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A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis

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: NCT02020889
Recruitment Status : Completed
First Posted : December 25, 2013
Results First Posted : January 26, 2018
Last Update Posted : January 31, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
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 Churg-Strauss Syndrome
Interventions Biological: Mepolizumab
Drug: Placebo
Enrollment 136
Recruitment Details Eligible participants at screening and run-in visit, entered a 52 week study treatment phase followed by 8-week follow-up phase. The total duration for the study participation was approximately 64 weeks.
Pre-assignment Details A total of 151 participants with a history of relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) were screened, out of which 4 were screen failures and 11 were run-in failures. 136 participants completed run-in period and received Mepolizumab 300 milligram (mg) or placebo in a randomized manner in the treatment phase.
Arm/Group Title Placebo Mepolizumab 300mg
Hide Arm/Group Description Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48. Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Period Title: Overall Study
Started 68 68
Completed 61 65
Not Completed 7 3
Reason Not Completed
Adverse Event             0             1
Lack of Efficacy             1             0
Lost to Follow-up             1             0
Physician Decision             2             0
Withdrawal by Subject             3             2
Arm/Group Title Placebo Mepolizumab 300mg Total
Hide Arm/Group Description Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48. Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48. Total of all reporting groups
Overall Number of Baseline Participants 68 68 136
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 68 participants 68 participants 136 participants
48.2  (14.32) 48.7  (12.39) 48.5  (13.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 68 participants 136 participants
Female
38
  55.9%
42
  61.8%
80
  58.8%
Male
30
  44.1%
26
  38.2%
56
  41.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race customized Number Analyzed 68 participants 68 participants 136 participants
American Indian or Alaskan Native
0
   0.0%
1
   1.5%
1
   0.7%
Asian - Japanese Heritage
3
   4.4%
3
   4.4%
6
   4.4%
Asian - South East Asian Heritage
2
   2.9%
0
   0.0%
2
   1.5%
White - Arabic/North African Heritage
0
   0.0%
2
   2.9%
2
   1.5%
White - White/Caucasian/European Heritage
61
  89.7%
62
  91.2%
123
  90.4%
Mixed Race
2
   2.9%
0
   0.0%
2
   1.5%
1.Primary Outcome
Title Number of Participants in Each Category of Accrued Duration of Remission
Hide Description Total accrued duration of remission is the accrued number of weeks where Birmingham Vasculitis Activity Score (BVAS) =0 plus prednisolone/prednisone dose <=4 mg/day over the 52 week study treatment period was reported. The accrued duration was categorized into zero, >0 to <12 weeks, 12 to <24 weeks, 24 to <36 weeks and >=36 weeks. Statistical analysis was based on a proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region. Intent-to-Treat (ITT) Population was used for the analysis and was defined as all participants who were randomized and received at least one dose of trial medication. Randomized participants were assumed to have received study treatment unless definitive evidence to the contrary exists. The odds ratio for treatment difference and associated probability (p)-value and 95 percent confidence interval (CI) were calculated.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Mepolizumab 300mg
Hide Arm/Group Description:
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Measure Type: Count of Participants
Unit of Measure: Participants
Zero
55
  80.9%
32
  47.1%
>0 to <12 weeks
8
  11.8%
8
  11.8%
12 to <24 weeks
3
   4.4%
9
  13.2%
24 to <36 weeks
0
   0.0%
10
  14.7%
>=36 weeks
2
   2.9%
9
  13.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 300mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Proportional odds regression model
Comments Proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score, region
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.91
Confidence Interval (2-Sided) 95%
2.68 to 13.03
Estimation Comments Mepolizumab 300mg/Placebo
2.Primary Outcome
Title Number of Participants Who Are in Remission at 36 and 48 Weeks
Hide Description The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone <=4 mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
Time Frame Week 36 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Mepolizumab 300mg
Hide Arm/Group Description:
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Measure Type: Number
Unit of Measure: Participants
2 22
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 300mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 16.74
Confidence Interval (2-Sided) 95%
3.61 to 77.56
Estimation Comments Mepolizumab 300mg/Placebo
3.Secondary Outcome
Title Time to First EGPA Relapse
Hide Description EGPA relapse was defined as worsening or persistence of active disease since the last visit characterized by active vasculitis or active asthma symptoms and/or signs with a corresponding worsening in Asthma Control Questionnaire-6 (ACQ-6) score or active nasal and/or sinus disease, with a corresponding worsening in at least one of the sino-nasal symptom questions warranting: i) an increased dose of OCS therapy (or other systemic corticosteroid therapy) to >4 mg/day prednisolone total daily dose or equivalent; OR ii) an increased dose or addition of immunosuppressive therapy; OR iii) hospitalization related to EGPA worsening. Participants who completed study, or withdrawn prematurely from the study without experiencing the event were censored. The number of participants with at least one EGPA relapse during the planned study treatment period are presented.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Mepolizumab 300mg
Hide Arm/Group Description:
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Measure Type: Number
Unit of Measure: Participants
56 38
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 300mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cox Proportional Hazard regression
Comments Cox proportional hazards model with covariates of treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.322
Confidence Interval (2-Sided) 95%
0.206 to 0.502
Estimation Comments Mepolizumab 300mg/Placebo
4.Secondary Outcome
Title Number of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period.
Hide Description The number of participants with an average daily prednisolone/prednisone dose during the last 4 weeks of the Study Treatment Period (48 through 52) was calculated. The average dose was categorized into zero, >0 to <=4.0mg, >4.0 to <=7.5mg and >7.5mg. The statistical analysis was performed using a proportional odds regression model with Baseline covariates of treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region and the comparison between treatment groups was presented as an odds ratio, p-value and 95 percent CI.
