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A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients

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ClinicalTrials.gov Identifier: NCT03560739
Recruitment Status : Completed
First Posted : June 18, 2018
Results First Posted : October 9, 2020
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Interventions Combination Product: ofatumumab with PRF
Combination Product: ofatumumab with AI
Enrollment 284
Recruitment Details  
Pre-assignment Details 344 participants were screened
Arm/Group Title OMB 20mg AI Abdomen OMB 20mg PFS Abdomen OMB 20mg AI Thigh OMB 20mg PFS Thigh
Hide Arm/Group Description Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on abdomen Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on abdomen Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on thigh Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on thigh
Period Title: Overall Study
Started 128 130 13 13
Completed 128 129 13 13
Not Completed 0 1 0 0
Reason Not Completed
Adverse Event             0             1             0             0
Arm/Group Title OMB 20mg AI Abdomen OMB 20mg PFS Abdomen OMB 20mg AI Thigh OMB 20mg PFS Thigh Total
Hide Arm/Group Description Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on abdomen Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on abdomen Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on thigh Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on thigh Total of all reporting groups
Overall Number of Baseline Participants 128 130 13 13 284
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 128 participants 130 participants 13 participants 13 participants 284 participants
18 to 30 years 32 29 5 2 68
31 to 40 years 42 53 3 10 108
41 to 55 years 54 48 5 1 108
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 130 participants 13 participants 13 participants 284 participants
Female
92
  71.9%
90
  69.2%
9
  69.2%
8
  61.5%
199
  70.1%
Male
36
  28.1%
40
  30.8%
4
  30.8%
5
  38.5%
85
  29.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 128 participants 130 participants 13 participants 13 participants 284 participants
American Indian or Alaska Native 1 0 0 0 1
Black or African American 2 4 0 0 6
White 125 125 13 12 275
Mixed 0 1 0 1 2
1.Primary Outcome
Title Bioequivalence of 20 mg Ofatumumab Injected by Pre-filled Syringe (PFS) vs Autoinjector (AI) to Abdomen as Measured by AUCtau
Hide Description Bioequivalence of AUCtau ) will be measured over the time period of Week 8 to Week 12 dosing interval comparing the pre-filled syringe (PFS) and autoinjector (AI) devices both administered to the abdomen. Bioequivalence established if both measures meet the corresponding criterion specified by the reference-scaled average bioequivalence (RSABE) approach
Time Frame Week 8 to Week 12 dosing interval
Hide Outcome Measure Data
Hide Analysis Population Description
Bio-equivalence analysis set
Arm/Group Title OMB 20mg AI Abdomen OMB 20mg PFS Abdomen
Hide Arm/Group Description:
Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on abdomen
Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on abdomen
Overall Number of Participants Analyzed 128 128
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h×µg/mL
487.7
(103.5%)
474.1
(79.7%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OMB 20mg AI Abdomen, OMB 20mg PFS Abdomen
Comments Criteria 1 for bioequivalence testing of AUCtau
Type of Statistical Test Equivalence
Comments For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in [0.8, 1.25]; 2) 95% upper bound of the linearized criterion needs to be <= 0. This part is regarding criterion 1.
Method of Estimation Estimation Parameter Geo-mean ratio
Estimated Value 1.03
Confidence Interval (2-Sided) 90%
.8 to 1.25
Estimation Comments The confidence interval reported in the Point Estimate section below is the one from the criterion, not the estimated confidence interval.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMB 20mg AI Abdomen, OMB 20mg PFS Abdomen
Comments Criteria 2 for bioequivalence testing of AUCtau
Type of Statistical Test Equivalence
Comments For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in [0.8, 1.25]; 2) 95% upper bound of the linearized criterion needs to be <= 0. This part is regarding criterion 2.
