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Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis (TANDEM)

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: NCT03517540
Recruitment Status : Completed
First Posted : May 7, 2018
Results First Posted : November 12, 2021
Last Update Posted : April 29, 2022
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Non-alcoholic Steatohepatitis (NASH)
Interventions Drug: Tropifexor (LJN452)
Drug: Cenicriviroc (CVC)
Enrollment 193
Recruitment Details 193 participants enrolled at 65 sites in 17 countries
Pre-assignment Details 450 of 643 subjects discontinued during screening phase
Arm/Group Title Arm A: Tropifexor (LJN452) - Dose 1 Arm B: Cenicriviroc (CVC) Arm C: Tropifexor (LJN452) Dose 1 + CVC Arm D: Tropifexor Dose 2 + CVC
Hide Arm/Group Description tropifexor 140 mg, once daily CVC 150 mg, once daily tropifexor 140 mg + CVC 150 mg, once daily tropifexor 90 mg + CVC 150 mg, once daily
Period Title: Overall Study
Started 50 48 47 48
Completed 36 41 38 43
Not Completed 14 7 9 5
Reason Not Completed
Protocol Violation             2             0             0             1
Adverse Event             9             3             8             1
Withdrawal by Subject             3             4             1             3
Arm/Group Title Arm A: Tropifexor (LJN452) - Dose 1 Arm B: Cenicriviroc (CVC) Arm C: Tropifexor (LJN452) Dose 1 + CVC Arm D: Tropifexor Dose 2 + CVC Total
Hide Arm/Group Description tropifexor 140 mg, once daily CVC 150 mg, once daily tropifexor 140 mg + CVC 150 mg, once daily tropifexor 90 mg + CVC 150 mg, once daily Total of all reporting groups
Overall Number of Baseline Participants 50 48 47 48 193
Hide Baseline Analysis Population Description
Full analysis set (FAS) - All participants to whom study treatment was assigned (excluding patients who were mis-randomized and did not take investigational drug. Mis-randomized participants were those who were not qualified for randomization but were inadvertently randomized into the study). Following the intent-to-treat (ITT) principle, patients were analyzed according to the treatment they had been assigned to at randomization.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 48 participants 47 participants 48 participants 193 participants
54.8  (13.35) 53.7  (11.79) 54.7  (12.65) 54.9  (12.29) 54.5  (12.52)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 47 participants 48 participants 193 participants
<65
35
  70.0%
39
  81.3%
37
  78.7%
38
  79.2%
149
  77.2%
>=65
15
  30.0%
9
  18.8%
10
  21.3%
10
  20.8%
44
  22.8%
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 47 participants 48 participants 193 participants
Male
20
  40.0%
17
  35.4%
18
  38.3%
25
  52.1%
80
  41.5%
Female
30
  60.0%
31
  64.6%
29
  61.7%
23
  47.9%
113
  58.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 47 participants 48 participants 193 participants
White
41
  82.0%
44
  91.7%
40
  85.1%
43
  89.6%
168
  87.0%
Asian
7
  14.0%
4
   8.3%
5
  10.6%
5
  10.4%
21
  10.9%
Black
1
   2.0%
0
   0.0%
2
   4.3%
0
   0.0%
3
   1.6%
Unknown
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.5%
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description

Occurrence of adverse events and serious adverse events

Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and then up to 66 weeks

Time Frame AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set (SAF) - All patients who received at least one dose of study drug and had at least one post-baseline safety assessment. Of note, the statement that a patient had no AEs also constituted a safety assessment. Patients were analyzed according to the treatment received
Arm/Group Title Arm A: Tropifexor (LJN452) - Dose 1 Arm B: Cenicriviroc (CVC) Arm C: Tropifexor (LJN452) Dose 1 + CVC Arm D: Tropifexor Dose 2 + CVC
Hide Arm/Group Description:
tropifexor 140 mg, once daily
CVC 150 mg, once daily
tropifexor 140 mg + CVC 150 mg, once daily
tropifexor 90 mg + CVC 150 mg, once daily
Overall Number of Participants Analyzed 50 48 47 48
Measure Type: Count of Participants
Unit of Measure: Participants
Number of participants with at least one Adverse Event (AE)
42
  84.0%
41
  85.4%
40
  85.1%
42
  87.5%
Number of participants with at least one Serious Adverse Events (SAEs)
5
  10.0%
3
   6.3%
4
   8.5%
10
  20.8%
Deaths
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Proportion of Participants Who Have at Least a One Point Improvement in Fibrosis
Hide Description Efficacy of tropifexor + CVC in patients with Nonalcoholic steatohepatitis (NASH) with fibrosis stage F2/F3 as assessed by histological improvement after 48 weeks of treatment compared to monotherapies (tropifexor and CVC) compared to baseline biopsy
Time Frame baseline to 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - All participants to whom study treatment was assigned (excluding patients who were mis-randomized and did not take investigational drug. Mis-randomized participants were those who were not qualified for randomization but were inadvertently randomized into the study). Following the intent-to-treat (ITT) principle, patients were analyzed according to the treatment they had been assigned to at randomization.
