Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03034967
Previous Study | Return to List | Next Study

Danirixin Dose Ranging Study in Participants With Chronic Obstructive Pulmonary Disease (COPD)

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: NCT03034967
Recruitment Status : Completed
First Posted : January 27, 2017
Results First Posted : November 29, 2019
Last Update Posted : October 28, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pulmonary Disease, Chronic Obstructive
Interventions Drug: Danirixin
Drug: Danirixin matching placebo
Drug: Standard of care
Drug: Rescue medication
Enrollment 614
Recruitment Details This study investigated the dose response and safety of danirixin compared with placebo in Chronic Obstructive Pulmonary Disease (COPD) participants with respiratory symptoms including cough, increased sputum production and dyspnoea.
Pre-assignment Details A total of 614 participants were randomized in this study across 9 countries.
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks. Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks. Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks. Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks. Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks. Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Period Title: Overall Study
Started 102 102 103 103 102 102
Completed 88 97 90 92 88 87
Not Completed 14 5 13 11 14 15
Reason Not Completed
Withdrawal by Subject             9             2             6             6             9             2
Physician Decision             1             0             1             1             1             0
Lost to Follow-up             0             0             0             1             0             2
Liver function test abnormality             0             0             1             0             0             0
Protocol Violation             1             0             0             0             0             2
Lack of Efficacy             0             1             2             1             1             0
Adverse Event, non-fatal             3             1             2             0             2             8
Adverse Event, Serious Fatal             0             1             1             2             1             1
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg Total
Hide Arm/Group Description Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks. Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks. Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks. Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks. Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks. Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 102 102 103 103 102 102 614
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 102 participants 103 participants 103 participants 102 participants 102 participants 614 participants
66.2  (7.31) 66.3  (6.79) 65.7  (7.48) 66.3  (7.28) 65.1  (7.58) 65.7  (6.98) 65.9  (7.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 102 participants 103 participants 103 participants 102 participants 102 participants 614 participants
Female
29
  28.4%
36
  35.3%
32
  31.1%
38
  36.9%
35
  34.3%
32
  31.4%
202
  32.9%
Male
73
  71.6%
66
  64.7%
71
  68.9%
65
  63.1%
67
  65.7%
70
  68.6%
412
  67.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 102 participants 103 participants 103 participants 102 participants 102 participants 614 participants
Asian - East Asian Heritage
10
   9.8%
6
   5.9%
18
  17.5%
17
  16.5%
10
   9.8%
17
  16.7%
78
  12.7%
Asian - South East Asian Heritage
1
   1.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.2%
Black or African American
2
   2.0%
2
   2.0%
1
   1.0%
0
   0.0%
0
   0.0%
1
   1.0%
6
   1.0%
Native Hawaiian or other Pacific Islander
1
   1.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.2%
White - Arabic/North African Heritage
1
   1.0%
1
   1.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.3%
White - White/Caucasian/European Heritage
87
  85.3%
93
  91.2%
84
  81.6%
86
  83.5%
92
  90.2%
84
  82.4%
526
  85.7%
1.Primary Outcome
Title Change From Baseline in Respiratory Symptoms Measured by Evaluating Respiratory Symptoms (E-RS) in COPD. E-RS: COPD Total Score
Hide Description E-RS: COPD is a subset of Exacerbations of Chronic pulmonary Disease Tool (EXACT). E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: respiratory symptoms (RS)-breathlessness (RS-BRL comprised of 5 items, score range [0-17]), RS-cough and sputum (RS-CSP comprised of 3 items, score range [0-11]), and RS-chest symptoms (RS-CSY comprised of 3 items, score range [0-12]). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Per protocol population included all participants from the mITT population who did not have a protocol deviation considered to impact efficacy. Posterior mean change and standard deviation has been presented.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Only those participants with data available at the specified data points was analyzed.
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 86 95 87 91 85 86
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-2.11  (0.345) -1.93  (0.289) -1.47  (0.349) -0.87  (0.286) -0.76  (0.259) -0.71  (0.281)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 5 mg
Comments 4-parameter Emax model selected.
Type of Statistical Test Other
Comments Emax
Method of Estimation Estimation Parameter Median Posterior Difference
Estimated Value 0.08
Confidence Interval (2-Sided) 90%
0.00 to 0.66
Estimation Comments Median posterior difference, 90 percent (%) credible interval for Placebo and Danirixin 5 mg has been presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 10 mg
Comments 4-parameter Emax model
Type of Statistical Test Other
Comments Emax
Method of Estimation Estimation Parameter Median Posterior Difference
Estimated Value 0.61
Confidence Interval (2-Sided) 90%
0.00 to 1.52
Estimation Comments Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 25 mg
Comments 4-parameter Emax model selected.
Type of Statistical Test Other
Comments Emax
Method of Estimation Estimation Parameter Median Posterior Difference
Estimated Value 1.25
Confidence Interval (2-Sided) 90%
0.43 to 1.97
Estimation Comments Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 35 mg
Comments 4-parameter Emax model selected.
Type of Statistical Test Other
Comments Emax
Method of Estimation Estimation Parameter Median Posterior Difference
Estimated Value 1.34
Confidence Interval (2-Sided) 90%
0.72 to 2.03
Estimation Comments Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 50 mg
Comments 4-parameter Emax model selected.
Type of Statistical Test Other
Comments Emax
Method of Estimation Estimation Parameter Median Posterior Difference
Estimated Value 1.38
Confidence Interval (2-Sided) 90%
0.79 to 2.07
Estimation Comments Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.
2.Primary Outcome
Title Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Breathlessness Score)
Hide Description E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Only those participants with available data at the specified time points were analyzed.
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 86 95 87 91 85 86
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.82  (0.202) -0.69  (0.162) -0.41  (0.183) -0.15  (0.148) -0.10  (0.141) -0.09  (0.158)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 5 mg
Comments 4-parameter Emax model selected.
