Efficacy and Safety of Intravenous and Subcutaneous Secuk... | NCT01412944 | Trialant
NCT01412944
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Mar 18, 2015Estimated
Enrollment
43Actual
Phase
Phase 3
Conditions
Plaque-type Psoriasis
Interventions
secukinumab 150mg
secukinumab 10mg/kg i.v. regimen
Countries
United States
Austria
Canada
France
Germany
India
Japan
Slovakia
Protocol Section
Identification Module
NCT ID
NCT01412944
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CAIN457A2307
Secondary IDs
ID
Type
Description
Link
2011-002510-36
EudraCT Number
Brief Title
Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis
Official Title
A Randomized, Double-blind, Double Dummy, Multicenter Study to Assess the Safety, Tolerability and Long-term Efficacy of Intravenous (10mg/kg) and Subcutaneous (300mg) Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Who Are Partial Responders to Secukinumab
Acronym
STATURE
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Mar 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 2011
Primary Completion Date
Apr 2013Actual
Completion Date
Apr 2013Actual
First Submitted Date
Aug 5, 2011
First Submission Date that Met QC Criteria
Aug 8, 2011
First Posted Date
Aug 9, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 28, 2015
Results First Submitted that Met QC Criteria
Mar 17, 2015
Results First Posted Date
Mar 18, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 17, 2015
Last Update Posted Date
Mar 18, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.
Detailed Description
Not provided
Conditions Module
Conditions
Plaque-type Psoriasis
Keywords
Psoriasis
plaque
inflammatory skin disease
scaly patches
AIN457
secukinumab
Moderate to severe
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
43Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
AIN457 subcutaneous (s.c.)
Experimental
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
Drug: secukinumab 150mg
AIN457 I.V.
Experimental
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
Drug: secukinumab 10mg/kg i.v. regimen
Interventions
Name
Type
Description
Arm Group Labels
Other Names
secukinumab 150mg
Drug
secukinumab 150mg (2 injections per dose)
AIN457 subcutaneous (s.c.)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in Psoriasis Area and Severity Index (PASI) After 12 Weeks of Treatment in Study AIN457A2304) With 75% Improvement From Baseline in PASI
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).
Week 8
Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in PASI After 12 Weeks of Treatment in Study AIN457A2304) With Investigator's Global Assessment Model 2011 (IGA Mod 2011) 0 or 1 Response
The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
Week 8
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Written Informed Consent must be obtained before any assessment is performed,
Subject must be able to understand and communicate with the investigator and comply with the requirements of the study.
Subjects must have participated in the study CAIN457A2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations.
A partial response is defined as having achieved ≥ PASI 50 but < 75 response.
Exclusion criteria
Pregnant women or lactating women
Forms of psoriasis other than chronic plaque -type
Ongoing use of prohibited psoriasis treatments
Ongoing use of other non-psoriasis prohibited treatments
Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor, except secukinumab in study CAIN457A2304
Active ongoing inflammation diseases other than psoriasis that might confound the evaluation of the benefits of secukinumab therapy
UV therapy or excessive exposure to sunlight
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Novartis Investigative Site
Jacksonville
Florida
32216
United States
Novartis Investigative Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Participants of the CAIN457A2304 150 mg or AIN457 300 mg treatment groups, who were partial responders at week 12 of CAIN457A2304, were randomized in a 1:1 ratio to the AIN457 300 mg s.c. or AIN457 10 mg/kg I.V. treatment groups of CAIN457A2307.
Recruitment Details
This study consisted of 3 study periods: I.V. (I.V. infusion and subcutaneous (s.c.) regimens given in a double-blind fashion), Maintenance and follow-up. Participants, who were identified as partial responders at week 12 of study CAIN457A2304 (NCT01406938), were eligible to roll into CAIN457A2307.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
AIN457 Subcutaneous (s.c.)
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.
Percentage of Participants in Each IGA Mod 2011 Score Category
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.
Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A DLQI of 0 or 1 indicates no impairment or little impairment, respectively. A negative mean percentage change from baseline indicates improvement.
Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Baseline, weeks 8, 16, 24, 32 and 40
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100)
The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.
Baseline, weeks 8, 16, 24, 32 and 40
Number of Participants Who Developed Anti-secukinumab Antibodies
The development of anti-secunimubab anti-bodies would decrease a participant's ability to respond to secukinumab treatment.
Baseline, weeks 12, 24 and 40
Relationship Between Response to AIN457 and Failed Response to Previous Biologic Psoriasis Therapy
This outcome measure was not analyzed due to the small sample size of the study (43 participants).
End of study
West Palm Beach
Florida
33409
United States
Novartis Investigative Site
Boston
Massachusetts
02111
United States
Novartis Investigative Site
St Louis
Missouri
63117
United States
Novartis Investigative Site
Greensboro
North Carolina
27401
United States
Novartis Investigative Site
Greer
South Carolina
29651
United States
Novartis Investigative Site
Wels
Austria
4600
Austria
Novartis Investigative Site
Graz
A-8036
Austria
Novartis Investigative Site
Vienna
A-1220
Austria
Novartis Investigative Site
Barrie
Ontario
L4M 6L2
Canada
Novartis Investigative Site
Waterloo
Ontario
N2J 1C4
Canada
Novartis Investigative Site
Montreal
Quebec
H2K 4L5
Canada
Novartis Investigative Site
Toulouse
France
31059
France
Novartis Investigative Site
Rouen
76031
France
Novartis Investigative Site
Essen
45147
Germany
Novartis Investigative Site
Frankfurt
60590
Germany
Novartis Investigative Site
Hamburg
22143
Germany
Novartis Investigative Site
Lübeck
23538
Germany
Novartis Investigative Site
Mainz
55131
Germany
Novartis Investigative Site
Mangalore
Karnataka
575 004
India
Novartis Investigative Site
Nagpur
Maharashtra
440 010
India
Novartis Investigative Site
Nashik
Maharashtra
422 001
India
Novartis Investigative Site
Kisarazu
Chiba
292-8535
Japan
Novartis Investigative Site
Hachiōji
Tokyo
193-0998
Japan
Novartis Investigative Site
Minato-ku
Tokyo
105-8471
Japan
Novartis Investigative Site
Shinjuku-ku
Tokyo
160-0023
Japan
Novartis Investigative Site
Košice
Slovak Republic
040 15
Slovakia
AIN457 I.V.
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
FG002
I.V. Period: AIN457 150 mg - AIN457 300 mg s.c.
FG003
AIN457 300 mg - AIN457 300 mg s.c.
FG004
AIN457 150 mg - AIN457 10 mg/kg I.V.
FG005
AIN457 300 mg - AIN457 10 mg/kg I.V.
FG0000 subjects
FG0010 subjects
FG00215 subjects
FG0036 subjects
FG00414 subjects
FG0058 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG00214 subjects
FG0036 subjects
FG00414 subjects
FG0056 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Protocol deviation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
IV: Per CAIN457A2307
Type
Comment
Milestone Data
STARTED
FG00021 subjects
FG00122 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG00020 subjects
FG00120 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG003
Entire: IV + Maintenance
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG00215 subjects
FG0036 subjects
FG00414 subjects
FG0058 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG00214 subjects
FG0035 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Entire: IV + Maintenance
Type
Comment
Milestone Data
STARTED
FG00021 subjects
FG00122 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG00019 subjects
FG00117 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0002 subjects
FG0015 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG003
Follow-up
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG0042 subjects
FG0050 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
AIN457 Subcutaneous (s.c.)
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
BG001
AIN457 I.V.
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00021
BG00122
BG00243
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
BG00047.6± 14.53
BG00145.7± 12.14
BG00246.6± 13.24
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG0019
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in Psoriasis Area and Severity Index (PASI) After 12 Weeks of Treatment in Study AIN457A2304) With 75% Improvement From Baseline in PASI
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).
