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Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Nail Psoriasis (TRANSFIGURE)

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ClinicalTrials.gov Identifier: NCT01807520
Recruitment Status : Completed
First Posted : March 8, 2013
Results First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Moderate to Severe Nail Psoriasis
Interventions Biological: Secukinumab
Biological: Placebo
Enrollment 198
Recruitment Details The study was made up of 4 periods: screening, treatment period 1, treatment period 2 and post-treatment follow-up.
Pre-assignment Details In treatment period 1, participants were randomized in a 1:1:1 ratio to secukinumab 150mg, secukinumab 300mg or placebo. In treatment period 2, placebo participants were re-randomized in a 1:1 ratio to secukinumab 150mg or secukinumab 300mg. The follow-up period occurred 8 weeks post treatment period 2 (12 weeks post the last dose of secukinumab).
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo Placebo - AIN457 150 mg Placebo - AIN457 300 mg Any AIN457 150 mg Any AIN457 300 mg
Hide Arm/Group Description Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections. Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections. Participants who received placebo during treatment period 1 Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 150 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections. Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 300 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections. Participants who received AIN457 150 mg during treatment period 1 and/or treatment period 2 Participants who received AIN457 300 mg during treatment period 1 and/or treatment period 2
Period Title: Treatment Period 1 (0-16 Weeks)
Started 67 66 65 0 0 0 0
Full Analysis Set 67 66 65 0 0 0 0
Safety Set 67 65 65 0 0 0 0
Completed 63 65 58 0 0 0 0
Not Completed 4 1 7 0 0 0 0
Reason Not Completed
Withdrawal by Subject             0             1             3             0             0             0             0
Protocol deviation             1             0             1             0             0             0             0
Physician Decision             0             0             1             0             0             0             0
Lost to Follow-up             1             0             0             0             0             0             0
Lack of Efficacy             0             0             2             0             0             0             0
Adverse Event             2             0             0             0             0             0             0
Period Title: Treatment Period 2 (16-132 Weeks)
Started 63 65 0 29 29 0 0
Safety Set 63 65 0 29 29 0 0
Full Analysis Set 67 66 0 29 29 0 0
Completed 38 47 0 22 24 0 0
Not Completed 25 18 0 7 5 0 0
Reason Not Completed
Study terminated             7             4             0             0             2             0             0
Protocol deviation             0             0             0             1             0             0             0
Pregnancy             1             0             0             0             0             0             0
Non-compliant with study treatment             0             2             0             0             0             0             0
Lost to Follow-up             4             0             0             1             0             0             0
Lack of Efficacy             5             3             0             0             1             0             0
Adverse Event             3             3             0             3             0             0             0
Withdrawal by Subject             5             6             0             2             2             0             0
Period Title: Follow-up Period (132-140 Weeks)
Started 0 0 2 [1] 0 0 81 [2] 76 [3]
Completed 0 0 2 0 0 77 75
Not Completed 0 0 0 0 0 4 1
Reason Not Completed
Lack of Efficacy             0             0             0             0             0             1             0
Study terminated             0             0             0             0             0             1             0
Lost to Follow-up             0             0             0             0             0             2             1
[1]
These participants discontinued from Treatment Period 1.
[2]
These participants received AIN457150mg during treatment period 1 and/or treatment period 2.
[3]
These participants received AIN457 300mg during treatment period 1 and/or treatment period 2.
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo Total
Hide Arm/Group Description Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections. Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections. Participants who received placebo during treatment period 1 Total of all reporting groups
Overall Number of Baseline Participants 67 66 65 198
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants 66 participants 65 participants 198 participants
43.5  (10.94) 45.1  (12.9) 43.6  (11.2) 44.1  (11.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 66 participants 65 participants 198 participants
Female
12
  17.9%
13
  19.7%
13
  20.0%
38
  19.2%
Male
55
  82.1%
53
  80.3%
52
  80.0%
160
  80.8%
1.Primary Outcome
Title Percentage Change From Baseline in Nail Psoriasis Severity Index (NAPSI) After 16 Weeks of Treatment
Hide Description The NAPSI is a tool to assess psoriatic nail involvement in patients with nail psoriasis. Each nail is divided with imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail matrix psoriasis (0-4) and nail bed psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail gets a nail matrix score and a nail bed score, the total of which is the NAPSI score for that nail ranging from 0 to 8. All 10 fingernails are assessed giving a total NAPSI score ranging from 0 to 80. A negative change from baseline indicates improvement. The adjusted mean is presented.
