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Trial record 2 of 2 for:    secukinumab, A2307

Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis (STATURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01412944
Recruitment Status : Completed
First Posted : August 9, 2011
Results First Posted : March 18, 2015
Last Update Posted : March 18, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Plaque-type Psoriasis
Interventions Drug: secukinumab 150mg
Drug: secukinumab 10mg/kg i.v. regimen
Enrollment 43
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.
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.
Arm/Group Title AIN457 Subcutaneous (s.c.) AIN457 I.V. I.V. Period: AIN457 150 mg - AIN457 300 mg s.c. AIN457 300 mg - AIN457 300 mg s.c. AIN457 150 mg - AIN457 10 mg/kg I.V. AIN457 300 mg - AIN457 10 mg/kg I.V.
Hide Arm/Group Description 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. 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. [Not Specified] [Not Specified] [Not Specified] [Not Specified]
Period Title: IV: Per Previous CAIN457A2304 Treatment
Started 0 0 15 6 14 8
Completed 0 0 14 6 14 6
Not Completed 0 0 1 0 0 2
Reason Not Completed
Withdrawal by Subject             0             0             1             0             0             0
Protocol deviation             0             0             0             0             0             1
Lost to Follow-up             0             0             0             0             0             1
Period Title: IV: Per CAIN457A2307
Started 21 22 0 0 0 0
Completed 20 20 0 0 0 0
Not Completed 1 2 0 0 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0             0             0             0
Protocol deviation             0             1             0             0             0             0
Lost to Follow-up             0             1             0             0             0             0
Period Title: Entire: IV + Maintenance
Started 0 0 15 6 14 8
Completed 0 0 14 5 11 6
Not Completed 0 0 1 1 3 2
Reason Not Completed
Withdrawal by Subject             0             0             1             1             1             0
Adverse Event             0             0             0             0             1             0
Protocol deviation             0             0             0             0             0             1
Lost to Follow-up             0             0             0             0             0             1
Lack of Efficacy             0             0             0             0             1             0
Period Title: Entire: IV + Maintenance
Started 21 22 0 0 0 0
Completed 19 17 0 0 0 0
Not Completed 2 5 0 0 0 0
Reason Not Completed
Withdrawal by Subject             2             1             0             0             0             0
Protocol deviation             0             1             0             0             0             0
Lost to Follow-up             0             1             0             0             0             0
Lack of Efficacy             0             1             0             0             0             0
Adverse Event             0             1             0             0             0             0
Period Title: Follow-up
Started 0 0 2 1 2 0
Completed 0 0 2 1 2 0
Not Completed 0 0 0 0 0 0
Arm/Group Title AIN457 Subcutaneous (s.c.) AIN457 I.V. Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 21 22 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 22 participants 43 participants
47.6  (14.53) 45.7  (12.14) 46.6  (13.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 22 participants 43 participants
Female
5
  23.8%
9
  40.9%
14
  32.6%
Male
16
  76.2%
13
  59.1%
29
  67.4%
1.Primary Outcome
Title 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
Hide Description 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).
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AIN457 Subcutaneous (s.c.) AIN457 I.V.
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 21 21
Measure Type: Number
Unit of Measure: Percentage of participants
66.7 90.5
2.Primary Outcome
Title 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
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AIN457 Subcutaneous (s.c.) AIN457 I.V.
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 21 21
Measure Type: Number
Unit of Measure: Percentage of participants
66.7 33.3
3.Secondary Outcome
Title Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Hide Description 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.
Time Frame Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AIN457 Subcutaneous (s.c.) AIN457 I.V.
