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Safety,Tolerability,Pharmacokinetics and Efficacy of CFZ533 in Moderate to Severe Myasthenia Gravis

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: NCT02565576
Recruitment Status : Completed
First Posted : October 1, 2015
Results First Posted : July 25, 2019
Last Update Posted : July 25, 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 Myasthenia Gravis, Generalized
Interventions Drug: Placebo
Drug: CFZ533
Enrollment 44
Recruitment Details A total of 44 patients were randomized to receive either IV CFZ533 or IV placebo, of which 34 patients (77%) completed the study.
Pre-assignment Details Safety analysis set, and Full analysis: 44 patients (22 treated with CFZ533 and 22 with placebo) PK analysis set : 20 patients treated with CFZ533 PD analysis set: 42 patients (20 treated with CFZ533 and 20 with placebo)
Arm/Group Title CFZ533 Placebo
Hide Arm/Group Description CFZ533 10 mg/kg Placebo
Period Title: Overall Study
Started 22 22
Completed 17 17
Not Completed 5 5
Reason Not Completed
abnormal lab value             2             0
subject / guardian decision             1             3
Lost to Follow-up             1             0
Death             0             2
Adverse Event             1             0
Arm/Group Title CFZ533 Placebo Total
Hide Arm/Group Description CFZ533 10 mg/kg Placebo Total of all reporting groups
Overall Number of Baseline Participants 22 22 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 22 participants 44 participants
44.7  (13.54) 43.3  (13.92) 44.0  (13.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
Female
12
  54.5%
16
  72.7%
28
  63.6%
Male
10
  45.5%
6
  27.3%
16
  36.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
caucasian
19
  86.4%
16
  72.7%
35
  79.5%
Asian (Chinese)
3
  13.6%
5
  22.7%
8
  18.2%
other
0
   0.0%
1
   4.5%
1
   2.3%
1.Primary Outcome
Title Mean Change From Baseline in the Quantitative Myastenia Gravis (QMG) Score at Week 25. Posterior Median Was Used as Measure Type.
Hide Description QMG score is an established validated measure of disease severity used in MG trials (Jaretzki et al 2000). The scoring system is based on quantitative testing of sentinel muscle groups by means of a 4 point scale ranging from 0 (no symptoms) to 3 (severe symptoms). The scale measures ocular, bulbar, respiratory, and limb function, grading each finding, and the total score ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits) (Sharshar et al 2000, Bedlack et al 2005).
Time Frame week 25
Hide Outcome Measure Data
Hide Analysis Population Description
pharmacodynamic (PD) analysis set, participants with non-detectable AChR or MuSK autoantibodies were excluded from the PD analysis set.
Arm/Group Title CFZ533 Placebo
Hide Arm/Group Description:
CFZ533 10 mg/kg
Placebo
Overall Number of Participants Analyzed 18 18
Median (90% Confidence Interval)
Unit of Measure: score
-4.07
(-5.67 to -2.47)
-2.93
(-4.53 to -1.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CFZ533, Placebo
Comments Primary analysis was performed on the PD analysis set. Changes from baseline in QMG scores at Week 25 were analyzed using a Bayesian model. The model investigated effects for treatment (CFZ533 or placebo) and baseline QMG score. A difference of 3 points on the mean change in QMG score between CFZ533 and placebo was deemed a clinical meaningful effect.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method bayesian
Comments [Not Specified]
Method of Estimation Estimation Parameter estimate of contrast posterior median
Estimated Value -1.14
Confidence Interval (2-Sided) 90%
-3.41 to 1.14
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Changes From Baseline in the Myasthenia Gravis Composite (MGC) Score. Posterior Median Was Used as Measure Type.
Hide Description

The Myasthenia Gravis Composite (MGC) score is another key efficacy outcome measure, ranging from 0 to 50. It is reliable and demonstrates concurrent and longitudinal construct validity in the MG practice care setting (Burns et al 2010). The MGC scale covers 10 important functional domains most frequently involved in patients with MG. The proportion of bulbar and respiratory items reflect the clinical importance of these domains in the disease, and are appropriately weighted.