The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had week 8 values, were included in the analysis.
Posted
Number
Percentage of participants
Week 8
ID
Title
Description
OG000
AIN457 Subcutaneous (s.c.)
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
OG001
AIN457 I.V.
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
Units
Counts
Participants
OG00021
OG00121
Title
Denominators
Categories
Title
Measurements
OG00066.7
OG00190.5
Primary
Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in PASI After 12 Weeks of Treatment in Study AIN457A2304) With Investigator's Global Assessment Model 2011 (IGA Mod 2011) 0 or 1 Response
The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had week 8 values, were included in the analysis.
Posted
Number
Percentage of participants
Week 8
ID
Title
Description
OG000
AIN457 Subcutaneous (s.c.)
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
OG001
AIN457 I.V.
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
Secondary
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
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.
The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.
Posted
Number
Percentage of participants
Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
ID
Title
Description
OG000
AIN457 Subcutaneous (s.c.)
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
Secondary
Mean Percent Change From Baseline in PASI Scores
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.
The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
OG001
AIN457 I.V.
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
Secondary
Percentage of Participants in Each IGA Mod 2011 Score Category
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.
The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.
Posted
Number
Percentage of participants
Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
ID
Title
Description
OG000
AIN457 Subcutaneous (s.c.)
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
OG001
AIN457 I.V.
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
Secondary
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A DLQI of 0 or 1 indicates no impairment or little impairment, respectively. A negative mean percentage change from baseline indicates improvement.
The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
OG001
Secondary
Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
The FAS population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.
Posted
Mean
Standard Deviation
Percent change
Baseline, weeks 8, 16, 24, 32 and 40
ID
Title
Description
OG000
AIN457 Subcutaneous (s.c.)
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
OG001
AIN457 I.V.
Secondary
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100)
The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.
The FAS population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.
Posted
Mean
Standard Deviation
Percent change
Baseline, weeks 8, 16, 24, 32 and 40
ID
Title
Description
OG000
AIN457 Subcutaneous (s.c.)
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
OG001
AIN457 I.V.
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
Secondary
Number of Participants Who Developed Anti-secukinumab Antibodies
The development of anti-secunimubab anti-bodies would decrease a participant's ability to respond to secukinumab treatment.
Participants from full analysis set (FAS), who had values at baseline and post-baseline, were included in the analysis. The FAS included all participants to whom treatment was assigned.
Posted
Number
Number of participants
Baseline, weeks 12, 24 and 40
ID
Title
Description
OG000
AIN457 Subcutaneous (s.c.)
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
OG001
AIN457 I.V.
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
Units
Counts
Participants
Secondary
Relationship Between Response to AIN457 and Failed Response to Previous Biologic Psoriasis Therapy
This outcome measure was not analyzed due to the small sample size of the study (43 participants).
Posted
End of study
ID
Title
Description
OG000
AIN457 Subcutaneous (s.c.)
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
OG001
AIN457 I.V.
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
SKIN PAPILLOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected6 at risk
EG0021 affected14 at risk
EG003
SCIATICA
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
TENSION HEADACHE
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
ENURESIS
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
NEPHROLITHIASIS
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
ERECTILE DYSFUNCTION
Reproductive system and breast disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
PHARYNGEAL OEDEMA
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
SINUS CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
DERMATITIS BULLOUS
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
DERMATITIS CONTACT
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
ECCHYMOSIS
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected6 at risk
EG0021 affected14 at risk
EG003
ECZEMA
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
INTERTRIGO
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected6 at risk
EG0021 affected14 at risk
EG003
PRURITUS GENERALISED
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected6 at risk
EG0021 affected14 at risk
EG003
PSORIASIS
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
SEBORRHOEIC DERMATITIS
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
SKIN FISSURES
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
SKIN LESION
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
FLUSHING
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
THROMBOPHLEBITIS
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected6 at risk
EG0020 affected14 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Novartis
862-778-8300
ID
Term
D011565
Psoriasis
D058225
Plaque, Amyloid
D003872
Dermatitis
Ancestor Terms
ID
Term
D017444
Skin Diseases, Papulosquamous
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
D020763
Pathological Conditions, Anatomical
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C555450
secukinumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0051 subjects
0 subjects
FG0051 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0040 subjects
FG0050 subjects
Protocol deviation
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
11 subjects
FG0056 subjects
3 subjects
FG0052 subjects
1 subjects
FG0041 subjects
FG0050 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
Protocol deviation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0040 subjects
FG0050 subjects
Protocol deviation
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Lack of Efficacy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
2 subjects
FG0050 subjects
0 subjects
FG0050 subjects
14
Male
BG00016
BG00113
BG00229
Units
Counts
Participants
OG00021
OG00121
Title
Denominators
Categories
Title
Measurements
OG00066.7
OG00133.3
OG001
AIN457 I.V.
