Study to Assess the Efficacy and Safety of CJM112 in Patients With Inadequately Controlled Severe Asthma

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ClinicalTrials.gov Identifier: NCT03299686

Recruitment Status : Completed

First Posted : October 3, 2017

Results First Posted : August 6, 2020

Last Update Posted : October 8, 2021

View this study on Beta.ClinicalTrials.gov

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	Asthma
Interventions	Drug: CJM112 Other: Placebo to CJM112
Enrollment	118

Participant Flow

Recruitment Details	Participants were from Argentina (2), Belgium (3), Germany (5), Denmark (4), France (2), Israel (3), Slovakia (2), The United States (7)
Pre-assignment Details	After an initial screening visit, run-in period and baseline assessments, the eligible subjects entered the treatment period and were randomized in a 3:2 ratio to one of the two treatment groups.


Arm/Group Title	CJM112 300 mg	Placebo
Arm/Group Description	Study treatment: 300 mg CJM112 s.c....	Placebo to CJM112: Placebo s.c. inj...
Arm/Group Description	Study treatment: 300 mg CJM112 s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12	Placebo to CJM112: Placebo s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12
Period Title: Treatment Epoch
Started	70	48
PD (Pharmacodynamics) Analysis Set ^[1]	69	48
Completed	59	44
Not Completed	11	4
Reason Not Completed
Subject/Guardian Decision	2	0
Physician Decision	1	0
Adverse Event	8	4
[1] All subjects with available PD data, who received any study drug, and no major protocol deviations
Period Title: Follow-up Epoch
Started	59	44
Completed	59	43
Not Completed	0	1
Reason Not Completed
Subject/Guardian Decision	0	1

Baseline Characteristics

Arm/Group Title		CJM112 300 mg	Placebo	Total
Arm/Group Description		Study treatment: 300 mg CJM112 s.c....	Placebo to CJM112: Placebo s.c. inj...	Total of all reporting groups
Arm/Group Description		Study treatment: 300 mg CJM112 s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12	Placebo to CJM112: Placebo s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12	Total of all reporting groups
Overall Number of Baseline Participants		70	48	118
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	70 participants	48 participants	118 participants
		57.1 (12.79)	55.9 (11.62)	56.6 (12.29)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	70 participants	48 participants	118 participants
	Female	39 55.7%	32 66.7%	71 60.2%
	Male	31 44.3%	16 33.3%	47 39.8%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	70 participants	48 participants	118 participants
	Asian	2 2.9%	0 0.0%	2 1.7%
	Black or African American	6 8.6%	1 2.1%	7 5.9%
	Other	1 1.4%	0 0.0%	1 0.8%
	White	61 87.1%	47 97.9%	108 91.5%

Outcome Measures

1.Primary Outcome


Title	Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Description	The primary efficacy analysis assessed the effect of CJM112 on the abs...
Description	The primary efficacy analysis assessed the effect of CJM112 on the absolute change from baseline in trough FEV1 in Liters compared to placebo on Day 92. Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline measurement was defined as the baseline visit pre-bronchodilator spirometry assessment.
Time Frame	Baseline, Day 92

Outcome Measure Data

Analysis Population Description

The analysis population included the Pharmacodynamics (PD) analysis set with evaluable FEV1 data at both timepoints.


Arm/Group Title	CJM112 300 mg	Placebo
Arm/Group Description:	Study treatment: 300 mg CJM112 s.c....	Placebo to CJM112: Placebo s.c. inj...
Arm/Group Description:	Study treatment: 300 mg CJM112 s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12	Placebo to CJM112: Placebo s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12
Overall Number of Participants Analyzed	53	36
Mean (Standard Deviation) Unit of Measure: Liters
	0.043 (0.031)	0.016 (0.030)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CJM112 300 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.7374
	Comments	Probability CJM112 better than placebo
	Method	Bayesian linear repeated measures model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.027
	Confidence Interval	(2-Sided) 80% -0.029 to 0.082
	Parameter Dispersion	Type: Standard Deviation Value: 0.043
	Estimation Comments	[Not Specified]

Other Statistical Analysis		Lower limit and upper limit represents the Credibility Interval from the Bayesian analysis.