The assessment of each of the 10 test items provides immediate insight into the status of that particular functional domain. A decrease in this score shows an improvement.

Time Frame From baseline to week 49
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CFZ533 Placebo
Hide Arm/Group Description:
CFZ533 10 mg/kg
Placebo
Overall Number of Participants Analyzed 18 18
Median (90% Confidence Interval)
Unit of Measure: score
-8.00
(-9.83 to -6.16)
-5.62
(-7.45 to -3.78)
3.Secondary Outcome
Title Proportion of Patients With Improvement or Worsening by ≥ 3 Points in the QMG Score
Hide Description QMG score is an established validated measure of disease severity used in MG trials (Jaretzki et al 2000). The scoring system is based on quantitative testing of sentinel muscle groups by means of a 4 point scale ranging from 0 (no symptoms) to 3 (severe symptoms). The scale measures ocular, bulbar, respiratory, and limb function, grading each finding, and the total score ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits) (Sharshar et al 2000, Bedlack et al 2005).
Time Frame at week 49
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set, participants with measure
Arm/Group Title CFZ533 Placebo
Hide Arm/Group Description:
CFZ533 10 mg/kg
Placebo
Overall Number of Participants Analyzed 18 19
Measure Type: Count of Participants
Unit of Measure: Participants
improvement by ≥ 3 points in the QMG score
10
  55.6%
9
  47.4%
worsening by ≥ 3 points in the QMG score
2
  11.1%
2
  10.5%
4.Secondary Outcome
Title Proportion of Patients Intolerant to Steroid Taper
Hide Description [Not Specified]
Time Frame week 49
Hide Outcome Measure Data
Hide Analysis Population Description
this data was not collected. No analysis could be performed for this outcome measure.
Arm/Group Title CFZ533 Placebo
Hide Arm/Group Description:
CFZ533 10 mg/kg
Placebo
Overall Number of Participants Analyzed 22 22
Measure Type: Count of Participants
Unit of Measure: Participants
NA [1]  NA [1] 
[1]
this data was not collected
5.Secondary Outcome
Title Number of Patients Who Discontinued Due to Inefficacy or Worsening
Hide Description [Not Specified]
Time Frame week 49
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title CFZ533 Placebo
Hide Arm/Group Description:
CFZ533 10 mg/kg
Placebo
Overall Number of Participants Analyzed 22 22
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Mean Change From Baseline in the Myasthenia Gravis-specific Activities of Daily Living Scale (MG-ADL)
Hide Description The MG-ADL is an 8-item survey to assess functional performance of daily activities that are sometimes impaired by MG e.g. talking, breathing, swallowing etc. (Muppidi et al 2011). The higher score on MG-ADL scale (0-24 points) indicates worse functional performance of daily activities.
Time Frame week 25
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set, participants with measure
Arm/Group Title CFZ533 Placebo
Hide Arm/Group Description:
CFZ533 10 mg/kg
Placebo
Overall Number of Participants Analyzed 19 18
Mean (Standard Deviation)
Unit of Measure: score
-2.6  (2.97) -1.1  (3.23)
7.Secondary Outcome
Title Mean Changes From Baseline in the QMG Score at Week 49
Hide Description QMG (quantitative myasthenia gravis) score is an established validated measure of disease severity used in MG trials (Jaretzki et al 2000). The scoring system is based on quantitative testing of sentinel muscle groups by means of a 4 point scale ranging from 0 (no symptoms) to 3 (severe symptoms). The scale measures ocular, bulbar, respiratory, and limb function, grading each finding, and the total score ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits) (Sharshar et al 2000, Bedlack et al 2005). A decrease in the QMG score indicated an improvement. Results given as a change in the score as compared from baseline
Time Frame week 49
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set, participants with measure
Arm/Group Title CFZ533 Placebo
Hide Arm/Group Description:
CFZ533 10 mg/kg
Placebo
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: score on a scale
-2.9  (5.16) -2.6  (4.30)
8.Secondary Outcome
Title Mean Change From Baseline in the Myasthenia Gravis Quality of Life (MG QOL-15)
Hide Description The MG-QOL15 is a 15-item survey, completed by MG patients and it is designed to assess some aspects of quality of life (QoL) related to MG (Burns et al 2011) e.g. assesment of mood, eating, speaking, driving a car etc.. The higher score on MG-QOL15 scale (0-60 points) indicates worse QoL.
