Judging the Efficacy of Secukinumab in Patients With Psor... | NCT01636687 | Trialant
NCT01636687
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Sep 27, 2018Actual
Enrollment
182Actual
Phase
Phase 3
Conditions
Plaque-type Psoriasis
Interventions
Placebo
Secukinumab 150mg
Secukinumab 300mg
Countries
United States
Canada
Estonia
France
Germany
Protocol Section
Identification Module
NCT ID
NCT01636687
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CAIN457A2309
Secondary IDs
ID
Type
Description
Link
2012-002609-22
EudraCT Number
Brief Title
Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results (JUNCTURE)
Official Title
A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Autoinjectors to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, Usability and Long-term Efficacy in Subjects With Chronic Plaque-type Psoriasis
Acronym
JUNCTURE
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Sep 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 17, 2012Actual
Primary Completion Date
Oct 27, 2016Actual
Completion Date
Oct 27, 2016Actual
First Submitted Date
Jul 6, 2012
First Submission Date that Met QC Criteria
Jul 9, 2012
First Posted Date
Jul 10, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 23, 2017
Results First Submitted that Met QC Criteria
Sep 26, 2018
Results First Posted Date
Sep 27, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 26, 2018
Last Update Posted Date
Sep 27, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study was to demonstrate efficacy of autoinjector administered secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.
Detailed Description
Not provided
Conditions Module
Conditions
Plaque-type Psoriasis
Keywords
Psoriasis
Moderate to Severe Plaque-type Psoriasis
Skin condition
skin disease
itching condition
psoriasis vulgaris
relapsing/remitting psoriasis
immune-mediated systemic disease
skin lesions
red skin lesions
scaly patches
papules
plaques
itching
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
182Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Subjects who were in placebo at Week 52 cannot continue in the extension treatment period
Drug: Placebo
Secukinumab 150 mg
Experimental
After the data base lock of week 52 data has been performed, subjects received secukinumab 150 mg treatment as open label for the remainder of the extension treatment period.
Drug: Secukinumab 150mg
Secukinumab 300 mg
Experimental
After the data base lock of week 52 data has been performed, subjects received secukinumab 300 mg treatment as open label for the remainder of the extension treatment period.
Drug: Secukinumab 300mg
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
2 injections of placebo to secukinumab 150mg per dose
Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response
Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis.
PASI score was based on assessment of the head, trunk, upper limbs and lower limbs for erythema, thickening (plaque elevation, induration), and scaling (desquamation). PASI scores can range from 0, corresponding to no signs of psoriasis, up to a theoretical maximum of 72.0. PASI-based secondary variables included absolute PASI score, response rates for PASI 75. PASI 50 and PASI 90 were defined as ≥ 50% and ≥ 90% improvement from Baseline in PASI score, respectively, while PASI 100 response corresponded to complete clearing of psoriasis (PASI = 0). IGA mod 2011 was used to evaluate the overall severity of psoriatic disease, with scores ranging from 0 (clear) to 4 (severe). Treatment success was defined as achievement of IGA mod 2011 0 or 1 score.
12 weeks
Secondary Outcomes
Measure
Description
Time Frame
Percentages of Subjects With Successful Self-administration of Study Drug at Week 1
To assess the subject's ability to follow instructions for use with the secukinumab autoinjector
Week 1
Percentage of Subjects With Possible Use-related Hazards
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.
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.
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
A total of 220 patients were screened at 39 study centers, and 182 patients were randomized at 38 study centers to 3 balanced groups.
Recruitment Details
59 placebo subjects completed induction phase. These 59 entered maintenance phase. Of those, 28 were assigned to 150mg AIN457 and 28 were assigned to 300 mg AIN457, while 3 remained with PLC treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
Secukinumab 150mg: 1 injection of 150 mg secukinumab and 1 injection of placebo to secukinumab 150mg per dose. After Week 52 database lock, study is open label so only 1 injection of secukinumab 150mg per dose were administered
Secukinumab 150 mg
Secukinumab 300mg
Drug
Secukinumab 300mg (2 injections of 150mg secukinumab per dose)
Secukinumab 300 mg
To assess potential use-related hazards with the secukinumab autoinjector for the subject.
Week 1
Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12
The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10; "0" corresponds to worst experience while "10" corresponds to best experience. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Week 12
Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48
The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10; "0" corresponds to worst experience while "10" corresponds to best experience. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Absolute change from baseline at week 48
Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - 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). 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 12
Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data)
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline.
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 12 up to Week 52
Absolute Change From Baseline for PASI Score - Induction Period
PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)
Baseline, Week 12
Absolute Change From Baseline for PASI Score Over Time up to Week 52 - Maintenance Period (Observed Data)
Psoriasis Area and Severity Index (PASI): Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4).