Type of Statistical Test Other
Comments Emax
Method of Estimation Estimation Parameter Median Posterior Difference
Estimated Value 0.09
Confidence Interval (2-Sided) 90%
0.00 to 0.42
Estimation Comments Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 10 mg
Comments 4-parameter Emax model
Type of Statistical Test Other
Comments Emax
Method of Estimation Estimation Parameter Median Posterior Difference
Estimated Value 0.43
Confidence Interval (2-Sided) 90%
0.00 to 0.87
Estimation Comments Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 25 mg
Comments 4-parameter Emax model selected.
Type of Statistical Test Other
Comments Emax
Method of Estimation Estimation Parameter Median Posterior Difference
Estimated Value 0.68
Confidence Interval (2-Sided) 90%
0.23 to 1.08
Estimation Comments Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 35 mg
Comments 4-parameter Emax model selected.
Type of Statistical Test Other
Comments Emax
Method of Estimation Estimation Parameter Median Posterior Difference
Estimated Value 0.72
Confidence Interval (2-Sided) 90%
0.37 to 1.10
Estimation Comments Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 50 mg
Comments 4-parameter Emax model selected.
Type of Statistical Test Other
Comments Emax
Method of Estimation Estimation Parameter Median Posterior Difference
Estimated Value 0.73
Confidence Interval (2-Sided) 90%
0.40 to 1.12
Estimation Comments Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.
3.Primary Outcome
Title Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Cough and Sputum Score)
Hide Description E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Only those participants with available data at the specified time points were analyzed.
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 86 95 87 91 85 86
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.83  (0.107) -0.79  (0.090) -0.67  (0.109) -0.46  (0.104) -0.40  (0.088) -0.37  (0.098)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 5 mg
Comments 4-parameter Emax model selected.
Type of Statistical Test Other
Comments Emax
Method of Estimation Estimation Parameter Median Posterior Difference
Estimated Value 0.01
Confidence Interval (2-Sided) 90%
0.00 to 0.16
Estimation Comments Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 10 mg
Comments 4-parameter Emax model
Type of Statistical Test Other
Comments Emax
Method of Estimation Estimation Parameter Median Posterior Difference
Estimated Value 0.12
Confidence Interval (2-Sided) 90%
0.00 to 0.43
Estimation Comments Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 25 mg
Comments 4-parameter Emax model selected.
Type of Statistical Test Other
Comments Emax
Method of Estimation Estimation Parameter Median Posterior Difference
Estimated Value 0.38
Confidence Interval (2-Sided) 90%
0.04 to 0.61
Estimation Comments Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 35 mg
Comments 4-parameter Emax model selected.
Type of Statistical Test Other
Comments Emax
Method of Estimation Estimation Parameter Median Posterior Difference
Estimated Value 0.42
Confidence Interval (2-Sided) 90%
0.21 to 0.64
Estimation Comments Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 50 mg
Comments 4-parameter Emax model selected.
Type of Statistical Test Other
Comments Emax
Method of Estimation Estimation Parameter Median Posterior Difference
Estimated Value 0.45
Confidence Interval (2-Sided) 90%
0.26 to 0.66
Estimation Comments Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.
4.Primary Outcome
Title Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Chest Symptoms Score)
Hide Description E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 86 95 87 91 85 86
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.36  (0.148) -0.35  (0.061) -0.34  (0.062) -0.34  (0.069) -0.34  (0.073) -0.34  (0.078)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 5 mg
Comments Log-linear model.
Type of Statistical Test Other
Comments Log-linear
Method of Estimation Estimation Parameter Median Posterior Difference
Estimated Value 0.01
Confidence Interval (2-Sided) 90%
-0.21 to 0.23
Estimation Comments Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 10 mg
Comments Log-linear model
Type of Statistical Test Other
Comments Log-linear
Method of Estimation Estimation Parameter Median Posterior Difference
Estimated Value 0.01
Confidence Interval (2-Sided) 90%
-0.23 to 0.25
Estimation Comments Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 25 mg
Comments Log-linear model
Type of Statistical Test Other
Comments Log-linear
Method of Estimation Estimation Parameter Median Posterior Difference
Estimated Value 0.01
Confidence Interval (2-Sided) 90%
-0.27 to 0.29
Estimation Comments Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 35 mg
Comments Log-linear model
Type of Statistical Test Other
Comments Log-linear
Method of Estimation Estimation Parameter Median Posterior Difference
Estimated Value 0.01
Confidence Interval (2-Sided) 90%
-0.28 to 0.30
Estimation Comments Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 50 mg
Comments Log-linear model
Type of Statistical Test Other
Comments Log-linear
Method of Estimation Estimation Parameter Median Posterior Difference
Estimated Value 0.01
Confidence Interval (2-Sided) 90%
-0.29 to 0.31
Estimation Comments Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.
5.Primary Outcome
Title Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Hide Description AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.
Time Frame Up to Day 196
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT) population. mIIT population comprised of all randomized participants who were randomized apart from those randomized in error, received a treatment randomization number, modified and data for this population were based on actual treatment received.
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 102 102 103 103 102 102
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE
63
  61.8%
63
  61.8%
69
  67.0%
68
  66.0%
63
  61.8%
71
  69.6%
Any SAE
8
   7.8%
7
   6.9%
13
  12.6%
10
   9.7%
7
   6.9%
11
  10.8%
6.Primary Outcome
Title Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI)
Hide Description Blood samples were collected from participants for analysis of following hematology parameters with PCI low and high values: Basophils % (High 5.00x), Eosinophils % (High 2.00x), Mean corpuscular hemoglobin concentration (MCHC) gram per deciliter (g/dL) (Low 0.85x, high 1.10x), Mean corpuscular hemoglobin (MCH) picograms (pg) (Low 0.85x, high 1.20x), Mean corpuscular volume (MCV) femtoliter (fL) (low 0.25x, high 2.00x), Erythrocytes (Ery.)(10^12cells/L) (Low 0.93x, high 1.07x), Hematocrit (Ratio of 1) (Low 0.50x, high 0.50x), Hemoglobin gram per liter (g/L) (Low 0.85x, high 1.20x), Leukocytes (x10^9/L) (Low 0.70x, high 1.60x), Lymphocytes % (Low 0.80x, high 1.20x), Monocytes % (Low 0.80x, high 1.60x), Neutrophils % (Low 0.65x, high 1.50x), Platelets (x10^9cells/L) (Low 0.90x, high 1.10x). Multipliers are identified by "x", otherwise actual comparison values are provided with units. Values above and below this range were considered of PCI.