2.Secondary Outcome


Title	Change From Baseline in Forced Expiratory Volume 1 (FEV1) % of Predicted
Description	The secondary efficacy analyses assessed the effect of CJM112 on the a...
Description	The secondary efficacy analyses assessed the effect of CJM112 on the absolute change from baseline in trough FEV1 in % of predicted compared to placebo on Day 92. Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1% of predicted is defined as FEV1% of the patient divided by the average FEV1% in the population for any person of similar age, sex and body composition. Pre-bronchodilator FEV1% of predicted was directly provided as part of the spirometry assessment.
Time Frame	Baseline, Day 92

Outcome Measure Data

Analysis Population Description

The analysis population included the Pharmacodynamics (PD) analysis set with evaluable FEV1 data at both timepoints


Arm/Group Title	CJM112 300 mg	Placebo
Arm/Group Description:	Study treatment: 300 mg CJM112 s.c....	Placebo to CJM112: Placebo s.c. inj...
Arm/Group Description:	Study treatment: 300 mg CJM112 s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12	Placebo to CJM112: Placebo s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12
Overall Number of Participants Analyzed	53	36
Least Squares Mean (Standard Error) Unit of Measure: Percent predicted
	1.064 (0.914)	0.151 (1.105)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CJM112 300 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.263
	Comments	1-sided p-value; p-value smaller than 0.1 is considered as statistically significant
	Method	Mixed Models Analysis
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.913
	Confidence Interval	(2-Sided) 80% -0.939 to 2.766
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.434
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Change From Baseline in Asthma Control Questionnaire 6 (ACQ6) Score
Description	The ACQ-6 is a validated asthma assessment tool that consists of 6 sel...
Description	The ACQ-6 is a validated asthma assessment tool that consists of 6 self-assessment questions. Each item on the ACQ-6 has a possible score ranging from 0 to 6 and the total score is the mean of all responses. The seven-point response scale goes from 0 = 'totally controlled' to 6 = 'severely uncontrolled. Negative change from baseline values indicate improved asthma control.
Time Frame	Baseline, Day 92

Outcome Measure Data

Analysis Population Description

The analysis population included the Pharmacodynamics (PD) analysis set with evaluable ACQ6 data at both timepoints


Arm/Group Title	CJM112 300 mg	Placebo
Arm/Group Description:	Study treatment: 300 mg CJM112 s.c....	Placebo to CJM112: Placebo s.c. inj...
Arm/Group Description:	Study treatment: 300 mg CJM112 s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12	Placebo to CJM112: Placebo s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12
Overall Number of Participants Analyzed	56	41
Least Squares Mean (Standard Error) Unit of Measure: units on scale
	-0.93 (0.09)	-0.71 (0.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CJM112 300 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.061
	Comments	1-sided p-value; p-value smaller than 0.1 is considered as statistically significant
	Method	Mixed Models Analysis
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.22
	Confidence Interval	(2-Sided) 80% -0.41 to -0.04
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.14
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Change From Baseline in Asthma Control Questionnaire 7 (ACQ7) Score
Description	The ACQ-7 measured asthma symptom control and consists of 7 items: 5 o...
Description	The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue medication use and 1 on airway calibre (FEV1 % predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating poor control. The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question was completed by the study investigator using data from the Master Scope spirometer. A negative change from baseline indicates improvement in lung function.
Time Frame	Baseline, Day 92

Outcome Measure Data

Analysis Population Description

The analysis population included the Pharmacodynamics (PD) analysis set with evaluable ACQ7 data at both timepoints