Time Frame week 25
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set, participants with measure
Arm/Group Title CFZ533 Placebo
Hide Arm/Group Description:
CFZ533 10 mg/kg
Placebo
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: score
-9.7  (11.0) -6.7  (10.86)
9.Secondary Outcome
Title Free CD40 on B Cells
Hide Description CD40 receptor occupancy by CFZ533 in peripheral blood was assessed by flow cytometry analysis, measuring free or total CD40 receptors on whole blood B cells. Free CD40 on CD19-positive B cells, using PE-conjugated CFZ533 whose binding was prevented by bound, unconjugated CFZ533 (drug bound to CD40 on peripheral blood B cells). The more CD40 was occupied by unlabeled CFZ533, the less binding of labeled CFZ533, manifest as a lower mean fluorescence intensity (MFI) of CD40 on B cells. MFI from free CD40 on B cells was converted into Molecules of Equivalent Soluble Fluorochrome (MESF) using PE-MESF beads.
Time Frame week 1, week 25
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic analysis set, participants with measure
Arm/Group Title CFZ533 Placebo
Hide Arm/Group Description:
CFZ533 10 mg/kg
Placebo
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: MESF
Free CD40 on B cells week 1 predose Number Analyzed 14 participants 17 participants
34242.9  (18455.80) 31025.9  (16138.97)
Free CD40 on B cells week 25 Number Analyzed 8 participants 12 participants
5259.1  (11341.57) 24908.3  (5022.03)
10.Secondary Outcome
Title Total Soluble CD40 (sCD40) in Plasma
Hide Description PD
Time Frame week1, week 25
Hide Outcome Measure Data
Hide Analysis Population Description
pharmacodynamic analysis set, participants with measure
Arm/Group Title CFZ533 Placebo
Hide Arm/Group Description:
CFZ533 10 mg/kg
Placebo
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: ng/ml
week 1 Number Analyzed 20 participants 21 participants
0.1778  (0.13077) 0.1577  (0.17243)
week 25 Number Analyzed 18 participants 19 participants
191.1278  (69.67597) 0.1163  (0.18298)
11.Secondary Outcome
Title Plasma CFZ533 Concentration at Steady State Conditions (Week 17)
Hide Description [Not Specified]
Time Frame week 17
Hide Outcome Measure Data
Hide Analysis Population Description
pharmacokinetic set, participants treated with CFZ533 only, with measure
Arm/Group Title CFZ533
Hide Arm/Group Description:
CFZ533 10 mg/kg
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: micrograms/mL
120  (40.5)
Time Frame up to week 49
Adverse Event Reporting Description AE additional description
 
Arm/Group Title CFZ533 10 mg/kg IV Infusion Placebo IV Infusion
Hide Arm/Group Description CFZ533 10 mg/kg IV infusion Placebo IV infusion
All-Cause Mortality
CFZ533 10 mg/kg IV Infusion Placebo IV Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   2/22 (9.09%) 