Time Frame Baseline, 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants from the full analysis set (FAS) who had values at both baseline and week 16, were analyzed. The FAS consisted of all randomized participants to whom treatment was assigned. The analysis was based on Last Observation Carried Forward (LOCF).
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo
Hide Arm/Group Description:
Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
Participants who received placebo during treatment period 1
Overall Number of Participants Analyzed 63 64 56
Mean (Standard Error)
Unit of Measure: percent change
-38.4  (4.54) -46.1  (3.43) -11.7  (4.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AIN457 150 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed model reapeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -26.7
Confidence Interval (2-Sided) 95%
-39.1 to -14.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.26
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AIN457 300 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed model repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -34.4
Confidence Interval (2-Sided) 95%
-45.2 to -23.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.47
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent Change From Baseline in NAPSI Score
Hide Description The NAPSI is a tool to assess psoriatic nail involvement in patients with nail psoriasis. Each nail is divided with imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail matrix psoriasis (0-4) and nail bed psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail gets a nail matrix score and a nail bed score, the total of which is the NAPSI score for that nail ranging from 0 to 8. All 10 fingernails are assessed giving a total NAPSI score ranging from 0 to 80. A negative change from baseline indicates improvement.
Time Frame baseline, 16 weeks, 132 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants from the full analysis set (FAS) who had values at both baseline and the post-baseline time point, were analyzed. The FAS consisted of all randomized participants to whom treatment was assigned. The analysis was based on Last Observation Carried Forward (LOCF).
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo - AIN457 150 mg Placebo - AIN457 300 mg
Hide Arm/Group Description:
Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 150 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.
Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 300 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.
Overall Number of Participants Analyzed 67 65 29 29
Mean (Standard Deviation)
Unit of Measure: percent change
Week 16 Number Analyzed 67 participants 65 participants 29 participants 29 participants
-37.9  (37.32) -45.3  (27.22) -15.4  (32.79) -7.8  (31.77)
Week 132 Number Analyzed 67 participants 65 participants 28 participants 29 participants
-52.9  (42.90) -70.5  (29.2) -62.9  (29.05) -72.7  (22.84)
3.Secondary Outcome
Title Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI75) and Investigator Global Assessment (IGA Mod 2011) Response 0 or 1 Over Time up to Week 16 of the Treatment Compared to Placebo and Over Time up to Week 132
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). The IGA scale referred exclusively to the participant's disease at the time of the assessment. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe. To be considered IGA responder at any point in time, the patient must have an IGA score of 0 or 1 and have achieved a reduction of at least two points on the IGA scale from baseline.
Time Frame 16 weeks, 132 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the FAS, who had evaluable data at a given time point, were analyzed for that time point. The FAS consisted of all randomized participants to whom treatment was assigned. Multiple imputation was applied where the number of evaluable participants was based on a rounded mean number of responders for 500 imputations.
Arm/Group Title AIN457 150 mg AIN457 300 mg
Hide Arm/Group Description:
Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
Overall Number of Participants Analyzed 67 65
Measure Type: Number
Unit of Measure: Percentage of participants
Week 16, PASI 75 76.6 87.1
Week 16, IGA 0/1 67.8 74.0
Week 132, PASI 75 61.6 82.7
Week 132, IGA 0/1 52.2 61.2
4.Secondary Outcome
Title Number of Participants Who Develop Immunogenicity Against Secukinumab
Hide Description The number of participants who tested positive for anti-secukinumab antibodies. It refers to the number of participants who had no positive values at baseline but developed them only after start of secukinumab treatment. None of the participants had a loss of efficacy and the test was only transiently positive.
Time Frame Week 132
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety set was analyzed. The safety set included all participants who took at least one dose of study treatment.
