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Trial record 19 of 90 for:    hidradenitis suppurativa

Efficacy, Safety, and Pharmacokinetics Study of CJM112 in Hidradenitis Suppurativa Patients

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ClinicalTrials.gov Identifier: NCT02421172
Recruitment Status : Completed
First Posted : April 20, 2015
Results First Posted : May 23, 2019
Last Update Posted : May 23, 2019
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 Hidradenitis Suppurativa (Acne Inversa)
Interventions Biological: CJM112
Drug: Placebo
Enrollment 66
Recruitment Details Study with 4 wks screening,two sequential treatment periods 16 wks (Period 1 & Extension Period 2)& 12 wks Follow-up. Randomization 2:1:1 to three sequences:Seq. 1: Period 1: CJM112 High Dose sc then Period 2: placebo sc; Seq. 2: Period 1: Placebo sc then Period 2: CJM112 Low Dose sc; Seq, 3: Period 1: Placebo sc then Period 2: CJM112 High Dose sc
Pre-assignment Details A total of 66 patients were enrolled, randomized and entered into two sequential periods (Period 1 and Extension Period 2) of which 60 patients completed Week 16 in Period 1 and entered Extension Period 2.
Arm/Group Title Period 1: CJM112 High Dose Period 1: Placebo Extension Period 2: CJM112 High Dose /Placebo Extension Period 2: Placebo/CJM112 Low Dose Extension Period 2: Placebo/CJM112 High Dose
Hide Arm/Group Description Period 1: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses Period 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses Extension Period 2: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on CJM112 High Dose in Period 1 Extension Period 2: CJM112 Low Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1 Extension Period 2: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1
Period Title: Period 1
Started 33 33 0 0 0
PD Analysis Set Period 1 31 33 0 0 0
PK Analysis Set Period 1 33 0 0 0 0
Completed 29 31 0 0 0
Not Completed 4 2 0 0 0
Reason Not Completed
Adverse Event             1             0             0             0             0
Lost to Follow-up             3             1             0             0             0
Patient/guardian decision             0             1             0             0             0
Period Title: Period 2
Started 0 0 29 16 15
Completed 0 0 22 13 14
Not Completed 0 0 7 3 1
Reason Not Completed
Adverse Event             0             0             4             0             0
Lost to Follow-up             0             0             0             1             0
Patient/guardian decision             0             0             3             2             1
Arm/Group Title Period 1: CJM112 High Dose Period 1: Placebo Total
Hide Arm/Group Description Period 1: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses Period 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses Total of all reporting groups
Overall Number of Baseline Participants 33 33 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 33 participants 66 participants
36  (9.8) 39  (10.9) 37  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 66 participants
Female
22
  66.7%
22
  66.7%
44
  66.7%
Male
11
  33.3%
11
  33.3%
22
  33.3%
1.Primary Outcome
Title Clinical Responder Rate at Period 1: Week 16
Hide Description Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) score An HS-PGA responder in period 1 was a participant who had an initial HS-PGA score of at least 3 at baseline (Day 1, inclusion criterion) that decreased by at least 2 points. The six-point Physician Global Assessment (PGA) (scores range from 0-5) based on the number of HS lesions ranges from clear to very severe.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set 1 includes all patients who were CJM112-treated or placebo-treated in Period 1 with available PD data and no protocol deviations with relevant impact on PD data in Period 1.
Arm/Group Title Period 1: CJM112 High Dose Period 1: Placebo
Hide Arm/Group Description:
Period 1: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
Period 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
Overall Number of Participants Analyzed 31 32
Measure Type: Number
Unit of Measure: participants
10 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Period 1: CJM112 High Dose, Period 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Posterior probablility
Estimated Value 0.9729
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Clinical Responder Rate Period 1 at Week 2, 4, 8 and 12
Hide Description Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) score A HS-PGA responder in Period 1 is a study participant who had an initial HS-PGA score of at least 3 at Baseline (Day 1, inclusion criterion) that decreased by at least 2 points. The six-point Physician Global Assessment (PGA) (scores range from 0-5) based on the number of HS lesions ranges from clear to very severe.
Time Frame Week 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set 1 includes all patients who were CJM112-treated or placebo-treated in Period 1 with available PD data and no protocol deviations with relevant impact on PD data in Period 1.
Arm/Group Title Period 1: CJM112 High Dose Period 1: Placebo
Hide Arm/Group Description:
Period 1: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
Period 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
Overall Number of Participants Analyzed 31 32
Measure Type: Number
Unit of Measure: count of participants
Week 2 4 3
Week 4 6 3
Week 8 5 6
Week 12 7 4
3.Secondary Outcome
Title Pharmacokinetics (PK): Ctrough for CJM112 Period 1 and Period 2
Hide Description Ctrough is the serum concentration that is just prior to the beginning of, or at the end, of a dosing interval (mass/volume) for Period 1 (week 16) and Period 2/End of Study (week 44)
Time Frame Week 16 and Week 44
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set 1 includes all patients who were CJM112-treated in Period 1 with available PK data & no protocol deviations with relevant impact on PK data. PK analysis set 2 & 3 includes all patients from safety analysis set 2 & set 3 with available PK data & no protocol deviations with relevant impact on PK data for Period 2/End of Study.