Hide Serious Adverse Events
CFZ533 10 mg/kg IV Infusion Placebo IV Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   7/22 (31.82%)   4/22 (18.18%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  1/22 (4.55%)  0/22 (0.00%) 
Cardiac disorders     
Myocardial ischaemia  1  0/22 (0.00%)  1/22 (4.55%) 
Eye disorders     
Glaucoma  1  1/22 (4.55%)  0/22 (0.00%) 
Gastrointestinal disorders     
Abdominal pain upper  1  1/22 (4.55%)  0/22 (0.00%) 
Constipation  1  1/22 (4.55%)  0/22 (0.00%) 
General disorders     
Pyrexia  1  1/22 (4.55%)  0/22 (0.00%) 
Hepatobiliary disorders     
Hepatitis toxic  1  0/22 (0.00%)  1/22 (4.55%) 
Infections and infestations     
Influenza  1  2/22 (9.09%)  0/22 (0.00%) 
Pneumonia  1  1/22 (4.55%)  0/22 (0.00%) 
Nervous system disorders     
Brachial plexopathy  1  0/22 (0.00%)  1/22 (4.55%) 
Myasthenia gravis  1  2/22 (9.09%)  1/22 (4.55%) 
Myasthenia gravis crisis  1  1/22 (4.55%)  0/22 (0.00%) 
Radial nerve palsy  1  0/22 (0.00%)  1/22 (4.55%) 
1
Term from vocabulary, MedDRA (20.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CFZ533 10 mg/kg IV Infusion Placebo IV Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   20/22 (90.91%)   21/22 (95.45%) 
Blood and lymphatic system disorders     
Anaemia  1  0/22 (0.00%)  2/22 (9.09%) 
Iron deficiency anaemia  1  1/22 (4.55%)  0/22 (0.00%) 
Leukocytosis  1  1/22 (4.55%)  0/22 (0.00%) 
Leukopenia  1  2/22 (9.09%)  2/22 (9.09%) 
Lymphocytosis  1  0/22 (0.00%)  1/22 (4.55%) 
Lymphopenia  1  1/22 (4.55%)  2/22 (9.09%) 
Neutropenia  1  1/22 (4.55%)  1/22 (4.55%) 
Neutrophilia  1  1/22 (4.55%)  0/22 (0.00%) 
Cardiac disorders     
Angina pectoris  1  0/22 (0.00%)  1/22 (4.55%) 
Atrial fibrillation  1  1/22 (4.55%)  0/22 (0.00%) 
Palpitations  1  0/22 (0.00%)  1/22 (4.55%) 
Congenital, familial and genetic disorders     
Von Willebrand's disease  1  1/22 (4.55%)  0/22 (0.00%) 
Eye disorders     
Cataract  1  0/22 (0.00%)  1/22 (4.55%) 
Vision blurred  1  1/22 (4.55%)  0/22 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  0/22 (0.00%)  1/22 (4.55%) 
Abdominal pain upper  1  0/22 (0.00%)  1/22 (4.55%) 
Dental caries  1  0/22 (0.00%)  1/22 (4.55%) 
Diarrhoea  1  1/22 (4.55%)  2/22 (9.09%) 
Food poisoning  1  1/22 (4.55%)  0/22 (0.00%) 
Gastroduodenitis  1  1/22 (4.55%)  0/22 (0.00%) 
Gingival bleeding  1  0/22 (0.00%)  1/22 (4.55%) 
Nausea  1  3/22 (13.64%)  2/22 (9.09%) 
Pancreatitis chronic  1  0/22 (0.00%)  1/22 (4.55%) 
General disorders     
Asthenia  1  0/22 (0.00%)  2/22 (9.09%) 
Chills  1  0/22 (0.00%)  1/22 (4.55%) 
Discomfort  1  0/22 (0.00%)  1/22 (4.55%) 
Fatigue  1  2/22 (9.09%)  0/22 (0.00%) 
Feeling cold  1  1/22 (4.55%)  0/22 (0.00%) 
Hyperthermia  1  0/22 (0.00%)  1/22 (4.55%) 