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
Units
Counts
Participants
OG00021
OG00121
Title
Denominators
Categories
Week 2 IGA 0/1
Title
Measurements
OG0009.5
OG0019.5
Week 2 PASI 75
Title
Measurements
OG00019.0
OG00147.6
Week 2 PASI 50
Title
Measurements
OG00085.7
OG001100.0
Week 2 PASI 90
Title
Measurements
OG0000.0
OG00119.0
Week 2 PASI 100
Title
Measurements
OG0000.0
OG0010.0
Week 4 IGA 0/1
Title
Measurements
OG0009.5
OG00147.6
Week 4 PASI 75
Title
Measurements
OG00033.3
OG00176.2
Week 4 PASI 50
Title
Measurements
OG00085.7
OG00195.2
Week 4 PASI 90
Title
Measurements
OG0004.8
OG00128.6
Week 4 PASI 100
Title
Measurements
OG0000.0
OG0019.5
Week 8 IGA 0/1
Title
Measurements
OG00033.3
OG00166.7
Week 8 PASI 75
Title
Measurements
OG00066.7
OG00190.5
Week 8 PASI 50
Title
Measurements
OG00090.5
OG00195.2
Week 8 PASI 90
Title
Measurements
OG0009.5
OG00161.9
Week 8 PASI 100
Title
Measurements
OG0000.0
OG00114.3
Week 12 IGA 0/1
Title
Measurements
OG00038.1
OG00171.4
Week 12 PASI 75
Title
Measurements
OG00061.9
OG00185.7
Week 12 PASI 50
Title
Measurements
OG00085.7
OG00195.2
Week 12 PASI 90
Title
Measurements
OG00019.0
OG00166.7
Week 12 PASI 100
Title
Measurements
OG0000.0
OG00114.3
Week 16 IGA 0/1
Title
Measurements
OG00028.6
OG00166.7
Week 16 PASI 75
Title
Measurements
OG00066.7
OG00181.0
Week 16 PASI 50
Title
Measurements
OG00085.7
OG00185.7
Week 16 PASI 90
Title
Measurements
OG00014.3
OG00157.1
Week 16 PASI 100
Title
Measurements
OG0000.0
OG00119.0
Week 20 IGA 0/1
Title
Measurements
OG00023.8
OG00161.9
Week 20 PASI 75
Title
Measurements
OG00066.7
OG00181.0
Week 20 PASI 50
Title
Measurements
OG00081.0
OG00185.7
Week 20 PASI 90
Title
Measurements
OG00014.3
OG00157.1
Week 20 PASI 100
Title
Measurements
OG0004.8
OG00114.3
Week 24 IGA 0/1
Title
Measurements
OG00023.8
OG00147.6
Week 24 PASI 75
Title
Measurements
OG00052.4
OG00176.2
Week 24 PASI 50
Title
Measurements
OG00081.0
OG00185.7
Week 24 PASI 90
Title
Measurements
OG00019.0
OG00157.1
Week 24 PASI 100
Title
Measurements
OG0009.5
OG00114.3
Week 28 IGA 0/1
Title
Measurements
OG00023.8
OG00142.9
Week 28 PASI 75
Title
Measurements
OG00061.9
OG00161.9
Week 28 PASI 50
Title
Measurements
OG00076.2
OG00185.7
Week 28 PASI 90
Title
Measurements
OG00023.8
OG00138.1
Week 28 PASI 100
Title
Measurements
OG0000.0
OG00114.3
Week 32 IGA 0/1
Title
Measurements
OG00014.3
OG00142.9
Week 32 PASI 75
Title
Measurements
OG00057.1
OG00166.7
Week 32 PASI 50
Title
Measurements
OG00076.2
OG00181.0
Week 32 PASI 90
Title
Measurements
OG00019.0
OG00142.9
Week 32 PASI 100
Title