Arm/Group Title AIN457 150 mg AIN457 300 mg Placebo - AIN457 150 mg Placebo - AIN457 300 mg
Hide Arm/Group Description:
Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 150 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.
Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 300 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.
Overall Number of Participants Analyzed 67 65 29 29
Measure Type: Number
Unit of Measure: Participants
2 5 4 3
Time Frame up to week 140
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Any AIN457 150 mg Any AIN457 300 mg Placebo Any AIN457 Dose
Hide Arm/Group Description Participants who received AIN457 150 mg during treatment period 1 and/or treatment period 2 Participants who received AIN457 300 mg during treatment period 1 and/or treatment period 2 Participants who received placebo during treatment period 1 Participants who received AIN457 150 mg or AIN457 300 mg
All-Cause Mortality
Any AIN457 150 mg Any AIN457 300 mg Placebo Any AIN457 Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Any AIN457 150 mg Any AIN457 300 mg Placebo Any AIN457 Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/96 (10.42%)   9/94 (9.57%)   1/65 (1.54%)   19/190 (10.00%) 
Blood and lymphatic system disorders         
Neutropenia  1  1/96 (1.04%)  0/94 (0.00%)  0/65 (0.00%)  1/190 (0.53%) 
Cardiac disorders         
Myocardial infarction  1  0/96 (0.00%)  1/94 (1.06%)  0/65 (0.00%)  1/190 (0.53%) 
Eye disorders         
Cataract subcapsular  1  0/96 (0.00%)  1/94 (1.06%)  0/65 (0.00%)  1/190 (0.53%) 
Gastrointestinal disorders         
Inguinal hernia  1  0/96 (0.00%)  1/94 (1.06%)  0/65 (0.00%)  1/190 (0.53%) 
General disorders         
Pyrexia  1  0/96 (0.00%)  1/94 (1.06%)  0/65 (0.00%)  1/190 (0.53%) 
Hepatobiliary disorders         
Hepatotoxicity  1  0/96 (0.00%)  1/94 (1.06%)  0/65 (0.00%)  1/190 (0.53%) 
Infections and infestations         
Eczema impetiginous  1  1/96 (1.04%)  0/94 (0.00%)  0/65 (0.00%)  1/190 (0.53%) 
Eczema infected  1  1/96 (1.04%)  0/94 (0.00%)  0/65 (0.00%)  1/190 (0.53%) 
Pyelonephritis  1  1/96 (1.04%)  1/94 (1.06%)  0/65 (0.00%)  2/190 (1.05%) 
Injury, poisoning and procedural complications         
Foot fracture  1  0/96 (0.00%)  1/94 (1.06%)  0/65 (0.00%)  1/190 (0.53%) 
Laceration  1  1/96 (1.04%)  0/94 (0.00%)  0/65 (0.00%)  1/190 (0.53%) 
Radius fracture  1  1/96 (1.04%)  0/94 (0.00%)  0/65 (0.00%)  1/190 (0.53%) 
Musculoskeletal and connective tissue disorders         
Rotator cuff syndrome  1  1/96 (1.04%)  0/94 (0.00%)  0/65 (0.00%)  1/190 (0.53%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal cell carcinoma  1  1/96 (1.04%)  0/94 (0.00%)  0/65 (0.00%)  1/190 (0.53%) 
