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Efficacy of Secukinumab Compared to Ustekinumab in Patients With Plaque-type Psoriasis

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ClinicalTrials.gov Identifier: NCT02074982
Recruitment Status : Completed
First Posted : March 3, 2014
Results First Posted : July 21, 2017
Last Update Posted : July 21, 2017
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 Chronic Plaque Type Psoriasis
Interventions Drug: AIN457 300 mg
Drug: ustekinumab 45/90 mg
Drug: placebo secukinumab
Enrollment 676
Recruitment Details Of the 676 patients who were randomized to the study, 571 patients completed the study (286 patients (84.9%) in the secukinumab group and 285 patients (84.1%) in the ustekinumab group. Efficacy Data up to 52 weeks and Safety Data included up to 104 weeks
Pre-assignment Details  
Arm/Group Title AIN457 300 mg Ustekinumab
Hide Arm/Group Description patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
Period Title: Overall Study
Started 337 339
Full Analysis Set (FAS) 336 339
Safety Set (SF) 335 336
Completed 286 285
Not Completed 51 54
Reason Not Completed
Adverse Event             15             7
Lack of Efficacy             6             1
Lost to Follow-up             9             10
Non-compliance with study treatment             0             2
Physician Decision             1             1
Pregnancy             1             2
Protocol deviation             4             3
Technical problems             0             2
Subject/guardian decision             15             24
Death             0             2
Arm/Group Title AIN457 300 mg Ustekinumab Total
Hide Arm/Group Description patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive Total of all reporting groups
Overall Number of Baseline Participants 337 339 676
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 337 participants 339 participants 676 participants
45.2  (13.95) 44.6  (13.67) 44.9  (13.81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 337 participants 339 participants 676 participants
Female
108
  32.0%
87
  25.7%
195
  28.8%
Male
229
  68.0%
252
  74.3%
481
  71.2%
1.Primary Outcome
Title Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16
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). 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 90 responders were defined as participants achieving ≥ 90% improvement at Week 16

Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all randomized patient minus 1 patient that was excluded due to missing informed consent prior to initiating study procedures.
Arm/Group Title AIN457 300 mg Ustekinumab
Hide Arm/Group Description:
patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
Overall Number of Participants Analyzed 334 335
Measure Type: Number
Unit of Measure: Percentage of Participants
79.0 57.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AIN457 300 mg, Ustekinumab
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 Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.85
Confidence Interval (2-Sided) 95%
2.01 to 4.02
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Speed of Onset Based on the Percentage of Participents Achieving PASI 75 at Week 4
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). 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).

Speed of Onset was based on percentage PASI 75 responders and were defined as participants achieving ≥ 75% improvement at Week 4

Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all randomized patient minus 1 patient that was excluded due to missing informed consent prior to initiating study procedures.