Arm/Group Title Period 1: CJM112 High Dose Extension Period 2: Placebo/CJM112 Low Dose Extension Period 2: Placebo/CJM112 High Dose
Hide Arm/Group Description:
Period 1: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
Extension Period 2: CJM112 Low Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1
Extension Period 2: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1
Overall Number of Participants Analyzed 28 13 14
Mean (Standard Deviation)
Unit of Measure: ug/mL
21.4  (11.6) 3.1  (2.6) 24.4  (19.0)
4.Secondary Outcome
Title Pharmacokinetic Profile: T1/2 The Terminal Elimination Half-life for Period 1 & Period 2/End of Study
Hide Description T1/2 The terminal elimination half-life for Period 1 (Week 16) and Period 2/End of Study (Week 44)
Time Frame Week 16 (period 1), Week 44 (End of Study Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set 1 includes all patients who were CJM112-treated in Period 1 with available PK data & no protocol deviations with relevant impact on PK data. PK analysis set 2 & 3 includes all patients from safety analysis set 2 & set 3 with available PK data & no protocol deviations with relevant impact on PK data for Period 2/End of Study.
Arm/Group Title Period 1: CJM112 High Dose Extension Period 2: Placebo/CJM112 Low Dose Extension Period 2: Placebo/CJM112 High Dose
Hide Arm/Group Description:
Period 1: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
Extension Period 2: CJM112 Low Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1
Extension Period 2: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1
Overall Number of Participants Analyzed 26 1 7
Mean (Standard Deviation)
Unit of Measure: days
16.09  (3.500) 22.81  (0) 19.85  (3.807)
5.Secondary Outcome
Title Immunogenicity - Incidence of ADA-positive and ADA-negative in Participants With or Without Pre-existing Antibodies in Period 1 and Period 2/End of Study
Hide Description Immunogenicity - Incidence of semi-quantitative determination of anti-CJM112 antibodies or ADAs. ADA-positive and ADA-negative in participants with or without pre-existing antibodies Period 1 (week 16) and Period 2/End of Study (week 44)
Time Frame Week 16 (period 1), Week 44 (End of Study Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set 1 includes all patients who were CJM112-treated in Period 1 with available PK data & no protocol deviations with relevant impact on PK data. PK analysis set 2 & 3 includes all patients from safety analysis set 2 & set 3 with available PK data & no protocol deviations with relevant impact on PK data for Period 2/End of Study.
Arm/Group Title Period 1: CJM112 High Dose Extension Period 2: Placebo/CJM112 Low Dose Extension Period 2: Placebo/CJM112 High Dose
Hide Arm/Group Description:
Period 1: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
Extension Period 2: CJM112 Low Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1
Extension Period 2: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1
Overall Number of Participants Analyzed 33 16 15
Measure Type: Number
Unit of Measure: participants
Pre-existing Antibodies ADA negative 2 1 7
Pre-existing Antibodies ADA positive 1 1 0
NO Pre-existing Antibodies ADA negative 21 10 9
NO Pre-existing Antibodies ADA positive 9 4 1
6.Secondary Outcome
Title Total Interleukin-17A (IL-17A Homodimer) in Serum at Pre-dose and Post-dose for Period 1 & Period 2
Hide Description Total Interleukin-17A (IL-17A homodimer) in serum at Pre-dose Period 1 (Day 1) & Pre-dose Period 2 (Day 113) and Post-dose Period 1 (Day 99) and Post-dose Period 2 (Day 211)
Time Frame Pre-dose (Period 1 Day 1 & Period 2 Day 113), Post-dose Period 1(Day 99) and post-dose Period 2 (Day 211)
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set 1 includes all patients who were CJM112-treated in Period 1 with available PK data & no protocol deviations with relevant impact on PK data. PK analysis set 2 & 3 includes all patients from safety analysis set 2 & set 3 with available PK data & no protocol deviations with relevant impact on PK data for Period 2/End of Study.