Influenza like illness  1  1/22 (4.55%)  0/22 (0.00%) 
Infusion site bruising  1  0/22 (0.00%)  1/22 (4.55%) 
Malaise  1  0/22 (0.00%)  1/22 (4.55%) 
Non-cardiac chest pain  1  1/22 (4.55%)  0/22 (0.00%) 
Pyrexia  1  0/22 (0.00%)  2/22 (9.09%) 
Hepatobiliary disorders     
Hepatitis toxic  1  0/22 (0.00%)  1/22 (4.55%) 
Infections and infestations     
Acute sinusitis  1  0/22 (0.00%)  1/22 (4.55%) 
Bronchitis  1  1/22 (4.55%)  0/22 (0.00%) 
Conjunctivitis  1  0/22 (0.00%)  1/22 (4.55%) 
Cystitis  1  1/22 (4.55%)  2/22 (9.09%) 
Ear infection  1  0/22 (0.00%)  1/22 (4.55%) 
Folliculitis  1  0/22 (0.00%)  1/22 (4.55%) 
Gastrointestinal infection  1  1/22 (4.55%)  0/22 (0.00%) 
Herpes virus infection  1  0/22 (0.00%)  1/22 (4.55%) 
Herpes zoster  1  0/22 (0.00%)  2/22 (9.09%) 
Influenza  1  1/22 (4.55%)  1/22 (4.55%) 
Laryngitis viral  1  1/22 (4.55%)  0/22 (0.00%) 
Nasopharyngitis  1  2/22 (9.09%)  3/22 (13.64%) 
Oral candidiasis  1  1/22 (4.55%)  0/22 (0.00%) 
Oral herpes  1  1/22 (4.55%)  1/22 (4.55%) 
Oropharyngeal candidiasis  1  0/22 (0.00%)  1/22 (4.55%) 
Pneumonia  1  2/22 (9.09%)  1/22 (4.55%) 
Respiratory tract infection  1  1/22 (4.55%)  0/22 (0.00%) 
Respiratory tract infection viral  1  2/22 (9.09%)  2/22 (9.09%) 
Rhinitis  1  1/22 (4.55%)  0/22 (0.00%) 
Skin candida  1  0/22 (0.00%)  1/22 (4.55%) 
Systemic infection  1  1/22 (4.55%)  0/22 (0.00%) 
Tonsillitis  1  0/22 (0.00%)  1/22 (4.55%) 
Tooth infection  1  1/22 (4.55%)  0/22 (0.00%) 
Tracheobronchitis  1  1/22 (4.55%)  0/22 (0.00%) 
Upper respiratory tract infection  1  1/22 (4.55%)  4/22 (18.18%) 
Urinary tract infection  1  1/22 (4.55%)  1/22 (4.55%) 
Viral pharyngitis  1  1/22 (4.55%)  0/22 (0.00%) 
Vulvovaginal candidiasis  1  0/22 (0.00%)  1/22 (4.55%) 
Injury, poisoning and procedural complications     
Ligament rupture  1  0/22 (0.00%)  1/22 (4.55%) 
Muscle strain  1  0/22 (0.00%)  1/22 (4.55%) 
Procedural headache  1  0/22 (0.00%)  1/22 (4.55%) 
Procedural pain  1  0/22 (0.00%)  1/22 (4.55%) 
Investigations     
Activated partial thromboplastin time prolonged  1  1/22 (4.55%)  0/22 (0.00%) 
Activated partial thromboplastin time shortened  1  1/22 (4.55%)  0/22 (0.00%) 
Alanine aminotransferase increased  1  1/22 (4.55%)  0/22 (0.00%) 
Blood bicarbonate decreased  1  0/22 (0.00%)  1/22 (4.55%) 
Blood creatine phosphokinase increased  1  0/22 (0.00%)  1/22 (4.55%) 
Blood creatinine increased  1  0/22 (0.00%)  1/22 (4.55%) 
Blood lactate dehydrogenase increased  1  0/22 (0.00%)  1/22 (4.55%) 
Blood pressure increased  1  0/22 (0.00%)  1/22 (4.55%) 
C-reactive protein increased  1  1/22 (4.55%)  0/22 (0.00%) 
Free haemoglobin present  1  2/22 (9.09%)  2/22 (9.09%) 
Gamma-glutamyltransferase increased  1  1/22 (4.55%)  0/22 (0.00%) 