Arm/Group Title AIN457 300 mg Ustekinumab
Hide Arm/Group Description:
patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
Overall Number of Participants Analyzed 334 335
Measure Type: Number
Unit of Measure: percentage of participants
49.7 20.6
3.Secondary Outcome
Title Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 52
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). 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 90 responders were defined as participants achieving ≥ 90% improvement at Week 52

Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all randomized patient minus 1 patient that was excluded due to missing informed consent prior to initiating study procedures.
Arm/Group Title AIN457 300 mg Ustekinumab
Hide Arm/Group Description:
patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
Overall Number of Participants Analyzed 334 335
Measure Type: Number
Unit of Measure: percentage of participants
74.9 60.6
Time Frame Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AIN457 300 mg Ustekinumab
Hide Arm/Group Description patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
All-Cause Mortality
AIN457 300 mg Ustekinumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AIN457 300 mg Ustekinumab
Affected / at Risk (%) Affected / at Risk (%)
Total   41/335 (12.24%)   32/336 (9.52%) 
Cardiac disorders     
ANGINA UNSTABLE  1  0/335 (0.00%)  1/336 (0.30%) 
ATRIAL FIBRILLATION  1  1/335 (0.30%)  0/336 (0.00%) 
ATRIAL FLUTTER  1  1/335 (0.30%)  0/336 (0.00%) 
MYOCARDIAL INFARCTION  1  0/335 (0.00%)  1/336 (0.30%) 
VENTRICULAR FAILURE  1  1/335 (0.30%)  0/336 (0.00%) 
Congenital, familial and genetic disorders     
HAMARTOMA  1  0/335 (0.00%)  1/336 (0.30%) 
Ear and labyrinth disorders     
TYMPANIC MEMBRANE PERFORATION  1  1/335 (0.30%)  0/336 (0.00%) 
Eye disorders     
OCULAR HYPERTENSION  1  1/335 (0.30%)  0/336 (0.00%) 
VITREOUS ADHESIONS  1  0/335 (0.00%)  1/336 (0.30%) 
Gastrointestinal disorders     
DIARRHOEA  1  1/335 (0.30%)  0/336 (0.00%) 
INGUINAL HERNIA  1  0/335 (0.00%)  1/336 (0.30%) 
NAUSEA  1  0/335 (0.00%)  1/336 (0.30%) 
PANCREATITIS ACUTE  1  1/335 (0.30%)  0/336 (0.00%) 
VOMITING  1  0/335 (0.00%)  1/336 (0.30%) 
General disorders     
DEATH  1  0/335 (0.00%)  1/336 (0.30%) 
GENERAL PHYSICAL HEALTH DETERIORATION  1  1/335 (0.30%)  0/336 (0.00%) 
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME  1  1/335 (0.30%)  0/336 (0.00%) 
Hepatobiliary disorders     
CHOLECYSTITIS  1  1/335 (0.30%)  1/336 (0.30%) 
CHOLELITHIASIS  1  1/335 (0.30%)  0/336 (0.00%) 
CIRRHOSIS ALCOHOLIC  1  1/335 (0.30%)  0/336 (0.00%) 
DRUG-INDUCED LIVER INJURY  1  1/335 (0.30%)  0/336 (0.00%) 
HEPATITIS ACUTE  1  1/335 (0.30%)  0/336 (0.00%) 
NON-ALCOHOLIC FATTY LIVER  1  1/335 (0.30%)  0/336 (0.00%) 
Infections and infestations     
ABSCESS  1  0/335 (0.00%)  1/336 (0.30%) 
ABSCESS LIMB  1  1/335 (0.30%)  0/336 (0.00%) 
APPENDICITIS  1  1/335 (0.30%)  0/336 (0.00%) 
DIVERTICULITIS  1  0/335 (0.00%)  1/336 (0.30%) 
ERYSIPELAS  1  0/335 (0.00%)  1/336 (0.30%) 
ESCHERICHIA URINARY TRACT INFECTION  1  1/335 (0.30%)  0/336 (0.00%) 
LARYNGITIS  1  1/335 (0.30%)  0/336 (0.00%) 
NASAL ABSCESS  1  1/335 (0.30%)  0/336 (0.00%) 
ORAL CANDIDIASIS  1  1/335 (0.30%)  0/336 (0.00%) 
PILONIDAL CYST  1  0/335 (0.00%)  1/336 (0.30%) 
PNEUMONIA  1  1/335 (0.30%)  0/336 (0.00%) 
SCROTAL ABSCESS  1  0/335 (0.00%)  1/336 (0.30%) 
SEPTIC SHOCK  1  0/335 (0.00%)  1/336 (0.30%) 
SUBCUTANEOUS ABSCESS  1  0/335 (0.00%)  1/336 (0.30%) 
TONSILLITIS  1  0/335 (0.00%)  1/336 (0.30%) 
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  1/335 (0.30%)  0/336 (0.00%) 
Injury, poisoning and procedural complications     
