumab Improves Physical Function in Subjects With Plaque Psoriasis and Psoriatic Arthritis: Results from Two Randomized, Phase 3 Trials. J Drugs Dermatol. 2015 Aug;14(8):821-33.
Ohtsuki M, Morita A, Abe M, Takahashi H, Seko N, Karpov A, Shima T, Papavassilis C, Nakagawa H; ERASURE Study Japanese subgroup. Secukinumab efficacy and safety in Japanese patients with moderate-to-severe plaque psoriasis: subanalysis from ERASURE, a randomized, placebo-controlled, phase 3 study. J Dermatol. 2014 Dec;41(12):1039-46. doi: 10.1111/1346-8138.12668. Epub 2014 Oct 30.
Langley RG, Elewski BE, Lebwohl M, Reich K, Griffiths CE, Papp K, Puig L, Nakagawa H, Spelman L, Sigurgeirsson B, Rivas E, Tsai TF, Wasel N, Tyring S, Salko T, Hampele I, Notter M, Karpov A, Helou S, Papavassilis C; ERASURE Study Group; FIXTURE Study Group. Secukinumab in plaque psoriasis--results of two phase 3 trials. N Engl J Med. 2014 Jul 24;371(4):326-38. doi: 10.1056/NEJMoa1314258. Epub 2014 Jul 9.
FG001
AIN457 300 mg
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
FG002
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
FG003
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
FG004
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
FG000245 subjects
FG001245 subjects
FG002248 subjects
FG0030 subjects
FG0040 subjects
COMPLETED
FG000230 subjects
FG001238 subjects
FG002232 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG00015 subjects
FG0017 subjects
FG00216 subjects
FG0030 subjects
FG0040 subjects
Type
Comment
Reasons
Adverse Event
FG0005 subjects
FG0013 subjects
FG0024 subjects
FG0030 subjects
FG0040 subjects
Lack of Efficacy
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Pregnancy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol deviation
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Subject/guardian decision
FG0009 subjects
FG0011 subjects
FG0028 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG004
Maintenance Period
Type
Comment
Milestone Data
STARTED
FG000230 subjects
FG001238 subjects
FG00218 subjects
FG003109 subjects
FG004105 subjects
COMPLETED
FG000201 subjects
FG001215 subjects
FG00215 subjects
FG003100 subjects
FG004
NOT COMPLETED
FG00029 subjects
FG00123 subjects
FG0023 subjects
FG0039 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG00012 subjects
FG0015 subjects
FG0021 subjects
FG003
Follow-up Period
Type
Comment
Milestone Data
STARTED
FG00058 subjects
FG00147 subjects
FG00218 subjects
FG0030 subjects
FG0040 subjects
COMPLETED
FG00058 subjects
FG00147 subjects
FG00218 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
BG001
AIN457 300 mg
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
BG002
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000245
BG001245
BG002248
BG003738
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
BG00044.9± 13.33
BG00144.9± 13.46
BG00245.4± 12.63
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00077
BG00176
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Who Achieved >75 or Higher (Psoriasis Area and Severity Index) PASI Score at 12 Weeks
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. 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).
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Posted
Number
Percentage of participants
12 weeks
ID
Title
Description
OG000
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG001
AIN457 300 mg
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG002
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Units
Counts
Participants
OG000243
OG001245
OG002246
Title
Denominators
Categories
Title
Measurements
OG00071.6
OG00181.6
OG0024.5
Primary
Percentage of Participants Who Achieved (Investigator's Global Assessment) IGA Score of 0 or 1
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. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1. IGA score of 0 or 1 as an indicator of efficacy.
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Posted
Number
Percentage of Participants
12 weeks
ID
Title
Description
OG000
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG001
AIN457 300 mg
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
Secondary
Percentage of Participants Who Achieved a PASI (Psoriasis Area and Severity Index) Score of 90 or Better at Week 12
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 90 was defined as participants who achievied ≥ 90% improvement from baseline.
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Posted
Number
Percentage of Participants
12 weeks
ID
Title
Description
OG000
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG001
AIN457 300 mg
Secondary
Number of Participants That Maintained the Psoriasis Area and Severity Index (PASI) 75 Response at 52 Weeks of Treatment for Participants Who Were PASI 75 Responders at Week 12
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).
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Posted
Number
number of participants
12 and 52 weeks
ID
Title
Description
OG000
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG001
AIN457 300 mg
Secondary
Number of Participants That Maintained the IGA Mod 2011 0 or 1 Response at 52 Weeks of Treatment for Participants Who Were IGA Mod 2011 0 or 1 Responders at Week 12
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. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Posted
Number
number of participants
12 and 52 weeks
ID
Title
Description
OG000
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG001
AIN457 300 mg
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
Secondary
Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Posted
Mean
Standard Error
Scores on a Scale
Week 12
ID
Title
Description
OG000
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
Secondary
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
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 (max). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Posted
Number
Percentage of participants
Week 1,2,3,4,8,12,
ID
Title
Description
OG000
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
Secondary
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to 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 (max). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Posted
Number
Percentage of participants
Week 13,14,15,16,20,24,28,32,36,40,44,48,52
ID
Title
Description
OG000
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
Secondary
Mean Percent Change From Baseline in PASI Scores up to Week 12 - Induction Period
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Posted
Mean
Standard Deviation
Percent Change
Baseline, Week 1,2,3,4,8,12,
ID
Title
Description
OG000
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG001
AIN457 300 mg
Secondary
Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to 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). A negative mean percentage change indicates improvement.
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Posted
Mean
Standard Deviation
Percent change
Week 13,14,15,16,20,24,28,32,36,40,44,48,52
ID
Title
Description
OG000
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG001
AIN457 300 mg
Secondary
Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
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): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Posted
Number
Percentage of participants
Baseline, Week 1,2,3,4,8,12,
ID
Title
Description
OG000
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG001
AIN457 300 mg
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
Secondary
Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
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): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Posted
Number
Percentage of participants
Week 13,14,15,16,20,24,28,32,36,40,44,48,52
ID
Title
Description
OG000
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG001
AIN457 300 mg
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
Secondary
Time to PASI 75 Response up to 12 Weeks
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 (max). 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 75 was defined as participants achieving ≥ 75% improvement from baseline.