Time Frame Up to Day 196
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Only those participants with available data at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 102 102 103 103 102 102
Measure Type: Count of Participants
Unit of Measure: Participants
Basophils, No change, n=97, 102, 101, 101, 101, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 101 participants 99 participants
97
 100.0%
102
 100.0%
101
 100.0%
101
 100.0%
101
 100.0%
99
 100.0%
Basophils, High, n=97, 102, 101, 101, 101, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 101 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils,No change,n=97,102,101,101,101,99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 101 participants 99 participants
97
 100.0%
101
  99.0%
101
 100.0%
98
  97.0%
100
  99.0%
98
  99.0%
Eosinophils, High, n=97, 102, 101, 101, 101, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 101 participants 99 participants
0
   0.0%
1
   1.0%
0
   0.0%
3
   3.0%
1
   1.0%
1
   1.0%
Ery. MCHC, Low, n=97, 102, 101, 101, 102, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 102 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ery. MCHC,No change,n=97,102,101,101,102,99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 102 participants 99 participants
97
 100.0%
102
 100.0%
101
 100.0%
101
 100.0%
102
 100.0%
99
 100.0%
Ery. MCHC, High, n=97, 102, 101, 101, 102, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 102 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ery. MCH, Low, n=97, 102, 101, 101, 102, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 102 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.0%
Ery. MCH, No Change, n=97, 102, 101, 101, 102, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 102 participants 99 participants
97
 100.0%
102
 100.0%
101
 100.0%
101
 100.0%
102
 100.0%
98
  99.0%
Ery. MCH, High, n=97, 102, 101, 101, 102, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 102 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ery. MCV, Low, n=97, 102, 101, 101, 102, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 102 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ery. MCV, No Change, n=97, 102, 101, 101, 102, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 102 participants 99 participants
97
 100.0%
102
 100.0%
101
 100.0%
101
 100.0%
102
 100.0%
99
 100.0%
Ery. MCV, High, n=97, 102, 101, 101, 102, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 102 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Erythrocytes, Low, n=97, 102, 101, 101, 102, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 102 participants 99 participants
2
   2.1%
1
   1.0%
3
   3.0%
3
   3.0%
2
   2.0%
2
   2.0%
Erythrocytes, No change,n=97,102,101,101,102,99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 102 participants 99 participants
93
  95.9%
99
  97.1%
97
  96.0%
97
  96.0%
99
  97.1%
97
  98.0%
Erythrocytes. High, n=97, 102, 101, 101, 102, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 102 participants 99 participants
2
   2.1%
2
   2.0%
1
   1.0%
1
   1.0%
1
   1.0%
0
   0.0%
Hematocrit, Low, n=97, 102, 101, 101, 102, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 102 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hematocrit, No Change, n=97,102,101,101,102,99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 102 participants 99 participants
97
 100.0%
102
 100.0%
101
 100.0%
101
 100.0%
102
 100.0%
99
 100.0%
Hematocrit, High, n=97, 102, 101, 101, 102, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 102 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin, Low, n=97, 102, 101, 101, 102, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 102 participants 99 participants
1
   1.0%
1
   1.0%
2
   2.0%
0
   0.0%
2
   2.0%
0
   0.0%
Hemoglobin, No change, n=97,102,101,101,102,99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 102 participants 99 participants
96
  99.0%
101
  99.0%
99
  98.0%
101
 100.0%
100
  98.0%
99
 100.0%
Hemoglobin, High, n=97, 102, 101, 101, 102, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 102 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Leukocytes, Low, n=97, 102, 101, 101, 102, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 102 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.0%
Leukocytes, No change, n=97,102,101,101,102,99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 102 participants 99 participants
97
 100.0%
102
 100.0%
101
 100.0%
101
 100.0%
102
 100.0%
98
  99.0%
Leukocytes, High, n=97, 102, 101, 101, 102, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 102 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes, Low, n=97, 102, 101, 101, 101, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 101 participants 99 participants
3
   3.1%
7
   6.9%
5
   5.0%
8
   7.9%
7
   6.9%
4
   4.0%
Lymphocytes, No change, n=97,102,101,101,101,99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 101 participants 99 participants
94
  96.9%
95
  93.1%
96
  95.0%
92
  91.1%
93
  92.1%
94
  94.9%
Lymphocytes, High, n=97, 102, 101, 101, 101, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 101 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.0%
1
   1.0%
1
   1.0%
Monocytes, No change, n=97, 102, 101, 101, 101, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 101 participants 99 participants
97
 100.0%
101
  99.0%
99
  98.0%
101
 100.0%
100
  99.0%
98
  99.0%
Monocytes, High, n=97, 102, 101, 101, 101, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 101 participants 99 participants
0
   0.0%
1
   1.0%
2
   2.0%
0
   0.0%
1
   1.0%
1
   1.0%
Neutrophils, Low, n=97, 102, 101, 101, 101, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 101 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.0%
3
   3.0%
1
   1.0%
Neutrophils, No change, n=97,102,101,101,101,99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 101 participants 99 participants
97
 100.0%
102
 100.0%
101
 100.0%
100
  99.0%
98
  97.0%
98
  99.0%
Neutrophils, High, n=97, 102, 101, 101, 101, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 101 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets, Low, n=97, 102, 101, 101, 101, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 101 participants 99 participants
0
   0.0%
1
   1.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets, No change, n=97, 102, 101, 101, 101, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 101 participants 99 participants
97
 100.0%
99
  97.1%
100
  99.0%
101
 100.0%
99
  98.0%
99
 100.0%
Platelets, High, n=97, 102, 101, 101, 101, 99 Number Analyzed 97 participants 102 participants 101 participants 101 participants 101 participants 99 participants
0
   0.0%
2
   2.0%
1
   1.0%
0
   0.0%
2
   2.0%
0
   0.0%
7.Primary Outcome
Title Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI
Hide Description Blood samples were collected from participants for analysis of following chemistry parameters with PCI low and high values: Alanine aminotransferase (ALT) International units per liter (IU/L) (High => 3x ULN), Alkaline phosphatase (ALP) (IU/L) (High ≥ 2x ULN); Aspartate aminotransferase (AST) (IU/L) (High=> 3x ULN); Bilirubin micromole per liter (umol/L) (High ≥ 2x ULN); Calcium millimole per liter (mmol/L) (Low 0.85x, high 1.08x), Chloride (mmol/L) (Low 0.90x, high 1.10x), Creatinine (umol/L) (High 1.30x), Direct bilirubin (umol/L) (High ≥ 2x ULN), Glucose (mmol/L) (Low <0.6x, high >4x), Potassium (mmol/L) (Low 0.75x, high 1.30x); Protein (g/L) (High 1.25x), Sodium (mmol/L) (Low 0.80x, high 1.15x), Multipliers are identified by "x", otherwise actual comparison values are provided with units. Values above and below this range were considered of PCI.