ALCOHOL POISONING  1  1/335 (0.30%)  0/336 (0.00%) 
CONCUSSION  1  1/335 (0.30%)  0/336 (0.00%) 
FIBULA FRACTURE  1  1/335 (0.30%)  0/336 (0.00%) 
FOOT FRACTURE  1  1/335 (0.30%)  0/336 (0.00%) 
HAND FRACTURE  1  0/335 (0.00%)  1/336 (0.30%) 
HUMERUS FRACTURE  1  0/335 (0.00%)  1/336 (0.30%) 
INJECTION RELATED REACTION  1  0/335 (0.00%)  1/336 (0.30%) 
JAW FRACTURE  1  1/335 (0.30%)  0/336 (0.00%) 
LOWER LIMB FRACTURE  1  1/335 (0.30%)  0/336 (0.00%) 
POST CONCUSSION SYNDROME  1  1/335 (0.30%)  0/336 (0.00%) 
RADIUS FRACTURE  1  1/335 (0.30%)  0/336 (0.00%) 
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  1/335 (0.30%)  1/336 (0.30%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  0/335 (0.00%)  2/336 (0.60%) 
BLOOD BILIRUBIN INCREASED  1  1/335 (0.30%)  0/336 (0.00%) 
HEPATIC ENZYME INCREASED  1  1/335 (0.30%)  0/336 (0.00%) 
Metabolism and nutrition disorders     
HYPONATRAEMIA  1  1/335 (0.30%)  0/336 (0.00%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  0/335 (0.00%)  1/336 (0.30%) 
BACK PAIN  1  0/335 (0.00%)  1/336 (0.30%) 
OSTEOARTHRITIS  1  1/335 (0.30%)  1/336 (0.30%) 
ROTATOR CUFF SYNDROME  1  0/335 (0.00%)  1/336 (0.30%) 
SPINAL PAIN  1  0/335 (0.00%)  1/336 (0.30%) 
TENDONITIS  1  0/335 (0.00%)  1/336 (0.30%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
BASAL CELL CARCINOMA  1  1/335 (0.30%)  0/336 (0.00%) 
BRAIN NEOPLASM BENIGN  1  0/335 (0.00%)  1/336 (0.30%) 
FIBROADENOMA OF BREAST  1  1/335 (0.30%)  0/336 (0.00%) 
HAEMANGIOMA OF LIVER  1  0/335 (0.00%)  1/336 (0.30%) 
KERATOACANTHOMA  1  1/335 (0.30%)  0/336 (0.00%) 
LUNG ADENOCARCINOMA  1  1/335 (0.30%)  0/336 (0.00%) 
MALIGNANT MELANOMA IN SITU  1  2/335 (0.60%)  0/336 (0.00%) 
Nervous system disorders     
AMNESIA  1  1/335 (0.30%)  0/336 (0.00%) 
CAROTID ARTERY DISEASE  1  1/335 (0.30%)  0/336 (0.00%) 
CARPAL TUNNEL SYNDROME  1  0/335 (0.00%)  1/336 (0.30%) 
CEREBRAL HAEMORRHAGE  1  1/335 (0.30%)  0/336 (0.00%) 
EMBOLIC STROKE  1  1/335 (0.30%)  0/336 (0.00%) 
FACIAL PARESIS  1  1/335 (0.30%)  0/336 (0.00%) 
FACIAL SPASM  1  1/335 (0.30%)  0/336 (0.00%) 
HEADACHE  1  1/335 (0.30%)  0/336 (0.00%) 
POSTICTAL PARALYSIS  1  1/335 (0.30%)  0/336 (0.00%) 
SYNCOPE  1  0/335 (0.00%)  1/336 (0.30%) 
TRANSIENT ISCHAEMIC ATTACK  1  1/335 (0.30%)  0/336 (0.00%) 
Psychiatric disorders     
ALCOHOL ABUSE  1  1/335 (0.30%)  0/336 (0.00%) 
INSOMNIA  1  1/335 (0.30%)  0/336 (0.00%) 
Renal and urinary disorders     
ACUTE KIDNEY INJURY  1  1/335 (0.30%)  0/336 (0.00%) 
HAEMATURIA  1  1/335 (0.30%)  0/336 (0.00%) 
NEPHROLITHIASIS  1  1/335 (0.30%)  0/336 (0.00%) 
URINARY RETENTION  1  1/335 (0.30%)  0/336 (0.00%) 
Reproductive system and breast disorders     
BENIGN PROSTATIC HYPERPLASIA  1  1/335 (0.30%)  1/336 (0.30%) 
PROSTATITIS  1  0/335 (0.00%)  1/336 (0.30%) 
UTERINE HAEMORRHAGE  1  0/335 (0.00%)  1/336 (0.30%) 
Respiratory, thoracic and mediastinal disorders     
ALVEOLITIS ALLERGIC  1  1/335 (0.30%)  0/336 (0.00%) 
INTERSTITIAL LUNG DISEASE  1  1/335 (0.30%)  0/336 (0.00%) 
PULMONARY EMBOLISM  1  0/335 (0.00%)  1/336 (0.30%) 
Skin and subcutaneous tissue disorders     
LICHENIFICATION  1  1/335 (0.30%)  0/336 (0.00%) 
PEMPHIGOID  1  0/335 (0.00%)  1/336 (0.30%) 
SEGMENTED HYALINISING VASCULITIS  1  1/335 (0.30%)  0/336 (0.00%) 
Vascular disorders     
AORTIC ANEURYSM RUPTURE  1  0/335 (0.00%)  1/336 (0.30%) 
DEEP VEIN THROMBOSIS  1  0/335 (0.00%)  1/336 (0.30%) 
VARICOSE VEIN  1  1/335 (0.30%)  0/336 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
AIN457 300 mg Ustekinumab
Affected / at Risk (%) Affected / at Risk (%)
Total   270/335 (80.60%)   246/336 (73.21%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  7/335 (2.09%)  10/336 (2.98%) 