Baseline, Week 52
Percentage of Participants in Each IGA Mod 2011 Category - 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
Week 12
Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data)
The Investigators' Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Week 52
Change From Baseline in EQ-5D up to Week 12 - Induction Period
ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state).
Week 12
Change From Baseline in EQ-5D Over Time up to Week 52 - Maintenance Period
ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state).
Week 52
Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score - Induction Period
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.
A negative median percent change from baseline indicates improvement.
Baseline, up to Week 12
Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52 - Maintenance Period
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.
A negative median percent change from baseline indicates improvement.
Baseline, Week 52
Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12 - Induction Period
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.
Week 12
Percentages of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52 - (Maintenance)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.
Week 52
Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data)
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline.
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 160
Absolute Change From Baseline for PASI Score After Week 52 (Observed Data)
PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4).
Week 160
Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data)
The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Week 160
Number of Participants Developing Treatment-emergent Anti-secukinumab Antibodies
The development of anti-secunimubab anti-bodies decreases a participant's ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to week 216.
Baseline and at Week 12, 24, 52, 100, 148, 196, 208, and 216
Los Angeles
California
90045
United States
Novartis Investigative Site
Oceanside
California
92056
United States
Novartis Investigative Site
Overland Park
Kansas
66215
United States
Novartis Investigative Site
Louisville
Kentucky
40202
United States
Novartis Investigative Site
Louisville
Kentucky
40291
United States
Novartis Investigative Site
Omaha
Nebraska
68144
United States
Novartis Investigative Site
Rochester
New York
14623
United States
Novartis Investigative Site
Duncansville
Pennsylvania
16635
United States
Novartis Investigative Site
Johnston
Rhode Island
02919
United States
Novartis Investigative Site
Nashville
Tennessee
37203
United States
Novartis Investigative Site
Norfolk
Virginia
23507
United States
Novartis Investigative Site
Calgary
Alberta
T3A 2N1
Canada
Novartis Investigative Site
Halifax
Nova Scotia
B3H 1Z2
Canada
Novartis Investigative Site
Hamilton
Ontario
L8N 1V6
Canada
Novartis Investigative Site
Mississauga
Ontario
L5H 1G9
Canada
Novartis Investigative Site
Montreal
Quebec
H3H 1V4
Canada
Novartis Investigative Site
Sainte-Foy
Quebec
G1V 4X7
Canada
Novartis Investigative Site
Tallinn
10134
Estonia
Novartis Investigative Site
Tallinn
13619
Estonia
Novartis Investigative Site
Nice
06202
France
Novartis Investigative Site
Poitiers
86021
France
Novartis Investigative Site
Toulouse
31400
France
Novartis Investigative Site
Regensburg
Bavaria
93053
Germany
Novartis Investigative Site
Augsburg
86163
Germany
Novartis Investigative Site
Augsburg
86179
Germany
Novartis Investigative Site
Bielefeld
33647
Germany
Novartis Investigative Site
Bonn
53105
Germany
Novartis Investigative Site
Dresden
01307
Germany
Novartis Investigative Site
Erlangen
91054
Germany
Novartis Investigative Site
Frankfurt
60590
Germany
Novartis Investigative Site
Gera
07548
Germany
Novartis Investigative Site
Hamburg
22143
Germany
Novartis Investigative Site
Hamburg
22391
Germany
Novartis Investigative Site
Heidelberg
69115
Germany
Novartis Investigative Site
Münster
48149
Germany
Novartis Investigative Site
Osnabrück
49074
Germany
Novartis Investigative Site
Selters
56242
Germany
Novartis Investigative Site
Tübingen
72076
Germany
Derived
Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.
Houghton K, Patil D, Gomez B, Feldman SR. Correlation Between Change in Psoriasis Area and Severity Index and Dermatology Life Quality Index in Patients with Psoriasis: Pooled Analysis from Four Phase 3 Clinical Trials of Secukinumab. Dermatol Ther (Heidelb). 2021 Aug;11(4):1373-1384. doi: 10.1007/s13555-021-00564-2. Epub 2021 Jun 10.
Menter A, Cather JC, Jarratt M, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab on Moderate-to-severe Plaque Psoriasis Affecting Different Body Regions: a Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):639-647. doi: 10.1007/s13555-016-0140-7. Epub 2016 Aug 30.
Kircik L, Fowler J, Weiss J, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab for Moderate-to-Severe Head and Neck Psoriasis Over 52 Weeks: Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):627-638. doi: 10.1007/s13555-016-0139-0. Epub 2016 Aug 30.