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Posted
Median
Inter-Quartile Range
days
Week 12
ID
Title
Description
OG000
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG001
AIN457 300 mg
Secondary
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Induction Period
The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Posted
Mean
Standard Deviation
percent change
Baseline, Week 4,8, 12
ID
Title
Description
OG000
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG001
AIN457 300 mg
Secondary
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Maintenance Period
The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Posted
Mean
Standard Deviation
Percent Change
Week 12, 24, 36, 52
ID
Title
Description
OG000
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG001
AIN457 300 mg
Secondary
Percentage Changes in the Dermatology Life Quality Index (DLQI) During Induction Period
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Posted
Median
95% Confidence Interval
Percent Change
Baseline, Week 4, 8 & 12
ID
Title
Description
OG000
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
Secondary
Percentage Changes in the Dermatology Life Quality Index (DLQI) During Maintenance Period
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Posted
Median
95% Confidence Interval
Percent Change
Week 12,24, 36 & 52
ID
Title
Description
OG000
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
Secondary
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Induction Period
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Posted
Number
Percentage of Participants
Week 4, 8, 12
ID
Title
Description
OG000
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
Secondary
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Maintenance Period
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Posted
Number
Percentage of Participants
Week 12,24,36, & 52
ID
Title
Description
OG000
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
Secondary
Percentage of Participants Achieving PASI 75, PASI 90 and IGA Mod 2011 0 or 1 Response at Week 12 by Previous Exposure to Biologic Systemic Therapy or Anti-TNF-α Therapy and Failed to Respond to a Previous Biologic or Anti-TNF-α Therapy Psoriasis Therapy
PASI is an assessment of lesion severity & affected area into a single score:0(no disease)to 72(max. disease).Body is divided into 4 areas for scoring(head,arms,trunk,legs)each area is scored separately & then added for final PASI.For each area, % of skin involved is estimated:0(0%)to 6(90-100%)& severity is estimated by clinical signs, erythema,induration & desquamation;scale 0(none) to 4(max). 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 75, 90 is patients achieving≥75%or90% improvement from baseline.The IGA mod 2011 scale is static, exclusively to the patients disease at assessment,& not with any of the patient's previous disease states at other visits.The scores are:0=clear,1=almost clear,2= mild,3=moderate&4=severe.Response variables PASI 75,90, IGA mod 2011 0 or 1 response at wk 12 was scored versus previous psoriasis systemic therapy & response to previous biologic systemic therapy by treatment
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
OG000
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
Secondary
Number of Participants Who Developed Anti-secukinumab Antibodies
The development of anti-secunimubab anti-bodies would decrease a participant's ability to respond to secukinumab treatment.
Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.
Posted
Number
participants
Week 12
ID
Title
Description
OG000
AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG001
AIN457 300 mg
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG002
Placebo
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
INDUCTION-AIN457 150mg
INDUCTION-AIN457 150mg
4
245
108
245
EG001
INDUCTION-AIN457 300mg
INDUCTION-AIN457 300mg
6
245
102
245
EG002
INDUCTION-Placebo
INDUCTION-Placebo
4
247
77
247
EG003
ENTIRE-AIN457 150mg
ENTIRE-AIN457 150mg
15
245
172
245
EG004
ENTIRE-AIN457 300mg
ENTIRE-AIN457 300mg
17
245
161
245
EG005
ENTIRE-Any AIN457 150mg
ENTIRE-Any AIN457 150mg
19
353
228
353
EG006
ENTIRE-Any AIN457 300mg
ENTIRE-Any AIN457 300mg
19
349
229
349
EG007
ENTIRE-Placebo
ENTIRE-Placebo
5
247
85
247
EG008
FOLLOW UP-Any AIN457 150mg
FOLLOW UP-Any AIN457 150mg
1
58
8
58
EG009
FOLLOW UP-Any AIN457 300mg
FOLLOW UP-Any AIN457 300mg
1
47
8
47
EG010
FOLLOW UP-Placebo
FOLLOW UP-Placebo
0
18
5
18
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
HAEMORRHAGIC ANAEMIA
Blood and lymphatic system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG0031 affected245 at risk
EG0040 affected245 at risk
EG0051 affected353 at risk
EG0060 affected349 at risk
EG0070 affected247 at risk
EG0080 affected58 at risk
EG0090 affected47 at risk
EG0100 affected18 at risk
LYMPHADENOPATHY
Blood and lymphatic system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
ANGINA UNSTABLE
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
ARRHYTHMIA
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
CARDIAC FAILURE
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
CORONARY ARTERY DISEASE
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
MYOCARDIAL INFARCTION
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
SUDDEN HEARING LOSS
Ear and labyrinth disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
ABDOMINAL HERNIA OBSTRUCTIVE
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
COLITIS ULCERATIVE
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0011 affected245 at risk
EG0020 affected247 at risk
EG003
GASTRITIS
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
INTESTINAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
PANCREATITIS
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
ASTHENIA
General disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
HERNIA
General disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
NON-CARDIAC CHEST PAIN
General disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0021 affected247 at risk
EG003
CHOLECYSTITIS
Hepatobiliary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
CHOLELITHIASIS
Hepatobiliary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0011 affected245 at risk
EG0020 affected247 at risk
EG003
BACTERAEMIA
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0021 affected247 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
PYELONEPHRITIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
UROSEPSIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
COMMINUTED FRACTURE