Arm/Group Title Period 1: CJM112 High Dose Extension Period 2: Placebo/CJM112 Low Dose Extension Period 2: Placebo/CJM112 High Dose
Hide Arm/Group Description:
Period 1: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
Extension Period 2: CJM112 Low Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1
Extension Period 2: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1
Overall Number of Participants Analyzed 33 16 15
Mean (Standard Deviation)
Unit of Measure: pg/mL
Pre-dose Number Analyzed 32 participants 16 participants 14 participants
361  (2010) 163  (647) 158  (372)
Post-dose Number Analyzed 28 participants 13 participants 14 participants
1160  (3190) 943  (583) 821  (538)
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 - End of Study Week 44.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Period 1: CJM112 High Dose Period 1: Placebo Extension Period 2: CJM112 High Dose /Placebo Extension Period 2: Placebo/CJM112 Low Dose Extension Period 2: Placebo/CJM112 High Dose
Hide Arm/Group Description Period 1: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses Period 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses Extension Period 2: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on CJM112 High Dose in Period 1 Extension Period 2: CJM112 Low Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1 Extension Period 2: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1
All-Cause Mortality
Period 1: CJM112 High Dose Period 1: Placebo Extension Period 2: CJM112 High Dose /Placebo Extension Period 2: Placebo/CJM112 Low Dose Extension Period 2: Placebo/CJM112 High Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Period 1: CJM112 High Dose Period 1: Placebo Extension Period 2: CJM112 High Dose /Placebo Extension Period 2: Placebo/CJM112 Low Dose Extension Period 2: Placebo/CJM112 High Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   1/33 (3.03%)   1/29 (3.45%)   0/16 (0.00%)   0/15 (0.00%) 
Cardiac disorders           
Angina pectoris  1  0/33 (0.00%)  1/33 (3.03%)  0/29 (0.00%)  0/16 (0.00%)  0/15 (0.00%) 
Infections and infestations           
Groin abscess  1  0/33 (0.00%)  0/33 (0.00%)  1/29 (3.45%)  0/16 (0.00%)  0/15 (0.00%) 
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 5%
Period 1: CJM112 High Dose Period 1: Placebo Extension Period 2: CJM112 High Dose /Placebo Extension Period 2: Placebo/CJM112 Low Dose Extension Period 2: Placebo/CJM112 High Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/33 (75.76%)   23/33 (69.70%)   20/29 (68.97%)   13/16 (81.25%)   14/15 (93.33%) 
Ear and labyrinth disorders           
Ear pain  1  1/33 (3.03%)  0/33 (0.00%)  0/29 (0.00%)  0/16 (0.00%)  1/15 (6.67%) 
Sudden hearing loss  1  0/33 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Tinnitus  1  0/33 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Eye disorders           
Eye pruritus  1  0/33 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Eyelid cyst  1  0/33 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Gastrointestinal disorders           
Abdominal pain  1  2/33 (6.06%)  0/33 (0.00%)  2/29 (6.90%)  0/16 (0.00%)  0/15 (0.00%) 
Abdominal pain upper  1  1/33 (3.03%)  0/33 (0.00%)  0/29 (0.00%)  0/16 (0.00%)  1/15 (6.67%) 
Diarrhoea  1  2/33 (6.06%)  5/33 (15.15%)  1/29 (3.45%)  0/16 (0.00%)  2/15 (13.33%) 
Nausea  1  5/33 (15.15%)  3/33 (9.09%)  2/29 (6.90%)  1/16 (6.25%)  0/15 (0.00%) 
Toothache  1  1/33 (3.03%)  3/33 (9.09%)  0/29 (0.00%)  2/16 (12.50%)  0/15 (0.00%) 
Vomiting  1  1/33 (3.03%)  1/33 (3.03%)  0/29 (0.00%)  2/16 (12.50%)  0/15 (0.00%) 
General disorders           
Fatigue  1  3/33 (9.09%)  1/33 (3.03%)  1/29 (3.45%)  0/16 (0.00%)  1/15 (6.67%) 
Non-cardiac chest pain  1  2/33 (6.06%)  1/33 (3.03%)  1/29 (3.45%)  0/16 (0.00%)  0/15 (0.00%) 
Oedema peripheral  1  0/33 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/16 (0.00%)  1/15 (6.67%) 
Pain  1  1/33 (3.03%)  2/33 (6.06%)  1/29 (3.45%)  0/16 (0.00%)  0/15 (0.00%) 
Pyrexia  1  3/33 (9.09%)  1/33 (3.03%)  3/29 (10.34%)  0/16 (0.00%)  0/15 (0.00%) 
Infections and infestations           
Abscess  1  0/33 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Bronchitis  1  0/33 (0.00%)  0/33 (0.00%)  2/29 (6.90%)  1/16 (6.25%)  0/15 (0.00%) 
Conjunctivitis  1  2/33 (6.06%)  0/33 (0.00%)  1/29 (3.45%)  0/16 (0.00%)  1/15 (6.67%) 