Paul C, Lacour JP, Tedremets L, Kreutzer K, Jazayeri S, Adams S, Guindon C, You R, Papavassilis C; JUNCTURE study group. Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol. 2015 Jun;29(6):1082-90. doi: 10.1111/jdv.12751. Epub 2014 Sep 22.
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
FG002
Placebo - AIN457 150 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
FG003
Placebo - AIN457 300mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study.
FG004
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
FG00061 subjects
FG00160 subjects
FG0020 subjects
FG0030 subjects
FG00461 subjects
COMPLETED
FG00058 subjects
FG00160 subjects
FG0020 subjects
FG0030 subjects
FG00459 subjects
NOT COMPLETED
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0042 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Maintenance Period
Type
Comment
Milestone Data
STARTED
FG00058 subjects
FG00160 subjects
FG00228 subjects
FG00328 subjects
FG0043 subjects
COMPLETED
FG00050 subjects
FG00158 subjects
FG00226 subjects
FG00328 subjects
FG004
NOT COMPLETED
FG0008 subjects
FG0012 subjects
FG0022 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG003
Extension Period
Type
Comment
Milestone Data
STARTED
FG00047 subjects
FG00154 subjects
FG00225 subjects
FG00328 subjects
FG0040 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG00047 subjects
FG00154 subjects
FG00225 subjects
FG00328 subjects
FG004
Type
Comment
Reasons
technical problems
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG003
Follow-up Period
Type
Comment
Milestone Data
STARTED
FG00038 subjects
FG00145 subjects
FG00221 subjects
FG00320 subjects
FG0042 subjects
COMPLETED
FG00037 subjects
FG00145 subjects
FG00221 subjects
FG00320 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG003
Randomized set for on treatment groups
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
BG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
BG002
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00061
BG00160
BG00261
BG003182
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
BG00043.9± 14.41
BG00146.6± 14.23
BG00243.7± 12.74
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00020
BG00114
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
Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response
Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis.
PASI score was based on assessment of the head, trunk, upper limbs and lower limbs for erythema, thickening (plaque elevation, induration), and scaling (desquamation). PASI scores can range from 0, corresponding to no signs of psoriasis, up to a theoretical maximum of 72.0. PASI-based secondary variables included absolute PASI score, response rates for PASI 75. PASI 50 and PASI 90 were defined as ≥ 50% and ≥ 90% improvement from Baseline in PASI score, respectively, while PASI 100 response corresponded to complete clearing of psoriasis (PASI = 0). IGA mod 2011 was used to evaluate the overall severity of psoriatic disease, with scores ranging from 0 (clear) to 4 (severe). Treatment success was defined as achievement of IGA mod 2011 0 or 1 score.
Full Analysis Set (FAS) comprises of all patients to whom study treatment has been assigned.
Posted
Number
Percentages of participants
12 weeks
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
OG002
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
Units
Counts
Participants
OG00060
OG00160
OG00261
Title
Denominators
Categories
PASI 75
Title
Measurements
OG00071.7
OG00186.7
OG0023.3
IGA 0/1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Response criterion: IGA 0/1
Fisher Exact
<0.0001
Risk Difference (RD)
53.3
2-Sided
95
36.6
67.7
Superiority or Other
OG001
OG002
Response Criterion: IGA 0/1
Fisher Exact
Secondary
Percentages of Subjects With Successful Self-administration of Study Drug at Week 1
To assess the subject's ability to follow instructions for use with the secukinumab autoinjector
Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were analyzed according to treatment received.
Posted
Number
Percentages of participants
Week 1
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
OG002
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
Units
Counts
Secondary
Percentage of Subjects With Possible Use-related Hazards
To assess potential use-related hazards with the secukinumab autoinjector for the subject.
Safety set
Posted
Number
Percentages of participants
Week 1
Participants
Participants
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
OG002
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
Units
Counts
Participants
Secondary
Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12
The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10; "0" corresponds to worst experience while "10" corresponds to best experience. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Safety Set
Posted
Mean
Standard Deviation
Score
Week 12
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
OG002
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
Secondary
Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48
The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10; "0" corresponds to worst experience while "10" corresponds to best experience. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Safety set
Posted
Mean
Standard Deviation
Score
Absolute change from baseline at week 48
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
OG002
Placebo - AIN457 150 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
Secondary
Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - 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). 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)
Posted
Number
Percentages of participants
Week 12
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
OG001
AIN457 300 mg
Secondary
Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data)
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline.
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). Results after Week 160 and beyond cannot be interpreted meaningfully due to low number of evaluable patients at these visits.