Time Frame Week 48 and Week52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Mepolizumab 300mg
Hide Arm/Group Description:
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Measure Type: Count of Participants
Unit of Measure: Participants
Zero
2
   2.9%
12
  17.6%
>0 to <=4.0mg
3
   4.4%
18
  26.5%
>4.0 to <=7.5mg
18
  26.5%
10
  14.7%
>7.5mg
45
  66.2%
28
  41.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 300mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Proportional odds regression model
Comments Proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score, region
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
0.09 to 0.41
Estimation Comments Mepolizumab 300mg/Placebo
5.Secondary Outcome
Title Number of Participants Who Achieved Remission Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period
Hide Description The number of participants who achieved remission (i.e., BVAS=0 and prednisolone/prednisone<=4 mg/day) within the first 24 weeks and remain in remission for the remainder of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Mepolizumab 300mg
Hide Arm/Group Description:
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Measure Type: Number
Unit of Measure: Participants
1 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 300mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 19.65
Confidence Interval (2-Sided) 95%
2.30 to 167.93
Estimation Comments Mepolizumab 300mg/Placebo
6.Secondary Outcome
Title Number of Participants in Each Category of Accrued Duration of Remission
Hide Description Total accrued duration of remission, i.e., the accrued number of weeks where Birmingham Vasculitis Activity Score (BVAS) =0 plus prednisolone/prednisone dose <=7.5mg/day over the 52 week study treatment period was reported. BVAS is a validated, clinician-completed tool used for the comprehensive multisystem clinical assessment of disease activity in systemic vasculitis. The duration was categorized into zero, >0 to <12 weeks, 12 to <24 weeks, 24 to <36 weeks and >=36 weeks. Statistical analysis was performed on ITT Population and was based on a proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Mepolizumab 300mg
Hide Arm/Group Description:
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Measure Type: Count of Participants
Unit of Measure: Participants
Zero
36
  52.9%
15
  22.1%
>0 to <12 weeks
19
  27.9%
15
  22.1%
12 to <24 weeks
0
   0.0%
7
  10.3%
24 to <36 weeks
7
  10.3%
9
  13.2%
>=36 weeks
6
   8.8%
22
  32.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 300mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Proportional odds regression model
Comments Proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score, region
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.31
Confidence Interval (2-Sided) 95%
2.63 to 10.74
Estimation Comments Mepolizumab 300mg/Placebo
7.Secondary Outcome
Title Number of Participants Who Are in Remission at 36 and 48 Weeks
Hide Description The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone <=7.5mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
Time Frame Week 36 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Mepolizumab 300mg
Hide Arm/Group Description:
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Measure Type: Number
Unit of Measure: Participants
7 28
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 300mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.19
Confidence Interval (2-Sided) 95%
2.60 to 19.87
Estimation Comments Mepolizumab 300mg/Placebo
8.Secondary Outcome
Title Number of Participants Who Achieved Remission (BVAS=0 and Prednisolone/Prednisone <=7.5 mg/Day) Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period
Hide Description The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone <=7.5mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Mepolizumab 300mg
Hide Arm/Group Description:
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Measure Type: Number
Unit of Measure: Participants
2 16
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 300mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 11.39
Confidence Interval (2-Sided) 95%
2.35 to 55.24
Estimation Comments Mepolizumab 300mg/Placebo
9.Secondary Outcome
Title Number of Participants With Local and Systemic Adverse Events (AEs)