Cystitis  1  3/33 (9.09%)  0/33 (0.00%)  1/29 (3.45%)  0/16 (0.00%)  0/15 (0.00%) 
Eyelid infection  1  0/33 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/16 (0.00%)  1/15 (6.67%) 
Gastroenteritis  1  0/33 (0.00%)  3/33 (9.09%)  0/29 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Influenza  1  3/33 (9.09%)  1/33 (3.03%)  2/29 (6.90%)  0/16 (0.00%)  1/15 (6.67%) 
Nasopharyngitis  1  7/33 (21.21%)  4/33 (12.12%)  4/29 (13.79%)  2/16 (12.50%)  3/15 (20.00%) 
Periorbital cellulitis  1  0/33 (0.00%)  1/33 (3.03%)  0/29 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Skin infection  1  0/33 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/16 (0.00%)  1/15 (6.67%) 
Tinea versicolour  1  0/33 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Upper respiratory tract infection  1  3/33 (9.09%)  0/33 (0.00%)  1/29 (3.45%)  2/16 (12.50%)  0/15 (0.00%) 
Urinary tract infection  1  2/33 (6.06%)  2/33 (6.06%)  1/29 (3.45%)  3/16 (18.75%)  0/15 (0.00%) 
Injury, poisoning and procedural complications           
Contusion  1  0/33 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/16 (0.00%)  1/15 (6.67%) 
Procedural pain  1  0/33 (0.00%)  0/33 (0.00%)  1/29 (3.45%)  1/16 (6.25%)  1/15 (6.67%) 
Investigations           
Blood creatine phosphokinase increased  1  1/33 (3.03%)  1/33 (3.03%)  1/29 (3.45%)  1/16 (6.25%)  0/15 (0.00%) 
QRS axis abnormal  1  0/33 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
White blood cells urine  1  0/33 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/16 (0.00%)  1/15 (6.67%) 
Metabolism and nutrition disorders           
Diabetes mellitus  1  0/33 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/16 (0.00%)  1/15 (6.67%) 
Hypomagnesaemia  1  0/33 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Vitamin D deficiency  1  0/33 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/16 (0.00%)  1/15 (6.67%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  0/33 (0.00%)  2/33 (6.06%)  3/29 (10.34%)  0/16 (0.00%)  1/15 (6.67%) 
Back pain  1  5/33 (15.15%)  0/33 (0.00%)  1/29 (3.45%)  0/16 (0.00%)  0/15 (0.00%) 
Myalgia  1  0/33 (0.00%)  2/33 (6.06%)  1/29 (3.45%)  0/16 (0.00%)  0/15 (0.00%) 
Tenosynovitis  1  0/33 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Nervous system disorders           
Dizziness  1  0/33 (0.00%)  0/33 (0.00%)  2/29 (6.90%)  0/16 (0.00%)  0/15 (0.00%) 
Headache  1  4/33 (12.12%)  3/33 (9.09%)  2/29 (6.90%)  3/16 (18.75%)  0/15 (0.00%) 
Paraesthesia  1  0/33 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Reproductive system and breast disorders           
Pruritus genital  1  0/33 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/16 (0.00%)  1/15 (6.67%) 
Respiratory, thoracic and mediastinal disorders           
Cough  1  1/33 (3.03%)  2/33 (6.06%)  2/29 (6.90%)  0/16 (0.00%)  0/15 (0.00%) 
Oropharyngeal pain  1  2/33 (6.06%)  3/33 (9.09%)  0/29 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Rhinalgia  1  0/33 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Skin and subcutaneous tissue disorders           
Dry skin  1  1/33 (3.03%)  0/33 (0.00%)  0/29 (0.00%)  1/16 (6.25%)  1/15 (6.67%) 
Dyshidrotic eczema  1  0/33 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/16 (0.00%)  1/15 (6.67%) 
Hidradenitis  1  0/33 (0.00%)  3/33 (9.09%)  0/29 (0.00%)  0/16 (0.00%)  2/15 (13.33%) 
Intertrigo  1  2/33 (6.06%)  1/33 (3.03%)  0/29 (0.00%)  0/16 (0.00%)  1/15 (6.67%) 
Pain of skin  1  0/33 (0.00%)  1/33 (3.03%)  0/29 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Pruritus  1  3/33 (9.09%)  2/33 (6.06%)  2/29 (6.90%)  0/16 (0.00%)  0/15 (0.00%) 
Rash  1  0/33 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  0/16 (0.00%)  1/15 (6.67%) 
Skin exfoliation  1  0/33 (0.00%)  0/33 (0.00%)  0/29 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Urticaria  1  0/33 (0.00%)  1/33 (3.03%)  0/29 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
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: 8627788300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02421172     History of Changes
Other Study ID Numbers: CCJM112X2202
First Submitted: March 18, 2015
First Posted: April 20, 2015
Results First Submitted: November 21, 2017
Results First Posted: May 23, 2019
Last Update Posted: May 23, 2019