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
CONCUSSION
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
LARYNGEAL INJURY
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0011 affected245 at risk
EG0020 affected247 at risk
EG003
MULTIPLE INJURIES
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
PELVIC FRACTURE
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
PULMONARY CONTUSION
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
RADIUS FRACTURE
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
RIB FRACTURE
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
TOXICITY TO VARIOUS AGENTS
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
WOUND
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
ELECTROLYTE IMBALANCE
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
HYPOALBUMINAEMIA
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
HYPOPROTEINAEMIA
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
TYPE 2 DIABETES MELLITUS
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
BURSITIS
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0011 affected245 at risk
EG0020 affected247 at risk
EG003
BASAL CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0001 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
BENIGN NEOPLASM OF SKIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
BLADDER CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0001 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
FOLLICULAR THYROID CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
THYROID CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
UTERINE LEIOMYOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0011 affected245 at risk
EG0020 affected247 at risk
EG003
CAROTID ARTERY DISSECTION
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
CEREBROVASCULAR ACCIDENT
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
ISCHAEMIC STROKE
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
ALCOHOL WITHDRAWAL SYNDROME
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0021 affected247 at risk
EG003
HALLUCINATION, AUDITORY
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
MENTAL STATUS CHANGES
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
PANIC ATTACK
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0021 affected247 at risk
EG003
NEPHROLITHIASIS
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
OBSTRUCTIVE UROPATHY
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
RENAL FAILURE ACUTE
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0011 affected245 at risk
EG0020 affected247 at risk
EG003
PNEUMOTHORAX
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
PULMONARY MASS
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
PULMONARY OEDEMA
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
PSORIASIS
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0021 affected247 at risk
EG003
ABORTION INDUCED
Surgical and medical procedures
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
AORTIC ANEURYSM
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
AORTIC THROMBOSIS
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
HYPERTENSIVE CRISIS
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
LYMPHADENOPATHY
Blood and lymphatic system disorders
MedDRA 16.0
Systematic Assessment
EG0002 affected245 at risk
EG0013 affected245 at risk
EG0020 affected247 at risk
EG0036 affected245 at risk
EG0043 affected245 at risk
EG0056 affected353 at risk
EG0063 affected349 at risk
EG0070 affected247 at risk
EG0080 affected58 at risk
EG0090 affected47 at risk
EG0100 affected18 at risk
SUPRAVENTRICULAR TACHYCARDIA
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected245 at risk
EG0011 affected245 at risk
EG0021 affected247 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0004 affected245 at risk
EG0015 affected245 at risk
EG0023 affected247 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected245 at risk
EG0011 affected245 at risk
EG0020 affected247 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0013 affected245 at risk
EG0020 affected247 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0006 affected245 at risk
EG0011 affected245 at risk
EG0026 affected247 at risk
EG003
TOOTHACHE
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0003 affected245 at risk
EG0012 affected245 at risk
EG0022 affected247 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0002 affected245 at risk
EG0015 affected245 at risk
EG0022 affected247 at risk
EG003
FATIGUE
General disorders
MedDRA 16.0
Systematic Assessment
EG0008 affected245 at risk
EG0012 affected245 at risk
EG0022 affected247 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA 16.0
Systematic Assessment
EG0003 affected245 at risk
EG0015 affected245 at risk
EG0023 affected247 at risk
EG003
ABSCESS LIMB
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0001 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0002 affected245 at risk
EG0013 affected245 at risk
EG0021 affected247 at risk
EG003
FOLLICULITIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0004 affected245 at risk
EG0012 affected245 at risk
EG0022 affected247 at risk
EG003
FURUNCLE
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0001 affected245 at risk
EG0012 affected245 at risk
EG0020 affected247 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0001 affected245 at risk
EG0012 affected245 at risk
EG0021 affected247 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0004 affected245 at risk
EG0011 affected245 at risk
EG0022 affected247 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG00023 affected245 at risk
EG00122 affected245 at risk
EG00219 affected247 at risk
EG003
ORAL HERPES
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0013 affected245 at risk
EG0022 affected247 at risk
EG003
OTITIS MEDIA
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0013 affected245 at risk
EG0021 affected247 at risk
EG003
PERIODONTITIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0002 affected245 at risk
EG0011 affected245 at risk
EG0021 affected247 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0002 affected245 at risk
EG0013 affected245 at risk
EG0020 affected247 at risk
EG003
RHINITIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0002 affected245 at risk
EG0012 affected245 at risk
EG0021 affected247 at risk
EG003
TINEA PEDIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0002 affected245 at risk
EG0012 affected245 at risk
EG0020 affected247 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG00010 affected245 at risk