Time Frame Up to Day 196
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Only those participants with available data at the specified time points were analyzed (represented by n= X in the category titles)..
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 102 102 103 103 102 102
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, No change,n=99,102,102,102,101,100 Number Analyzed 99 participants 102 participants 102 participants 102 participants 101 participants 100 participants
99
 100.0%
102
 100.0%
101
  99.0%
102
 100.0%
101
 100.0%
100
 100.0%
ALT, High, n=99,102,102,102,101,100 Number Analyzed 99 participants 102 participants 102 participants 102 participants 101 participants 100 participants
0
   0.0%
0
   0.0%
1
   1.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALP, No change,n=99,102,102,102,101,100 Number Analyzed 99 participants 102 participants 102 participants 102 participants 101 participants 100 participants
99
 100.0%
102
 100.0%
102
 100.0%
102
 100.0%
101
 100.0%
100
 100.0%
ALP, High, n=99,102,102,102,101,100 Number Analyzed 99 participants 102 participants 102 participants 102 participants 101 participants 100 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AST, No change,n=99,102,102,102,101,100 Number Analyzed 99 participants 102 participants 102 participants 102 participants 101 participants 100 participants
99
 100.0%
102
 100.0%
101
  99.0%
102
 100.0%
101
 100.0%
100
 100.0%
AST, High, n=99,102,102,102,101,100 Number Analyzed 99 participants 102 participants 102 participants 102 participants 101 participants 100 participants
0
   0.0%
0
   0.0%
1
   1.0%
0
   0.0%
0
   0.0%
0
   0.0%
Bilirubin, No change, n=99,102,102,102,101,100 Number Analyzed 99 participants 102 participants 102 participants 102 participants 101 participants 100 participants
99
 100.0%
101
  99.0%
102
 100.0%
102
 100.0%
101
 100.0%
100
 100.0%
Bilirubin, High, n=99, 102,102,102,101,100 Number Analyzed 99 participants 102 participants 102 participants 102 participants 101 participants 100 participants
0
   0.0%
1
   1.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Calcium, Low, n=96,102,101,101,101,99 Number Analyzed 96 participants 102 participants 101 participants 101 participants 101 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Calcium, No change, n=96,102,101,101,101,99 Number Analyzed 96 participants 102 participants 101 participants 101 participants 101 participants 99 participants
96
 100.0%
102
 100.0%
101
 100.0%
101
 100.0%
101
 100.0%
99
 100.0%
Calcium, High, n=96,102,101,101,101,99 Number Analyzed 96 participants 102 participants 101 participants 101 participants 101 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
CO2, Low, n=96,102,101,101,101,99 Number Analyzed 96 participants 102 participants 101 participants 101 participants 101 participants 99 participants
1
   1.0%
0
   0.0%
2
   2.0%
1
   1.0%
0
   0.0%
1
   1.0%
CO2, No change, n=96,102,101,101,101,99 Number Analyzed 96 participants 102 participants 101 participants 101 participants 101 participants 99 participants
94
  97.9%
102
 100.0%
99
  98.0%
99
  98.0%
101
 100.0%
98
  99.0%
CO2, High, n=96,102,101,101,101,99 Number Analyzed 96 participants 102 participants 101 participants 101 participants 101 participants 99 participants
1
   1.0%
0
   0.0%
0
   0.0%
1
   1.0%
0
   0.0%
0
   0.0%
Chloride, Low, n=96,102,101,101,101,99 Number Analyzed 96 participants 102 participants 101 participants 101 participants 101 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Chloride, No change, n=96,102,101,101,101,99 Number Analyzed 96 participants 102 participants 101 participants 101 participants 101 participants 99 participants
96
 100.0%
102
 100.0%
101
 100.0%
101
 100.0%
101
 100.0%
99
 100.0%
Chloride, High, n=96,102,101,101,101,99 Number Analyzed 96 participants 102 participants 101 participants 101 participants 101 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine, No change, n=96,102,101,101,101,99 Number Analyzed 96 participants 102 participants 101 participants 101 participants 101 participants 99 participants
94
  97.9%
100
  98.0%
99
  98.0%
99
  98.0%
99
  98.0%
99
 100.0%
Creatinine, High, n=96, 102, 101, 101, 101, 99 Number Analyzed 96 participants 102 participants 101 participants 101 participants 101 participants 99 participants
2
   2.1%
2
   2.0%
2
   2.0%
2
   2.0%
2
   2.0%
0
   0.0%
Direct bilirubin,NoChange,n=99,102,102,102,101,100 Number Analyzed 99 participants 102 participants 102 participants 102 participants 101 participants 100 participants
98
  99.0%
102
 100.0%
102
 100.0%
102
 100.0%
101
 100.0%
100
 100.0%
Direct bilirubin,High,n=99,102,102,102,101,100 Number Analyzed 99 participants 102 participants 102 participants 102 participants 101 participants 100 participants
1
   1.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Glucose, Low, n=96, 102, 101, 101, 101, 99 Number Analyzed 96 participants 102 participants 101 participants 101 participants 101 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Glucose, No change, n=96, 102, 101, 101, 101, 99 Number Analyzed 96 participants 102 participants 101 participants 101 participants 101 participants 99 participants
96
 100.0%
102
 100.0%
101
 100.0%
101
 100.0%
101
 100.0%
99
 100.0%
Glucose, High, n=96, 102, 101, 101, 101, 99 Number Analyzed 96 participants 102 participants 101 participants 101 participants 101 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potassium, Low, n=96, 102, 101, 101, 101, 99 Number Analyzed 96 participants 102 participants 101 participants 101 participants 101 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potassium, No change, n=96, 102, 101, 101, 101, 99 Number Analyzed 96 participants 102 participants 101 participants 101 participants 101 participants 99 participants
96
 100.0%
102
 100.0%
101
 100.0%
101
 100.0%
101
 100.0%
99
 100.0%