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs including systemic allergic and non-allergic reactions as well as local site injection-related reactions were counted throughout treatment phase and follow up phase. Systemic allergic reactions included Facial paralysis, flushing, hypersensitivity and rash pruritic. Injection related reactions were considered as systemic non-allergic reactions. Local site reactions included injection site bruising, erythema, pain and reaction. The analysis was performed on Safety Population which comprised of all participants who receive at least one dose of study treatment.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Mepolizumab 300mg
Hide Arm/Group Description:
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Measure Type: Number
Unit of Measure: Participants
Facial paralysis 1 0
Flushing 0 1
Hypersensitivity 0 1
Rash pruritic 0 1
Injection related reactions 0 1
Injection site bruising 0 1
Injection site erythema 1 1
Injection site pain 1 0
Injection site reaction 7 9
10.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) Levels
Hide Description Blood samples were collected to evaluate change from Baseline in ALT, Alk.phosph., AST, creatinine kinase, GGT and lactate dehydro values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time Frame Baseline and up to Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Placebo Mepolizumab 300mg
Hide Arm/Group Description:
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Mean (Standard Deviation)
Unit of Measure: International Unit per Liter (IU/L)
Absolute ALT; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
19.9  (8.91) 21.3  (14.22)
ALT; Week 4; n= 68, 68 Number Analyzed 68 participants 68 participants
0.2  (6.17) -2.2  (8.59)
ALT; Week 8; n= 67, 66 Number Analyzed 67 participants 66 participants
-0.9  (5.66) -1.7  (10.14)
ALT; Week 12; n= 65, 68 Number Analyzed 65 participants 68 participants
-0.9  (4.53) -0.7  (12.65)
ALT; Week 16; n= 65, 68 Number Analyzed 65 participants 68 participants
-0.4  (6.56) -2.2  (9.73)
ALT; Week 20; n= 63, 68 Number Analyzed 63 participants 68 participants
-0.3  (6.25) -1.2  (12.30)
ALT; Week 24; n= 63, 66 Number Analyzed 63 participants 66 participants
-1.3  (5.38) -0.2  (15.77)
ALT; Week 28; n= 62, 66 Number Analyzed 62 participants 66 participants
-0.9  (6.73) -0.4  (13.62)
ALT; Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
-0.7  (6.79) -2.4  (11.30)
ALT; Week 36; n= 60, 67 Number Analyzed 60 participants 67 participants
-0.1  (6.21) -3.0  (11.66)
ALT; Week 40; n= 61, 66 Number Analyzed 61 participants 66 participants
0.3  (9.01) -2.3  (11.70)
ALT; Week 44; n= 61, 66 Number Analyzed 61 participants 66 participants
0.9  (9.68) -2.7  (9.51)
ALT; Week 48; n= 61, 64 Number Analyzed 61 participants 64 participants
1.7  (9.04) -1.6  (15.47)
ALT; Week 52; n= 60, 65 Number Analyzed 60 participants 65 participants
1.5  (10.42) -2.8  (12.87)
ALT; Week 56; n= 61, 63 Number Analyzed 61 participants 63 participants
-0.1  (7.35) -3.6  (12.79)
ALT; Week 60; n= 60, 65 Number Analyzed 60 participants 65 participants
-0.3  (7.33) -4.7  (14.11)
Absolute Alk.phosph.; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
61.2  (17.83) 60.4  (20.90)
Alk.phosph.; Week 4; n= 68, 68 Number Analyzed 68 participants 68 participants
-0.9  (6.65) -3.2  (10.01)
Alk.phosph.; Week 8; n= 67, 66 Number Analyzed 67 participants 66 participants
-1.7  (9.95) -1.7  (11.56)
Alk. phosph.; Week 12; n= 65, 68 Number Analyzed 65 participants 68 participants
-1.9  (8.36) -1.1  (12.99)
Alk. phosph.; Week 16; n= 65, 68 Number Analyzed 65 participants 68 participants
-1.3  (9.35) -1.1  (14.61)
Alk. phosph.; Week 20; n= 63, 68 Number Analyzed 63 participants 68 participants
0.0  (11.24) 4.4  (21.90)
Alk. phosph.; Week 24; n= 63, 66 Number Analyzed 63 participants 66 participants
-1.1  (10.65) 2.8  (17.64)
Alk. phosph.; Week 28; n= 62, 66 Number Analyzed 62 participants 66 participants
0.2  (10.95) 4.9  (17.17)
Alk. phosph.; Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
0.2  (11.14) 4.4  (15.83)
Alk. phosph.; Week 36; n= 60, 67 Number Analyzed 60 participants 67 participants
0.2  (10.42) 4.8  (14.71)
Alk. phosph.; Week 40; n= 61, 66 Number Analyzed 61 participants 66 participants
1.0  (10.08) 6.2  (18.43)
Alk. phosph.; Week 44; n= 61, 66 Number Analyzed 61 participants 66 participants
1.1  (12.55) 5.1  (16.53)
Alk. phosph.; Week 48; n= 61, 64 Number Analyzed 61 participants 64 participants
1.2  (11.66) 5.1  (17.56)
Alk. phosph.; Week 52; n= 60, 65 Number Analyzed 60 participants 65 participants
0.3  (12.30) 2.3  (14.47)
Alk. phosph.; Week 56; n= 61, 63 Number Analyzed 61 participants 63 participants
-0.9  (12.04) 1.7  (16.42)
Alk. phosph.; Week 60; n= 60, 65 Number Analyzed 60 participants 65 participants
-1.5  (13.16) 1.0  (15.08)