EG0019 affected245 at risk
EG0020 affected247 at risk
EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0002 affected245 at risk
EG0014 affected245 at risk
EG0022 affected247 at risk
EG003
VULVOVAGINAL MYCOTIC INFECTION
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0002 affected245 at risk
EG0015 affected245 at risk
EG0021 affected247 at risk
EG003
EXCORIATION
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0002 affected245 at risk
EG0012 affected245 at risk
EG0020 affected247 at risk
EG003
LIGAMENT SPRAIN
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0001 affected245 at risk
EG0011 affected245 at risk
EG0020 affected247 at risk
EG003
MUSCLE STRAIN
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0003 affected245 at risk
EG0014 affected245 at risk
EG0020 affected247 at risk
EG003
BLOOD CREATININE INCREASED
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0021 affected247 at risk
EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
HYPERLIPIDAEMIA
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected245 at risk
EG0013 affected245 at risk
EG0022 affected247 at risk
EG003
HYPERTRIGLYCERIDAEMIA
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0011 affected245 at risk
EG0020 affected247 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0006 affected245 at risk
EG0012 affected245 at risk
EG0027 affected247 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0003 affected245 at risk
EG0012 affected245 at risk
EG0024 affected247 at risk
EG003
INTERVERTEBRAL DISC PROTRUSION
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected245 at risk
EG0011 affected245 at risk
EG0024 affected247 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0003 affected245 at risk
EG0014 affected245 at risk
EG0022 affected247 at risk
EG003
PSORIATIC ARTHROPATHY
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected245 at risk
EG0010 affected245 at risk
EG0023 affected247 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG00013 affected245 at risk
EG00112 affected245 at risk
EG0027 affected247 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0011 affected245 at risk
EG0020 affected247 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0003 affected245 at risk
EG0010 affected245 at risk
EG0020 affected247 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0002 affected245 at risk
EG0014 affected245 at risk
EG0023 affected247 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG00010 affected245 at risk
EG0014 affected245 at risk
EG0023 affected247 at risk
EG003
RHINITIS ALLERGIC
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0013 affected245 at risk
EG0020 affected247 at risk
EG003
DERMATITIS CONTACT
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected245 at risk
EG0012 affected245 at risk
EG0021 affected247 at risk
EG003
ECZEMA
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0002 affected245 at risk
EG0013 affected245 at risk
EG0020 affected247 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0009 affected245 at risk
EG00111 affected245 at risk
EG0026 affected247 at risk
EG003
PSORIASIS
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0004 affected245 at risk
EG0010 affected245 at risk
EG0027 affected247 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0003 affected245 at risk
EG0013 affected245 at risk
EG0020 affected247 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0009 affected245 at risk
EG0010 affected245 at risk
EG0023 affected247 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Novartis Pharmaceuticals
862-778-8300
ID
Term
D011565
Psoriasis
D058225
Plaque, Amyloid
D015535
Arthritis, Psoriatic
Ancestor Terms
ID
Term
D017444
Skin Diseases, Papulosquamous
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
D020763
Pathological Conditions, Anatomical
D013568
Pathological Conditions, Signs and Symptoms
D025242
Spondylarthropathies
D025241
Spondylarthritis
D013166
Spondylitis
D013122
Spinal Diseases
D001847
Bone Diseases
D009140
Musculoskeletal Diseases
D001168
Arthritis
D007592
Joint Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C555450
secukinumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
0 subjects
0 subjects
0 subjects
0 subjects
92 subjects
13 subjects
2 subjects
FG0044 subjects
Lack of Efficacy
FG00010 subjects
FG0012 subjects
FG0020 subjects
FG0032 subjects
FG0042 subjects
Lost to Follow-up
FG0002 subjects
FG0014 subjects
FG0020 subjects
FG0030 subjects
FG0043 subjects
Non-compliance with study treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
Pregnancy
FG0000 subjects
FG0014 subjects
FG0020 subjects
FG0030 subjects
FG0042 subjects
Protocol deviation
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Subject/guardian decision
FG0004 subjects
FG0016 subjects
FG0022 subjects
FG0034 subjects
FG0041 subjects
0 subjects
0 subjects
45.1
± 13.13
76
BG003229
Male
BG000168
BG001169
BG002172
BG003509
OG002
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Units
Counts
Participants
OG000244
OG001245
OG002246
Title
Denominators
Categories
Title
Measurements
OG00051.2
OG00165.3
OG0022.4
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG002
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Units
Counts
Participants
OG000243
OG001245
OG002246
Title
Denominators
Categories
Title
Measurements
OG00039.1
OG00159.2
OG0021.2
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG002
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Units
Counts
Participants
OG000245
OG001245
OG002248
Title
Denominators
Categories
PASI 75 response at Week 12 (n=243, 245, 246)
Title
Measurements
OG000174
OG001200
OG00211
Maintained PASI 75 response at Wk 52(n=174,200,11)
Title
Measurements
OG000126
OG001161
OG002NAAfter W12: Efficacy was not focus for PBO group and therefore no data was provided at Week 52
OG002
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
OG002NAAfter W12: Efficacy was not focus for PBO group and therefore no data was provided at Week 52
OG001
AIN457 300 mg
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG002
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Units
Counts
Participants
OG000245
OG001245
OG002248
Title
Denominators
Categories
itching (n=86,79,84)
Title
Measurements
OG000-4.86± 0.299
OG001-545± 0.276
OG002-0.22± 0.260
pain (n=86,79,84)
Title
Measurements
OG000-3.92± 0.337
OG001-4.59± 0.322
OG0020.06± 0.246
scaling (n=86,79,84)
Title
Measurements
OG000-4.74± 0.307
OG001-5.49± 0.289
OG002-0.11± 0.248
OG001
AIN457 300 mg
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG002