Potassium, High, n=96, 102, 101, 101, 101, 99 Number Analyzed 96 participants 102 participants 101 participants 101 participants 101 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Protein, No change, n=99, 102, 102, 102, 101, 100 Number Analyzed 99 participants 102 participants 102 participants 102 participants 101 participants 100 participants
99
 100.0%
102
 100.0%
102
 100.0%
102
 100.0%
101
 100.0%
100
 100.0%
Protein, High, n=99, 102, 102, 102, 101, 100 Number Analyzed 99 participants 102 participants 102 participants 102 participants 101 participants 100 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sodium, Low, n=96, 102, 101, 101, 101, 99 Number Analyzed 96 participants 102 participants 101 participants 101 participants 101 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sodium, No change, n=96, 102, 101, 101, 101, 99 Number Analyzed 96 participants 102 participants 101 participants 101 participants 101 participants 99 participants
96
 100.0%
102
 100.0%
101
 100.0%
101
 100.0%
101
 100.0%
99
 100.0%
Sodium, High, n=96, 102, 101, 101, 101, 99 Number Analyzed 96 participants 102 participants 101 participants 101 participants 101 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Urea, Low, n=96, 102, 101, 101, 101, 99 Number Analyzed 96 participants 102 participants 101 participants 101 participants 101 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Urea, No change, n=96, 102, 101, 101, 101, 99 Number Analyzed 96 participants 102 participants 101 participants 101 participants 101 participants 99 participants
96
 100.0%
101
  99.0%
101
 100.0%
100
  99.0%
101
 100.0%
98
  99.0%
Urea, High, n=96, 102, 101, 101, 101, 99 Number Analyzed 96 participants 102 participants 101 participants 101 participants 101 participants 99 participants
0
   0.0%
1
   1.0%
0
   0.0%
1
   1.0%
0
   0.0%
1
   1.0%
Bilirubin/ALT,No change,n=99,102,102,102,101,100 Number Analyzed 99 participants 102 participants 102 participants 102 participants 101 participants 100 participants
99
 100.0%
102
 100.0%
102
 100.0%
102
 100.0%
101
 100.0%
100
 100.0%
Bilirubin/ALT, High,n=99,102,102,102,101,100 Number Analyzed 99 participants 102 participants 102 participants 102 participants 101 participants 100 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8.Primary Outcome
Title Number of Participants With Worst Case Vital Signs Parameter Results by PCI
Hide Description Vital signs parameters includes systolic blood pressure (SBP) and diastolic blood pressure (DBP), pulse rate and respiration rate were measured in a semi-supine position after 5 minutes rest for the participants at indicated time points. PCI ranges for vital signs parameters were as follows: <90 to >160 millimeters of mercury (mmHg) for SBP and <40 to >110 mmHg for DBP, <35 or >120 beats per minute for heart rate and <8 or >30 breaths per minute for respiration rate. Values above and below this range were considered of PCI.
Time Frame Up to Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Only those participants with available data at the specified time points were analyzed.
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 96 102 101 101 102 99
Measure Type: Count of Participants
Unit of Measure: Participants
SBP, Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.0%
SBP, No change
93
  96.9%
92
  90.2%
95
  94.1%
98
  97.0%
98
  96.1%
94
  94.9%
SBP, High
3
   3.1%
10
   9.8%
6
   5.9%
3
   3.0%
4
   3.9%
4
   4.0%
DBP, Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
DBP, No change
96
 100.0%
102
 100.0%
101
 100.0%
101
 100.0%
102
 100.0%
99
 100.0%
DBP, High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Pulse rate, Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Pulse rate, No change
96
 100.0%
102
 100.0%
99
  98.0%
100
  99.0%
102
 100.0%
98
  99.0%
Pulse rate, High
0
   0.0%
0
   0.0%
2
   2.0%
1
   1.0%
0
   0.0%
1
   1.0%
Respiratory rate, Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Respiratory rate, No change
96
 100.0%
102
 100.0%
101
 100.0%
101
 100.0%
102
 100.0%
98
  99.0%
Respiratory rate, High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.0%
9.Primary Outcome
Title Number of Participants With Worst Case Post-Baseline Abnormal 12-lead Electrocardiogram (ECG) Findings
Hide Description Triplicate 12-lead ECG obtained to measure PR, QRS, QT, and Corrected QT intervals. Only those participants with worst case post-Baseline data have been represented for abnormal - not clinical significant and abnormal - clinical significant. Day 1 was considered as Baseline.
Time Frame Baseline and Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Only those participants with available data at the specified time points were analyzed.
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 96 102 101 101 102 99
Measure Type: Count of Participants
Unit of Measure: Participants
Not Clinical significant
52
  54.2%
65
  63.7%
68
  67.3%
67
  66.3%
62
  60.8%
53
  53.5%
Clinical significant
2
   2.1%
1
   1.0%
1
   1.0%
0
   0.0%
3
   2.9%
1
   1.0%
10.Secondary Outcome
Title Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant
Hide Description Participants with moderate or severe COPD exacerbations, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness analyzed. Mild exacerbations are defined as exacerbations that did not require treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization, Emergency Room [ER] visit or resulting in death). Moderate exacerbations are defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization, ER visit or resulting in death). Severe exacerbations are defined as exacerbations that required hospitalization, ER visit or resulted in death. Number of moderate or severe HCRU exacerbations per participant has been presented, where 0= participants in each treatment group who did not experience an event; 1= participants in each treatment group who experienced 1 event and >=2= participants in each treatment group who experienced 2 or more events.