Method of Estimation Estimation Parameter 95% upper bound of the linearized criter
Estimated Value -.3131
Confidence Interval (1-Sided) 95%
0
Estimation Comments The upper limit reported in the Point Estimate section below is the limit on the 95% upper bound from the criterion, not the estimated upper limit of the 95% upper bound of the linearized criterion
2.Primary Outcome
Title Bioequivalence of 20 mg Ofatumumab Injected by Pre-filled Syringe (PFS) vs Autoinjector (AI) to Abdomen as Measured by Cmax
Hide Description Bioequivalence of Cmax will be measured over the time period of Week 8 to Week 12 dosing interval comparing the pre-filled syringe (PFS) and autoinjector (AI) devices both administered to the abdomen. Bioequivalence established if both measures meet the corresponding criterion specified by the reference-scaled average bioequivalence (RSABE) approach
Time Frame Week 8 to Week 12 dosing interval
Hide Outcome Measure Data
Hide Analysis Population Description
Bioequivalence analysis set
Arm/Group Title OMB 20mg AI Abdomen OMB 20mg PFS Abdomen
Hide Arm/Group Description:
Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on abdomen
Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on abdomen
Overall Number of Participants Analyzed 128 128
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
1.409
(89.2%)
1.409
(67.9%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OMB 20mg AI Abdomen, OMB 20mg PFS Abdomen
Comments Criteria 1 for bioequivalence testing of Cmax
Type of Statistical Test Equivalence
Comments For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in [0.8, 1.25]; 2) 95% upper bound of the linearized criterion needs to be <= 0. This part is regarding criterion 1.
Method of Estimation Estimation Parameter geo-mean ratio
Estimated Value 1.00
Confidence Interval (2-Sided) 90%
.8 to 1.25
Estimation Comments The confidence interval reported in the Point Estimate section below is the one from the criterion, not the estimated confidence interval.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMB 20mg AI Abdomen, OMB 20mg PFS Abdomen
Comments Criteria 2 for bioequivalence testing of Cmax
Type of Statistical Test Equivalence
Comments For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in [0.8, 1.25]; 2) 95% upper bound of the linearized criterion needs to be <= 0. This part is regarding criterion 2.
Method of Estimation Estimation Parameter 95% upper bound of the linearized criter
Estimated Value -0.2446
Confidence Interval (1-Sided) 95%
0
Estimation Comments The upper limit reported in the Point Estimate section below is the limit on the 95% upper bound from the criterion, not the estimated upper limit of the 95% upper bound of the linearized criterion.
3.Secondary Outcome
Title Pharmacokinetics of the Study Drug as Measured by AUCtau for PFS and AI Devices When Administered to Abdomen or Thigh
Hide Description Pharmacokinetics following subcutaneous administration of ofatumumab to either the abdominal region or the thigh as measured by the area under the concentration-time curve over the Week 8 - Week 12 dosing interval (AUCtau)
Time Frame Week 8 to Week 12 dosing interval
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set
Arm/Group Title OMB 20mg AI Abdomen OMB 20mg PFS Abdomen OMB 20mg AI Thigh OMB 20mg PFS Thigh
Hide Arm/Group Description:
Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on abdomen
Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on abdomen
Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on thigh
Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on thigh
Overall Number of Participants Analyzed 128 128 13 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h×µg/mL
487.7
(103.5%)
474.1
(79.7%)
476.0
(73.1%)
544.1
(93.8%)
4.Secondary Outcome
Title Pharmacokinetics of the Study Drug as Measured by Cmax for PFS and AI Devices When Administered to Abdomen or Thigh
Hide Description Pharmacokinetics following subcutaneous administration of ofatumumab to either the abdominal region or the thigh as measured by the maximum concentration (Cmax)
Time Frame Week 8 to Week 12 dosing interval
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set
Arm/Group Title OMB 20mg AI Abdomen OMB 20mg PFS Abdomen OMB 20mg AI Thigh OMB 20mg PFS Thigh
Hide Arm/Group Description:
Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on abdomen
Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on abdomen
Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on thigh
Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on thigh
Overall Number of Participants Analyzed 128 128 13 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
1.409
(89.2%)
1.409
(67.9%)
1.563
(71.3%)
1.635
(50.7%)
5.Secondary Outcome
Title Plasma Concentrations of the Study Drug for PFS and AI Devices When Administered to Abdomen or Thigh
Hide Description Plasma concentrations following subcutaneous administration of ofatumumab via PFS or AI to either the abdominal region or the thigh
Time Frame Days 4, 7, 14, 28, 42, 56, 57, 59, 63, 70, 77, 84
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set
Arm/Group Title OMB 20mg AI Abdomen OMB 20mg PFS Abdomen OMB 20mg AI Thigh OMB 20mg PFS Thigh
Hide Arm/Group Description:
Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on abdomen
Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on abdomen
Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on thigh
Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on thigh
Overall Number of Participants Analyzed 128 130 13 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
Day 4 n=128,127,13,13 Number Analyzed 128 participants 127 participants 13 participants 13 participants
0.43076
(147.591319%)
0.40075
(119.330376%)
0.86747
(24.481350%)
0.55704
(105.432315%)
Day 7 n=128, 130,13,13 Number Analyzed 128 participants 130 participants 13 participants 13 participants
0.33544
(133.205087%)
0.30511
(119.511321%)
0.36750
(94.007762%)
0.29662
(119.353006%)
Day 14 n=128, 130,12,11 Number Analyzed 128 participants 130 participants 12 participants 11 participants
1.07408
(105.566707%)
0.96359
(105.735963%)
0.89788
(125.726458%)
1.30586
(83.153962%)
Day 28 Week 4 n=127, 130,13,13 Number Analyzed 127 participants 130 participants 13 participants 13 participants
0.95571
(113.510035%)
0.95774
(117.852822%)
1.11008
(66.780045%)
1.41434
(117.959678%)
Day 42 Week 6 n=128, 130,13,13 Number Analyzed 128 participants 130 participants 13 participants 13 participants
0.97327
(125.421064%)
1.12006
(113.137164%)
1.12006
(86.390639%)
1.18239
(133.082660%)
Day 56 Week 8 n=128, 130,13,13 Number Analyzed 128 participants 130 participants 13 participants 13 participants
0.28358
(142.760137%)
0.24644
(133.056913%)
0.23874
(98.041287%)
0.45529
(143.614763%)
Day 57 Week 8 n=127, 127,12,13 Number Analyzed 127 participants 127 participants 12 participants 13 participants
0.89424
(121.357310%)
0.80986
(107.929658%)
0.96356
(122.222991%)
1.04905
(54.771002%)
Day 59 Week 8 n=127, 127,13,13 Number Analyzed 127 participants 127 participants 13 participants 13 participants
1.24143
(103.274314%)
1.23458
(81.737063%)
1.34837
(82.596695%)
1.52705
(52.253239%)
Day 63 Week 9 n=126, 128,13,13 Number Analyzed 126 participants 128 participants 13 participants 13 participants
1.27031
(84.610014%)
1.23163
(77.294222%)
1.28263
(67.076249%)
1.43075
(66.345270%)
Day 70 Week 10 n=128, 127,13,13 Number Analyzed 128 participants 127 participants 13 participants 13 participants
0.78732
(97.440131%)
0.74111
(82.870974%)
0.67151
(82.769087%)
0.95821
(83.645358%)
Day 77 Week 11 n=127, 127,13,13 Number Analyzed 127 participants 127 participants 13 participants 13 participants
0.40249
(109.581877%)
0.33720
(114.373887%)
0.40173
(52.479338%)
0.54085
(97.862609%)
Early Exit n=0,1,0,0 Number Analyzed 0 participants 1 participants 0 participants 0 participants
0.1870
EOS Week 12 n=126, 118,12,13 Number Analyzed 126 participants 118 participants 12 participants 13 participants
0.20290
(113.812416%)
0.17862
(102.507484%)
0.17361
(63.899086%)
0.27276
(98.256573%)
6.Secondary Outcome
Title Percentage of Patients With Anti-ofatumumab Antibodies
Hide Description Anti-drug antibodies (ADA) were assessed to evaluate the immunogenicity potential of ofatumumab. Samples for ADA assessment were taken prior to dosing at the visit. Samples were analyzed as per laboratory's SOPs by a Meso Scale Discovery (MSD) electrochemiluminescense assay. All samples confirmed to be positive for the presence of anti-ofatumumab antibodies were assessed to evaluate their ability to neutralize the ofatumumab biologic effect.