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Units
Counts
Participants
OG000245
OG001245
OG002247
Title
Denominators
Categories
Week 1 IGA 0/1 (n=244,245,246)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
Week 1 PASI 75 (n=243,245,246)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
Week 1 PASI 50 (n=243,245,246)
Title
Measurements
OG0002.1
OG0014.5
OG0020.4
Week 1 PASI 90 (n=243,245,246)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
Week 1 PASI 100 (n=243,245,246)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
Week 2 IGA 0/1 n=244,245,246)
Title
Measurements
OG0001.2
OG0014.5
OG0020.0
Week 2 PASI 75 (n=243,245,246)
Title
Measurements
OG0000.8
OG0014.1
OG0020.0
Week 2 PASI 50 (n=243,245,246)
Title
Measurements
OG00018.5
OG00128.2
OG0023.3
Week 2 PASI 90 (n=243,245,246)
Title
Measurements
OG0000.0
OG0010.8
OG0020.0
Week 2 PASI 100 (n=243,245,246)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
Week 3 IGA 0/1( n=244,245,246)
Title
Measurements
OG0006.6
OG00111.0
OG0020.4
Week 3 PASI 75 (n=243,245,246)
Title
Measurements
OG0008.2
OG00115.5
OG0021.2
Week 3 PASI 50 (n=243,245,246)
Title
Measurements
OG00041.2
OG00153.1
OG0024.9
Week 3 PASI 90 (n=243,245,246)
Title
Measurements
OG0000.8
OG0012.9
OG0020.0
Week 3 PASI 100 (n=243,245,246)
Title
Measurements
OG0000.0
OG0010.8
OG0020.0
Week 4 IGA 0/1( n=244,245,246)
Title
Measurements
OG00017.2
OG00126.1
OG0021.2
Week 4 PASI 75 (n=243,245,246)
Title
Measurements
OG00024.3
OG00138.0
OG0020.8
Week 4 PASI 50 (n=243,245,246)
Title
Measurements
OG00063.0
OG00174.7
OG0027.3
Week 4 PASI 90 (n=243,245,246)
Title
Measurements
OG0005.8
OG00110.6
OG0020.4
Week 4 PASI 100 (n=243,245,246)
Title
Measurements
OG0000.8
OG0013.7
OG0020.0
Week 8 IGA 0/1( n=244,245,246)
Title
Measurements
OG00042.2
OG00160.0
OG0021.6
Week 8 PASI 75 (n=243,245,246)
Title
Measurements
OG00061.7
OG00176.7
OG0022.8
Week 8 PASI 50 (n=243,245,246)
Title
Measurements
OG00088.5
OG00192.2
OG0029.3
Week 8 PASI 90 (n=243,245,246)
Title
Measurements
OG00028.8
OG00147.8
OG0021.2
Week 8 PASI 100 (n=243,245,246)
Title
Measurements
OG0008.2
OG00116.7
OG0020.0
Week 12 IGA 0/1( n=244,245,246)
Title
Measurements
OG00051.2
OG00165.3
OG0022.4
Week 12 PASI 75 (n=243,245,246)
Title
Measurements
OG00071.6
OG00181.6
OG0024.5
Week 12 PASI 50 (n=243,245,246)
Title
Measurements
OG00083.5
OG00190.6
OG0028.9
Week 12 PASI 90 (n=243,245,246)
Title
Measurements
OG00039.1
OG00159.2
OG0021.2
Week 12 PASI 100 (n=243,245,246)
Title
Measurements
OG00012.8
OG00128.6
OG0020.8
OG001
AIN457 300 mg
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG002
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
OG003
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
OG004
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Units
Counts
Participants
OG000245
OG001245
OG00218
OG003108
OG004105
Title
Denominators
Categories
Week 13 IGA 0/1 (n=244,245,18, 108, 104)
Title
Measurements
OG00051.6
OG00166.9
OG00233.3
OG0030.9
OG0041.9
Week 13 PASI 75 (n=243,245,18, 108, 104)
Title
Measurements
OG00070.8
OG00179.6
OG00255.6
OG003
Week 13 PASI 50 (n=243,245,18, 108, 104)
Title
Measurements
OG00081.5
OG00187.3
OG00277.8
OG003
Week 13 PASI 90 (n=243,245,18, 108, 104)
Title
Measurements
OG00044.9
OG00160.8
OG00222.2
OG003
Week 13 PASI 100 (n=243,245,18, 108, 104)
Title
Measurements
OG00014.0
OG00130.2
OG00211.1
OG003
Week 14 IGA 0/1 (n=244,245,18, 108, 104)
Title
Measurements
OG00055.3
OG00174.7
OG00233.3
OG003
Week 14 PASI 75 (n=243,245,18, 108, 104)
Title
Measurements
OG00072.0
OG00186.1
OG00255.6
OG003
Week 14 PASI 50 (n=243,245,18, 108, 104)
Title
Measurements
OG00083.1
OG00191.4
OG00283.3
OG003
Week 14 PASI 90 (n=243,245,18, 108, 104)
Title
Measurements
OG00048.6
OG00168.2
OG00227.8
OG003
Week 14 PASI 100 (n=243,245,18, 108, 104)
Title
Measurements
OG00016.5
OG00135.5
OG00211.1
OG003
Week 15 IGA 0/1 (n=244,245,18, 108, 104)
Title
Measurements
OG00057.4
OG00175.1
OG00233.3
OG003
Week 15 PASI 75 (n=243,245,18, 108, 104)
Title
Measurements
OG00075.3
OG00187.8
OG00255.6
OG003
Week 15 PASI 50 (n=243,245,18, 108, 104)
Title
Measurements
OG00086.4
OG00192.2
OG00272.2
OG003
Week 15 PASI 90 (n=243,245,18, 108, 104)
Title
Measurements
OG00051.0
OG00168.6
OG00227.8
OG003
Week 15 PASI 100 (n=243,245,18, 108, 104)
Title
Measurements
OG00019.8
OG00140.8
OG00211.1
OG003
Week 16 IGA 0/1 (n=244,245,18, 108, 104)
Title
Measurements
OG00058.2
OG00173.5
OG00238.9
OG003
Week 16 PASI 75 (n=243,245,18, 108, 104)
Title
Measurements
OG00077.4
OG00186.1
OG00261.1
OG003
Week 16 PASI 50 (n=243,245,18, 108, 104)
Title
Measurements
OG00087.2
OG00191.4
OG00277.8
OG003
Week 16 PASI 90 (n=243,245,18, 108, 104)
Title
Measurements
OG00053.5
OG00169.8
OG00233.3
OG003
Week 16 PASI 100 (n=243,245,18, 108, 104)
Title
Measurements
OG00021.0
OG00141.6
OG00222.2
OG003
Week 20 IGA 0/1 (n=244,245,18, 108, 104)
Title
Measurements
OG00057.4
OG00174.7
OG00238.9
OG003
Week 20 PASI 75 (n=243,245,18, 108, 104)
Title
Measurements
OG00077.0
OG00186.9
OG00272.2
OG003
Week 20 PASI 50 (n=243,245,18, 108, 104)
Title
Measurements
OG00089.3
OG00192.7
OG00288.9
OG003
Week 20 PASI 90 (n=243,245,18, 108, 104)
Title
Measurements
OG00051.9
OG00169.8
OG00238.9
OG003
Week 20 PASI 100 (n=243,245,18, 108, 104)
Title
Measurements
OG00021.8
OG00143.3
OG00216.7
OG003
Week 24 IGA 0/1 (n=244,245,18, 108, 104)
Title
Measurements
OG00058.2
OG00171.4
OG00250.0
OG003
Week 24 PASI 75 (n=243,245,18, 108, 104)
Title
Measurements
OG00077.8
OG00185.7
OG00266.7
OG003
Week 24 PASI 50 (n=243,245,18, 108, 104)
Title
Measurements
OG00086.8
OG00191.0
OG00288.9
OG003
Week 24 PASI 90 (n=243,245,18, 108, 104)
Title
Measurements
OG00054.7
OG00170.2
OG00238.9
OG003
Week 24 PASI 100 (n=243,245,18, 108, 104)
Title
Measurements
OG00023.9
OG00142.4
OG00216.7
OG003
Week 28 IGA 0/1 (n=244,245,18, 108, 104)
Title
Measurements
OG00053.7
OG00168.6
OG00250.0
OG003
Week 28 PASI 75 (n=243,245,18, 108, 104)
Title
Measurements
OG00072.4
OG00182.9
OG00272.2
OG003
Week 28 PASI 50 (n=243,245,18, 108, 104)
Title
Measurements
OG00084.4
OG00190.2
OG00283.3
OG003
Week 28 PASI 90 (n=243,245,18, 108, 104)
Title
Measurements
OG00053.1
OG00168.6
OG00250.0
OG003
Week 28 PASI 100 (n=243,245,18, 108, 104)
Title
Measurements
OG00024.3
OG00143.3
OG00216.7
OG003
Week 32 IGA 0/1 (n=244,245,18, 108, 104)
Title
Measurements
OG00050.8
OG00168.2
OG00244.4
OG003
Week 32 PASI 75 (n=243,245,18, 108, 104)
Title
Measurements
OG00072.0
OG00181.2
OG00261.1
OG003
Week 32 PASI 50 (n=243,245,18, 108, 104)
Title
Measurements
OG00086.4
OG00188.6
OG00277.8
OG003