Measurements
OG0000.0
OG0019.5
Week 36 IGA 0/1
Title
Measurements
OG00019.0
OG00152.4
Week 36 PASI 75
Title
Measurements
OG00057.1
OG00161.9
Week 36 PASI 50
Title
Measurements
OG00081.0
OG00176.2
Week 36PASI 90
Title
Measurements
OG00023.8
OG00147.6
Week 36 PASI 100
Title
Measurements
OG0000.0
OG0019.5
Week 40 IGA 0/1
Title
Measurements
OG00028.6
OG00142.9
Week 40 PASI 75
Title
Measurements
OG00047.6
OG00161.9
Week 40 PASI 50
Title
Measurements
OG00085.7
OG00171.4
Week 40 PASI 90
Title
Measurements
OG00023.8
OG00147.6
Week 40 PASI 100
Title
Measurements
OG0000.0
OG00114.3
Units
Counts
Participants
OG00021
OG00121
Title
Denominators
Categories
Week 2
Title
Measurements
OG000-65.427± 14.1732
OG001-74.824± 10.6180
Week 4
Title
Measurements
OG000-69.804± 14.4443
OG001-83.063± 10.7849
Week 8
Title
Measurements
OG000-75.422± 15.0913
OG001-90.980± 9.6116
Week 12
Title
Measurements
OG000-76.026± 17.0949
OG001-89.754± 11.1194
Week 16
Title
Measurements
OG000-75.079± 18.6092
OG001-89.645± 13.4471
Week 20
Title
Measurements
OG000-74.494± 20.5253
OG001-86.816± 19.4202
Week 24
Title
Measurements
OG000-72.703± 22.4086
OG001-85.803± 19.8869
Week 28
Title
Measurements
OG000-72.281± 23.4549
OG001-80.487± 25.7435
Week 32
Title
Measurements
OG000-71.770± 22.7398
OG001-79.557± 27.2634
Week 36
Title
Measurements
OG000-72.151± 21.4637
OG001-79.329± 27.2362
Week 40
Title
Measurements
OG000-73.663± 18.2709
OG001-77.416± 28.5592
Units
Counts
Participants
OG00021
OG00121
Title
Denominators
Categories
week 2 - clear
Title
Measurements
OG0000.0
OG0010.0
week 2 - almost clear
Title
Measurements
OG0009.5
OG0019.5
week 2 - mild
Title
Measurements
OG00057.1
OG00166.7
week 2 - moderate
Title
Measurements
OG00033.3
OG00123.8
week 2 - severe
Title
Measurements
OG0000.0
OG0010.0
week 4 - clear
Title
Measurements
OG0000.0
OG0019.5
week 4 - almost clear
Title
Measurements
OG0009.5
OG00138.1
week 4 - mild
Title
Measurements
OG00061.9
OG00147.6
week 4 - moderate
Title
Measurements
OG00028.6
OG0014.8
week 4 - severe
Title
Measurements
OG0000.0
OG0010.0
week 8 - clear
Title
Measurements
OG0000.0
OG00119.0
week 8 - almost clear
Title
Measurements
OG00033.3
OG00147.6
week 8 - mild
Title
Measurements
OG00038.1
OG00123.8
week 8 - moderate
Title
Measurements
OG00028.6
OG0019.5
week 8 - severe
Title
Measurements
OG0000.0
OG0010.0
week 12 - clear
Title
Measurements
OG0000.0
OG00114.3
week 12 - almost clear
Title
Measurements
OG00038.1
OG00157.1
week 12 - mild
Title
Measurements
OG00033.3
OG00119.0
week 12 - moderate
Title
Measurements
OG00028.6
OG0019.5