Time Frame Baseline, Week 4, 8, 12 and Overall
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set
Arm/Group Title OMB 20mg AI Abdomen OMB 20mg PFS Abdomen OMB 20mg AI Thigh OMB 20mg PFS Thigh
Hide Arm/Group Description:
Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on abdomen
Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on abdomen
Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on thigh
Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on thigh
Overall Number of Participants Analyzed 128 130 13 13
Measure Type: Number
Unit of Measure: percentage of participants
Baseline n= 128,130,13,13 Number Analyzed 128 participants 130 participants 13 participants 13 participants
0.8 3.1 0.0 7.7
Week 4 n= 128,130,13,13 Number Analyzed 128 participants 130 participants 13 participants 13 participants
0.8 0.0 0.0 0.0
Week 8 n= 124,126,13,13 Number Analyzed 124 participants 126 participants 13 participants 13 participants
0.0 0.8 0.0 0.0
Week 12 n= 125,121, 12,13 Number Analyzed 125 participants 121 participants 12 participants 13 participants
0.8 0.0 0.0 0.0
Overall n= 128,130,13,13 Number Analyzed 128 participants 130 participants 13 participants 13 participants
0.8 3.8 0.0 7.7
Time Frame Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of 226 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OMB 20mg AI (ABD) OMB 20mg PFS Abdomen OMB 20mg AI (THI) OMB 20mg PFS (THI)
Hide Arm/Group Description Ofatumumab 20 mg subcutaneous (sc.) injection with autoinjector (AI) administrated on abdomen Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on abdomen Ofatumumab 20 mg subcutaneous (sc.) injection with autoinjector (AI) administrated on thigh Ofatumumab 20 mg subcutaneous (sc.) injection with pre-filled syringes (PFS) administrated on thigh
All-Cause Mortality
OMB 20mg AI (ABD) OMB 20mg PFS Abdomen OMB 20mg AI (THI) OMB 20mg PFS (THI)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/128 (0.00%)   0/130 (0.00%)   0/13 (0.00%)   0/13 (0.00%) 
Hide Serious Adverse Events
OMB 20mg AI (ABD) OMB 20mg PFS Abdomen OMB 20mg AI (THI) OMB 20mg PFS (THI)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/128 (1.56%)   4/130 (3.08%)   0/13 (0.00%)   0/13 (0.00%) 
Ear and labyrinth disorders         
Vertigo  1  0/128 (0.00%)  1/130 (0.77%)  0/13 (0.00%)  0/13 (0.00%) 
Gastrointestinal disorders         
Gastrointestinal motility disorder  1  1/128 (0.78%)  0/130 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
Infections and infestations         
Appendicitis  1  0/128 (0.00%)  1/130 (0.77%)  0/13 (0.00%)  0/13 (0.00%) 
Pneumonia  1  0/128 (0.00%)  1/130 (0.77%)  0/13 (0.00%)  0/13 (0.00%) 
Injury, poisoning and procedural complications         
Burns second degree  1  1/128 (0.78%)  0/130 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
Reproductive system and breast disorders         
Menometrorrhagia  1  0/128 (0.00%)  1/130 (0.77%)  0/13 (0.00%)  0/13 (0.00%) 
1
Term from vocabulary, MedDRA (23.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OMB 20mg AI (ABD) OMB 20mg PFS Abdomen OMB 20mg AI (THI) OMB 20mg PFS (THI)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   61/128 (47.66%)   53/130 (40.77%)   7/13 (53.85%)   7/13 (53.85%) 