Arm/Group Title Arm A: Tropifexor (LJN452) - Dose 1 Arm B: Cenicriviroc (CVC) Arm C: Tropifexor (LJN452) Dose 1 + CVC Arm D: Tropifexor Dose 2 + CVC
Hide Arm/Group Description:
tropifexor 140 mg, once daily
CVC 150 mg, once daily
tropifexor 140 mg + CVC 150 mg, once daily
tropifexor 90 mg + CVC 150 mg, once daily
Overall Number of Participants Analyzed 31 38 37 40
Measure Type: Count of Participants
Unit of Measure: Participants
10
  32.3%
12
  31.6%
11
  29.7%
13
  32.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Tropifexor (LJN452) - Dose 1, Arm C: Tropifexor (LJN452) Dose 1 + CVC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.688
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.25 to 2.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm A: Tropifexor (LJN452) - Dose 1, Arm D: Tropifexor Dose 2 + CVC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.985
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.51 to 1.99
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm C: Tropifexor (LJN452) Dose 1 + CVC, Arm D: Tropifexor Dose 2 + CVC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.870
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.3 to 2.84
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Arm B: Cenicriviroc (CVC), Arm D: Tropifexor Dose 2 + CVC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.710
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.41 to 3.61
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Proportion of Participants With Resolution of Steatohepatitis
Hide Description Efficacy of tropifexor + CVC in patients with Nonalcoholic steatohepatitis (NASH) with fibrosis stage F2/F3 as assessed by histological improvement after 48 weeks of treatment compared to monotherapies (tropifexor and CVC) compared to baseline biopsy
Time Frame baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - All participants to whom study treatment was assigned (excluding patients who were mis-randomized and did not take investigational drug. Mis-randomized participants were those who were not qualified for randomization but were inadvertently randomized into the study). Following the intent-to-treat (ITT) principle, patients were analyzed according to the treatment they had been assigned to at randomization.
Arm/Group Title Arm A: Tropifexor (LJN452) - Dose 1 Arm B: Cenicriviroc (CVC) Arm C: Tropifexor (LJN452) Dose 1 + CVC Arm D: Tropifexor Dose 2 + CVC
Hide Arm/Group Description:
tropifexor 140 mg, once daily
CVC 150 mg, once daily
tropifexor 140 mg + CVC 150 mg, once daily
tropifexor 90 mg + CVC 150 mg, once daily
Overall Number of Participants Analyzed 31 38 37 40
Measure Type: Count of Participants
Unit of Measure: Participants
8
  25.8%
8
  21.1%
5
  13.5%
9
  22.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Tropifexor (LJN452) - Dose 1, Arm C: Tropifexor (LJN452) Dose 1 + CVC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.136
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
0.08 to 1.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm A: Tropifexor (LJN452) - Dose 1, Arm D: Tropifexor Dose 2 + CVC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.747
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.24 to 2.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm B: Cenicriviroc (CVC), Arm C: Tropifexor (LJN452) Dose 1 + CVC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.784
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.18 to 3.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Arm B: Cenicriviroc (CVC), Arm D: Tropifexor Dose 2 + CVC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.521