Posted
Number
Percentages of participants
Week 12 up to Week 52
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
OG001
Secondary
Absolute Change From Baseline for PASI Score - Induction Period
PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)
Full Analysis Set (FAS)
Posted
Mean
Standard Deviation
Units on a scale
Baseline, Week 12
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
OG002
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
Secondary
Absolute Change From Baseline for PASI Score Over Time up to Week 52 - Maintenance Period (Observed Data)
Psoriasis Area and Severity Index (PASI): Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4).
Full Analysis Set (FAS)
Posted
Mean
Standard Deviation
Units on a scale
Baseline, Week 52
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
OG002
Placebo - AIN457 150 mg
Secondary
Percentage of Participants in Each IGA Mod 2011 Category - 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) - All patients to whom study treatment was assigned.
Posted
Number
Percentages of participants
Week 12
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
OG002
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
Secondary
Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data)
The Investigators' Global Assessment (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)
Posted
Number
Percentages of participants
Week 52
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
OG002
Placebo - AIN457 150 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
Secondary
Change From Baseline in EQ-5D up to Week 12 - Induction Period
ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state).
Full Analysis Set (FAS)
Posted
Mean
Standard Deviation
unit on a scale
Week 12
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
OG002
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
Secondary
Change From Baseline in EQ-5D Over Time up to Week 52 - Maintenance Period
ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state).
Full Analysis Set (FAS)
Posted
Mean
Standard Deviation
unit on a scale
Week 52
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
OG002
Placebo - AIN457 150 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
Secondary
Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score - Induction Period
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.
A negative median percent change from baseline indicates improvement.
Full Analysis Set (FAS)
Posted
Median
95% Confidence Interval
percent change
Baseline, up to Week 12
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
OG002
Placebo
Secondary
Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52 - Maintenance Period
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.
A negative median percent change from baseline indicates improvement.
Full Analysis Set (FAS)
Posted
Median
95% Confidence Interval
Percent change
Baseline, Week 52
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
OG002
Placebo - AIN457 150 mg
Secondary
Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12 - Induction Period
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.
Full analysis set (FAS)
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
OG002
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
Secondary
Percentages of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52 - (Maintenance)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.
Full Analysis Set (FAS) - All patients to whom study treatment was assigned.
Posted
Number
Percentage of participants
Week 52
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
OG002
Placebo - AIN457 150 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
Secondary
Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data)
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline.
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). Results after Week 160 and beyond cannot be interpreted meaningfully due to low number of evaluable patients at these visits.
Posted
Number
Percentages of participants
Week 160
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
OG001
Secondary
Absolute Change From Baseline for PASI Score After Week 52 (Observed Data)
PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4).
Full analysis set (FAS).
Posted
Mean
Standard Deviation
Units on a scale
Week 160
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
OG002
Placebo - AIN457 150 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
Secondary
Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data)
The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Full analysis set (FAS).
Posted
Number
Percentages of participants
Week 160
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
OG002
Placebo - AIN457 150 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
OG003
Secondary
Number of Participants Developing Treatment-emergent Anti-secukinumab Antibodies
The development of anti-secunimubab anti-bodies decreases a participant's ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to week 216.
FAS
Posted
Number
Number of participants
Baseline and at Week 12, 24, 52, 100, 148, 196, 208, and 216
ID
Title
Description
OG000
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
OG001
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
OG002
Placebo-AIN457 150 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
OG003
Placebo - AIN457 300mg
Time Frame
Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
Description
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 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
3
61
35
61
EG001
Induction AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
1
60
37
60
EG002
Induction Placebo
placebo secukinumab (2 s.c. injections) at each dosing
1
61
30
61
EG003
Entire Any AIN457 150 mg
Includes all patients in the AIN457 150 mg and in the placebo- AIN457 150 mg treatment groups.
18
89
81
89
EG004
Entire Any AIN457 300 mg
Includes all patients in the AIN457 300 mg and in the placebo- AIN457 300 mg treatment groups.