Time Frame Up to Day 196
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population.
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 101 102 100 103 100 99
Measure Type: Number
Unit of Measure: Exacerbations per participant
0 66 51 61 63 55 50
1 28 34 23 28 30 36
>=2 7 17 16 12 15 13
11.Secondary Outcome
Title Number of Responders E-RS in COPD (E-RS): COPD Total Score
Hide Description E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. E-RS is intended to capture information related to the respiratory symptoms of COPD, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness. The E-RS has a scoring range of 0-40; higher scores indicate more severe symptoms. Response is defined as an E-RS: COPD total score of 2 units below baseline or lower. Non-response is defined as an E-RS: COPD total score higher than 2 units below Baseline.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the per protocol population without missing covariate information and with at least one post baseline measurement are included in the analysis.
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 86 95 87 91 85 86
Measure Type: Number
Unit of Measure: Participants
33 48 33 30 29 32
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.089
Comments Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.
Method linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.71
Confidence Interval (2-Sided) 90%
1.02 to 2.86
Estimation Comments Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 10 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.881
Comments Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.
Method linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.05
Confidence Interval (2-Sided) 90%
0.62 to 1.79
Estimation Comments Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 25 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.674
Comments Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.
Method linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.87
Confidence Interval (2-Sided) 90%
0.51 to 1.48
Estimation Comments Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 35 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.804
Comments Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.
Method linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.92
Confidence Interval (2-Sided) 90%
0.54 to 1.58
Estimation Comments Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 50 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.987
Comments Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.
Method linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.01
Confidence Interval (2-Sided) 90%
0.59 to 1.71
Estimation Comments Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.
12.Secondary Outcome
Title Number of EXACT Events Per Participant
Hide Description EXACT is a 14 item patient reported outcome (PRO) instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Events were categorized as recovered, censored, or persistent worsening. Number of EXACT events per participant has been presented, where 0= participants in each treatment group who did not experience an event; 1= participants in each treatment group who experienced 1 event and >=2= participants in each treatment group who experienced 2 or more events.
Time Frame Up to Day 196
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population.
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 101 102 100 103 100 99
Measure Type: Number
Unit of Measure: Events
0 92 92 92 92 86 86
1 9 6 7 9 10 10
>=2 0 4 1 2 4 3
13.Secondary Outcome
Title Time to First EXACT Event
Hide Description The time to first on-treatment EXACT event was calculated as the onset date of the first on-treatment EXACT event minus date of start of treatment plus 1.
Time Frame Up to Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population.
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 101 102 100 103 100 99
Measure Type: Number
Unit of Measure: Days
First quartile (Q1) time to event NA [1]  NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
Median time to event NA [2]  NA [2]  NA [2]  NA [2]  NA [2]  NA [2] 
[1]
If <25% of participants experienced the event within a treatment then Q1 time to event are displayed as NA (not applicable) for that treatment.
[2]
If <50% of participants experienced the event within a treatment then median time to event are displayed as NA (not applicable) for that treatment.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Posterior Hazard Ratio
Estimated Value 1.2
Confidence Interval (2-Sided) 90%
0.5 to 2.6
Estimation Comments Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.
Other Statistical Analysis DNX versus (vs.) Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted Forced Expiratory Volume in one second (FEV1)at Screening.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 10 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Posterior Hazard Ratio
Estimated Value 1.0
Confidence Interval (2-Sided) 90%
0.4 to 2.4
Estimation Comments Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.
Other Statistical Analysis DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 25 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Posterior Hazard Ratio
Estimated Value 1.4
Confidence Interval (2-Sided) 90%
0.6 to 3.2
Estimation Comments Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.
Other Statistical Analysis DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 35 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Posterior Hazard Ratio
Estimated Value 2.0
Confidence Interval (2-Sided) 90%
1.0 to 4.3
Estimation Comments Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.
Other Statistical Analysis DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 50 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Posterior Hazard Ratio
Estimated Value 2.0
Confidence Interval (2-Sided) 90%
0.9 to 4.5
Estimation Comments Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.
Other Statistical Analysis DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
14.Secondary Outcome
Title Severity of EXACT Event
Hide Description EXACT is a 14 item PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Severity is the highest EXACT total score during the period from onset to recovery.
Time Frame Up to Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Only those participants with data available at the specified data points were analyzed
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 9 15 9 13 19 16
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
22.1  (6.60) 26.7  (3.71) 22.9  (5.28) 28.6  (5.68) 25.0  (5.54) 26.4  (6.36)
15.Secondary Outcome
Title EXACT Event Duration for All Events
Hide Description EXACT is a 14 item PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Severity is the highest EXACT total score during the period from onset to recovery. Duration of EXACT events has been reported.
Time Frame Up to Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 9 15 9 13 19 16
Mean (Standard Deviation)
Unit of Measure: Days
45.3  (50.37) 11.6  (10.15) 45.8  (51.97) 25.5  (42.11) 17.6  (16.28) 18.7  (37.75)
16.Secondary Outcome
Title Time to First HCRU-defined COPD Exacerbation
Hide Description The time to first on-treatment Moderate/Severe HCRU exacerbation was calculated as exacerbation onset date of first on-treatment moderate or severe on-treatment exacerbation - date of start of treatment +1.
Time Frame Up to Day 196
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population.
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 101 102 100 103 100 99
Measure Type: Number
Unit of Measure: Days
Q1 time to event 110 47 63 79 70 57
Median time to event NA [1]  NA [1]  NA [1]  NA [1]  NA [1]  152
[1]
If <50% of participants experienced the event within a treatment then median time to event are displayed as NA (not applicable) for that treatment.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Bayesian proportional hazards model
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.5
Confidence Interval (2-Sided) 90%
1.0 to 2.2
Estimation Comments Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.