Prothrombin time prolonged  1  1/22 (4.55%)  0/22 (0.00%) 
Weight decreased  1  1/22 (4.55%)  0/22 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/22 (4.55%)  0/22 (0.00%) 
Dyslipidaemia  1  1/22 (4.55%)  0/22 (0.00%) 
Hypercholesterolaemia  1  1/22 (4.55%)  0/22 (0.00%) 
Hypoglycaemia  1  0/22 (0.00%)  1/22 (4.55%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/22 (4.55%)  1/22 (4.55%) 
Arthritis reactive  1  1/22 (4.55%)  0/22 (0.00%) 
Joint swelling  1  0/22 (0.00%)  1/22 (4.55%) 
Muscle spasms  1  0/22 (0.00%)  2/22 (9.09%) 
Muscular weakness  1  2/22 (9.09%)  1/22 (4.55%) 
Musculoskeletal pain  1  0/22 (0.00%)  1/22 (4.55%) 
Myalgia  1  1/22 (4.55%)  0/22 (0.00%) 
Neck pain  1  1/22 (4.55%)  0/22 (0.00%) 
Osteochondrosis  1  0/22 (0.00%)  1/22 (4.55%) 
Tendonitis  1  1/22 (4.55%)  0/22 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Skin papilloma  1  0/22 (0.00%)  1/22 (4.55%) 
Nervous system disorders     
Dementia Alzheimer's type  1  1/22 (4.55%)  0/22 (0.00%) 
Dizziness  1  2/22 (9.09%)  2/22 (9.09%) 
Headache  1  4/22 (18.18%)  3/22 (13.64%) 
Migraine  1  1/22 (4.55%)  0/22 (0.00%) 
Myasthenia gravis  1  2/22 (9.09%)  1/22 (4.55%) 
Nerve compression  1  0/22 (0.00%)  1/22 (4.55%) 
Neuralgia  1  1/22 (4.55%)  0/22 (0.00%) 
Paraesthesia  1  1/22 (4.55%)  0/22 (0.00%) 
Post herpetic neuralgia  1  0/22 (0.00%)  1/22 (4.55%) 
Psychiatric disorders     
Depressed mood  1  1/22 (4.55%)  0/22 (0.00%) 
Nervousness  1  1/22 (4.55%)  0/22 (0.00%) 
Panic attack  1  0/22 (0.00%)  1/22 (4.55%) 
Sleep disorder  1  1/22 (4.55%)  0/22 (0.00%) 
Renal and urinary disorders     
Calculus urinary  1  1/22 (4.55%)  0/22 (0.00%) 
Haematuria  1  1/22 (4.55%)  0/22 (0.00%) 
Reproductive system and breast disorders     
Balanoposthitis  1  0/22 (0.00%)  1/22 (4.55%) 
Breast pain  1  0/22 (0.00%)  1/22 (4.55%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/22 (4.55%)  0/22 (0.00%) 
Cough  1  1/22 (4.55%)  0/22 (0.00%) 
Laryngeal inflammation  1  0/22 (0.00%)  1/22 (4.55%) 
Nasal congestion  1  0/22 (0.00%)  1/22 (4.55%) 
Sinus disorder  1  1/22 (4.55%)  0/22 (0.00%) 
Skin and subcutaneous tissue disorders     
Acne  1  0/22 (0.00%)  1/22 (4.55%) 
Dermatitis allergic  1  1/22 (4.55%)  0/22 (0.00%) 
Erythema  1  1/22 (4.55%)  0/22 (0.00%) 
Hyperhidrosis  1  0/22 (0.00%)  1/22 (4.55%) 
Pruritus  1  1/22 (4.55%)  0/22 (0.00%) 
Rash  1  0/22 (0.00%)  1/22 (4.55%) 
Swelling face  1  1/22 (4.55%)  0/22 (0.00%) 
1
Term from vocabulary, MedDRA (20.1)
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: NCT02565576    
Other Study ID Numbers: CCFZ533X2204
First Submitted: June 23, 2015
First Posted: October 1, 2015
Results First Submitted: December 12, 2018
Results First Posted: July 25, 2019
Last Update Posted: July 25, 2019