Tonsil cancer  1  0/96 (0.00%)  1/94 (1.06%)  0/65 (0.00%)  1/190 (0.53%) 
Nervous system disorders         
Sciatica  1  0/96 (0.00%)  1/94 (1.06%)  0/65 (0.00%)  1/190 (0.53%) 
Psychiatric disorders         
Alcohol withdrawal syndrome  1  0/96 (0.00%)  1/94 (1.06%)  0/65 (0.00%)  1/190 (0.53%) 
Psychotic disorder  1  1/96 (1.04%)  0/94 (0.00%)  0/65 (0.00%)  1/190 (0.53%) 
Suicidal ideation  1  0/96 (0.00%)  1/94 (1.06%)  0/65 (0.00%)  1/190 (0.53%) 
Respiratory, thoracic and mediastinal disorders         
Haemoptysis  1  0/96 (0.00%)  1/94 (1.06%)  0/65 (0.00%)  1/190 (0.53%) 
Laryngeal oedema  1  1/96 (1.04%)  0/94 (0.00%)  0/65 (0.00%)  1/190 (0.53%) 
Skin and subcutaneous tissue disorders         
Erythrodermic psoriasis  1  0/96 (0.00%)  0/94 (0.00%)  1/65 (1.54%)  0/190 (0.00%) 
Psoriasis  1  1/96 (1.04%)  0/94 (0.00%)  0/65 (0.00%)  1/190 (0.53%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Any AIN457 150 mg Any AIN457 300 mg Placebo Any AIN457 Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   76/96 (79.17%)   79/94 (84.04%)   37/65 (56.92%)   155/190 (81.58%) 
Cardiac disorders         
Palpitations  1  1/96 (1.04%)  3/94 (3.19%)  0/65 (0.00%)  4/190 (2.11%) 
Ear and labyrinth disorders         
Vertigo  1  2/96 (2.08%)  1/94 (1.06%)  0/65 (0.00%)  3/190 (1.58%) 
Endocrine disorders         
Hypothyroidism  1  2/96 (2.08%)  1/94 (1.06%)  0/65 (0.00%)  3/190 (1.58%) 
Eye disorders         
Dry eye  1  2/96 (2.08%)  0/94 (0.00%)  0/65 (0.00%)  2/190 (1.05%) 
Eye irritation  1  2/96 (2.08%)  0/94 (0.00%)  0/65 (0.00%)  2/190 (1.05%) 
Eye pruritus  1  0/96 (0.00%)  2/94 (2.13%)  0/65 (0.00%)  2/190 (1.05%) 
Visual impairment  1  0/96 (0.00%)  2/94 (2.13%)  0/65 (0.00%)  2/190 (1.05%) 
Gastrointestinal disorders         
Abdominal pain  1  0/96 (0.00%)  2/94 (2.13%)  2/65 (3.08%)  2/190 (1.05%) 
Abdominal pain upper  1  0/96 (0.00%)  2/94 (2.13%)  0/65 (0.00%)  2/190 (1.05%) 
Diarrhoea  1  5/96 (5.21%)  5/94 (5.32%)  5/65 (7.69%)  10/190 (5.26%) 
Dyspepsia  1  3/96 (3.13%)  5/94 (5.32%)  0/65 (0.00%)  8/190 (4.21%) 
Haemorrhoids  1  2/96 (2.08%)  1/94 (1.06%)  0/65 (0.00%)  3/190 (1.58%) 
Loose tooth  1  2/96 (2.08%)  0/94 (0.00%)  0/65 (0.00%)  2/190 (1.05%) 
Nausea  1  4/96 (4.17%)  3/94 (3.19%)  1/65 (1.54%)  7/190 (3.68%) 
Toothache  1  3/96 (3.13%)  1/94 (1.06%)  0/65 (0.00%)  4/190 (2.11%) 
Vomiting  1  3/96 (3.13%)  1/94 (1.06%)  0/65 (0.00%)  4/190 (2.11%) 
General disorders         
Fatigue  1  4/96 (4.17%)  5/94 (5.32%)  0/65 (0.00%)  9/190 (4.74%) 