Absolute AST; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
19.3  (6.11) 21.8  (10.73)
AST; Week 4; n= 68, 68 Number Analyzed 68 participants 68 participants
0.0  (4.41) -1.7  (8.61)
AST; Week 8; n= 67, 66 Number Analyzed 67 participants 66 participants
-0.4  (4.77) -1.0  (8.21)
AST; Week 12; n= 65, 68 Number Analyzed 65 participants 68 participants
0.5  (4.41) -0.7  (9.62)
AST; Week 16; n= 65, 68 Number Analyzed 65 participants 68 participants
0.4  (5.48) -0.6  (7.90)
AST; Week 20; n= 63, 68 Number Analyzed 63 participants 68 participants
0.8  (4.66) -0.6  (8.49)
AST; Week 24; n= 63, 66 Number Analyzed 63 participants 66 participants
0.0  (4.46) -0.4  (10.44)
AST; Week 28; n= 61, 66 Number Analyzed 61 participants 66 participants
-0.9  (5.34) -0.4  (10.59)
AST; Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
-0.2  (4.91) -1.3  (10.67)
AST; Week 36; n= 60, 67 Number Analyzed 60 participants 67 participants
0.2  (4.68) -2.2  (9.61)
AST; Week 40; n= 61, 66 Number Analyzed 61 participants 66 participants
0.5  (5.51) -1.6  (8.97)
AST; Week 44; n= 61, 66 Number Analyzed 61 participants 66 participants
0.4  (5.77) -2.4  (9.02)
AST; Week 48; n= 61, 64 Number Analyzed 61 participants 64 participants
1.1  (6.86) -2.3  (10.14)
AST; Week 52; n= 60, 65 Number Analyzed 60 participants 65 participants
0.9  (6.84) -3.0  (10.49)
AST; Week 56; n= 61, 63 Number Analyzed 61 participants 63 participants
-0.2  (4.92) -2.8  (10.64)
AST; Week 60; n= 60, 65 Number Analyzed 60 participants 65 participants
-0.4  (5.24) -3.7  (10.92)
Absolute Creatinine kinase; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
99.0  (75.99) 88.8  (75.18)
Creatinine kinase; Week 4; n= 68, 68 Number Analyzed 68 participants 68 participants
-2.4  (83.23) 2.0  (60.92)
Creatinine kinase; Week 8; n= 67, 66 Number Analyzed 67 participants 66 participants
-5.0  (62.41) 3.5  (50.48)
Creatinine kinase; Week 12; n= 65, 68 Number Analyzed 65 participants 68 participants
5.4  (93.24) 6.1  (40.86)
Creatinine kinase; Week 16; n= 65, 68 Number Analyzed 65 participants 68 participants
15.8  (125.84) 0.5  (49.65)
Creatinine kinase; Week 20; n= 63, 68 Number Analyzed 63 participants 68 participants
1.3  (78.35) 6.5  (54.83)
Creatinine kinase; Week 24; n= 63, 66 Number Analyzed 63 participants 66 participants
-0.6  (56.55) 6.0  (66.69)
Creatinine kinase; Week 28; n= 62, 66 Number Analyzed 62 participants 66 participants
-15.9  (59.38) 6.3  (55.84)
Creatinine kinase; Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
-13.1  (59.29) 0.2  (49.68)
Creatinine kinase; Week 36; n= 60, 67 Number Analyzed 60 participants 67 participants
-12.0  (65.11) 4.9  (52.71)
Creatinine kinase; Week 40; n= 61, 66 Number Analyzed 61 participants 66 participants
2.6  (91.89) 2.8  (62.74)
Creatinine kinase; Week 44; n= 61, 66 Number Analyzed 61 participants 66 participants
5.8  (86.76) -2.4  (62.13)
Creatinine kinase; Week 48; n= 61, 64 Number Analyzed 61 participants 64 participants
-8.1  (70.09) -2.6  (90.09)
Creatinine kinase; Week 52; n= 60, 65 Number Analyzed 60 participants 65 participants
0.9  (67.51) 0.2  (53.45)
Creatinine kinase; Week 56; n= 61, 63 Number Analyzed 61 participants 63 participants
-8.7  (60.58) -0.2  (62.08)
Creatinine kinase; Week 60; n= 60, 65 Number Analyzed 60 participants 65 participants
-10.3  (65.83) 0.4  (61.45)
Absolute GGT; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
30.8  (25.49) 30.1  (27.24)
GGT; Week 4; n= 68, 68 Number Analyzed 68 participants 68 participants
0.2  (11.70) -2.0  (9.68)
GGT; Week 8; n= 67, 66 Number Analyzed 67 participants 66 participants
-1.0  (8.59) -0.6  (17.99)
GGT; Week 12; n= 65, 68 Number Analyzed 65 participants 68 participants
-2.9  (6.68) -1.9  (18.70)
GGT; Week 16; n= 65, 68 Number Analyzed 65 participants 68 participants
-2.1  (10.18) -1.5  (21.36)
GGT; Week 20; n= 63, 68 Number Analyzed 63 participants 68 participants
1.7  (19.02) -1.1  (24.50)
GGT; Week 24; n= 63, 66 Number Analyzed 63 participants 66 participants
-1.7  (11.83) -3.3  (22.52)
GGT; Week 28; n= 62, 66 Number Analyzed 62 participants 66 participants
-1.9  (11.71) -3.1  (16.86)
GGT; Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
-1.5  (15.77) -3.6  (17.87)
GGT; Week 36; n= 60, 67 Number Analyzed 60 participants 67 participants
-2.1  (10.64) -4.7  (14.96)
GGT; Week 40; n= 61, 66 Number Analyzed 61 participants 66 participants
-0.2  (16.05) -0.3  (19.75)
GGT; Week 44; n= 61, 66 Number Analyzed 61 participants 66 participants
-2.9  (8.26) -2.7  (15.25)
GGT; Week 48; n= 61, 64 Number Analyzed 61 participants 64 participants
