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

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: NCT01806597
Recruitment Status : Completed
First Posted : March 7, 2013
Results First Posted : February 22, 2018
Last Update Posted : February 22, 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 Palmoplantar Psoriasis
Interventions Biological: secukinumab 150 mg
Biological: secukinumab 300 mg
Biological: Placebo
Enrollment 205
Recruitment Details Week 16 was considered the first dose of Treatment Period 2. Week 132 visit was the final visit of Treatment Period 2, and no study treatment was administered at this visit.
Pre-assignment Details Patients who completed Period 2 & patients who prematurely discontinued treatment or withdrew from study entered the treatment-free Follow-up (FU) Period (no study treatment was administered during Period) included only 1 visit at Week 140 (End of FU), which was 8 weeks after the end of Period 2 & 12 weeks after the last dose of study drug.
Arm/Group Title AIN457 150mg AIN457 300 mg Placebo - AIN457 150 mg Placebo - AIN457 300mg Placebo Any AIN457 Dose
Hide Arm/Group Description AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks all placebo patients who were re-randomized to secukinumab 150 mg at re-randomization all placebo patients who were re-randomized to AIN457 300 mg at re-randomization placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks. All patients who were injected with AIN457
Period Title: Period 1 (Baseline to Week 16)
Started 68 69 0 0 68 0
Completed 63 64 0 0 63 0
Not Completed 5 5 0 0 5 0
Reason Not Completed
Adverse Event             1             1             0             0             2             0
Lack of Efficacy             1             0             0             0             1             0
Protocol Violation             0             1             0             0             0             0
Withdrawal by Subject             3             2             0             0             2             0
Physician Decision             0             1             0             0             0             0
Period Title: Treatment Period 2 (Week 16 to Week 132)
Started 63 64 31 31 1 0
Completed 24 44 17 20 0 0
Not Completed 39 20 14 11 1 0
Reason Not Completed
Adverse Event             9             6             4             3             1             0
Lack of Efficacy             12             5             3             1             0             0
Lost to Follow-up             2             0             0             0             0             0
Physician Decision             1             1             0             0             0             0
Protocol Violation             2             0             0             0             0             0
study terminated by sponsor             0             1             0             1             0             0
Withdrawal by Subject             10             5             6             5             0             0
non-compliance with study treatment             2             2             1             1             0             0
Death             1             0             0             0             0             0
Period Title: Follow-up Period (Week 132 to Week 140)
Started 0 0 0 0 3 161
Completed 0 0 0 0 3 149
Not Completed 0 0 0 0 0 12
Reason Not Completed
Withdrawal by Subject             0             0             0             0             0             5
Adverse Event             0             0             0             0             0             2
Lack of Efficacy             0             0             0             0             0             2
Lost to Follow-up             0             0             0             0             0             2
Physician Decision             0             0             0             0             0             1
Arm/Group Title AIN457 150mg AIN457 300 mg Placebo Total
Hide Arm/Group Description AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks. Total of all reporting groups
Overall Number of Baseline Participants 68 69 68 205
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 68 participants 69 participants 68 participants 205 participants
52.4  (12.56) 48.8  (14.21) 50.9  (12.95) 50.7  (13.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 69 participants 68 participants 205 participants
Female
28
  41.2%
31
  44.9%
34
  50.0%
93
  45.4%
Male
40
  58.8%
38
  55.1%
34
  50.0%
112
  54.6%
1.Primary Outcome
Title Percentages of Participants With Palmoplantar Investigator Global Assessmnet (ppIGA) 0 or 1 Response After 16 Weeks of Treatment
Hide Description palmoplantar Investigator's Global Assessment (ppIGA) response after 16 weeks of treatment. To be considered a ppIGA responder at Week 16, a subject must have ppIGA of 0 or 1 at Week 16 and a reduction of at least 2 points on the ppIGA scale from baseline.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): The FAS comprised of all patients from the randomized set to who study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization.
Arm/Group Title AIN457 150mg AIN457 300 mg Placebo
Hide Arm/Group Description:
AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks.
Overall Number of Participants Analyzed 68 69 68
Measure Type: Number
Unit of Measure: Percentages of participants
22 33.3 1.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AIN457 150mg, Placebo
Comments Data at Week 16 was analyzed using the stratified Cochran-Mantel-Haenszel-test. The test was stratified by body-weight category (<90 kg or ≥90 kg).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 19.3
Confidence Interval (2-Sided) 95%
2.4 to 154.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AIN457 300 mg, Placebo
Comments Data at Week 16 was analyzed using the stratified Cochran-Mantel-Haenszel-test. The test was stratified by body-weight category (<90 kg or ≥90 kg).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 29.4
Confidence Interval (2-Sided) 95%
4.1 to 211.9
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I
Hide Description

ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: 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.

Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline).

Time Frame Week 1, week 2, week 4, week, 8, week 12, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150mg AIN457 300 mg Placebo
Hide Arm/Group Description:
AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks.
Overall Number of Participants Analyzed 68 69 68
Measure Type: Number
Unit of Measure: Percentages of participants
Week 1 1.5 1.4 0
Week 2 1.5 7.2 0
Week 4 4.4 8.7 0
Week 8 17.6 26.1 0
Week 12 20.6 33.3 1.5
Week 16 22.1 33.3 1.5
3.Secondary Outcome
Title Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II
Hide Description

ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: 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.

Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline).

Time Frame Week 16, Week 20, Week 28, Week 32, Week 64, Week 132
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150mg AIN457 300 mg Placebo - AIN457 150 mg Placebo - AIN457 300 mg Placebo
Hide Arm/Group Description:
AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
all placebo patients who were re-randomized to secukinumab 150 mg at re-randomization.
all placebo patients who were re-randomized to secukinumab 300 mg at re-randomization.
Placebo AIN457 (2sc injections) once weekly for 5 weeks followed by dosing every 4 weeks
Overall Number of Participants Analyzed 68 69 31 31 1
Measure Type: Number
Unit of Measure: Percentages of participants
Week 16 22.1 33.3 0.0 0.0 100.0
Week 20 32.4 33.3 12.9 9.7 0.0
Week 28 29.4 44.9 32.3 51.6 100.0
Week 32 29.4 42.0 35.5 41.9 0.0
Week 64 26.5 46.4 29.0 48.4 0.0
Week 132 22.1 27.5 12.9 35.5 0.0
4.Secondary Outcome
Title Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period
Hide Description

ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: 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.

Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline).

Time Frame Week 16, Week 24, Week 28, Week 80
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150mg AIN457 300 mg Placebo - AIN457 150 mg Placebo - AIN457 300 mg Placebo
Hide Arm/Group Description:
AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
all placebo patients who were re-randomized to secukinumab 150 mg at re-randomization.
all placebo patients who were re-randomized to secukinumab 300 mg at re-randomization.
Placebo AIN457 (2sc injections) once weekly for 5 weeks followed by dosing every 4 weeks
Overall Number of Participants Analyzed 68 69 31 31 6
Measure Type: Number
Unit of Measure: Percentages of participants
Week 16 Number Analyzed 68 participants 69 participants 31 participants 31 participants 4 participants
23.4 37.7 0.0 0.0 25.0
Week 24 Number Analyzed 68 participants 69 participants 31 participants 31 participants 1 participants
40.7 44.1 20.0 36.7 100.0
Week 28 Number Analyzed 68 participants 69 participants 31 participants 31 participants 1 participants
34.5 50.8 20.0 48.3 0.0
Week 80 Number Analyzed 68 participants 69 participants 31 participants 31 participants 0 participants
41.7 65.3 45.0 68.2
5.Secondary Outcome
Title Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I
Hide Description Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).
Time Frame Week 1, Week 2, Week 4, Week 8, Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150mg AIN457 300 mg Placebo
Hide Arm/Group Description:
AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks.
Overall Number of Participants Analyzed 68 69 68
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 -1.13  (4.797) -2.22  (4.334) -0.85  (3.355)
Week 2 -3.11  (7.669) -5.32  (6.120) -1.90  (5.434)
Week 4 -6.69  (9.890) -9.18  (9.734) -3.95  (7.424)
Week 8 -9.74  (12.779) -11.30  (11.954) -3.22  (8.316)
Week 12 -10.15  (14.409) -12.83  (12.286) -3.07  (8.479)
Week 16 -9.41  (15.984) -13.35  (12.941) -2.43  (8.527)
6.Secondary Outcome
Title Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set
Hide Description Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).
Time Frame Week 16, Week 32, Week 80, Week 132
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150mg AIN457 300 mg Placebo - AIN457 150 mg Placebo - AIN457 300 mg Placebo
Hide Arm/Group Description:
AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
all placebo patients who were re-randomized to secukinumab 150 mg at re-randomization.
all placebo patients who were re-randomized to secukinumab 300 mg at re-randomization.