Influenza like illness  1  3/96 (3.13%)  1/94 (1.06%)  0/65 (0.00%)  4/190 (2.11%) 
Injection site erythema  1  0/96 (0.00%)  0/94 (0.00%)  2/65 (3.08%)  0/190 (0.00%) 
Pyrexia  1  3/96 (3.13%)  1/94 (1.06%)  1/65 (1.54%)  4/190 (2.11%) 
Hepatobiliary disorders         
Hepatic steatosis  1  2/96 (2.08%)  2/94 (2.13%)  0/65 (0.00%)  4/190 (2.11%) 
Immune system disorders         
Seasonal allergy  1  2/96 (2.08%)  1/94 (1.06%)  0/65 (0.00%)  3/190 (1.58%) 
Infections and infestations         
Bronchitis  1  4/96 (4.17%)  7/94 (7.45%)  0/65 (0.00%)  11/190 (5.79%) 
Cellulitis  1  1/96 (1.04%)  3/94 (3.19%)  0/65 (0.00%)  4/190 (2.11%) 
Conjunctivitis  1  3/96 (3.13%)  4/94 (4.26%)  0/65 (0.00%)  7/190 (3.68%) 
Ear infection  1  2/96 (2.08%)  1/94 (1.06%)  0/65 (0.00%)  3/190 (1.58%) 
Erysipelas  1  2/96 (2.08%)  1/94 (1.06%)  1/65 (1.54%)  3/190 (1.58%) 
Fungal skin infection  1  2/96 (2.08%)  1/94 (1.06%)  1/65 (1.54%)  3/190 (1.58%) 
Gastroenteritis  1  6/96 (6.25%)  6/94 (6.38%)  0/65 (0.00%)  12/190 (6.32%) 
Herpes zoster  1  3/96 (3.13%)  3/94 (3.19%)  0/65 (0.00%)  6/190 (3.16%) 
Hordeolum  1  2/96 (2.08%)  1/94 (1.06%)  0/65 (0.00%)  3/190 (1.58%) 
Influenza  1  0/96 (0.00%)  6/94 (6.38%)  2/65 (3.08%)  6/190 (3.16%) 
Localised infection  1  0/96 (0.00%)  3/94 (3.19%)  0/65 (0.00%)  3/190 (1.58%) 
Lower respiratory tract infection  1  2/96 (2.08%)  3/94 (3.19%)  0/65 (0.00%)  5/190 (2.63%) 
Nasopharyngitis  1  25/96 (26.04%)  27/94 (28.72%)  8/65 (12.31%)  52/190 (27.37%) 
Onychomycosis  1  2/96 (2.08%)  1/94 (1.06%)  0/65 (0.00%)  3/190 (1.58%) 
Oral candidiasis  1  1/96 (1.04%)  3/94 (3.19%)  0/65 (0.00%)  4/190 (2.11%) 
Oral herpes  1  2/96 (2.08%)  2/94 (2.13%)  4/65 (6.15%)  4/190 (2.11%) 
Otitis externa  1  1/96 (1.04%)  2/94 (2.13%)  0/65 (0.00%)  3/190 (1.58%) 
Pharyngitis  1  2/96 (2.08%)  3/94 (3.19%)  0/65 (0.00%)  5/190 (2.63%) 
Pneumonia  1  0/96 (0.00%)  2/94 (2.13%)  0/65 (0.00%)  2/190 (1.05%) 
Pulpitis dental  1  4/96 (4.17%)  4/94 (4.26%)  1/65 (1.54%)  8/190 (4.21%) 
Respiratory tract infection  1  2/96 (2.08%)  2/94 (2.13%)  0/65 (0.00%)  4/190 (2.11%) 
Rhinitis  1  2/96 (2.08%)  7/94 (7.45%)  0/65 (0.00%)  9/190 (4.74%) 
Sinusitis  1  3/96 (3.13%)  6/94 (6.38%)  0/65 (0.00%)  9/190 (4.74%) 
Skin infection  1  1/96 (1.04%)  3/94 (3.19%)  0/65 (0.00%)  4/190 (2.11%) 
Tinea pedis  1  5/96 (5.21%)  1/94 (1.06%)  0/65 (0.00%)  6/190 (3.16%) 
Tonsillitis  1  4/96 (4.17%)  4/94 (4.26%)  0/65 (0.00%)  8/190 (4.21%) 
Tooth abscess  1  0/96 (0.00%)  3/94 (3.19%)  0/65 (0.00%)  3/190 (1.58%) 
Upper respiratory tract infection  1  15/96 (15.63%)  8/94 (8.51%)  2/65 (3.08%)  23/190 (12.11%) 