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 21 21
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 IGA 0/1 9.5 9.5
Week 2 PASI 75 19.0 47.6
Week 2 PASI 50 85.7 100.0
Week 2 PASI 90 0.0 19.0
Week 2 PASI 100 0.0 0.0
Week 4 IGA 0/1 9.5 47.6
Week 4 PASI 75 33.3 76.2
Week 4 PASI 50 85.7 95.2
Week 4 PASI 90 4.8 28.6
Week 4 PASI 100 0.0 9.5
Week 8 IGA 0/1 33.3 66.7
Week 8 PASI 75 66.7 90.5
Week 8 PASI 50 90.5 95.2
Week 8 PASI 90 9.5 61.9
Week 8 PASI 100 0.0 14.3
Week 12 IGA 0/1 38.1 71.4
Week 12 PASI 75 61.9 85.7
Week 12 PASI 50 85.7 95.2
Week 12 PASI 90 19.0 66.7
Week 12 PASI 100 0.0 14.3
Week 16 IGA 0/1 28.6 66.7
Week 16 PASI 75 66.7 81.0
Week 16 PASI 50 85.7 85.7
Week 16 PASI 90 14.3 57.1
Week 16 PASI 100 0.0 19.0
Week 20 IGA 0/1 23.8 61.9
Week 20 PASI 75 66.7 81.0
Week 20 PASI 50 81.0 85.7
Week 20 PASI 90 14.3 57.1
Week 20 PASI 100 4.8 14.3
Week 24 IGA 0/1 23.8 47.6
Week 24 PASI 75 52.4 76.2
Week 24 PASI 50 81.0 85.7
Week 24 PASI 90 19.0 57.1
Week 24 PASI 100 9.5 14.3
Week 28 IGA 0/1 23.8 42.9
Week 28 PASI 75 61.9 61.9
Week 28 PASI 50 76.2 85.7
Week 28 PASI 90 23.8 38.1
Week 28 PASI 100 0.0 14.3
Week 32 IGA 0/1 14.3 42.9
Week 32 PASI 75 57.1 66.7
Week 32 PASI 50 76.2 81.0
Week 32 PASI 90 19.0 42.9
Week 32 PASI 100 0.0 9.5
Week 36 IGA 0/1 19.0 52.4
Week 36 PASI 75 57.1 61.9
Week 36 PASI 50 81.0 76.2
Week 36PASI 90 23.8 47.6
Week 36 PASI 100 0.0 9.5
Week 40 IGA 0/1 28.6 42.9
Week 40 PASI 75 47.6 61.9
Week 40 PASI 50 85.7 71.4
Week 40 PASI 90 23.8 47.6
Week 40 PASI 100 0.0 14.3
4.Secondary Outcome
Title Mean Percent Change From Baseline in PASI Scores
Hide Description 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.
Time Frame Baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AIN457 Subcutaneous (s.c.) AIN457 I.V.
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: Percent change
Week 2 -65.427  (14.1732) -74.824  (10.6180)
Week 4 -69.804  (14.4443) -83.063  (10.7849)
Week 8 -75.422  (15.0913) -90.980  (9.6116)
Week 12 -76.026  (17.0949) -89.754  (11.1194)
Week 16 -75.079  (18.6092) -89.645  (13.4471)
Week 20 -74.494  (20.5253) -86.816  (19.4202)
Week 24 -72.703  (22.4086) -85.803  (19.8869)
Week 28 -72.281  (23.4549) -80.487  (25.7435)
Week 32 -71.770  (22.7398) -79.557  (27.2634)
Week 36 -72.151  (21.4637) -79.329  (27.2362)
Week 40 -73.663  (18.2709) -77.416  (28.5592)
5.Secondary Outcome
Title Percentage of Participants in Each IGA Mod 2011 Score Category
Hide Description 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.
Time Frame Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AIN457 Subcutaneous (s.c.) AIN457 I.V.