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.45
Confidence Interval (2-Sided) 95%
0.4 to 5.69
Estimation Comments [Not Specified]
Time Frame AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Event Reporting Description Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
 
Arm/Group Title Tropifexor 140mg CVC 150mg Tropifexor 140mcg + CVC 150mg Tropifexor 90 mg + CVC 150 mg
Hide Arm/Group Description Tropifexor 140mg CVC 150mg Tropifexor 140mg + CVC 150mg Tropifexor 90 mg + CVC 150 mg
All-Cause Mortality
Tropifexor 140mg CVC 150mg Tropifexor 140mcg + CVC 150mg Tropifexor 90 mg + CVC 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/48 (0.00%)   0/47 (0.00%)   0/48 (0.00%) 
Hide Serious Adverse Events
Tropifexor 140mg CVC 150mg Tropifexor 140mcg + CVC 150mg Tropifexor 90 mg + CVC 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/50 (10.00%)   3/48 (6.25%)   4/47 (8.51%)   10/48 (20.83%) 
Cardiac disorders         
Coronary artery disease  1  0/50 (0.00%)  1/48 (2.08%)  0/47 (0.00%)  0/48 (0.00%) 
Myocardial infarction  1  0/50 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  1/48 (2.08%) 
Gastrointestinal disorders         
Duodenal ulcer  1  1/50 (2.00%)  0/48 (0.00%)  0/47 (0.00%)  0/48 (0.00%) 
Gastritis  1  1/50 (2.00%)  0/48 (0.00%)  0/47 (0.00%)  0/48 (0.00%) 
Oesophageal ulcer  1  1/50 (2.00%)  0/48 (0.00%)  0/47 (0.00%)  0/48 (0.00%) 
Pancreatitis acute  1  0/50 (0.00%)  1/48 (2.08%)  0/47 (0.00%)  0/48 (0.00%) 
General disorders         
Non-cardiac chest pain  1  1/50 (2.00%)  0/48 (0.00%)  0/47 (0.00%)  0/48 (0.00%) 
Hepatobiliary disorders         
Biliary dyskinesia  1  0/50 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  1/48 (2.08%) 
Gallbladder polyp  1  1/50 (2.00%)  0/48 (0.00%)  0/47 (0.00%)  0/48 (0.00%) 
Infections and infestations         
Appendicitis  1  0/50 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  1/48 (2.08%) 
COVID-19  1  0/50 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  2/48 (4.17%) 
COVID-19 pneumonia  1  1/50 (2.00%)  0/48 (0.00%)  0/47 (0.00%)  0/48 (0.00%) 
Sepsis  1  0/50 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  1/48 (2.08%) 
Injury, poisoning and procedural complications         
Anaesthetic complication  1  0/50 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  1/48 (2.08%) 
Cervical vertebral fracture  1  0/50 (0.00%)  1/48 (2.08%)  0/47 (0.00%)  0/48 (0.00%) 
Road traffic accident  1  0/50 (0.00%)  1/48 (2.08%)  0/47 (0.00%)  0/48 (0.00%) 
Spinal compression fracture  1  0/50 (0.00%)  1/48 (2.08%)  0/47 (0.00%)  0/48 (0.00%) 
Metabolism and nutrition disorders         
Euglycaemic diabetic ketoacidosis  1  0/50 (0.00%)  1/48 (2.08%)  0/47 (0.00%)  0/48 (0.00%) 
Musculoskeletal and connective tissue disorders         
Spondylitis  1  1/50 (2.00%)  0/48 (0.00%)  0/47 (0.00%)  0/48 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Acute lymphocytic leukaemia  1  0/50 (0.00%)  0/48 (0.00%)  1/47 (2.13%)  0/48 (0.00%) 
Colon cancer  1  1/50 (2.00%)  0/48 (0.00%)  0/47 (0.00%)  0/48 (0.00%) 
Nervous system disorders         
Cerebrovascular accident  1  0/50 (0.00%)  0/48 (0.00%)  1/47 (2.13%)  1/48 (2.08%) 
Syncope  1  1/50 (2.00%)  0/48 (0.00%)  0/47 (0.00%)  0/48 (0.00%) 
Psychiatric disorders         
Depression suicidal  1  0/50 (0.00%)  0/48 (0.00%)  1/47 (2.13%)  0/48 (0.00%) 
Reproductive system and breast disorders         