0.9  (18.91) -3.0  (16.51)
GGT; Week 52; n= 60, 65 Number Analyzed 60 participants 65 participants
-1.6  (16.44) -4.2  (13.53)
GGT; Week 56; n= 61, 63 Number Analyzed 61 participants 63 participants
-5.0  (16.77) -3.6  (17.02)
GGT; Week 60; n= 60, 65 Number Analyzed 60 participants 65 participants
-4.8  (16.45) -5.6  (15.37)
Absolute Lactate dehydro; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
186.5  (47.82) 179.6  (38.88)
Lactate dehydro; Week 4; n= 68, 68 Number Analyzed 68 participants 68 participants
-3.6  (19.73) -2.3  (27.80)
Lactate dehydro; Week 8; n= 67, 66 Number Analyzed 67 participants 66 participants
-8.2  (29.91) -5.3  (24.46)
Lactate dehydro; Week 12; n= 65, 68 Number Analyzed 65 participants 68 participants
-2.2  (27.17) -7.7  (25.56)
Lactate dehydro; Week 16; n= 65, 68 Number Analyzed 65 participants 68 participants
-2.6  (32.13) -10.6  (26.12)
Lactate dehydro; Week 20; n= 63, 68 Number Analyzed 63 participants 68 participants
2.2  (26.80) -13.7  (25.79)
Lactate dehydro; Week 24; n= 63, 66 Number Analyzed 63 participants 66 participants
-4.3  (26.22) -13.5  (26.99)
Lactate dehydro; Week 28; n= 61, 66 Number Analyzed 61 participants 66 participants
-8.5  (27.77) -15.9  (30.44)
Lactate dehydro; Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
-8.3  (25.49) -17.1  (24.88)
Lactate dehydro; Week 36; n= 60, 67 Number Analyzed 60 participants 67 participants
-3.6  (36.45) -16.2  (30.54)
Lactate dehydro; Week 40; n= 61, 66 Number Analyzed 61 participants 66 participants
-4.5  (35.81) -13.5  (36.31)
Lactate dehydro; Week 44; n= 61, 66 Number Analyzed 61 participants 66 participants
-2.7  (33.40) -17.0  (31.37)
Lactate dehydro; Week 48; n= 61, 64 Number Analyzed 61 participants 64 participants
0.8  (43.82) -19.0  (30.66)
Lactate dehydro; Week 52; n= 60, 65 Number Analyzed 60 participants 65 participants
-0.1  (34.99) -17.8  (33.45)
Lactate dehydro; Week 56; n= 61, 63 Number Analyzed 61 participants 63 participants
-5.2  (32.69) -16.0  (30.87)
Lactate dehydro; Week 60; n= 60, 65 Number Analyzed 60 participants 65 participants
-3.5  (34.15) -12.4  (33.23)
11.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels
Hide Description Blood samples were collected to evaluate change from Baseline in albumin and protein levels values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time Frame Baseline and up to Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Mepolizumab 300mg
Hide Arm/Group Description:
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Mean (Standard Deviation)
Unit of Measure: gram per liter (g/L)
Absolute Albumin; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
43.4  (2.45) 43.5  (3.01)
Albumin; Week 4; n= 68, 68 Number Analyzed 68 participants 68 participants
-0.6  (2.25) -0.1  (2.16)
Albumin; Week 8; n= 67, 66 Number Analyzed 67 participants 66 participants
-0.8  (2.16) -0.6  (2.72)
Albumin; Week 12; n= 65, 68 Number Analyzed 65 participants 68 participants
-0.2  (2.47) -0.4  (2.64)
Albumin; Week 16; n= 65, 68 Number Analyzed 65 participants 68 participants
-0.6  (2.57) -0.6  (2.54)
Albumin; Week 20; n= 63, 68 Number Analyzed 63 participants 68 participants
-0.1  (2.35) -0.2  (2.92)
Albumin; Week 24; n= 63, 66 Number Analyzed 63 participants 66 participants
0.0  (2.80) 0.1  (2.72)
Albumin; Week 28; n= 62, 66 Number Analyzed 62 participants 66 participants
-0.2  (2.67) 0.1  (2.67)
Albumin; Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
-0.4  (2.71) -0.1  (2.69)
Albumin; Week 36; n= 60, 67 Number Analyzed 60 participants 67 participants
-0.1  (2.58) 0.3  (3.01)
Albumin; Week 40; n= 61, 66 Number Analyzed 61 participants 66 participants
-0.2  (2.98) 0.2  (2.82)
Albumin; Week 44; n= 61, 66 Number Analyzed 61 participants 66 participants
0.3  (2.95) -0.3  (2.87)
Albumin; Week 48; n= 61, 64 Number Analyzed 61 participants 64 participants
-0.4  (2.74) -0.3  (2.77)
Albumin; Week 52; n= 60, 65 Number Analyzed 60 participants 65 participants
-0.5  (2.45) -0.3  (3.10)
Albumin; Week 56; n= 61, 63 Number Analyzed 61 participants 63 participants
-0.7  (2.84) -0.5  (2.88)
Albumin; Week 60; n= 60, 65 Number Analyzed 60 participants 65 participants
-0.9  (2.55) -0.7  (3.04)
Absolute Protein; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
67.7  (4.26) 67.3  (4.46)
Protein; Week 4; n= 68, 68 Number Analyzed 68 participants 68 participants
-0.8  (3.00) -0.5  (3.19)
Protein; Week 8; n= 67, 66 Number Analyzed 67 participants 66 participants
-1.5  (2.97) -0.9  (3.60)
Protein; Week 12; n= 65, 68 Number Analyzed 65 participants 68 participants