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 21 21
Measure Type: Number
Unit of Measure: Percentage of participants
week 2 - clear 0.0 0.0
week 2 - almost clear 9.5 9.5
week 2 - mild 57.1 66.7
week 2 - moderate 33.3 23.8
week 2 - severe 0.0 0.0
week 4 - clear 0.0 9.5
week 4 - almost clear 9.5 38.1
week 4 - mild 61.9 47.6
week 4 - moderate 28.6 4.8
week 4 - severe 0.0 0.0
week 8 - clear 0.0 19.0
week 8 - almost clear 33.3 47.6
week 8 - mild 38.1 23.8
week 8 - moderate 28.6 9.5
week 8 - severe 0.0 0.0
week 12 - clear 0.0 14.3
week 12 - almost clear 38.1 57.1
week 12 - mild 33.3 19.0
week 12 - moderate 28.6 9.5
week 12 - severe 0.0 0.0
week 16 - clear 0.0 19.0
week 16 - almost clear 28.6 52.4
week 16 - mild 42.9 19.0
week 16 - moderate 28.6 9.5
week 16 - severe 0.0 0.0
week 20 - clear 4.8 14.3
week 20 - almost clear 19.0 52.4
week 20 - mild 47.6 23.8
week 20 - moderate 28.6 9.5
week 20 - severe 0.0 0.0
week 24 - clear 9.5 14.3
week 24 - almost clear 14.3 38.1
week 24 - mild 33.3 28.6
week 24 - moderate 42.9 14.3
week 24 - severe 0.0 4.8
week 28 - clear 9.5 4.8
week 28 - almost clear 14.3 42.9
week 28 - mild 47.6 28.6
week 28 - moderate 28.6 23.8
week 28 - severe 0.0 0.0
week 32 - clear 4.8 4.8
week 32 - almost clear 9.5 42.9
week 32 - mild 47.6 23.8
week 32 - moderate 38.1 23.8
week 32 - severe 0.0 4.8
week 36 - clear 0.0 4.8
week 36 - almost clear 19.0 52.4
week 36 - mild 42.9 19.0
week 36 - moderate 38.1 19.0
week 36 - severe 0.0 4.8
week 40 - clear 0.0 14.3
week 40 - almost clear 28.6 33.3
week 40 - mild 33.3 23.8
week 40 - moderate 38.1 23.8
week 40 - severe 0.0 4.8
6.Secondary Outcome
Title Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1
Hide Description 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.
Time Frame Baseline, Week 8, Week 16, Week 24, Week 32,up to Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AIN457 Subcutaneous (s.c.) AIN457 I.V.
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 21 21
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline 0.0 4.8
Week 8 (n=20,20) 25.0 75.0
Week 16 (n=20,20) 40.0 70.0
Week 24 (n=20,20) 40.0 55.0
Week 32 (n=20,20) 40.0 55.0
Week 40 (n=20,20) 40.0 55.0
7.Secondary Outcome
Title Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores
Hide Description 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.
Time Frame Baseline, weeks 8, 16, 24, 32 and 40
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AIN457 Subcutaneous (s.c.) AIN457 I.V.
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: Percent change
week 8 -67.1  (28.35) -82.4  (31.13)
week 16 -68.7  (32.34) -74.8  (42.19)
week 24 -66.9  (29.27) -63.2  (42.65)
week 32 -65.4  (34.64) -58.1  (53.40)
week 40 -74.2  (24.25) -53.8  (56.21)
8.Secondary Outcome
Title Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100)
Hide Description 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.
Time Frame Baseline, weeks 8, 16, 24, 32 and 40
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AIN457 Subcutaneous (s.c.) AIN457 I.V.
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: Percent change
week 8 71.0  (157.11) 73.1  (99.42)
week 16 76.9  (153.63) 57.5  (98.10)
week 24 74.6  (171.69) 45.3  (82.05)
week 32 80.2  (177.33) 40.9  (80.96)
week 40 87.2  (173.59) 41.3  (86.92)
9.Secondary Outcome
Title Number of Participants Who Developed Anti-secukinumab Antibodies
Hide Description The development of anti-secunimubab anti-bodies would decrease a participant's ability to respond to secukinumab treatment.
Time Frame Baseline, weeks 12, 24 and 40
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AIN457 Subcutaneous (s.c.) AIN457 I.V.
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: Number of participants
0 0
10.Secondary Outcome
Title Relationship Between Response to AIN457 and Failed Response to Previous Biologic Psoriasis Therapy
Hide Description This outcome measure was not analyzed due to the small sample size of the study (43 participants).
Time Frame End of study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AIN457 Subcutaneous (s.c.) AIN457 I.V.
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title I.V. Period: AIN457 150 mg - AIN457 300 mg s.c. I.V. Period: AIN457 300 mg - AIN457 300 mg s.c. I.V. Period: AIN457 150 mg - AIN457 10 mg/kg i.v. I.V. Period: AIN457 300 mg - AIN457 10 mg/kg i.v. Entire Period: AIN457 150 mg - AIN457 300 mg s.c. Entire Period: AIN457 300 mg - AIN457 300 mg s.c. Entire Period: AIN457 150 mg - AIN457 10 mg/kg i.v. Entire Period: AIN457 300 mg - AIN457 10 mg/kg i.v. Follow up: AIN457 300 mg - AIN457 300 mg s.c. Follow-up: AIN457 300 mg - 10 mg/kg i.v. Follow-up: AIN457 150 mg - 300 mg s.c. Follow-up: AIN457 150 mg - 10 mg/kg i.v.