Placebo AIN457 (2sc injections) once weekly for 5 weeks followed by dosing every 4 weeks
Overall Number of Participants Analyzed 68 69 31 31 6
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 16 Number Analyzed 64 participants 61 participants 30 participants 30 participants 4 participants
-8.97  (15.624) -12.67  (12.074) -1.57  (8.880) -3.11  (7.983) -7.15  (4.479)
Week 32 Number Analyzed 52 participants 60 participants 25 participants 29 participants 1 participants
-16.29  (14.307) -17.43  (13.104) -15.49  (11.570) -15.09  (12.625) -11.40
Week 80 Number Analyzed 36 participants 49 participants 20 participants 22 participants 0 participants
-18.05  (15.232) -19.27  (14.258) -13.71  (14.560) -16.70  (10.441)
Week 132 Number Analyzed 21 participants 28 participants 12 participants 18 participants 0 participants
-16.74  (14.658) -19.16  (11.688) -17.07  (11.728) -13.82  (5.844)
7.Secondary Outcome
Title Number of Participants Developing Anti-secukinumab Antibodies
Hide Description To investigate the development of immunogenicity against secukinumab
Time Frame Over time up to week 132
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150mg AIN457 300 mg Placebo - AIN 150mg Placebo - AIN457 300mg
Hide Arm/Group Description:
AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
all placebo patients who were re-randomized to AIN457 150 mg at re-randomization
all placebo patients who were re-randomized to AIN457 300 mg at re-randomization
Overall Number of Participants Analyzed 68 69 31 31
Measure Type: Count of Participants
Unit of Measure: Participants
2
   2.9%
2
   2.9%
2
   6.5%
3
   9.7%
Time Frame Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First treatment until Last Patient Last Visit.
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 AIN457 150mg subcutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks AIN457 300mg subcutaneous ((2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks. All patients who were injected with AIN457
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   --/--   --/--   --/--   --/-- 
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   19/99 (19.19%)   13/100 (13.00%)   2/68 (2.94%)   32/199 (16.08%) 
Cardiac disorders         
Angina pectoris  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Coronary artery occlusion  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Gastrointestinal disorders         
Dyspepsia  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Small intestinal obstruction  1  0/99 (0.00%)  0/100 (0.00%)  1/68 (1.47%)  0/199 (0.00%) 
General disorders         
Asthenia  1  0/99 (0.00%)  1/100 (1.00%)  0/68 (0.00%)  1/199 (0.50%) 
Non-cardiac chest pain  1  0/99 (0.00%)  1/100 (1.00%)  0/68 (0.00%)  1/199 (0.50%) 
Hepatobiliary disorders         
Hepatitis  1  0/99 (0.00%)  1/100 (1.00%)  0/68 (0.00%)  1/199 (0.50%) 
Infections and infestations         
Cellulitis of male external genital organ  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Diverticulitis  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Gastroenteritis  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Infective keratitis  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Pyelonephritis  1  0/99 (0.00%)  0/100 (0.00%)  1/68 (1.47%)  0/199 (0.00%) 
Sepsis  1  0/99 (0.00%)  1/100 (1.00%)  0/68 (0.00%)  1/199 (0.50%) 