Blood and lymphatic system disorders         
Leukopenia  1  3/128 (2.34%)  0/130 (0.00%)  1/13 (7.69%)  0/13 (0.00%) 
Lymphopenia  1  1/128 (0.78%)  2/130 (1.54%)  0/13 (0.00%)  1/13 (7.69%) 
Gastrointestinal disorders         
Diarrhoea  1  6/128 (4.69%)  4/130 (3.08%)  1/13 (7.69%)  0/13 (0.00%) 
Nausea  1  1/128 (0.78%)  0/130 (0.00%)  0/13 (0.00%)  1/13 (7.69%) 
General disorders         
Asthenia  1  2/128 (1.56%)  1/130 (0.77%)  0/13 (0.00%)  1/13 (7.69%) 
Fatigue  1  3/128 (2.34%)  5/130 (3.85%)  1/13 (7.69%)  0/13 (0.00%) 
Injection site pain  1  0/128 (0.00%)  0/130 (0.00%)  0/13 (0.00%)  1/13 (7.69%) 
Injection site reaction  1  11/128 (8.59%)  17/130 (13.08%)  0/13 (0.00%)  1/13 (7.69%) 
Pain  1  1/128 (0.78%)  1/130 (0.77%)  0/13 (0.00%)  1/13 (7.69%) 
Infections and infestations         
Herpes zoster  1  0/128 (0.00%)  0/130 (0.00%)  1/13 (7.69%)  0/13 (0.00%) 
Influenza  1  1/128 (0.78%)  1/130 (0.77%)  0/13 (0.00%)  1/13 (7.69%) 
Nasopharyngitis  1  2/128 (1.56%)  5/130 (3.85%)  0/13 (0.00%)  1/13 (7.69%) 
Oral herpes  1  2/128 (1.56%)  1/130 (0.77%)  1/13 (7.69%)  0/13 (0.00%) 
Rhinitis  1  3/128 (2.34%)  3/130 (2.31%)  0/13 (0.00%)  1/13 (7.69%) 
Sinusitis  1  0/128 (0.00%)  1/130 (0.77%)  0/13 (0.00%)  1/13 (7.69%) 
Upper respiratory tract infection  1  1/128 (0.78%)  2/130 (1.54%)  0/13 (0.00%)  1/13 (7.69%) 
Injury, poisoning and procedural complications         
Injection related reaction  1  41/128 (32.03%)  29/130 (22.31%)  5/13 (38.46%)  6/13 (46.15%) 
Ligament sprain  1  0/128 (0.00%)  0/130 (0.00%)  1/13 (7.69%)  0/13 (0.00%) 
Musculoskeletal and connective tissue disorders         
Muscle contracture  1  0/128 (0.00%)  0/130 (0.00%)  0/13 (0.00%)  1/13 (7.69%) 
Spinal pain  1  0/128 (0.00%)  1/130 (0.77%)  1/13 (7.69%)  0/13 (0.00%) 
Tendonitis  1  2/128 (1.56%)  0/130 (0.00%)  0/13 (0.00%)  1/13 (7.69%) 
Nervous system disorders         
Head discomfort  1  0/128 (0.00%)  0/130 (0.00%)  1/13 (7.69%)  0/13 (0.00%) 
Headache  1  13/128 (10.16%)  7/130 (5.38%)  0/13 (0.00%)  1/13 (7.69%) 
Neuralgia  1  1/128 (0.78%)  0/130 (0.00%)  0/13 (0.00%)  1/13 (7.69%) 
Post herpetic neuralgia  1  0/128 (0.00%)  0/130 (0.00%)  1/13 (7.69%)  0/13 (0.00%) 
Psychiatric disorders         
Sleep disorder  1  2/128 (1.56%)  1/130 (0.77%)  1/13 (7.69%)  0/13 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  1/128 (0.78%)  2/130 (1.54%)  0/13 (0.00%)  1/13 (7.69%) 
Oropharyngeal pain  1  2/128 (1.56%)  1/130 (0.77%)  0/13 (0.00%)  1/13 (7.69%) 
Rhinitis allergic  1  1/128 (0.78%)  0/130 (0.00%)  0/13 (0.00%)  1/13 (7.69%) 
Skin and subcutaneous tissue disorders         
Pruritus  1  0/128 (0.00%)  3/130 (2.31%)  1/13 (7.69%)  0/13 (0.00%) 
1
Term from vocabulary, MedDRA (23.0)
Indicates events were collected by systematic assessment
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: NCT03560739    
Other Study ID Numbers: COMB157G2102
First Submitted: May 15, 2018
First Posted: June 18, 2018
Results First Submitted: September 16, 2020
Results First Posted: October 9, 2020
Last Update Posted: October 8, 2021