Arm/Group Title	CJM112 300 mg	Placebo
Arm/Group Description:	Study treatment: 300 mg CJM112 s.c....	Placebo to CJM112: Placebo s.c. inj...
Arm/Group Description:	Study treatment: 300 mg CJM112 s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12	Placebo to CJM112: Placebo s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12
Overall Number of Participants Analyzed	53	36
Least Squares Mean (Standard Error) Unit of Measure: units on scale
	-0.83 (0.08)	-0.60 (0.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CJM112 300 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.040
	Comments	1-sided p-value; p-value smaller than 0.1 is considered as statistically significant
	Method	Mixed Models Analysis
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.23
	Confidence Interval	(2-Sided) 80% -0.40 to -0.06
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.13
	Estimation Comments	[Not Specified]

5.Secondary Outcome


Title	Percentage of Patients With at Least 0.5 Decrease in ACQ7 Score
Description	The ACQ-7 measured asthma symptom control and consists of 7 items: 5 o...
Description	The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue medication use and 1 on airway calibre (FEV1 % predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating poor control. The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question was completed by the study investigator using data from the Master Scope spirometer. A negative change from baseline indicates improvement in lung function. An ACQ7 responder is defined as a patient with a decrease in score of greater or equal to 0.5 when compared to baseline.
Time Frame	Baseline, Day 92

Outcome Measure Data

Analysis Population Description

The analysis population included the Pharmacodynamics (PD) analysis set with evaluable ACQ7 data at both timepoints


Arm/Group Title	CJM112 300 mg	Placebo
Arm/Group Description:	Study treatment: 300 mg CJM112 s.c....	Placebo to CJM112: Placebo s.c. inj...
Arm/Group Description:	Study treatment: 300 mg CJM112 s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12	Placebo to CJM112: Placebo s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12
Overall Number of Participants Analyzed	53	36
Measure Type: Count of Participants Unit of Measure: Participants
	38 71.7%	19 52.8%

6.Secondary Outcome


Title	Percentage of Patients With Adverse Events (AEs) Leading to Discontinuation of Study Treatment
Description	Number of patients with at least one adverse event leading to disconti...
Description	Number of patients with at least one adverse event leading to discontinuation of study treatment
Time Frame	85 days

Outcome Measure Data

Analysis Population Description

Safety analysis set: Subjects who received any study drug


Arm/Group Title	CJM112 300 mg	Placebo
Arm/Group Description:	Study treatment: 300 mg CJM112 s.c....	Placebo to CJM112: Placebo s.c. inj...
Arm/Group Description:	Study treatment: 300 mg CJM112 s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12	Placebo to CJM112: Placebo s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12
Overall Number of Participants Analyzed	70	48
Measure Type: Count of Participants Unit of Measure: Participants
	8 11.4%	4 8.3%

Adverse Events

Time Frame	Adverse events were collected from first dose of study treatment until end of study treatment plus 91 days post treatment, up to maximum duration of 6 months
Adverse Event Reporting Description	Any sign or symptom that occurs during the study treatment plus the 91 days post treatment