Skin infection  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Injury, poisoning and procedural complications         
Fibula fracture  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Foot fracture  1  0/99 (0.00%)  1/100 (1.00%)  0/68 (0.00%)  1/199 (0.50%) 
Fracture displacement  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Humerus fracture  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Peripheral nerve injury  1  0/99 (0.00%)  1/100 (1.00%)  0/68 (0.00%)  1/199 (0.50%) 
Tendon injury  1  0/99 (0.00%)  1/100 (1.00%)  0/68 (0.00%)  1/199 (0.50%) 
Metabolism and nutrition disorders         
Dehydration  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Electrolyte imbalance  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Hypokalaemia  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Musculoskeletal and connective tissue disorders         
Intervertebral disc protrusion  1  0/99 (0.00%)  1/100 (1.00%)  0/68 (0.00%)  1/199 (0.50%) 
Musculoskeletal pain  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Osteoarthritis  1  0/99 (0.00%)  1/100 (1.00%)  0/68 (0.00%)  1/199 (0.50%) 
Psoriatic arthropathy  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Spinal column stenosis  1  0/99 (0.00%)  1/100 (1.00%)  0/68 (0.00%)  1/199 (0.50%) 
Tenosynovitis stenosans  1  0/99 (0.00%)  1/100 (1.00%)  0/68 (0.00%)  1/199 (0.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal cell carcinoma  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Leiomyoma  1  0/99 (0.00%)  1/100 (1.00%)  0/68 (0.00%)  1/199 (0.50%) 
Uterine leiomyoma  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Nervous system disorders         
Cerebrovascular accident  1  0/99 (0.00%)  1/100 (1.00%)  0/68 (0.00%)  1/199 (0.50%) 
Hypoaesthesia  1  0/99 (0.00%)  1/100 (1.00%)  0/68 (0.00%)  1/199 (0.50%) 
Lumbar radiculopathy  1  0/99 (0.00%)  1/100 (1.00%)  0/68 (0.00%)  1/199 (0.50%) 
Paraesthesia  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Polyneuropathy  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Transient global amnesia  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Psychiatric disorders         
Completed suicide  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Reproductive system and breast disorders         
Benign prostatic hyperplasia  1  0/99 (0.00%)  1/100 (1.00%)  0/68 (0.00%)  1/199 (0.50%) 
Postmenopausal haemorrhage  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Respiratory, thoracic and mediastinal disorders         
Pneumothorax spontaneous  1  0/99 (0.00%)  1/100 (1.00%)  0/68 (0.00%)  1/199 (0.50%) 
Skin and subcutaneous tissue disorders         
Psoriasis  1  2/99 (2.02%)  1/100 (1.00%)  0/68 (0.00%)  3/199 (1.51%) 
Social circumstances         
Miscarriage of partner  1  1/99 (1.01%)  0/100 (0.00%)  0/68 (0.00%)  1/199 (0.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.1)
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   75/99 (75.76%)   68/100 (68.00%)   30/68 (44.12%)   143/199 (71.86%) 
Eye disorders         
Blepharitis  1  2/99 (2.02%)  0/100 (0.00%)  0/68 (0.00%)  2/199 (1.01%) 
Gastrointestinal disorders         
Abdominal pain  1  2/99 (2.02%)  2/100 (2.00%)  1/68 (1.47%)  4/199 (2.01%) 
Constipation  1  3/99 (3.03%)  0/100 (0.00%)  0/68 (0.00%)  3/199 (1.51%) 
Dental caries  1  2/99 (2.02%)  0/100 (0.00%)  1/68 (1.47%)  2/199 (1.01%) 