16
88
81
88
EG005
Entire Placebo
placebo secukinumab (2 s.c. injections) at each dosing
1
61
31
61
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANGINA PECTORIS
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG0030 affected89 at risk
EG0041 affected88 at risk
EG0050 affected61 at risk
ANGINA UNSTABLE
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
AORTIC VALVE STENOSIS
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
ATRIOVENTRICULAR BLOCK COMPLETE
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
CARDIAC FAILURE
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
CORONARY ARTERY DISEASE
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
LEFT VENTRICULAR DYSFUNCTION
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
MYOCARDIAL INFARCTION
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
PALPITATIONS
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
POSTINFARCTION ANGINA
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
SINUS TACHYCARDIA
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
AMAUROSIS FUGAX
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
CATARACT
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
ASCITES
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
COLITIS ULCERATIVE
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
GASTRITIS
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
INGUINAL HERNIA
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
RECTAL PROLAPSE
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
CHOLELITHIASIS
Hepatobiliary disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
CHRONIC TONSILLITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
ERYSIPELAS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
MYELITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
BONE CONTUSION
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
DISLOCATION OF VERTEBRA
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
FOOT FRACTURE
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
HUMERUS FRACTURE
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
POST PROCEDURAL HAEMORRHAGE
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
ULNA FRACTURE
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
HEART RATE IRREGULAR
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
FLUID OVERLOAD
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
INTERVERTEBRAL DISC PROTRUSION
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
LUMBAR SPINAL STENOSIS
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
OSTEOARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
OSTEOLYSIS
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
ROTATOR CUFF SYNDROME
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
ANOGENITAL WARTS
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
BASAL CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
BOWEN'S DISEASE
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
LUNG CANCER METASTATIC
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
MALIGNANT MELANOMA IN SITU
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
CAROTID ARTERY ANEURYSM
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
CEREBROVASCULAR ACCIDENT
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
NEUROPATHY PERIPHERAL
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
MAJOR DEPRESSION
Psychiatric disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0021 affected61 at risk
EG003
SUICIDE ATTEMPT
Psychiatric disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
BLADDER PROLAPSE
Renal and urinary disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
UTERINE PROLAPSE
Reproductive system and breast disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
PSORIASIS
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
TRANSIENT ACANTHOLYTIC DERMATOSIS
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
PERIPHERAL ARTERY ANEURYSM
Vascular disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
PERIPHERAL ARTERY THROMBOSIS
Vascular disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
EOSINOPHILIA
Blood and lymphatic system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG0031 affected89 at risk
EG0042 affected88 at risk
EG0050 affected61 at risk
LYMPHADENOPATHY
Blood and lymphatic system disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
ANGINA PECTORIS
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
AORTIC VALVE INCOMPETENCE
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
ATRIOVENTRICULAR BLOCK FIRST DEGREE
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
BUNDLE BRANCH BLOCK LEFT
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0021 affected61 at risk
EG003
SINUS BRADYCARDIA
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
BLEPHARITIS
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0012 affected60 at risk
EG0020 affected61 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0021 affected61 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
DENTAL CARIES
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0021 affected61 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
GASTRITIS
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
INGUINAL HERNIA
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0012 affected60 at risk
EG0020 affected61 at risk
EG003
TOOTHACHE
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0012 affected60 at risk
EG0022 affected61 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
CYST
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
FATIGUE
General disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0021 affected61 at risk
EG003
INJECTION SITE BRUISING
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
INJECTION SITE HAEMATOMA
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0022 affected61 at risk
EG003
INJECTION SITE PAIN
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
NON-CARDIAC CHEST PAIN
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
PYREXIA
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
HEPATIC STEATOSIS
Hepatobiliary disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
DRUG HYPERSENSITIVITY
Immune system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0022 affected61 at risk
EG003
CANDIDA INFECTION
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
CONJUNCTIVITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
CYSTITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
EAR INFECTION
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
FOLLICULITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0021 affected61 at risk
EG003
FUNGAL INFECTION
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
FUNGAL SKIN INFECTION
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0011 affected60 at risk
EG0022 affected61 at risk
EG003
GASTROENTERITIS VIRAL
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
GASTROINTESTINAL VIRAL INFECTION
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
HORDEOLUM
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0021 affected61 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0022 affected61 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG00014 affected61 at risk
EG00119 affected60 at risk
EG0029 affected61 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0021 affected61 at risk
EG003
ORAL HERPES
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
OTITIS EXTERNA
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
OTITIS MEDIA
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
PERIODONTITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
PHARYNGITIS STREPTOCOCCAL
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
PULPITIS DENTAL
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
PYURIA
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
RHINITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0002 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0013 affected60 at risk
EG0020 affected61 at risk
EG003
TINEA PEDIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
TONSILLITIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
TOOTH ABSCESS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0021 affected61 at risk
EG003
TOOTH INFECTION
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0021 affected61 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
VULVOVAGINAL CANDIDIASIS
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
VULVOVAGINAL MYCOTIC INFECTION
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
ANIMAL BITE
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
ARTHROPOD BITE
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
ARTHROPOD STING
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
JOINT DISLOCATION
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
LACERATION
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
MUSCLE STRAIN
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
POST PROCEDURAL COMPLICATION
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
PROCEDURAL PAIN
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
SUNBURN
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
TENDON RUPTURE
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
TOOTH FRACTURE
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
BLOOD URINE PRESENT
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
LIVER FUNCTION TEST INCREASED
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0021 affected61 at risk
EG003
WEIGHT INCREASED
Investigations
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
GOUT
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
HYPERCHOLESTEROLAEMIA
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
HYPERLIPIDAEMIA
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
HYPERTRIGLYCERIDAEMIA
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
HYPERURICAEMIA
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
VITAMIN B12 DEFICIENCY
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
BURSITIS
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
FIBROMYALGIA
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
INTERVERTEBRAL DISC DEGENERATION
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
OSTEOARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0022 affected61 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0011 affected60 at risk
EG0021 affected61 at risk
EG003
PSORIATIC ARTHROPATHY
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
TENDONITIS
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0021 affected61 at risk
EG003
BASAL CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
MELANOCYTIC NAEVUS
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
SKIN PAPILLOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0005 affected61 at risk
EG0013 affected60 at risk
EG0023 affected61 at risk
EG003
HYPOAESTHESIA
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
SCIATICA
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
ADJUSTMENT DISORDER WITH DEPRESSED MOOD
Psychiatric disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
DYSMENORRHOEA
Reproductive system and breast disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
ASTHMA
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0013 affected60 at risk
EG0022 affected61 at risk
EG003
DYSPHONIA
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0012 affected60 at risk
EG0020 affected61 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
NASAL CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0021 affected61 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0022 affected61 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
ACTINIC KERATOSIS
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
DERMATITIS
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
DRUG ERUPTION
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
ECZEMA
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
HYPERKERATOSIS
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
INTERTRIGO
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
PAIN OF SKIN
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0021 affected61 at risk
EG003
PITYRIASIS ROSEA
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected61 at risk
EG0014 affected60 at risk
EG0022 affected61 at risk
EG003
PRURITUS GENERALISED
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
PSORIASIS
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0021 affected61 at risk
EG003
SEBORRHOEA
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
SEBORRHOEIC DERMATITIS
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0012 affected60 at risk
EG0020 affected61 at risk
EG003
STASIS DERMATITIS