Arm/Group Title	CJM112 300 mg	Placebo
Arm/Group Description	Study treatment: 300 mg CJM112 s.c....	Placebo to CJM112: Placebo s.c. inj...
Arm/Group Description	Study treatment: 300 mg CJM112 s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12	Placebo to CJM112: Placebo s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12
All-Cause Mortality
	CJM112 300 mg	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/70 (0.00%)	0/48 (0.00%)
Serious Adverse Events Serious Adverse Events
	CJM112 300 mg	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/70 (4.29%)	2/48 (4.17%)
Cardiac disorders
Stress cardiomyopathy ^† 1	0/70 (0.00%)	1/48 (2.08%)
General disorders
Asthenia ^† 1	1/70 (1.43%)	0/48 (0.00%)
Infections and infestations
Pneumonia ^† 1	0/70 (0.00%)	1/48 (2.08%)
Urinary tract infection ^† 1	1/70 (1.43%)	0/48 (0.00%)
Psychiatric disorders
Depression ^† 1	1/70 (1.43%)	0/48 (0.00%)
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis ^† 1	1/70 (1.43%)	0/48 (0.00%)
1 Term from vocabulary, MedDRA (22.0) † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	2%
	CJM112 300 mg	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	55/70 (78.57%)	38/48 (79.17%)
Cardiac disorders
Arrhythmia supraventricular ^† 1	0/70 (0.00%)	1/48 (2.08%)
Endocrine disorders
Hypothyroidism ^† 1	0/70 (0.00%)	1/48 (2.08%)
Gastrointestinal disorders
Abdominal pain ^† 1	0/70 (0.00%)	1/48 (2.08%)
Constipation ^† 1	0/70 (0.00%)	1/48 (2.08%)
Diarrhoea ^† 1	3/70 (4.29%)	3/48 (6.25%)
Gastrooesophageal reflux disease ^† 1	2/70 (2.86%)	1/48 (2.08%)
Nausea ^† 1	3/70 (4.29%)	2/48 (4.17%)
Proctalgia ^† 1	0/70 (0.00%)	1/48 (2.08%)
Toothache ^† 1	1/70 (1.43%)	1/48 (2.08%)
Vomiting ^† 1	0/70 (0.00%)	2/48 (4.17%)
General disorders
Asthenia ^† 1	0/70 (0.00%)	1/48 (2.08%)
Fatigue ^† 1	4/70 (5.71%)	3/48 (6.25%)
Injection site haematoma ^† 1	1/70 (1.43%)	1/48 (2.08%)
Oedema peripheral ^† 1	1/70 (1.43%)	1/48 (2.08%)
Pyrexia ^† 1	1/70 (1.43%)	1/48 (2.08%)
Infections and infestations
Bronchitis ^† 1	5/70 (7.14%)	3/48 (6.25%)
Conjunctivitis ^† 1	0/70 (0.00%)	1/48 (2.08%)
Cystitis ^† 1	2/70 (2.86%)	1/48 (2.08%)
Gastroenteritis ^† 1	2/70 (2.86%)	1/48 (2.08%)
Gastroenteritis viral ^† 1	0/70 (0.00%)	1/48 (2.08%)
Lower respiratory tract infection ^† 1	2/70 (2.86%)	0/48 (0.00%)
Nasopharyngitis ^† 1	16/70 (22.86%)	6/48 (12.50%)
Oral candidiasis ^† 1	4/70 (5.71%)	0/48 (0.00%)
Oral herpes ^† 1	0/70 (0.00%)	1/48 (2.08%)
Pharyngitis ^† 1	1/70 (1.43%)	2/48 (4.17%)
Respiratory tract infection ^† 1	2/70 (2.86%)	1/48 (2.08%)
Respiratory tract infection viral ^† 1	2/70 (2.86%)	1/48 (2.08%)
Rhinitis ^† 1	0/70 (0.00%)	1/48 (2.08%)
Sinusitis ^† 1	3/70 (4.29%)	0/48 (0.00%)
Tooth abscess ^† 1	0/70 (0.00%)	1/48 (2.08%)
Upper respiratory tract infection ^† 1	4/70 (5.71%)	2/48 (4.17%)
Urinary tract infection ^† 1	1/70 (1.43%)	2/48 (4.17%)
Viral upper respiratory tract infection ^† 1	2/70 (2.86%)	1/48 (2.08%)
Injury, poisoning and procedural complications
Arthropod sting ^† 1	0/70 (0.00%)	1/48 (2.08%)