Diarrhoea  1  4/99 (4.04%)  4/100 (4.00%)  0/68 (0.00%)  8/199 (4.02%) 
Gastrooesophageal reflux disease  1  3/99 (3.03%)  3/100 (3.00%)  1/68 (1.47%)  6/199 (3.02%) 
Nausea  1  3/99 (3.03%)  1/100 (1.00%)  0/68 (0.00%)  4/199 (2.01%) 
Toothache  1  2/99 (2.02%)  2/100 (2.00%)  0/68 (0.00%)  4/199 (2.01%) 
General disorders         
Chills  1  2/99 (2.02%)  0/100 (0.00%)  0/68 (0.00%)  2/199 (1.01%) 
Fatigue  1  4/99 (4.04%)  1/100 (1.00%)  0/68 (0.00%)  5/199 (2.51%) 
Influenza like illness  1  1/99 (1.01%)  3/100 (3.00%)  0/68 (0.00%)  4/199 (2.01%) 
Injection site haematoma  1  2/99 (2.02%)  1/100 (1.00%)  0/68 (0.00%)  3/199 (1.51%) 
Injection site reaction  1  2/99 (2.02%)  0/100 (0.00%)  0/68 (0.00%)  2/199 (1.01%) 
Oedema peripheral  1  5/99 (5.05%)  4/100 (4.00%)  0/68 (0.00%)  9/199 (4.52%) 
Peripheral swelling  1  2/99 (2.02%)  0/100 (0.00%)  1/68 (1.47%)  2/199 (1.01%) 
Pyrexia  1  4/99 (4.04%)  1/100 (1.00%)  0/68 (0.00%)  5/199 (2.51%) 
Hepatobiliary disorders         
Hepatic steatosis  1  2/99 (2.02%)  1/100 (1.00%)  0/68 (0.00%)  3/199 (1.51%) 
Infections and infestations         
Bronchitis  1  2/99 (2.02%)  2/100 (2.00%)  1/68 (1.47%)  4/199 (2.01%) 
Cellulitis  1  2/99 (2.02%)  2/100 (2.00%)  0/68 (0.00%)  4/199 (2.01%) 
Conjunctivitis  1  2/99 (2.02%)  3/100 (3.00%)  0/68 (0.00%)  5/199 (2.51%) 
Folliculitis  1  2/99 (2.02%)  0/100 (0.00%)  0/68 (0.00%)  2/199 (1.01%) 
Gastroenteritis  1  5/99 (5.05%)  4/100 (4.00%)  0/68 (0.00%)  9/199 (4.52%) 
Genital infection fungal  1  2/99 (2.02%)  0/100 (0.00%)  0/68 (0.00%)  2/199 (1.01%) 
Impetigo  1  2/99 (2.02%)  0/100 (0.00%)  0/68 (0.00%)  2/199 (1.01%) 
Influenza  1  4/99 (4.04%)  7/100 (7.00%)  4/68 (5.88%)  11/199 (5.53%) 
Localised infection  1  0/99 (0.00%)  3/100 (3.00%)  0/68 (0.00%)  3/199 (1.51%) 
Nasopharyngitis  1  14/99 (14.14%)  8/100 (8.00%)  4/68 (5.88%)  22/199 (11.06%) 
Oral candidiasis  1  0/99 (0.00%)  5/100 (5.00%)  0/68 (0.00%)  5/199 (2.51%) 
Oral herpes  1  3/99 (3.03%)  2/100 (2.00%)  1/68 (1.47%)  5/199 (2.51%) 
Pharyngitis  1  3/99 (3.03%)  6/100 (6.00%)  0/68 (0.00%)  9/199 (4.52%) 
Rhinitis  1  2/99 (2.02%)  2/100 (2.00%)  0/68 (0.00%)  4/199 (2.01%) 
Sinusitis  1  1/99 (1.01%)  3/100 (3.00%)  0/68 (0.00%)  4/199 (2.01%) 
Skin infection  1  2/99 (2.02%)  2/100 (2.00%)  1/68 (1.47%)  4/199 (2.01%) 
Tinea pedis  1  5/99 (5.05%)  1/100 (1.00%)  0/68 (0.00%)  6/199 (3.02%) 
Tonsillitis  1  1/99 (1.01%)  3/100 (3.00%)  0/68 (0.00%)  4/199 (2.01%) 
Tooth abscess  1  2/99 (2.02%)  0/100 (0.00%)  0/68 (0.00%)  2/199 (1.01%) 
Upper respiratory tract infection  1  10/99 (10.10%)  20/100 (20.00%)  3/68 (4.41%)  30/199 (15.08%) 
Urinary tract infection  1  3/99 (3.03%)  7/100 (7.00%)  0/68 (0.00%)  10/199 (5.03%) 
Viral upper respiratory tract infection  1  2/99 (2.02%)  1/100 (1.00%)  0/68 (0.00%)  3/199 (1.51%) 
Injury, poisoning and procedural complications         
Arthropod bite  1  2/99 (2.02%)  0/100 (0.00%)  0/68 (0.00%)  2/199 (1.01%) 
Muscle strain  1  2/99 (2.02%)  2/100 (2.00%)  0/68 (0.00%)  4/199 (2.01%) 
Procedural pain  1  1/99 (1.01%)  4/100 (4.00%)  0/68 (0.00%)  5/199 (2.51%) 
Investigations         
Weight increased  1  2/99 (2.02%)  0/100 (0.00%)  0/68 (0.00%)  2/199 (1.01%) 
Metabolism and nutrition disorders         
Decreased appetite  1  1/99 (1.01%)  0/100 (0.00%)  2/68 (2.94%)  1/199 (0.50%) 