Week 32 PASI 90 (n=243,245,18, 108, 104)
Title
Measurements
OG00048.1
OG00168.2
OG00244.4
OG003
Week 32 PASI 100 (n=243,245,18, 108, 104)
Title
Measurements
OG00022.2
OG00143.7
OG00216.7
OG003
Week 36 IGA 0/1 (n=244,245,18, 108, 104)
Title
Measurements
OG00048.0
OG00166.9
OG00238.9
OG003
Week 36 PASI 75 (n=243,245,18, 108, 104)
Title
Measurements
OG00067.5
OG00179.2
OG00261.1
OG003
Week 36 PASI 50 (n=243,245,18, 108, 104)
Title
Measurements
OG00080.2
OG00186.9
OG00288.9
OG003
Week 36 PASI 90 (n=243,245,18, 108, 104)
Title
Measurements
OG00044.4
OG00167.3
OG00244.4
OG003
Week 36 PASI 100 (n=243,245,18, 108, 104)
Title
Measurements
OG00022.2
OG00142.4
OG00216.7
OG003
Week 40 IGA 0/1 (n=244,245,18, 108, 104)
Title
Measurements
OG00047.1
OG00164.9
OG00244.4
OG003
Week 40 PASI 75 (n=243,245,18, 108, 104)
Title
Measurements
OG00065.4
OG00176.7
OG00266.7
OG003
Week 40 PASI 50 (n=243,245,18, 108, 104)
Title
Measurements
OG00078.6
OG00184.9
OG00283.3
OG003
Week 40 PASI 90 (n=243,245,18, 108, 104)
Title
Measurements
OG00044.0
OG00164.9
OG00244.4
OG003
Week 40 PASI 100 (n=243,245,18, 108, 104)
Title
Measurements
OG00021.0
OG00140.8
OG00227.8
OG003
Week 44 IGA 0/1 (n=244,245,18, 108, 104)
Title
Measurements
OG00044.3
OG00160.4
OG00244.4
OG003
Week 44 PASI 75 (n=243,245,18, 108, 104)
Title
Measurements
OG00063.4
OG00179.2
OG00261.1
OG003
Week 44 PASI 50 (n=243,245,18, 108, 104)
Title
Measurements
OG00077.4
OG00184.5
OG00283.3
OG003
Week 44 PASI 90 (n=243,245,18, 108, 104)
Title
Measurements
OG00042.8
OG00161.2
OG00238.9
OG003
Week 44 PASI 100 (n=243,245,18, 108, 104)
Title
Measurements
OG00021.8
OG00137.1
OG00211.1
OG003
Week 48 IGA 0/1 (n=244,245,18, 108, 104)
Title
Measurements
OG00041.4
OG00162.9
OG00227.8
OG003
Week 48 PASI 75 (n=243,245,18, 108, 104)
Title
Measurements
OG00062.1
OG00177.6
OG00266.7
OG003
Week 48 PASI 50 (n=243,245,18, 108, 104)
Title
Measurements
OG00077.4
OG00184.9
OG00283.3
OG003
Week 48 PASI 90 (n=243,245,18, 108, 104)
Title
Measurements
OG00039.5
OG00163.7
OG00238.9
OG003
Week 48 PASI 100 (n=243,245,18, 108, 104)
Title
Measurements
OG00022.2
OG00140.4
OG00211.1
OG003
Week 52 IGA 0/1 (n=244,245,18, 108, 104)
Title
Measurements
OG00073.4
OG00187.3
OG00238.9
OG003
Week 52 PASI 75 (n=243,245,18, 108, 104)
Title
Measurements
OG00086.8
OG00194.3
OG00266.7
OG003
Week 52 PASI 50(n=243,245,18, 108, 104)
Title
Measurements
OG00091.8
OG00195.9
OG00283.3
OG003
Week 52 PASI 90 (n=243,245,18, 108, 104)
Title
Measurements
OG00073.3
OG00184.5
OG00233.3
OG003
Week 52 PASI 100 (n=243,245,18, 108, 104)
Title
Measurements
OG00041.2
OG00162.0
OG00211.1
OG003
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG002
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Units
Counts
Participants
OG000245
OG001245
OG002247
Title
Denominators
Categories
Week 1 (n=243,243,242)
Title
Measurements
OG000-12.08± 19.225
OG001-17.50± 17.317
OG002-3.70± 14.756
Week 2 (n=243,245,243)
Title
Measurements
OG000-28.61± 21.982
OG001-36.51± 21.850
OG002-5.63± 23.616
Week 3 (n=243,245,243)
Title
Measurements
OG000-42.79± 23.695
OG001-51.59± 22.415
OG002-8.62± 25.785
Week 4 (n=243,245,245)
Title
Measurements
OG000-55.73± 24.252
OG001-64.61± 22.080
OG002-8.89± 28.165
Week 8 (n=243,245,245)
Title
Measurements
OG000-76.35± 20.427
OG001-82.98± 19.331
OG002-8.15± 32.755
Week 12 (n=243,245,245)
Title
Measurements
OG000-80.87± 20.512
OG001-87.72± 17.729
OG002-5.89± 36.606
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG002
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
OG003
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
OG004
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Units
Counts
Participants
OG000245
OG001245
OG00218
OG003108
OG004105
Title
Denominators
Categories
Week 13 (n=243,245,18,102,96)
Title
Measurements
OG000-83.12± 19.313
OG001-89.55± 15.935
OG002-63.10± 36.827
OG003-21.03± 28.240
OG004-21.66± 29.891
Week 14 (n=243,245,18,107,102)
Title
Measurements
OG000-84.47± 18.832
OG001-90.83± 15.013
OG002-68.74± 30.225
OG003
Week 15 (n=243,245,18,107,103)
Title
Measurements
OG000-84.67± 19.407
OG001-91.40± 14.769
OG002-67.15± 32.972
OG003
Week 16 (n=243,245,18,107,103)
Title
Measurements
OG000-85.20± 19.213
OG001-91.37± 15.367
OG002-73.38± 28.051
OG003
Week 20 (n=243,245,18,107,103)
Title
Measurements
OG000-85.75± 17.904
OG001-90.86± 16.263
OG002-80.57± 22.454
OG003
Week 24 (n=243,245,18,107,103)
Title
Measurements
OG000-85.46± 20.240
OG001-90.83± 16.652
OG002-78.06± 25.062
OG003
Week 28 (n=243,245,18,107,103)
Title
Measurements
OG000-84.72± 20.417
OG001-90.15± 17.600
OG002-79.55± 23.943
OG003
Week 32 (n=243,245,18,107,103)
Title
Measurements
OG000-83.98± 21.887
OG001-89.90± 17.775
OG002-75.94± 25.879
OG003
Week 36(n=243,245,18,107,103)
Title
Measurements
OG000-81.87± 25.048
OG001-90.04± 17.981
OG002-78.37± 24.608
OG003
Week 40(n=243,245,18,107,103)
Title
Measurements
OG000-81.37± 25.395
OG001-89.62± 17.385
OG002-78.32± 24.770
OG003
Week 44 (n=243,245,18,107,103)
Title
Measurements
OG000-80.81± 25.651
OG001-88.97± 17.804
OG002-79.96± 22.354
OG003
Week 48(n=243,245,18,107,103)
Title
Measurements
OG000-79.78± 26.471
OG001-89.35± 17.281
OG002-79.54± 21.506
OG003
Week 52 (n=243,245,18,107,103)
Title
Measurements
OG000-79.74± 26.524
OG001-88.42± 19.132
OG002-79.64± 22.169
OG003
OG002
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Units
Counts
Participants
OG000245
OG001245
OG002247
Title
Denominators
Categories
Week 1 (n=244,243,243) clear
Title
Measurements
OG0000.0± 19.225
OG0010.0± 17.317
OG0020.0± 14.756
Week 1 (n=244,243,243) almost clear
Title
Measurements
OG0000.0± 21.982
OG0010.0± 21.850
OG0020.0± 23.616
Week 1 (n=244,243,243) mild
Title
Measurements
OG0006.6± 23.695
OG0019.1± 22.415
OG0024.1± 25.785
Week 1 (n=244,243,243) moderate
Title
Measurements
OG00066.4± 24.252
OG00168.7± 22.080
OG00260.9± 28.165
Week 1 (n=244,243,243) severe
Title
Measurements
OG00027.0
OG00122.2
OG00235.0
Week 2 (n=244,245,244) clear
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
Week 2 (n=244,245,244) almost clear
Title
Measurements
OG0001.2
OG0014.5
OG0020.0
Week 2 (n=244,245,244) mild
Title
Measurements
OG00023.0
OG00127.8
OG0025.3
Week 2 (n=244,245,244) moderate
Title
Measurements
OG00057.0
OG00155.5
OG00259.8
Week 2 (n=244,245,244) severe
Title
Measurements
OG00018.9
OG00112.2
OG00234.8
Week 3 (n=244,245,244) clear
Title
Measurements
OG0000.0
OG0011.2
OG0020.0
Week 3 (n=244,245,244) almost clear
Title
Measurements
OG0006.6
OG0019.8
OG0020.4
Week 3 (n=244,245,244) mild
Title
Measurements
OG00034.0
OG00143.3
OG0027.0
Week 3 (n=244,245,244) moderate