-0.6  (3.57) -0.6  (3.30)
Protein; Week 16; n= 65, 68 Number Analyzed 65 participants 68 participants
-0.3  (3.56) -0.8  (3.93)
Protein; Week 20; n= 63, 68 Number Analyzed 63 participants 68 participants
0.0  (3.21) 0.1  (4.28)
Protein; Week 24; n= 63, 66 Number Analyzed 63 participants 66 participants
0.2  (3.99) 0.0  (3.96)
Protein; Week 28; n= 62, 66 Number Analyzed 62 participants 66 participants
-0.2  (4.13) -0.1  (3.59)
Protein; Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
-0.5  (4.09) -0.4  (3.91)
Protein; Week 36; n= 60, 67 Number Analyzed 60 participants 67 participants
-0.2  (3.82) 0.2  (4.45)
Protein; Week 40; n= 61, 66 Number Analyzed 61 participants 66 participants
-0.4  (3.48) 0.1  (3.98)
Protein; Week 44; n= 61, 66 Number Analyzed 61 participants 66 participants
0.4  (4.43) -0.6  (4.19)
Protein; Week 48; n= 61, 64 Number Analyzed 61 participants 64 participants
-0.5  (3.94) -0.5  (4.29)
Protein; Week 52; n= 60, 65 Number Analyzed 60 participants 65 participants
-0.3  (3.75) -0.4  (4.08)
Protein; week 56; n= 61, 63 Number Analyzed 61 participants 63 participants
-0.1  (4.77) -0.5  (4.21)
Protein; Week 60; n= 60, 65 Number Analyzed 60 participants 65 participants
-0.4  (5.88) -0.7  (4.17)
12.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels
Hide Description Blood samples were collected to evaluate change from Baseline in direct, indirect and total bilirubin and creatinine values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time Frame Baseline and up to Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Mepolizumab 300mg
Hide Arm/Group Description:
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Mean (Standard Deviation)
Unit of Measure: micromole per liter (µmol/L)
Absolute Total bilirubin; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
9.8  (6.14) 8.8  (4.10)
Total bilirubin; week 4; n= 68, 68 Number Analyzed 68 participants 68 participants
-0.9  (4.02) 0.1  (3.48)
Total bilirubin; Week 8; n= 67, 66 Number Analyzed 67 participants 66 participants
-1.2  (4.38) 0.0  (3.50)
Total bilirubin; Week 12; n= 65, 68 Number Analyzed 65 participants 68 participants
-0.3  (3.01) 0.1  (3.27)
Total bilirubin; Week 16; n= 65, 68 Number Analyzed 65 participants 68 participants
-1.1  (4.15) 0.0  (4.14)
Total bilirubin; Week 20; n= 63, 68 Number Analyzed 63 participants 68 participants
-0.5  (2.90) 0.3  (3.57)
Total bilirubin; Week 24; n= 63, 66 Number Analyzed 63 participants 66 participants
-0.3  (3.36) 0.0  (2.71)
Total bilirubin; Week 28; n= 62, 66 Number Analyzed 62 participants 66 participants
-0.8  (3.13) 0.3  (4.43)
Total bilirubin; Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
-1.1  (3.07) -0.1  (3.63)
Total bilirubin; Week 36; n= 60, 67 Number Analyzed 60 participants 67 participants
-0.7  (3.39) 0.1  (4.09)
Total bilirubin; Week 40; n= 61, 66 Number Analyzed 61 participants 66 participants
-0.2  (3.22) -0.3  (3.78)
Total bilirubin; Week 44; n= 61, 66 Number Analyzed 61 participants 66 participants
0.0  (2.50) 0.1  (3.64)
Total bilirubin; Week 48; n= 61, 64 Number Analyzed 61 participants 64 participants
-0.2  (2.59) -0.1  (3.77)
Total bilirubin; Week 52; n= 60, 65 Number Analyzed 60 participants 65 participants
-0.1  (3.41) 0.7  (3.92)
Total bilirubin; Week 56; n= 61, 63 Number Analyzed 61 participants 63 participants
-0.8  (3.17) 0.5  (3.24)
Total bilirubin; Week 60; n= 60, 65 Number Analyzed 60 participants 65 participants
-0.5  (3.21) 0.0  (3.42)
Absolute Creatinine; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
75.49  (12.878) 73.00  (12.289)
Creatinine; Week 4; n= 68, 68 Number Analyzed 68 participants 68 participants
0.69  (7.195) 2.09  (5.533)
Creatinine; Week 8; n= 67, 66 Number Analyzed 67 participants 66 participants
1.87  (7.505) 1.15  (6.737)
Creatinine; Week 12; n= 65, 68 Number Analyzed 65 participants 68 participants
1.50  (9.029) 0.34  (7.006)
Creatinine; Week 16; n= 65, 68 Number Analyzed 65 participants 68 participants
1.53  (10.012) 2.72  (6.702)
Creatinine; Week 20; n= 63, 68 Number Analyzed 63 participants 68 participants
1.73  (6.916) 2.60  (7.739)
Creatinine; Week 24; n= 63, 66 Number Analyzed 63 participants 66 participants
0.74  (7.775) 0.06  (6.538)
Creatinine; Week 28; n= 62, 66 Number Analyzed 62 participants 66 participants
0.96  (7.504) 1.02  (7.764)
Creatinine; Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
1.89  (9.809) 1.85  (8.589)
Creatinine; Week 36; n= 60, 67 Number Analyzed 60 participants 67 participants
1.42  (6.957) 0.40  (7.839)
Creatinine; Week 40; n= 61, 66 Number Analyzed 61 participants 66 participants