Fall ^† 1	0/70 (0.00%)	1/48 (2.08%)
Ligament sprain ^† 1	0/70 (0.00%)	1/48 (2.08%)
Rib fracture ^† 1	0/70 (0.00%)	1/48 (2.08%)
Spinal compression fracture ^† 1	0/70 (0.00%)	1/48 (2.08%)
Subcutaneous haematoma ^† 1	0/70 (0.00%)	1/48 (2.08%)
Investigations
Alanine aminotransferase increased ^† 1	0/70 (0.00%)	2/48 (4.17%)
Amylase increased ^† 1	0/70 (0.00%)	1/48 (2.08%)
Aspartate aminotransferase increased ^† 1	0/70 (0.00%)	1/48 (2.08%)
Blood alkaline phosphatase increased ^† 1	0/70 (0.00%)	1/48 (2.08%)
Blood bicarbonate decreased ^† 1	0/70 (0.00%)	1/48 (2.08%)
Blood cholesterol increased ^† 1	1/70 (1.43%)	1/48 (2.08%)
Blood creatine phosphokinase increased ^† 1	1/70 (1.43%)	1/48 (2.08%)
Blood creatinine increased ^† 1	1/70 (1.43%)	1/48 (2.08%)
Blood lactate dehydrogenase increased ^† 1	1/70 (1.43%)	1/48 (2.08%)
Blood potassium increased ^† 1	0/70 (0.00%)	1/48 (2.08%)
Blood triglycerides increased ^† 1	0/70 (0.00%)	1/48 (2.08%)
Gamma-glutamyltransferase increased ^† 1	0/70 (0.00%)	1/48 (2.08%)
Lipase increased ^† 1	0/70 (0.00%)	1/48 (2.08%)
Protein urine present ^† 1	0/70 (0.00%)	1/48 (2.08%)
Red blood cell sedimentation rate increased ^† 1	0/70 (0.00%)	1/48 (2.08%)
Metabolism and nutrition disorders
Gout ^† 1	0/70 (0.00%)	1/48 (2.08%)
Type 2 diabetes mellitus ^† 1	0/70 (0.00%)	1/48 (2.08%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	3/70 (4.29%)	1/48 (2.08%)
Back pain ^† 1	3/70 (4.29%)	5/48 (10.42%)
Intervertebral disc protrusion ^† 1	0/70 (0.00%)	1/48 (2.08%)
Limb discomfort ^† 1	2/70 (2.86%)	0/48 (0.00%)
Musculoskeletal pain ^† 1	0/70 (0.00%)	1/48 (2.08%)
Musculoskeletal stiffness ^† 1	0/70 (0.00%)	1/48 (2.08%)
Osteoarthritis ^† 1	0/70 (0.00%)	2/48 (4.17%)
Pain in extremity ^† 1	2/70 (2.86%)	0/48 (0.00%)
Nervous system disorders
Dizziness ^† 1	4/70 (5.71%)	0/48 (0.00%)
Headache ^† 1	8/70 (11.43%)	6/48 (12.50%)
Intercostal neuralgia ^† 1	0/70 (0.00%)	1/48 (2.08%)
Migraine ^† 1	2/70 (2.86%)	0/48 (0.00%)
Sciatica ^† 1	0/70 (0.00%)	1/48 (2.08%)
Psychiatric disorders
Insomnia ^† 1	0/70 (0.00%)	1/48 (2.08%)
Reproductive system and breast disorders
Prostatitis ^† 1	0/70 (0.00%)	1/48 (2.08%)
Respiratory, thoracic and mediastinal disorders
Asthma ^† 1	16/70 (22.86%)	13/48 (27.08%)
Cough ^† 1	4/70 (5.71%)	4/48 (8.33%)
Dysphonia ^† 1	2/70 (2.86%)	0/48 (0.00%)
Dyspnoea ^† 1	2/70 (2.86%)	0/48 (0.00%)
Epistaxis ^† 1	0/70 (0.00%)	1/48 (2.08%)
Haemoptysis ^† 1	0/70 (0.00%)	1/48 (2.08%)
Nasal congestion ^† 1	0/70 (0.00%)	1/48 (2.08%)
Oropharyngeal pain ^† 1	3/70 (4.29%)	3/48 (6.25%)
Skin and subcutaneous tissue disorders
Rash ^† 1	1/70 (1.43%)	3/48 (6.25%)
1 Term from vocabulary, MedDRA (22.0) † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

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:	NCT03299686
Other Study ID Numbers:	CCJM112X2204
First Submitted:	August 7, 2017
First Posted:	October 3, 2017
Results First Submitted:	July 3, 2020
Results First Posted:	August 6, 2020
Last Update Posted:	October 8, 2021

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