Title
Measurements
OG00049.2
OG00140.4
OG00258.6
Week 3 (n=244,245,244) severe
Title
Measurements
OG00010.2
OG0015.3
OG00234.0
Week 4 (n=244,245,246) clear
Title
Measurements
OG0000.4
OG0013.7
OG0020.0
Week 4 (n=244,245,246) almost clear
Title
Measurements
OG00016.8
OG00122.9
OG0021.6
Week 4 (n=244,245,246) mild
Title
Measurements
OG00040.2
OG00143.7
OG0027.3
Week 4 (n=244,245,246) moderate
Title
Measurements
OG00037.3
OG00126.5
OG00258.1
Week 4 (n=244,245,246) severe
Title
Measurements
OG0005.3
OG0013.3
OG00232.9
Week 8 (n=244,245,246) clear
Title
Measurements
OG00010.2
OG00120.4
OG0020.0
Week 8 (n=244,245,246) almost clear
Title
Measurements
OG00032.0
OG00139.6
OG0021.6
Week 8 (n=244,245,246) mild
Title
Measurements
OG00038.9
OG00129.0
OG0028.1
Week 8 (n=244,245,246) moderate
Title
Measurements
OG00016.4
OG00110.2
OG00253.3
Week 8 (n=244,245,246) severe
Title
Measurements
OG0002.5
OG0010.8
OG00237.0
Week 12 (n=244,245,246) clear
Title
Measurements
OG00016.4
OG00132.2
OG0020.8
Week 12 (n=244,245,246) almost clear
Title
Measurements
OG00038.5
OG00136.3
OG0021.6
Week 12 (n=244,245,246) mild
Title
Measurements
OG00029.1
OG00123.3
OG0026.5
Week 12 (n=244,245,246) moderate
Title
Measurements
OG00014.8
OG0016.9
OG00255.3
Week 12 (n=244,245,246) severe
Title
Measurements
OG0001.2
OG0011.2
OG00235.8
OG002
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
OG003
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
OG004
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Units
Counts
Participants
OG000245
OG001245
OG00218
OG003108
OG004105
Title
Denominators
Categories
Week 13 (n=244,245,18,103,96) clear
Title
Measurements
OG00017.6± 19.313
OG00138.0± 15.935
OG00211.1± 36.827
OG0030.0± 28.240
OG0040.0± 29.891
Week 13 (n=244,245,18,103,96) almost clear
Title
Measurements
OG00040.6± 18.832
OG00135.9± 15.013
OG00222.2± 30.225
OG003
Week 13 (n=244,245,18,103,96) mild
Title
Measurements
OG00027.0± 19.407
OG00119.2± 14.769
OG00227.8± 32.972
OG003
Week 13 (n=244,245,18,103,96) moderate
Title
Measurements
OG00012.7± 19.213
OG0016.5± 15.367
OG00227.8± 28.051
OG003
Week 13 (n=244,245,18,103,96) severe
Title
Measurements
OG0002.0± 17.904
OG0010.4± 16.263
OG00211.1± 22.454
OG003
Week 14 (n=244,245,18,108,102) clear
Title
Measurements
OG00019.3± 20.240
OG00141.6± 16.652
OG00216.7± 25.062
OG003
Week 14 (n=244,245,18,108,102)almost clear
Title
Measurements
OG00042.3± 20.417
OG00136.7± 17.600
OG00216.7± 23.943
OG003
Week 14 (n=244,245,18,108,102) mild
Title
Measurements
OG00025.0± 21.887
OG00113.5± 17.775
OG00233.3± 25.879
OG003
Week 14 (n=244,245,18,108,102)moderate
Title
Measurements
OG00012.3± 25.048
OG0017.3± 17.981
OG00222.2± 24.608
OG003
Week 14 (n=244,245,18,108,102)severe
Title
Measurements
OG0001.2± 25.395
OG0010.8± 17.385
OG00211.1± 24.770
OG003
Week 15 (n=244,245,18,108,103) clear
Title
Measurements
OG00022.1± 25.651
OG00145.3± 17.804
OG00211.1± 22.354
OG003
Week 15 (n=244,245,18,108,103) almost clear
Title
Measurements
OG00038.9± 26.471
OG00133.9± 17.281
OG00222.2± 21.506
OG003
Week 15 (n=244,245,18,108,103) mild
Title
Measurements
OG00027.5± 26.524
OG00114.7± 19.132
OG00233.3± 22.169
OG003
Week 15 (n=244,245,18,108,103) moderate
Title
Measurements
OG00010.2
OG0015.3
OG00222.2
OG003
Week 15 (n=244,245,18,108,103) severe
Title
Measurements
OG0001.2
OG0010.8
OG00211.1
OG003
Week 16 (n=244,245,18,108,103) clear
Title
Measurements
OG00023.8
OG00147.3
OG00222.2
OG003
Week 16 (n=244,245,18,108,103) almost clear
Title
Measurements
OG00037.7
OG00130.6
OG00216.7
OG003
Week 16 (n=244,245,18,108,103) mild
Title
Measurements
OG00026.6
OG00115.9
OG00227.8
OG003
Week 16 (n=244,245,18,108,103) moderate
Title
Measurements
OG00010.7
OG0015.3
OG00222.2
OG003
Week 16 (n=244,245,18,108,103) severe
Title
Measurements
OG0001.2
OG0010.8
OG00211.1
OG003
Week 20 (n=244,245,18,108,103) clear
Title
Measurements
OG00023.8
OG00146.1
OG00216.7
OG003
Week 20 (n=244,245,18,108,103) almost clear
Title
Measurements
OG00037.3
OG00131.8
OG00222.2
OG003
Week 20 (n=244,245,18,108,103) mild
Title
Measurements
OG00026.2
OG00114.3
OG00233.3
OG003
Week 20 (n=244,245,18,108,103) moderate
Title
Measurements
OG00011.5
OG0017.3
OG00216.7
OG003
Week 20 (n=244,245,18,108,103) severe
Title
Measurements
OG0001.2
OG0010.4
OG00211.1
OG003
Week 24 (n=244,245,18,108,103) clear
Title
Measurements
OG00027.0
OG00146.5
OG00216.7
OG003
Week 24 (n=244,245,18,108,103) almost clear
Title
Measurements
OG00035.7
OG00129.0
OG00233.3
OG003
Week 24 (n=244,245,18,108,103) mild
Title
Measurements
OG00024.6
OG00115.1
OG00222.2
OG003
Week 24 (n=244,245,18,108,103) moderate
Title
Measurements
OG00010.7
OG0017.8
OG00216.7
OG003
Week 24 (n=244,245,18,108,103) severe
Title
Measurements
OG0002.0
OG0011.6
OG00211.1
OG003
Week 28 (n=244,245,18,108,103) clear
Title
Measurements
OG00026.6
OG00146.5
OG00211.1
OG003
Week 28 (n=244,245,18,108,103) almost clear
Title
Measurements
OG00032.8
OG00126.5
OG00238.9
OG003
Week 28 (n=244,245,18,108,103) mild
Title
Measurements
OG00025.8
OG00116.7
OG00216.7
OG003
Week 28 (n=244,245,18,108,103) moderate
Title
Measurements
OG00012.7
OG0019.4
OG00227.8
OG003
Week 28 (n=244,245,18,108,103) severe
Title
Measurements
OG0002.0
OG0010.8
OG0025.6
OG003
Week 32 (n=244,245,18,108,103) clear
Title
Measurements
OG00026.2
OG00146.5
OG00216.7
OG003
Week 32 (n=244,245,18,108,103) almost clear
Title
Measurements
OG00030.3
OG00126.5
OG00227.8
OG003
Week 32 (n=244,245,18,108,103) mild
Title
Measurements
OG00027.0
OG00116.7
OG00227.8
OG003
Week 32 (n=244,245,18,108,103) moderate
Title
Measurements
OG00014.3
OG0019.0
OG00222.2
OG003
Week 32 (n=244,245,18,108,103) severe
Title
Measurements
OG0002.0
OG0011.2
OG0025.6
OG003
Week 36 (n=244,245,18,108,103) clear
Title
Measurements
OG00028.3
OG00146.5
OG00211.1
OG003
Week 36 (n=244,245,18,108,103) almost clear
Title
Measurements
OG00027.0
OG00126.9
OG00227.8
OG003
Week 36 (n=244,245,18,108,103) mild
Title
Measurements
OG00025.4
OG00116.7
OG00233.3
OG003
Week 36 (n=244,245,18,108,103) moderate
Title
Measurements
OG00016.8
OG0018.2
OG00216.7
OG003
Week 36 (n=244,245,18,108,103) severe
Title
Measurements
OG0002.5
OG0011.6
OG00211.1
OG003
Week 40 (n=244,245,18,108,103) clear
Title
Measurements
OG00028.7
OG00146.1
OG00222.2
OG003
Week 40 (n=244,245,18,108,103) almost clear
Title
Measurements
OG00025.8
OG00125.3
OG00222.2
OG003
Week 40 (n=244,245,18,108,103) mild
Title
Measurements
OG00025.0
OG00117.1
OG00227.8
OG003
Week 40 (n=244,245,18,108,103) moderate
Title
Measurements
OG00018.4
OG00110.2
OG00216.7
OG003
Week 40 (n=244,245,18,108,103) severe