Benign prostatic hyperplasia  1  0/50 (0.00%)  0/48 (0.00%)  1/47 (2.13%)  0/48 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pneumonitis  1  0/50 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  1/48 (2.08%) 
Surgical and medical procedures         
Cataract operation  1  0/50 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  1/48 (2.08%) 
1
Term from vocabulary, MedDRA (23.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tropifexor 140mg CVC 150mg Tropifexor 140mcg + CVC 150mg Tropifexor 90 mg + CVC 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   39/50 (78.00%)   30/48 (62.50%)   33/47 (70.21%)   32/48 (66.67%) 
Eye disorders         
Cataract  1  0/50 (0.00%)  3/48 (6.25%)  0/47 (0.00%)  0/48 (0.00%) 
Gastrointestinal disorders         
Abdominal distension  1  2/50 (4.00%)  3/48 (6.25%)  1/47 (2.13%)  4/48 (8.33%) 
Abdominal pain  1  5/50 (10.00%)  3/48 (6.25%)  5/47 (10.64%)  2/48 (4.17%) 
Abdominal pain upper  1  3/50 (6.00%)  2/48 (4.17%)  5/47 (10.64%)  2/48 (4.17%) 
Constipation  1  5/50 (10.00%)  2/48 (4.17%)  6/47 (12.77%)  3/48 (6.25%) 
Diarrhoea  1  2/50 (4.00%)  7/48 (14.58%)  4/47 (8.51%)  0/48 (0.00%) 
Dyspepsia  1  1/50 (2.00%)  0/48 (0.00%)  3/47 (6.38%)  2/48 (4.17%) 
Flatulence  1  1/50 (2.00%)  1/48 (2.08%)  3/47 (6.38%)  2/48 (4.17%) 
Nausea  1  2/50 (4.00%)  6/48 (12.50%)  7/47 (14.89%)  6/48 (12.50%) 
General disorders         
Asthenia  1  4/50 (8.00%)  2/48 (4.17%)  5/47 (10.64%)  3/48 (6.25%) 
Fatigue  1  7/50 (14.00%)  4/48 (8.33%)  5/47 (10.64%)  4/48 (8.33%) 
Oedema peripheral  1  0/50 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  4/48 (8.33%) 
Infections and infestations         
Bronchitis  1  1/50 (2.00%)  0/48 (0.00%)  3/47 (6.38%)  1/48 (2.08%) 
Ear infection  1  0/50 (0.00%)  0/48 (0.00%)  3/47 (6.38%)  0/48 (0.00%) 
Gastroenteritis  1  1/50 (2.00%)  1/48 (2.08%)  3/47 (6.38%)  3/48 (6.25%) 
Nasopharyngitis  1  2/50 (4.00%)  3/48 (6.25%)  2/47 (4.26%)  2/48 (4.17%) 
Sinusitis  1  2/50 (4.00%)  1/48 (2.08%)  4/47 (8.51%)  3/48 (6.25%) 
Upper respiratory tract infection  1  3/50 (6.00%)  2/48 (4.17%)  5/47 (10.64%)  5/48 (10.42%) 
Urinary tract infection  1  7/50 (14.00%)  3/48 (6.25%)  2/47 (4.26%)  4/48 (8.33%) 
Injury, poisoning and procedural complications         
Ligament sprain  1  2/50 (4.00%)  0/48 (0.00%)  0/47 (0.00%)  3/48 (6.25%) 
Investigations         
Blood alkaline phosphatase increased  1  3/50 (6.00%)  0/48 (0.00%)  1/47 (2.13%)  0/48 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  6/50 (12.00%)  3/48 (6.25%)  6/47 (12.77%)  1/48 (2.08%) 
Back pain  1  1/50 (2.00%)  3/48 (6.25%)  5/47 (10.64%)  4/48 (8.33%) 
Muscle spasms  1  1/50 (2.00%)  2/48 (4.17%)  3/47 (6.38%)  1/48 (2.08%) 
Osteoarthritis  1  1/50 (2.00%)  0/48 (0.00%)  3/47 (6.38%)  0/48 (0.00%) 
Pain in extremity  1  0/50 (0.00%)  3/48 (6.25%)  0/47 (0.00%)  1/48 (2.08%) 
Nervous system disorders         
Dizziness  1  2/50 (4.00%)  3/48 (6.25%)  2/47 (4.26%)  1/48 (2.08%) 
Psychiatric disorders         
Insomnia  1  1/50 (2.00%)  1/48 (2.08%)  3/47 (6.38%)  1/48 (2.08%) 
Skin and subcutaneous tissue disorders         
Pruritus  1  20/50 (40.00%)  10/48 (20.83%)  15/47 (31.91%)  10/48 (20.83%) 
1
Term from vocabulary, MedDRA (23.1)
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: +1 (862) 778-8300
EMail: novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT03517540    
Other Study ID Numbers: CLJC242A2201J
2017-004208-24 ( EudraCT Number )
LJC242A2201J ( Other Identifier: Novartis )
First Submitted: April 9, 2018
First Posted: May 7, 2018
Results First Submitted: October 14, 2021
Results First Posted: November 12, 2021
Last Update Posted: April 29, 2022