ABDOMINAL PAIN UPPER  1  12/335 (3.58%)  6/336 (1.79%) 
DIARRHOEA  1  22/335 (6.57%)  24/336 (7.14%) 
DYSPEPSIA  1  10/335 (2.99%)  9/336 (2.68%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  7/335 (2.09%)  3/336 (0.89%) 
NAUSEA  1  12/335 (3.58%)  10/336 (2.98%) 
TOOTHACHE  1  12/335 (3.58%)  10/336 (2.98%) 
VOMITING  1  15/335 (4.48%)  7/336 (2.08%) 
General disorders     
FATIGUE  1  20/335 (5.97%)  12/336 (3.57%) 
PYREXIA  1  14/335 (4.18%)  8/336 (2.38%) 
Infections and infestations     
BRONCHITIS  1  20/335 (5.97%)  14/336 (4.17%) 
CONJUNCTIVITIS  1  18/335 (5.37%)  8/336 (2.38%) 
CYSTITIS  1  9/335 (2.69%)  6/336 (1.79%) 
EAR INFECTION  1  9/335 (2.69%)  2/336 (0.60%) 
FOLLICULITIS  1  11/335 (3.28%)  4/336 (1.19%) 
GASTROENTERITIS  1  11/335 (3.28%)  12/336 (3.57%) 
HERPES ZOSTER  1  1/335 (0.30%)  10/336 (2.98%) 
INFLUENZA  1  33/335 (9.85%)  16/336 (4.76%) 
NASOPHARYNGITIS  1  96/335 (28.66%)  87/336 (25.89%) 
ORAL CANDIDIASIS  1  14/335 (4.18%)  2/336 (0.60%) 
ORAL HERPES  1  13/335 (3.88%)  6/336 (1.79%) 
PHARYNGITIS  1  10/335 (2.99%)  12/336 (3.57%) 
RHINITIS  1  13/335 (3.88%)  12/336 (3.57%) 
SINUSITIS  1  12/335 (3.58%)  9/336 (2.68%) 
TINEA PEDIS  1  10/335 (2.99%)  9/336 (2.68%) 
TONSILLITIS  1  11/335 (3.28%)  5/336 (1.49%) 
UPPER RESPIRATORY TRACT INFECTION  1  42/335 (12.54%)  36/336 (10.71%) 
URINARY TRACT INFECTION  1  15/335 (4.48%)  7/336 (2.08%) 
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  11/335 (3.28%)  6/336 (1.79%) 
Injury, poisoning and procedural complications     
ARTHROPOD BITE  1  7/335 (2.09%)  0/336 (0.00%) 
CONTUSION  1  7/335 (2.09%)  8/336 (2.38%) 
LIGAMENT SPRAIN  1  6/335 (1.79%)  8/336 (2.38%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  36/335 (10.75%)  33/336 (9.82%) 
BACK PAIN  1  29/335 (8.66%)  26/336 (7.74%) 
MUSCULOSKELETAL PAIN  1  9/335 (2.69%)  7/336 (2.08%) 
MYALGIA  1  8/335 (2.39%)  6/336 (1.79%) 
NECK PAIN  1  7/335 (2.09%)  3/336 (0.89%) 
PAIN IN EXTREMITY  1  11/335 (3.28%)  11/336 (3.27%) 
PSORIATIC ARTHROPATHY  1  10/335 (2.99%)  11/336 (3.27%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
SKIN PAPILLOMA  1  7/335 (2.09%)  4/336 (1.19%) 
Nervous system disorders     
HEADACHE  1  50/335 (14.93%)  46/336 (13.69%) 
Psychiatric disorders     
ANXIETY  1  9/335 (2.69%)  3/336 (0.89%) 
DEPRESSION  1  6/335 (1.79%)  9/336 (2.68%) 
Respiratory, thoracic and mediastinal disorders     
COUGH  1  21/335 (6.27%)  20/336 (5.95%) 
OROPHARYNGEAL PAIN  1  32/335 (9.55%)  18/336 (5.36%) 
RHINORRHOEA  1  7/335 (2.09%)  6/336 (1.79%) 
Skin and subcutaneous tissue disorders     
DRY SKIN  1  7/335 (2.09%)  4/336 (1.19%) 
ECZEMA  1  19/335 (5.67%)  12/336 (3.57%) 
PRURITUS  1  25/335 (7.46%)  28/336 (8.33%) 
PRURITUS GENERALISED  1  8/335 (2.39%)  8/336 (2.38%) 
PSORIASIS  1  22/335 (6.57%)  21/336 (6.25%) 
SEBORRHOEIC DERMATITIS  1  9/335 (2.69%)  5/336 (1.49%) 
URTICARIA  1  4/335 (1.19%)  7/336 (2.08%) 
Vascular disorders     
HYPERTENSION  1  15/335 (4.48%)  18/336 (5.36%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
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
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Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
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Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02074982     History of Changes
Other Study ID Numbers: CAIN457A2317
2013-003434-32 ( EudraCT Number )
First Submitted: February 27, 2014
First Posted: March 3, 2014
Results First Submitted: June 23, 2017
Results First Posted: July 21, 2017
Last Update Posted: July 21, 2017