1.16  (8.253) 0.34  (8.119)
Creatinine; Week 44; n= 61, 66 Number Analyzed 61 participants 66 participants
2.14  (8.991) 0.04  (9.070)
Creatinine; Week 48; n= 61, 64 Number Analyzed 61 participants 64 participants
1.53  (7.972) -2.25  (7.398)
Creatinine; Week 52; n= 60, 65 Number Analyzed 60 participants 65 participants
0.52  (7.719) -1.35  (7.182)
Creatinine; Week 56; n= 61, 63 Number Analyzed 61 participants 63 participants
1.39  (7.367) -0.30  (8.695)
Creatinine; Week 60; n= 60, 65 Number Analyzed 60 participants 65 participants
0.34  (7.014) -1.22  (10.896)
Absolute Direct bilirubin; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
2.1  (1.33) 1.9  (0.98)
Direct bilirubin; Week 4; n= 68, 68 Number Analyzed 68 participants 68 participants
0.0  (1.06) 0.0  (0.84)
Direct bilirubin; Week 8; n= 67, 66 Number Analyzed 67 participants 66 participants
0.0  (1.01) 0.1  (0.96)
Direct bilirubin; Week 12; n= 65, 68 Number Analyzed 65 participants 68 participants
0.0  (0.97) 0.0  (1.04)
Direct bilirubin; Week 16; n= 65, 68 Number Analyzed 65 participants 68 participants
-0.2  (0.96) -0.1  (1.20)
Direct bilirubin; Week 20; n= 63, 68 Number Analyzed 63 participants 68 participants
0.0  (0.86) 0.1  (1.03)
Direct bilirubin; Week 24; n= 63, 66 Number Analyzed 63 participants 66 participants
0.1  (0.90) 0.0  (0.88)
Direct bilirubin; Week 28; n= 62, 66 Number Analyzed 62 participants 66 participants
-0.1  (1.20) 0.2  (1.15)
Direct bilirubin; Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
-0.2  (0.99) 0.1  (0.99)
Direct bilirubin; Week 36; n= 60, 67 Number Analyzed 60 participants 67 participants
-0.1  (1.11) 0.1  (1.17)
Direct bilirubin; Week 40; n= 61, 66 Number Analyzed 61 participants 66 participants
0.0  (1.11) 0.0  (0.94)
Direct bilirubin; Week 44; n= 61, 66 Number Analyzed 61 participants 66 participants
0.1  (0.93) 0.0  (1.12)
Direct bilirubin; Week 48; n= 61, 64 Number Analyzed 61 participants 64 participants
0.1  (0.99) 0.0  (1.17)
Direct bilirubin; Week 52; n= 60, 65 Number Analyzed 60 participants 65 participants
0.1  (1.05) 0.2  (1.06)
Direct bilirubin; Week 56; n= 61, 63 Number Analyzed 61 participants 63 participants
0.1  (1.08) 0.1  (1.06)
Direct bilirubin; Week 60; n= 60, 65 Number Analyzed 60 participants 65 participants
0.1  (1.10) 0.1  (1.07)
Absolute Indirect bilirubin; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
7.7  (5.09) 6.9  (3.38)
Indirect bilirubin; Week 4; n= 68, 68 Number Analyzed 68 participants 68 participants
-0.8  (3.68) 0.0  (3.06)
Indirect bilirubin; Week 8; n= 67, 66 Number Analyzed 67 participants 66 participants
-1.2  (3.86) -0.1  (2.94)
Indirect bilirubin; Week 12; n= 65, 68 Number Analyzed 65 participants 68 participants
-0.3  (2.61) 0.1  (2.79)
Indirect bilirubin; Week 16; n= 65, 68 Number Analyzed 65 participants 68 participants
-0.9  (3.67) 0.1  (3.37)
Indirect bilirubin; Week 20; n= 63, 68 Number Analyzed 63 participants 68 participants
-0.5  (2.37) 0.2  (3.00)
Indirect bilirubin; Week 24; n= 63, 66 Number Analyzed 63 participants 66 participants
-0.4  (2.94) 0.0  (2.37)
Indirect bilirubin; Week 28; n= 62, 66 Number Analyzed 62 participants 66 participants
-0.7  (2.60) 0.1  (3.71)
Indirect bilirubin; Week 32; n= 61, 66 Number Analyzed 61 participants 66 participants
-0.9  (2.48) -0.2  (3.02)
Indirect bilirubin; Week 36; n= 60, 67 Number Analyzed 60 participants 67 participants
-0.6  (2.77) 0.0  (3.30)
Indirect bilirubin; Week 40; n= 61, 66 Number Analyzed 61 participants 66 participants
-0.1  (2.56) -0.2  (3.16)
Indirect bilirubin; Week 44; n= 61, 66 Number Analyzed 61 participants 66 participants
-0.1  (2.19) 0.1  (2.99)
Indirect bilirubin; Week 48; n= 61, 64 Number Analyzed 61 participants 64 participants
-0.3  (2.19) -0.1  (3.13)
Indirect bilirubin; Week 52; n= 60, 65 Number Analyzed 60 participants 65 participants
-0.2  (2.84) 0.5  (3.32)
Indirect bilirubin; Week 56; n= 61, 63 Number Analyzed 61 participants 63 participants
-0.9  (2.72) 0.4  (2.64)
Indirect bilirubin; Week 60; n= 60, 65 Number Analyzed 60 participants 65 participants
-0.6  (2.64) -0.1  (2.81)
13.Secondary Outcome
Title Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol Levels
Hide Description Blood samples were collected to evaluate change from Baseline in calcium, chloride, cholesterol, glucose, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, phosphorus, potassium, sodium, urea nitrogen and very low density lipoprotein (VLDL) cholesterol values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured. NA indicates that data were not available.