Urinary tract infection  1  3/96 (3.13%)  5/94 (5.32%)  0/65 (0.00%)  8/190 (4.21%) 
Viral upper respiratory tract infection  1  3/96 (3.13%)  2/94 (2.13%)  0/65 (0.00%)  5/190 (2.63%) 
Vulvovaginal candidiasis  1  2/96 (2.08%)  1/94 (1.06%)  0/65 (0.00%)  3/190 (1.58%) 
Injury, poisoning and procedural complications         
Arthropod sting  1  2/96 (2.08%)  1/94 (1.06%)  0/65 (0.00%)  3/190 (1.58%) 
Avulsion fracture  1  0/96 (0.00%)  2/94 (2.13%)  0/65 (0.00%)  2/190 (1.05%) 
Contusion  1  2/96 (2.08%)  0/94 (0.00%)  1/65 (1.54%)  2/190 (1.05%) 
Fall  1  2/96 (2.08%)  0/94 (0.00%)  0/65 (0.00%)  2/190 (1.05%) 
Ligament sprain  1  2/96 (2.08%)  1/94 (1.06%)  0/65 (0.00%)  3/190 (1.58%) 
Limb injury  1  2/96 (2.08%)  2/94 (2.13%)  0/65 (0.00%)  4/190 (2.11%) 
Skin abrasion  1  0/96 (0.00%)  0/94 (0.00%)  2/65 (3.08%)  0/190 (0.00%) 
Tendon rupture  1  2/96 (2.08%)  0/94 (0.00%)  0/65 (0.00%)  2/190 (1.05%) 
Investigations         
Aspartate aminotransferase increased  1  2/96 (2.08%)  1/94 (1.06%)  0/65 (0.00%)  3/190 (1.58%) 
Weight increased  1  0/96 (0.00%)  2/94 (2.13%)  0/65 (0.00%)  2/190 (1.05%) 
Metabolism and nutrition disorders         
Gout  1  2/96 (2.08%)  0/94 (0.00%)  1/65 (1.54%)  2/190 (1.05%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  4/96 (4.17%)  8/94 (8.51%)  2/65 (3.08%)  12/190 (6.32%) 
Back pain  1  9/96 (9.38%)  7/94 (7.45%)  1/65 (1.54%)  16/190 (8.42%) 
Dactylitis  1  0/96 (0.00%)  2/94 (2.13%)  0/65 (0.00%)  2/190 (1.05%) 
Joint swelling  1  2/96 (2.08%)  0/94 (0.00%)  0/65 (0.00%)  2/190 (1.05%) 
Muscle spasms  1  2/96 (2.08%)  0/94 (0.00%)  0/65 (0.00%)  2/190 (1.05%) 
Musculoskeletal pain  1  1/96 (1.04%)  2/94 (2.13%)  0/65 (0.00%)  3/190 (1.58%) 
Pain in extremity  1  5/96 (5.21%)  1/94 (1.06%)  2/65 (3.08%)  6/190 (3.16%) 
Psoriatic arthropathy  1  2/96 (2.08%)  1/94 (1.06%)  1/65 (1.54%)  3/190 (1.58%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Melanocytic naevus  1  1/96 (1.04%)  2/94 (2.13%)  0/65 (0.00%)  3/190 (1.58%) 
Skin papilloma  1  1/96 (1.04%)  2/94 (2.13%)  1/65 (1.54%)  3/190 (1.58%) 
Nervous system disorders         
Dizziness  1  3/96 (3.13%)  1/94 (1.06%)  0/65 (0.00%)  4/190 (2.11%) 
Headache  1  9/96 (9.38%)  10/94 (10.64%)  4/65 (6.15%)  19/190 (10.00%) 
Poor quality sleep  1  2/96 (2.08%)  0/94 (0.00%)  0/65 (0.00%)  2/190 (1.05%) 
Sciatica  1  2/96 (2.08%)  1/94 (1.06%)  0/65 (0.00%)  3/190 (1.58%) 
Psychiatric disorders         
Anxiety  1  6/96 (6.25%)  0/94 (0.00%)  1/65 (1.54%)  6/190 (3.16%) 
Depression  1  3/96 (3.13%)  4/94 (4.26%)  2/65 (3.08%)  7/190 (3.68%) 
Insomnia  1  2/96 (2.08%)  3/94 (3.19%)  0/65 (0.00%)  5/190 (2.63%) 