Other Statistical Analysis DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator %predicted FEV1 at Screening.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 10 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Bayesian proportional hazards model
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.1
Confidence Interval (2-Sided) 90%
0.8 to 1.7
Estimation Comments Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.
Other Statistical Analysis DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 25 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Bayesian proportional hazards model
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.1
Confidence Interval (2-Sided) 90%
0.7 to 1.6
Estimation Comments Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.
Other Statistical Analysis DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 35 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Bayesian proportional hazards model
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.4
Confidence Interval (2-Sided) 90%
1.0 to 2.1
Estimation Comments Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.
Other Statistical Analysis DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 50 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Bayesian proportional hazards model
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.6
Confidence Interval (2-Sided) 90%
1.1 to 2.3
Estimation Comments Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.
Other Statistical Analysis DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
17.Secondary Outcome
Title Time to First Severe HCRU-defined COPD Exacerbation
Hide Description A COPD exacerbation defined as a severe exacerbation if it requires hospitalization or ER visit or extended observation. The time to first on-treatment Moderate/Severe HCRU exacerbation was calculated as exacerbation onset date of first on-treatment moderate or severe on-treatment exacerbation - date of start of treatment +1.
Time Frame Up to Day 196
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population.
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 101 102 100 103 100 99
Measure Type: Number
Unit of Measure: Days
Q1 time to event NA [1]  NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
Median time to event NA [2]  NA [2]  NA [2]  NA [2]  NA [2]  NA [2] 
[1]
If <25% of participants experienced the event within a treatment then Q1 time to event are displayed as NA (not applicable) for that treatment.
[2]
If <50% of participants experienced the event within a treatment then median time to event are displayed as NA (not applicable) for that treatment.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Bayesian proportional hazards model
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.8
Confidence Interval (2-Sided) 90%
0.7 to 5.5
Estimation Comments Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.
Other Statistical Analysis DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 10 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Bayesian proportional hazards model
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.9
Confidence Interval (2-Sided) 90%
0.7 to 5.8
Estimation Comments Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.
Other Statistical Analysis DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 25 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Bayesian proportional hazards model
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.8
Confidence Interval (2-Sided) 90%
0.7 to 5.6
Estimation Comments Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.
Other Statistical Analysis DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 35 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Bayesian proportional hazards model
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.3
Confidence Interval (2-Sided) 90%
0.9 to 6.9
Estimation Comments Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.
Other Statistical Analysis DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 50 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Bayesian proportional hazards model
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.8
Confidence Interval (2-Sided) 90%
0.2 to 2.7
Estimation Comments Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.
Other Statistical Analysis DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
18.Secondary Outcome
Title HCRU-defined Exacerbation Duration
Hide Description The duration of HCRU exacerbation were determined. The duration of the exacerbation was calculated as (exacerbation resolution date or date of death - exacerbation onset date + 1). For exacerbations which were not resolved but where the participant later died from other causes, the duration was calculated using date of death as the end date of the event.
Time Frame Up to Day 196
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 44 75 58 56 66 65
Mean (Standard Deviation)
Unit of Measure: Days
10.3  (7.37) 12.3  (8.95) 12.9  (9.58) 14.0  (8.71) 10.7  (7.21) 14.2  (9.29)
19.Secondary Outcome
Title Change From Baseline in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score
Hide Description The SGRQ-C consists of 40 items aggregated into 3 component scores: Symptoms, Activity, Impacts, and a Total score. Each response to a question is assigned a weight. Component scores are calculated by summing the weights from all positive items in that component, dividing by the sum of weights for all items in that component, and multiplying this number by 100. Component scores could range from 0-100, with a higher component score indicating greater disease burden. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.
Time Frame Baseline, Days 84 and 168
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the per protocol population without missing covariate information and with at least one post baseline measurement are included in the analysis.
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 101 102 100 103 100 99
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Day 84, n=93, 97, 94, 96, 91, 90 Number Analyzed 93 participants 97 participants 94 participants 96 participants 91 participants 90 participants
-3.79  (1.172) -3.63  (1.150) -1.31  (1.146) -3.19  (1.148) -2.83  (1.189) -2.48  (1.175)
Day 168, n=85, 96, 86, 90, 86, 85 Number Analyzed 85 participants 96 participants 86 participants 90 participants 86 participants 85 participants
-4.11  (1.292) -3.44  (1.246) -4.19  (1.292) -4.94  (1.251) -4.12  (1.287) -3.41  (1.302)
20.Secondary Outcome
Title Number of SGRQ Responder
Hide Description A participant was consider Responder according to SGRQ total score if their change from Baseline SGRQ total score of 4 units below Baseline or lower.
Time Frame Day 84 and Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 101 102 100 103 100 99
Measure Type: Number
Unit of Measure: Participants
Day 84, n=93, 97, 94, 96, 91, 90 Number Analyzed 93 participants 97 participants 94 participants 96 participants 91 participants 90 participants
39 40 35 49 35 38
Day 168, n=85, 96, 86, 90, 86, 85 Number Analyzed 85 participants 96 participants 86 participants 90 participants 86 participants 85 participants
35 47 40 47 41 34
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.208
Comments Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.51
Confidence Interval (2-Sided) 90%
0.88 to 2.59
Estimation Comments Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 10 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.482
Comments Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.27
Confidence Interval (2-Sided) 90%
0.73 to 2.20
Estimation Comments Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 25 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.239
Comments Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.47
Confidence Interval (2-Sided) 90%
0.86 to 2.53
Estimation Comments Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 35 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.426
Comments Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.31
Confidence Interval (2-Sided) 90%
0.75 to 2.26
Estimation Comments Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 50 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.763
Comments Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.90
Confidence Interval (2-Sided) 90%
0.52 to 1.58
Estimation Comments Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.