Title
Measurements
OG0002.0
OG0011.2
OG00211.1
OG003
Week 44 (n=244,245,18,108,103) clear
Title
Measurements
OG00027.5
OG00142.9
OG0025.6
OG003
Week 44 (n=244,245,18,108,103) almost clear
Title
Measurements
OG00025.0
OG00124.1
OG00238.9
OG003
Week 44 (n=244,245,18,108,103) mild
Title
Measurements
OG00025.4
OG00120.4
OG00222.2
OG003
Week 44 (n=244,245,18,108,103) moderate
Title
Measurements
OG00020.1
OG00111.8
OG00227.8
OG003
Week 44 (n=244,245,18,108,103) severe
Title
Measurements
OG0002.0
OG0010.8
OG0025.6
OG003
Week 48 (n=244,245,18,108,103) clear
Title
Measurements
OG00027.0
OG00144.5
OG00211.1
OG003
Week 48 (n=244,245,18,108,103) almost clear
Title
Measurements
OG00022.1
OG00125.3
OG00216.7
OG003
Week 48 (n=244,245,18,108,103) mild
Title
Measurements
OG00027.9
OG00116.3
OG00250.0
OG003
Week 48 (n=244,245,18,108,103) moderate
Title
Measurements
OG00020.1
OG00112.7
OG00216.7
OG003
Week 48 (n=244,245,18,108,103) severe
Title
Measurements
OG0002.9
OG0011.2
OG0025.6
OG003
Week 52 (n=244,245,18,108,103) clear
Title
Measurements
OG00025.8
OG00143.3
OG00211.1
OG003
Week 52 (n=244,245,18,108,103) almost clear
Title
Measurements
OG00024.2
OG00124.1
OG00227.8
OG003
Week 52 (n=244,245,18,108,103) mild
Title
Measurements
OG00029.1
OG00119.6
OG00227.8
OG003
Week 52 (n=244,245,18,108,103) moderate
Title
Measurements
OG00016.0
OG00111.4
OG00227.8
OG003
Week 52 (n=244,245,18,108,103) severe
Title
Measurements
OG0004.9
OG0011.6
OG0025.6
OG003
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG002
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Units
Counts
Participants
OG000245
OG001245
OG002247
Title
Denominators
Categories
Title
Measurements
OG00057(55 to 85)
OG00157(29 to 59)
OG002NA(NA to NA)median could not be calculated because less than 50% of the participants achieved PASI 75
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG002
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Units
Counts
Participants
OG000245
OG001245
OG002247
Title
Denominators
Categories
Week 4 (238, 236,235)
Title
Measurements
OG00038.1± 95.93(55 to 85)
OG00157.1± 234.10(29 to 59)
OG0026.3± 59.30(NA to NA)
Week 8 (241, 242,241)
Title
Measurements
OG00052.3± 142.28
OG00172.7± 306.36
OG0026.3± 65.47
Week 12 (242, 242,242)
Title
Measurements
OG00058.5± 158.66
OG00176.3± 281.48
OG0025.4± 67.60
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG002
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
OG003
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
OG004
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Units
Counts
Participants
OG000245
OG001245
OG00218
OG003108
OG004105
Title
Denominators
Categories
Week 12 (242, 242,18, 108, 104)
Title
Measurements
OG00058.5± 158.66
OG00176.3± 281.48
OG00237.7± 83.41
OG003-0.1± 38.95
OG0043.3± 79.45
Week 24 (242, 242,18, 108, 97)
Title
Measurements
OG00055.8± 140.46
OG00178.0± 299.91
OG00248.1± 92.06
OG003
Week 36 (242, 242,18, 108, 100)
Title
Measurements
OG00055.1± 129.87
OG00180.5± 300.89
OG00245.3± 77.11
OG003
Week 52 (242, 242,18, 108,100)
Title
Measurements
OG00054.3± 128.86
OG00176.9± 299.07
OG00243.9± 81.50
OG003
OG001
AIN457 300 mg
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG002
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Units
Counts
Participants
OG000245
OG001245
OG002247
Title
Denominators
Categories
Week 4 (n=237,236,232)
Title
Measurements
OG000-55.0(-58.9 to -50.7)
OG001-62.5(-66.7 to -58.6)
OG002-5.0(-10.1 to 0.0)
Week 8 (n=241,242,239)
Title
Measurements
OG000-73.1(-76.7 to -69.2)
OG001-81.5(-84.4 to -79.0)
OG002-8.3(-13.3 to -2.6)
Week 12 (n=242,242,240)
Title
Measurements
OG000-77.8(-81.3 to -75.0)
OG001-86.4(-88.9 to -83.3)
OG002-9.1(-15.6 to -3.3)
OG001
AIN457 300 mg
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG002
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
OG003
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
OG004
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Units
Counts
Participants
OG000245
OG001245
OG00218
OG003108
OG004105
Title
Denominators
Categories
Week 12 (242,242,17,108,104)
Title
Measurements
OG000-77.8(-81.3 to -75.0)
OG001-86.4(-88.9 to -83.3)
OG002-58.3(-80.0 to -41.7)
OG003-7.1(-16.7 to 3.4)
OG004-4.4(-13.9 to 3.4)
Week 24 (242,242,17,108,97)
Title
Measurements
OG000-83.3(-87.5 to -79.4)
OG001-89.6(-92.5 to -86.0)
OG002-76.6(-88.9 to -59.6)
OG003
Week 36 (242,242,17,108,100)
Title
Measurements
OG000-78.6(-83.3 to -75.0)
OG001-91.7(-94.2 to -88.9)
OG002-77.9(-93.3 to -47.2)
OG003
Week 52 (242,242,17,108,100)
Title
Measurements
OG000-76.5(-80.6 to -72.3)
OG001-88.9(-92.3 to -85.7)
OG002-64.4(-83.3 to -12.5)
OG003
OG001
AIN457 300 mg
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG002
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Units
Counts
Participants
OG000245
OG001245
OG002247
Title
Denominators
Categories
Week 4 (238, 237, 235)
Title
Measurements
OG00017.6
OG00123.6
OG0026.4
Week 8 (242,243,241)
Title
Measurements
OG00039.7
OG00148.1
OG00210.0
Week 12 (243,243,243)
Title
Measurements
OG00046.1
OG00158.8
OG00210.3
OG001
AIN457 300 mg
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG002
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
OG003
AIN457 150mg From Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
OG004
AIN457 300mg From Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Units
Counts
Participants
OG000245
OG001245
OG00218
OG003108
OG004105
Title
Denominators
Categories
Week 12 (243,243,18,108,105)
Title
Measurements
OG00046.1
OG00158.8
OG00227.8
OG00310.2
OG0048.6
Week 24 (243,243,18,108,98)
Title
Measurements
OG00054.7
OG00164.6
OG00250.0
OG003
Week 36 (243,243,18,108,101)
Title
Measurements
OG00051.9
OG00168.7
OG00250.0
OG003
Week 52 (243,243,18,108,101)
Title
Measurements
OG00048.6
OG00166.3
OG00222.2
OG003
OG001
AIN457 300 mg
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
OG002
Placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Units
Counts
Participants
OG000245
OG001245
OG002247
Title
Denominators
Categories
IGA 0/1 biologic (29, 19, 24)
Title
Measurements
OG00041.4
OG00157.9
OG0024.2
PASI 75 biologic (29, 19, 24)
Title
Measurements
OG00048.3
OG00157.9
OG00212.5
PASI 90 biologic (29, 19, 24)
Title
Measurements
OG00024.1
OG00131.6
OG0024.2
IGA 0/1 anti-TNF-α therapy (18,17,21)
Title
Measurements
OG00050.0
OG00164.7
OG0024.8
PASI 75 anti-TNF-α therapy (18,17,21)
Title
Measurements
OG00055.6
OG00164.7
OG00214.3
PASI 90 anti-TNF-α therapy (18,17,21)
Title
Measurements
OG00033.3
OG00135.3
OG0024.8
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.