Stress  1  3/96 (3.13%)  0/94 (0.00%)  0/65 (0.00%)  3/190 (1.58%) 
Renal and urinary disorders         
Haematuria  1  2/96 (2.08%)  1/94 (1.06%)  0/65 (0.00%)  3/190 (1.58%) 
Respiratory, thoracic and mediastinal disorders         
Asthma  1  1/96 (1.04%)  3/94 (3.19%)  0/65 (0.00%)  4/190 (2.11%) 
Chronic obstructive pulmonary disease  1  1/96 (1.04%)  2/94 (2.13%)  0/65 (0.00%)  3/190 (1.58%) 
Cough  1  7/96 (7.29%)  7/94 (7.45%)  2/65 (3.08%)  14/190 (7.37%) 
Dyspnoea  1  1/96 (1.04%)  2/94 (2.13%)  0/65 (0.00%)  3/190 (1.58%) 
Nasal congestion  1  2/96 (2.08%)  2/94 (2.13%)  0/65 (0.00%)  4/190 (2.11%) 
Oropharyngeal pain  1  4/96 (4.17%)  0/94 (0.00%)  0/65 (0.00%)  4/190 (2.11%) 
Productive cough  1  2/96 (2.08%)  0/94 (0.00%)  0/65 (0.00%)  2/190 (1.05%) 
Rhinitis allergic  1  2/96 (2.08%)  2/94 (2.13%)  0/65 (0.00%)  4/190 (2.11%) 
Rhinorrhoea  1  0/96 (0.00%)  3/94 (3.19%)  1/65 (1.54%)  3/190 (1.58%) 
Wheezing  1  0/96 (0.00%)  2/94 (2.13%)  0/65 (0.00%)  2/190 (1.05%) 
Skin and subcutaneous tissue disorders         
Acne  1  1/96 (1.04%)  2/94 (2.13%)  0/65 (0.00%)  3/190 (1.58%) 
Actinic keratosis  1  1/96 (1.04%)  2/94 (2.13%)  0/65 (0.00%)  3/190 (1.58%) 
Alopecia areata  1  2/96 (2.08%)  1/94 (1.06%)  0/65 (0.00%)  3/190 (1.58%) 
Dermatitis  1  3/96 (3.13%)  0/94 (0.00%)  0/65 (0.00%)  3/190 (1.58%) 
Dry skin  1  3/96 (3.13%)  4/94 (4.26%)  0/65 (0.00%)  7/190 (3.68%) 
Eczema  1  1/96 (1.04%)  4/94 (4.26%)  0/65 (0.00%)  5/190 (2.63%) 
Intertrigo  1  1/96 (1.04%)  3/94 (3.19%)  0/65 (0.00%)  4/190 (2.11%) 
Pruritus  1  5/96 (5.21%)  3/94 (3.19%)  1/65 (1.54%)  8/190 (4.21%) 
Pruritus generalised  1  2/96 (2.08%)  0/94 (0.00%)  1/65 (1.54%)  2/190 (1.05%) 
Psoriasis  1  16/96 (16.67%)  6/94 (6.38%)  7/65 (10.77%)  22/190 (11.58%) 
Seborrhoeic dermatitis  1  2/96 (2.08%)  0/94 (0.00%)  0/65 (0.00%)  2/190 (1.05%) 
Skin fissures  1  2/96 (2.08%)  1/94 (1.06%)  2/65 (3.08%)  3/190 (1.58%) 
Vascular disorders         
Hypertension  1  5/96 (5.21%)  4/94 (4.26%)  0/65 (0.00%)  9/190 (4.74%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.1)
The overall study completed. However, in Spain, the study terminated early in accordance with study protocol amendment 1.
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 Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01807520     History of Changes
Other Study ID Numbers: CAIN457A2313
2012-005413-40 ( EudraCT Number )
First Submitted: January 23, 2013
First Posted: March 8, 2013
Results First Submitted: December 14, 2017
Results First Posted: March 13, 2018
Last Update Posted: March 13, 2018