week 12 - severe
Title
Measurements
OG0000.0
OG0010.0
week 16 - clear
Title
Measurements
OG0000.0
OG00119.0
week 16 - almost clear
Title
Measurements
OG00028.6
OG00152.4
week 16 - mild
Title
Measurements
OG00042.9
OG00119.0
week 16 - moderate
Title
Measurements
OG00028.6
OG0019.5
week 16 - severe
Title
Measurements
OG0000.0
OG0010.0
week 20 - clear
Title
Measurements
OG0004.8
OG00114.3
week 20 - almost clear
Title
Measurements
OG00019.0
OG00152.4
week 20 - mild
Title
Measurements
OG00047.6
OG00123.8
week 20 - moderate
Title
Measurements
OG00028.6
OG0019.5
week 20 - severe
Title
Measurements
OG0000.0
OG0010.0
week 24 - clear
Title
Measurements
OG0009.5
OG00114.3
week 24 - almost clear
Title
Measurements
OG00014.3
OG00138.1
week 24 - mild
Title
Measurements
OG00033.3
OG00128.6
week 24 - moderate
Title
Measurements
OG00042.9
OG00114.3
week 24 - severe
Title
Measurements
OG0000.0
OG0014.8
week 28 - clear
Title
Measurements
OG0009.5
OG0014.8
week 28 - almost clear
Title
Measurements
OG00014.3
OG00142.9
week 28 - mild
Title
Measurements
OG00047.6
OG00128.6
week 28 - moderate
Title
Measurements
OG00028.6
OG00123.8
week 28 - severe
Title
Measurements
OG0000.0
OG0010.0
week 32 - clear
Title
Measurements
OG0004.8
OG0014.8
week 32 - almost clear
Title
Measurements
OG0009.5
OG00142.9
week 32 - mild
Title
Measurements
OG00047.6
OG00123.8
week 32 - moderate
Title
Measurements
OG00038.1
OG00123.8
week 32 - severe
Title
Measurements
OG0000.0
OG0014.8
week 36 - clear
Title
Measurements
OG0000.0
OG0014.8
week 36 - almost clear
Title
Measurements
OG00019.0
OG00152.4
week 36 - mild
Title
Measurements
OG00042.9
OG00119.0
week 36 - moderate
Title
Measurements
OG00038.1
OG00119.0
week 36 - severe
Title
Measurements
OG0000.0
OG0014.8
week 40 - clear
Title
Measurements
OG0000.0
OG00114.3
week 40 - almost clear
Title
Measurements
OG00028.6
OG00133.3
week 40 - mild
Title
Measurements
OG00033.3
OG00123.8
week 40 - moderate
Title
Measurements
OG00038.1
OG00123.8
week 40 - severe
Title
Measurements
OG0000.0
OG0014.8
AIN457 I.V.
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
Units
Counts
Participants
OG00021
OG00121
Title
Denominators
Categories
Baseline
Title
Measurements
OG0000.0
OG0014.8
Week 8 (n=20,20)
Title
Measurements
OG00025.0
OG00175.0
Week 16 (n=20,20)
Title
Measurements
OG00040.0
OG00170.0
Week 24 (n=20,20)
Title
Measurements
OG00040.0
OG00155.0
Week 32 (n=20,20)
Title
Measurements
OG00040.0
OG00155.0
Week 40 (n=20,20)
Title
Measurements
OG00040.0
OG00155.0
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.