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0011 affected60 at risk
EG0020 affected61 at risk
EG003
HAEMATOMA
Vascular disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected61 at risk
EG0010 affected60 at risk
EG0020 affected61 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA (19.1)
Systematic Assessment
EG0003 affected61 at risk
EG0011 affected60 at risk
EG0024 affected61 at risk
EG003
Efficacy results after Wk 160 can't be interpreted meaningfully due to low # of evaluable patients. As per protocol, availability of AIN457 in participating countries led to discontinuation of most patients before they reached the later visits.
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
+1-862-778-8300
Novartis.email@novartis.com
ID
Term
D011565
Psoriasis
D012871
Skin Diseases
D012008
Recurrence
D058225
Plaque, Amyloid
D011537
Pruritus
Ancestor Terms
ID
Term
D017444
Skin Diseases, Papulosquamous
D017437
Skin and Connective Tissue Diseases
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
D020763
Pathological Conditions, Anatomical
D012877
Skin Manifestations
D012816
Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C555450
secukinumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
1 subjects
0 subjects
1 subjects
2 subjects
0 subjects
FG0040 subjects
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Lack of Efficacy
FG0004 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
0 subjects
0 subjects
1 subjects
FG0040 subjects
Adverse Event
FG0004 subjects
FG0013 subjects
FG0022 subjects
FG0031 subjects
FG0040 subjects
Lack of Efficacy
FG0007 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG0040 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
study terminated by sponsor
FG00033 subjects
FG00150 subjects
FG00217 subjects
FG00323 subjects
FG0040 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
1 subjects
1 subjects
0 subjects
FG0041 subjects
44.7
± 13.80
23
BG00357
Male
BG00041
BG00146
BG00238
BG003125
Title
Measurements
OG00053.3
OG00173.3
OG0020.0
<0.0001
Risk Difference (RD)
73.3
2-Sided
95
58.8
83.9
Superiority or Other
OG000
OG002
Response criterion: PASI 75
Fisher Exact
<0.0001
Risk Difference (RD)
68.4
2-Sided
95
53.1
79.8
Superiority or Other
OG001
OG002
Response criterion: PASI 75
Fisher Exact
<0.0001
Risk Difference (RD)
83.4
2-Sided
95
70.7
91.7
Superiority or Other
Participants
OG00061
OG00160
OG00260
Title
Denominators
Categories
Title
Measurements
OG000100
OG001100
OG002100
OG00061
OG00160
OG00261
Participants
OG00059
OG00158
OG00260
Title
Denominators
Categories
Needle stick in a critical area
Title
Measurements
OG0000
OG0010
OG0020
Needle stick in non-critical area
Title
Measurements
OG0000
OG0010
OG0020
Any part of the device swallowed
Title
Measurements
OG0000
OG0010
OG0020
Allergic reaction to devise material
Title
Measurements
OG0000
OG0010
OG0020
Pain due to bent needle
Title
Measurements
OG0000
OG0010
OG0020
Any breakage of the device
Title
Measurements
OG0000
OG0010
OG0020
Swallowing of material debris observed
Title
Measurements
OG0000
OG0010
OG0020
Any other problem
Title
Measurements
OG0000
OG0015.1
OG0020
Less than full dose administered
Title
Measurements
OG0000
OG0011.7
OG0020
Units
Counts
Participants
OG00061
OG00160
OG00261
Title
Denominators
Categories
Feelings about injections
ParticipantsOG00054
ParticipantsOG00159
ParticipantsOG00258
Title
Measurements
OG0000.94± 2.190
OG0011.13± 1.796
OG0020.93± 1.887
Self confidence
ParticipantsOG00054
ParticipantsOG00160
ParticipantsOG00259
Title
Measurements
OG000
Satisfaction with self-injection
ParticipantsOG00053
ParticipantsOG00158
ParticipantsOG00257
Title
Measurements
OG000
OG003
Placebo - AIN457 300 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
OG004
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
Units
Counts
Participants
OG00058
OG00160
OG00228
OG00328
OG0043
Title
Denominators
Categories
Feelings about injections
Title
Measurements
OG0000.92± 1.853
OG0011.34± 2.336
OG0021.43± 2.049
OG0030.73± 1.450
OG0040.42± 1.768
Self confidence
Title
Measurements
OG0001.88± 1.926
OG0011.86± 2.052
OG0021.17± 3.033
OG003
Satisfaction with self-injection
Title
Measurements
OG0002.93± 2.853
OG0012.50± 2.121
OG0022.29± 2.650
OG003
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
OG002
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
Units
Counts
Participants
OG00061
OG00160
OG00261
Title
Denominators
Categories
PASI 50
Title
Measurements
OG00078.3
OG00196.7
OG0028.2
PASI 90
Title
Measurements
OG00040.0
OG00155.0
OG0020.0
PASI 100
Title
Measurements
OG00016.7
OG00126.7
OG0020.0
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
OG002
Placebo - AIN457 150 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
OG003
Placebo - AIN457 300 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
Units
Counts
Participants
OG00061
OG00160
OG00228
OG00328
Title
Denominators
Categories
Week 52 IGA 0/1
Title
Measurements
OG00064.7
OG00170.7
OG00256.0
OG00385.7
Week 52 PASI 75
Title
Measurements
OG00082.4
OG00182.8
OG00276.0
OG003
Week 52 PASI 50
Title
Measurements
OG00096.1
OG00194.8
OG00288.0
OG003
Week 52 PASI 90
Title
Measurements
OG00062.7
OG00165.5
OG00252.0
OG003
Week 52 PASI 100
Title
Measurements
OG00035.3
OG00139.7
OG00240.0
OG003
Units
Counts
Participants
OG00061
OG00160
OG00261
Title
Denominators
Categories
Title
Measurements
OG000-15.52± 7.841
OG001-16.67± 6.552
OG002-1.26± 6.621
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
OG003
Placebo - AIN457 300mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study.
Units
Counts
Participants
OG00061
OG00160
OG00228
OG00328
Title
Denominators
Categories
Title
Measurements
OG000-18.3± 6.75
OG001-16.4± 5.99
OG002-15.2± 5.85
OG003-18.8± 5.59
Units
Counts
Participants
OG00061
OG00160
OG00261
Title
Denominators
Categories
clear
ParticipantsOG00060
ParticipantsOG00160
ParticipantsOG00261
Title
Measurements
OG00018.3
OG00130.0
OG0020.0
almost clear
ParticipantsOG00060
ParticipantsOG00160
ParticipantsOG00261
Title
Measurements
OG000
mild
ParticipantsOG00060
ParticipantsOG00160
ParticipantsOG00261
Title
Measurements
OG000
moderate
ParticipantsOG00060
ParticipantsOG00160
ParticipantsOG00261
Title
Measurements
OG000
severe
ParticipantsOG00060
ParticipantsOG00160
ParticipantsOG00261
Title
Measurements
OG000
OG003
Placebo - AIN457 300mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study.