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
I.V. Period: AIN457 150 mg - AIN457 300 mg s.c. I.V. Period: AIN457 300 mg - AIN457 300 mg s.c. I.V. Period: AIN457 150 mg - AIN457 10 mg/kg i.v. I.V. Period: AIN457 300 mg - AIN457 10 mg/kg i.v. Entire Period: AIN457 150 mg - AIN457 300 mg s.c. Entire Period: AIN457 300 mg - AIN457 300 mg s.c. Entire Period: AIN457 150 mg - AIN457 10 mg/kg i.v. Entire Period: AIN457 300 mg - AIN457 10 mg/kg i.v. Follow up: AIN457 300 mg - AIN457 300 mg s.c. Follow-up: AIN457 300 mg - 10 mg/kg i.v. Follow-up: AIN457 150 mg - 300 mg s.c. Follow-up: AIN457 150 mg - 10 mg/kg i.v.
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
I.V. Period: AIN457 150 mg - AIN457 300 mg s.c. I.V. Period: AIN457 300 mg - AIN457 300 mg s.c. I.V. Period: AIN457 150 mg - AIN457 10 mg/kg i.v. I.V. Period: AIN457 300 mg - AIN457 10 mg/kg i.v. Entire Period: AIN457 150 mg - AIN457 300 mg s.c. Entire Period: AIN457 300 mg - AIN457 300 mg s.c. Entire Period: AIN457 150 mg - AIN457 10 mg/kg i.v. Entire Period: AIN457 300 mg - AIN457 10 mg/kg i.v. Follow up: AIN457 300 mg - AIN457 300 mg s.c. Follow-up: AIN457 300 mg - 10 mg/kg i.v. Follow-up: AIN457 150 mg - 300 mg s.c. Follow-up: AIN457 150 mg - 10 mg/kg i.v.
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/6 (0.00%)   0/14 (0.00%)   0/8 (0.00%)   0/15 (0.00%)   0/6 (0.00%)   1/14 (7.14%)   0/8 (0.00%)   0/1 (0.00%)   0/0   0/2 (0.00%)   0/2 (0.00%) 
Skin and subcutaneous tissue disorders                         
DERMATITIS ALLERGIC  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
I.V. Period: AIN457 150 mg - AIN457 300 mg s.c. I.V. Period: AIN457 300 mg - AIN457 300 mg s.c. I.V. Period: AIN457 150 mg - AIN457 10 mg/kg i.v. I.V. Period: AIN457 300 mg - AIN457 10 mg/kg i.v. Entire Period: AIN457 150 mg - AIN457 300 mg s.c. Entire Period: AIN457 300 mg - AIN457 300 mg s.c. Entire Period: AIN457 150 mg - AIN457 10 mg/kg i.v. Entire Period: AIN457 300 mg - AIN457 10 mg/kg i.v. Follow up: AIN457 300 mg - AIN457 300 mg s.c. Follow-up: AIN457 300 mg - 10 mg/kg i.v. Follow-up: AIN457 150 mg - 300 mg s.c. Follow-up: AIN457 150 mg - 10 mg/kg i.v.