Dyslipidaemia  1  1/99 (1.01%)  3/100 (3.00%)  0/68 (0.00%)  4/199 (2.01%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  5/99 (5.05%)  4/100 (4.00%)  4/68 (5.88%)  9/199 (4.52%) 
Arthritis  1  3/99 (3.03%)  0/100 (0.00%)  1/68 (1.47%)  3/199 (1.51%) 
Back pain  1  2/99 (2.02%)  10/100 (10.00%)  2/68 (2.94%)  12/199 (6.03%) 
Muscle spasms  1  2/99 (2.02%)  2/100 (2.00%)  0/68 (0.00%)  4/199 (2.01%) 
Musculoskeletal pain  1  4/99 (4.04%)  3/100 (3.00%)  2/68 (2.94%)  7/199 (3.52%) 
Myalgia  1  4/99 (4.04%)  1/100 (1.00%)  0/68 (0.00%)  5/199 (2.51%) 
Osteoarthritis  1  4/99 (4.04%)  1/100 (1.00%)  0/68 (0.00%)  5/199 (2.51%) 
Pain in extremity  1  5/99 (5.05%)  1/100 (1.00%)  1/68 (1.47%)  6/199 (3.02%) 
Psoriatic arthropathy  1  1/99 (1.01%)  3/100 (3.00%)  0/68 (0.00%)  4/199 (2.01%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal cell carcinoma  1  2/99 (2.02%)  0/100 (0.00%)  0/68 (0.00%)  2/199 (1.01%) 
Melanocytic naevus  1  2/99 (2.02%)  1/100 (1.00%)  0/68 (0.00%)  3/199 (1.51%) 
Seborrhoeic keratosis  1  4/99 (4.04%)  0/100 (0.00%)  0/68 (0.00%)  4/199 (2.01%) 
Nervous system disorders         
Dizziness  1  0/99 (0.00%)  1/100 (1.00%)  2/68 (2.94%)  1/199 (0.50%) 
Headache  1  10/99 (10.10%)  11/100 (11.00%)  6/68 (8.82%)  21/199 (10.55%) 
Paraesthesia  1  2/99 (2.02%)  1/100 (1.00%)  0/68 (0.00%)  3/199 (1.51%) 
Psychiatric disorders         
Anxiety  1  2/99 (2.02%)  0/100 (0.00%)  0/68 (0.00%)  2/199 (1.01%) 
Depression  1  2/99 (2.02%)  1/100 (1.00%)  0/68 (0.00%)  3/199 (1.51%) 
Renal and urinary disorders         
Nephrolithiasis  1  3/99 (3.03%)  2/100 (2.00%)  0/68 (0.00%)  5/199 (2.51%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  3/99 (3.03%)  2/100 (2.00%)  1/68 (1.47%)  5/199 (2.51%) 
Dyspnoea  1  3/99 (3.03%)  1/100 (1.00%)  0/68 (0.00%)  4/199 (2.01%) 
Oropharyngeal pain  1  2/99 (2.02%)  2/100 (2.00%)  1/68 (1.47%)  4/199 (2.01%) 
Skin and subcutaneous tissue disorders         
Acne  1  0/99 (0.00%)  1/100 (1.00%)  2/68 (2.94%)  1/199 (0.50%) 
Actinic keratosis  1  2/99 (2.02%)  0/100 (0.00%)  0/68 (0.00%)  2/199 (1.01%) 
Dermatitis  1  2/99 (2.02%)  0/100 (0.00%)  0/68 (0.00%)  2/199 (1.01%) 
Dermatitis contact  1  3/99 (3.03%)  0/100 (0.00%)  0/68 (0.00%)  3/199 (1.51%) 
Eczema  1  4/99 (4.04%)  2/100 (2.00%)  1/68 (1.47%)  6/199 (3.02%) 
Pruritus  1  2/99 (2.02%)  2/100 (2.00%)  1/68 (1.47%)  4/199 (2.01%) 
Psoriasis  1  12/99 (12.12%)  11/100 (11.00%)  4/68 (5.88%)  23/199 (11.56%) 
Pustular psoriasis  1  0/99 (0.00%)  0/100 (0.00%)  2/68 (2.94%)  0/199 (0.00%) 
Rash  1  2/99 (2.02%)  2/100 (2.00%)  0/68 (0.00%)  4/199 (2.01%) 
Skin mass  1  2/99 (2.02%)  0/100 (0.00%)  0/68 (0.00%)  2/199 (1.01%) 
Urticaria  1  2/99 (2.02%)  2/100 (2.00%)  0/68 (0.00%)  4/199 (2.01%) 
Vascular disorders         
Haematoma  1  2/99 (2.02%)  0/100 (0.00%)  0/68 (0.00%)  2/199 (1.01%) 
Hypertension  1  5/99 (5.05%)  3/100 (3.00%)  0/68 (0.00%)  8/199 (4.02%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.1)
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 (ie, data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: Novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01806597    
Other Study ID Numbers: CAIN457A2312
2012-005412-25 ( EudraCT Number )
First Submitted: January 23, 2013
First Posted: March 7, 2013
Results First Submitted: October 31, 2017
Results First Posted: February 22, 2018
Last Update Posted: February 22, 2018