Units
Counts
Participants
OG00061
OG00160
OG00228
OG00328
Title
Denominators
Categories
Clear
Title
Measurements
OG00035.3
OG00139.7
OG00240.0
OG00364.3
Almost clear
Title
Measurements
OG00029.4
OG00131.0
OG00216.0
OG003
Mild
Title
Measurements
OG00019.6
OG00119.0
OG00224.0
OG003
Moderate
Title
Measurements
OG00011.8
OG0016.9
OG00220.0
OG003
Severe
Title
Measurements
OG0003.9
OG0013.4
OG0020.0
OG003
Units
Counts
Participants
OG00061
OG00160
OG00261
Title
Denominators
Categories
Title
Measurements
OG00013.5± 19.63
OG00115.3± 19.80
OG002-0.5± 14.89
OG003
Placebo - AIN457 300mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study.
OG004
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
Units
Counts
Participants
OG00061
OG00160
OG00228
OG00328
OG0043
Title
Denominators
Categories
Title
Measurements
OG00016.8± 20.34
OG00117.4± 20.38
OG00212.9± 28.45
OG0039.9± 10.94
OG00410.0± 9.00
placebo secukinumab (2 s.c. injections) at each dosing
Units
Counts
Participants
OG00056
OG00155
OG00255
Title
Denominators
Categories
Title
Measurements
OG000-83.3(-88.9 to -75.0)
OG001-86.8(-95.0 to -82.5)
OG002-17.9(-32.7 to -1.1)
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
OG003
Placebo - AIN457 300mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study.
OG004
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
Units
Counts
Participants
OG00056
OG00155
OG00225
OG00327
OG0043
Title
Denominators
Categories
Title
Measurements
OG000-90.9(-95.0 to -85.0)
OG001-91.2(-94.7 to -84.2)
OG002-78.5(-90.0 to -59.5)
OG003-97.7(-100 to -81.3)
OG004-53.7(-72.7 to NA)Too few events to calculate the upper limit.
Units
Counts
Participants
OG00059
OG00159
OG00259
Title
Denominators
Categories
Title
Measurements
OG00059.3
OG00174.6
OG00215.3
OG003
Placebo - AIN457 300mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study.
OG004
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
Units
Counts
Participants
OG00059
OG00160
OG00228
OG00328
OG0043
Title
Denominators
Categories
Title
Measurements
OG00066.1
OG00170.0
OG00257.1
OG00385.7
OG0040.0
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
OG002
Placebo - AIN457 150 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
OG003
Placebo - AIN457 300mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study.
Units
Counts
Participants
OG00061
OG00160
OG00228
OG00328
Title
Denominators
Categories
IGA 0/1 Week 160
ParticipantsOG00016
ParticipantsOG00124
ParticipantsOG00210
ParticipantsOG00315
Title
Measurements
OG00043.8
OG00158.3
OG00220.0
OG003
PASI 75 Week 160
ParticipantsOG00016
ParticipantsOG00124
ParticipantsOG00210
ParticipantsOG00315
PASI 50 Week 160
ParticipantsOG00016
ParticipantsOG00124
ParticipantsOG00210
ParticipantsOG00315
PASI 90 Week 160
ParticipantsOG00016
ParticipantsOG00124
ParticipantsOG00210
ParticipantsOG00315
PASI 100 (n=16, 24, 10, 15) Week 160
ParticipantsOG00016
ParticipantsOG00124
ParticipantsOG00210
ParticipantsOG00315
OG003
Placebo - AIN457 300mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study.
Units
Counts
Participants
OG00061
OG00160
OG00228
OG00328
Title
Denominators
Categories
Title
Measurements
OG000-18.7± 5.66
OG001-15.9± 4.58
OG002-12.7± 8.08
OG003-18.1± 5.49
Placebo - AIN457 300mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study.
Units
Counts
Participants
OG00061
OG00160
OG00228
OG00328
Title
Denominators
Categories
clear Week 160
ParticipantsOG00016
ParticipantsOG00124
ParticipantsOG00210
ParticipantsOG00315
Title
Measurements
OG00025.0
OG00145.8
OG00220.0
OG003
almost clear Week 160
ParticipantsOG00016
ParticipantsOG00124
ParticipantsOG00210
ParticipantsOG00315
mild Week 160
ParticipantsOG00016
ParticipantsOG00124
ParticipantsOG00210
ParticipantsOG00315
moderate Week 160
ParticipantsOG00016
ParticipantsOG00124
ParticipantsOG00210
ParticipantsOG00315
severe Week 160
ParticipantsOG00016
ParticipantsOG00124
ParticipantsOG00210
ParticipantsOG00315
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study
OG004
Placebo
Placebo secukinumab (2 s.c. injections) at each dosing