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/15 (46.67%)   4/6 (66.67%)   5/14 (35.71%)   5/8 (62.50%)   10/15 (66.67%)   5/6 (83.33%)   12/14 (85.71%)   6/8 (75.00%)   1/1 (100.00%)   0/0   0/2 (0.00%)   0/2 (0.00%) 
Blood and lymphatic system disorders                         
LYMPHADENOPATHY  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
Cardiac disorders                         
ATRIAL FIBRILLATION  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
ATRIOVENTRICULAR BLOCK FIRST DEGREE  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
Eye disorders                         
CONJUNCTIVITIS  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
CONJUNCTIVITIS ALLERGIC  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
EYELIDS PRURITUS  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
Gastrointestinal disorders                         
DIARRHOEA  1  0/15 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
GINGIVITIS ULCERATIVE  1  0/15 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
ILEAL ULCER  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
TOOTHACHE  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
General disorders                         
CHEST PAIN  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
FATIGUE  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
INJECTION SITE PAIN  1  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
Immune system disorders                         
ALLERGY TO PLANTS  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
SEASONAL ALLERGY  1  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
Infections and infestations                         
BRONCHITIS  1  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
BRONCHITIS BACTERIAL  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
EAR INFECTION  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  1/8 (12.50%)  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
FOLLICULITIS  1  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  2/14 (14.29%)  1/8 (12.50%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
HELICOBACTER INFECTION  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
HERPES ZOSTER  1  0/15 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
INFLUENZA  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
NASOPHARYNGITIS  1  2/15 (13.33%)  1/6 (16.67%)  1/14 (7.14%)  1/8 (12.50%)  3/15 (20.00%)  1/6 (16.67%)  3/14 (21.43%)  2/8 (25.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
ONYCHOMYCOSIS  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
ORAL CANDIDIASIS  1  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
PHARYNGITIS  1  0/15 (0.00%)  1/6 (16.67%)  1/14 (7.14%)  0/8 (0.00%)  1/15 (6.67%)  1/6 (16.67%)  1/14 (7.14%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
PHARYNGITIS STREPTOCOCCAL  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
PILONIDAL CYST  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
RHINITIS  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
SINUSITIS  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  1/8 (12.50%)  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
TINEA PEDIS  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
TONSILLITIS  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  1/8 (12.50%)  1/15 (6.67%)  0/6 (0.00%)  1/14 (7.14%)  1/8 (12.50%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION BACTERIAL  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
Injury, poisoning and procedural complications                         
EXCORIATION  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
FALL  1  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
JOINT INJURY  1  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
LIMB INJURY  1  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
TOOTH FRACTURE  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
UPPER LIMB FRACTURE  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
Investigations                         
HAEMOGLOBIN DECREASED  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
WEIGHT DECREASED  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
Metabolism and nutrition disorders                         
DEHYDRATION  1  0/15 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
TYPE 2 DIABETES MELLITUS  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders                         
BACK PAIN  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  1/8 (12.50%)  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
INTERVERTEBRAL DISC PROTRUSION  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
MUSCLE SPASMS  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
MYALGIA  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                         
PYOGENIC GRANULOMA  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
SKIN PAPILLOMA  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
Nervous system disorders                         
HEADACHE  1  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  2/14 (14.29%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
SCIATICA  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
TENSION HEADACHE  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
Renal and urinary disorders                         
ENURESIS  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
NEPHROLITHIASIS  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
Reproductive system and breast disorders                         
ERECTILE DYSFUNCTION  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders                         
EPISTAXIS  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
OROPHARYNGEAL PAIN  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
PHARYNGEAL OEDEMA  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
PRODUCTIVE COUGH  1  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
SINUS CONGESTION  1  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
Skin and subcutaneous tissue disorders                         
ALOPECIA  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
DERMATITIS BULLOUS  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
DERMATITIS CONTACT  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
ECCHYMOSIS  1  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
ECZEMA  1  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
INTERTRIGO  1  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  1/8 (12.50%)  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  1/8 (12.50%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
PRURITUS GENERALISED  1  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
PSORIASIS  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/1 (100.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
SEBORRHOEIC DERMATITIS  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
SKIN FISSURES  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
SKIN LESION  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  1/14 (7.14%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
Vascular disorders                         
FLUSHING  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
HYPERTENSION  1  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  1/14 (7.14%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
HYPOTENSION  1  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
THROMBOPHLEBITIS  1  0/15 (0.00%)  0/6 (0.00%)  0/14 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/14 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/0  0/2 (0.00%)  0/2 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01412944    
Other Study ID Numbers: CAIN457A2307
2011-002510-36 ( EudraCT Number )
First Submitted: August 5, 2011
First Posted: August 9, 2011
Results First Submitted: January 28, 2015
Results First Posted: March 18, 2015
Last Update Posted: March 18, 2015