21.Secondary Outcome
Title Change From Baseline COPD Assessment Test (CAT) Total Score
Hide Description The CAT is an 8 item questionnaire (cough, sputum, chest tightness, breathlessness, going up hills/stairs, activity limitation at home, confidence leaving the home, and sleep and energy) that measures health status of participants with COPD. Participants were completed each question by rating their experience on a 6 point scale ranging from 0 (maximum impairment) to 5 (no impairment) with a total scoring range of 0-40; higher scores indicate worse health status. A CAT score was calculated by summing the non-missing scores on the eight items. Individual items are scored from 0 to 5 with a total score range from 0 - 40, higher scores indicate greater disease impact. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.
Time Frame Baseline, Days 84 and 168
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the per protocol population without missing covariate information and with at least one post baseline measurement are included in the analysis.
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 101 102 100 103 100 99
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Day 84, n=89, 97, 92, 89, 88, 85 Number Analyzed 89 participants 97 participants 92 participants 89 participants 88 participants 85 participants
-2.02  (0.536) -0.86  (0.525) -0.63  (0.524) -0.55  (0.542) -1.51  (0.543) -0.36  (0.549)
Day 168, n=84, 94, 86, 87, 85, 83 Number Analyzed 84 participants 94 participants 86 participants 87 participants 85 participants 83 participants
-1.39  (0.557) -1.39  (0.537) -1.23  (0.548) -0.97  (0.560) -1.56  (0.560) -1.32  (0.565)
22.Secondary Outcome
Title Number of CAT Responder
Hide Description A participant was considered as a responder according to CAT score if their change from Baseline CAT score 2.0 units below Baseline or lower.
Time Frame Day 84 and Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 101 102 100 103 100 99
Measure Type: Count of Participants
Unit of Measure: Participants
Day 84, n=89, 97, 92, 89, 88, 85 Number Analyzed 89 participants 97 participants 92 participants 89 participants 88 participants 85 participants
46
  51.7%
44
  45.4%
38
  41.3%
37
  41.6%
43
  48.9%
36
  42.4%
Day 168, n=84, 94, 86, 87, 85, 83 Number Analyzed 84 participants 94 participants 86 participants 87 participants 85 participants 83 participants
41
  48.8%
44
  46.8%
39
  45.3%
42
  48.3%
46
  54.1%
44
  53.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.973
Comments Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.01
Confidence Interval (2-Sided) 90%
0.58 to 1.76
Estimation Comments Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 10 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.825
Comments Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.93
Confidence Interval (2-Sided) 90%
0.53 to 1.63
Estimation Comments Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 25 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.887
Comments Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.95
Confidence Interval (2-Sided) 90%
0.55 to 1.66
Estimation Comments Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 35 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.567
Comments Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.21
Confidence Interval (2-Sided) 90%
0.69 to 2.13
Estimation Comments Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Danirixin 50 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.501
Comments Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.26
Confidence Interval (2-Sided) 90%
0.72 to 2.20
Estimation Comments Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.
23.Secondary Outcome
Title Change From Baseline in Post-bronchodilator FEV1 as a Lung Function Assessment
Hide Description Spirometric analysis was done to determine FEV1. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented.
Time Frame Baseline, Days 84 and 168
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the mITT population without missing covariate information and with at least one post baseline measurement are included in the analysis.
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 102 102 103 103 102 102
Least Squares Mean (Standard Error)
Unit of Measure: Liters
Day 84, n=94, 99, 98, 97, 92, 93 Number Analyzed 94 participants 99 participants 98 participants 97 participants 92 participants 93 participants
0.016  (0.0208) -0.031  (0.0203) -0.029  (0.0204) -0.018  (0.0206) -0.027  (0.0211) 0.027  (0.0210)
Day 168, n=88, 97, 90, 90, 88, 86 Number Analyzed 88 participants 97 participants 90 participants 90 participants 88 participants 86 participants
-0.016  (0.0199) -0.043  (0.0191) -0.033  (0.0197) -0.058  (0.0198) -0.012  (0.0201) -0.011  (0.0202)
24.Secondary Outcome
Title Percent Predicted Normal FEV1
Hide Description Spirometric analysis was done to determine percent predicted FEVI at screening. FEV1 is forced expiratory volume in one second. Percent predicted FEV1 is defined as the percent FEV1 of the participant is divided by average FEV1 percent in the population of any person similar age, sex and body composition.
Time Frame At Screening
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Only those participants with available data at the specified time points were analyzed.
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 100 102 100 103 100 99
Mean (Standard Deviation)
Unit of Measure: Percent predicted FEV1
58.98  (12.838) 56.75  (12.038) 56.62  (11.848) 56.84  (12.813) 57.51  (14.076) 57.84  (12.794)
25.Secondary Outcome
Title Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) as a Lung Function Assessment
Hide Description Spirometric analysis was done to determine FVC. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented.
Time Frame Baseline, Days 84 and 168
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the mITT population without missing covariate information and with at least one post baseline measurement are included in the analysis.
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Overall Number of Participants Analyzed 102 102 103 103 102 102
Least Squares Mean (Standard Error)
Unit of Measure: Liters
Day 84, n=94, 99, 98, 97, 92, 93 Number Analyzed 94 participants 99 participants 98 participants 97 participants 92 participants 93 participants
0.024  (0.0321) -0.054  (0.0313) -0.043  (0.0315) 0.027  (0.0317) -0.049  (0.0326) 0.014  (0.0323)
Day 168, n=88, 97, 90, 90, 88, 86 Number Analyzed 88 participants 97 participants 90 participants 90 participants 88 participants 86 participants
-0.011  (0.0348) -0.079  (0.0335) -0.043  (0.0344) -0.024  (0.0345) -0.036  (0.0351) -0.016  (0.0353)
26.Secondary Outcome
Title Change From Baseline in Post-bronchodilator FEV1/FVC Ratio as a Lung Function Assessment
Hide Description Spirometric analysis was done to determine FEV1 and FVC. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time Frame Baseline, Days 84 and 168
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the mITT population without missing covariate information and with at least one post baseline measurement are included in the analysis.
Arm/Group Title Placebo Danirixin 5 mg Danirixin 10 mg Danirixin 25 mg Danirixin 35 mg Danirixin 50 mg
Hide Arm/Group Description:
Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.
Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.