Time Frame Baseline and up to Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Mepolizumab 300mg
Hide Arm/Group Description:
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Mean (Standard Deviation)
Unit of Measure: millimoles per liter (mmol/L)
Absolute Calcium; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
2.365  (0.0864) 2.382  (0.1189)
Calcium; Week 4; n= 68, 68 Number Analyzed 68 participants 68 participants
-0.011  (0.0836) -0.012  (0.1200)
Calcium; Week 8; n= 67, 66 Number Analyzed 67 participants 66 participants
-0.013  (0.0877) -0.010  (0.1003)
Calcium; Week 12; n= 65, 68 Number Analyzed 65 participants 68 participants
-0.013  (0.0844) -0.026  (0.0889)
Calcium; Week 16; n= 65, 68 Number Analyzed 65 participants 68 participants
0.000  (0.1091) -0.029  (0.1018)
Calcium; Week 20; n= 63, 68 Number Analyzed 63 participants 68 participants
0.002  (0.0882) -0.016  (0.1032)
Calcium; Week 24; n= 63, 66 Number Analyzed 63 participants 66 participants
0.001  (0.0901) -0.013  (0.1111)
Calcium; Week 28; n= 61, 66 Number Analyzed 61 participants 66 participants
0.001  (0.0962) -0.001  (0.1039)
Calcium; Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
-0.000  (0.0911) -0.006  (0.0977)
Calcium; Week 36; n= 60, 67 Number Analyzed 60 participants 67 participants
-0.006  (0.0931) -0.006  (0.1133)
Calcium; Week 40; n= 61, 66 Number Analyzed 61 participants 66 participants
0.014  (0.1126) 0.005  (0.1115)
Calcium; Week 44; n= 61, 66 Number Analyzed 61 participants 66 participants
0.016  (0.1144) -0.020  (0.1115)
Calcium; Week 48; n= 61, 64 Number Analyzed 61 participants 64 participants
-0.007  (0.1007) -0.018  (0.1002)
Calcium; Week 52; n= 60, 65 Number Analyzed 60 participants 65 participants
-0.008  (0.1001) -0.027  (0.1110)
Calcium; Week 56; n= 61, 63 Number Analyzed 61 participants 63 participants
-0.008  (0.0931) -0.015  (0.0994)
Calcium; Week 60; n= 60, 65 Number Analyzed 60 participants 65 participants
-0.025  (0.0946) -0.019  (0.1058)
Absolute Chloride; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
103.4  (2.05) 104.0  (2.21)
Chloride; Week 4; n= 68, 68 Number Analyzed 68 participants 68 participants
0.6  (1.97) 0.2  (2.00)
Chloride; Week 8; n= 67, 66 Number Analyzed 67 participants 66 participants
0.9  (2.05) 0.5  (2.06)
Chloride; Week 12; n= 65, 68 Number Analyzed 65 participants 68 participants
0.7  (2.32) 0.7  (2.20)
Chloride; Week 16; n= 65, 68 Number Analyzed 65 participants 68 participants
0.5  (2.08) 0.8  (1.95)
Chloride; Week 20; n= 63, 68 Number Analyzed 63 participants 68 participants
0.3  (2.38) 0.7  (2.04)
Chloride; Week 24; n= 63, 66 Number Analyzed 63 participants 66 participants
0.6  (2.51) 0.8  (2.20)
Chloride; Week 28; n= 62, 66 Number Analyzed 62 participants 66 participants
0.7  (2.17) 0.8  (2.59)
Chloride; Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
0.4  (2.24) 0.5  (2.32)
Chloride; Week 36; n= 60, 67 Number Analyzed 60 participants 67 participants
0.8  (2.53) 0.6  (2.08)
Chloride; Week 40; n= 61, 66 Number Analyzed 61 participants 66 participants
0.9  (2.22) 0.7  (2.13)
Chloride; Week 44; n= 61, 66 Number Analyzed 61 participants 66 participants
0.5  (2.13) 0.6  (2.55)
Chloride; Week 48; n= 61, 64 Number Analyzed 61 participants 64 participants
0.5  (2.38) 0.5  (2.34)
Chloride; Week 52; n= 60, 65 Number Analyzed 60 participants 65 participants
0.3  (2.26) 0.4  (2.24)
Chloride; Week 56; n= 61, 63 Number Analyzed 61 participants 63 participants
0.7  (2.27) 0.2  (2.06)
Chloride; Week 60; n= 60, 65 Number Analyzed 60 participants 65 participants
0.4  (2.01) 0.4  (2.20)
Absolute Cholesterol; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
5.771  (1.2033) 5.788  (1.2386)
Cholesterol; Week 8; n= 2, 0 Number Analyzed 2 participants 0 participants
-0.250  (0.1414)
Cholesterol; Week 12; n= 1, 0 Number Analyzed 1 participants 0 participants
0.050 [1]   (NA)
Cholesterol; Week 16; n= 1, 1 Number Analyzed 1 participants 1 participants
-0.400 [2]   (NA) -0.300 [2]   (NA)
Cholesterol; Week 20; n= 1, 1 Number Analyzed 1 participants 1 participants
0.050 [2]   (NA) -0.300 [2]   (NA)
Cholesterol; Week 24; n= 0, 1 Number Analyzed 0 participants 1 participants
-0.560 [2]   (NA)
Cholesterol; Week 36; n= 0, 1 Number Analyzed 0 participants 1 participants
0.420 [2]   (NA)
Cholesterol; Week 52; n= 60, 65 Number Analyzed 60 participants 65 participants
-0.006  (0.9364) -0.384  (0.8798)
Cholesterol; Week 56; n= 1, 0 Number Analyzed 1 participants 0 participants
-0.220 [2]   (NA)
Absolute Glucose; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
5.76  (2.000) 5.35  (1.195)
Glucose; Week 4; n= 68, 68 Number Analyzed 68 participants 68 participants
0.27  (1.619) -0.01  (1.050)
Glucose; Week 8; n= 67, 66 Number Analyzed 67 participants 66 participants
0.09  (1.695) 0.07  (0.986)
Glucose; Week 12; n= 65, 68 Number Analyzed 65 participants 68 participants
0.27  (1.961) 0.26  (1.079)
Glucose; Week 16; n= 65, 68 Number Analyzed 65 participants 68 participants
0.03  (1.454) 0.04  (1.077)
Glucose; Week 20; n= 63, 68 Number Analyzed 63 participants 68 participants
0.25  (1.644) -0.03  (1.351)
Glucose; Week 24; n= 63, 66 Number Analyzed 63 participants 66 participants
0.02  (1.588) 0.16  (1.211)
Glucose; Week 28; n= 62, 66 Number Analyzed 62 participants 66 participants
0.14  (1.613) 0.21  (1.551)
Glucose; Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
-0.03  (1.808) -0.14  (1.162)
Glucose; Week 36; n= 60, 67 Number Analyzed 60 participants 67 participants
0.11  (1.525) 0.03  (1.003)
Glucose; Week 40; n= 61, 66 Number Analyzed 61 participants 66 participants
0.34  (1.831) -0.03  (1.305)
Glucose; Week 44; n= 61, 66 Number Analyzed 61 participants 66 participants
0.21  (1.766) -0.05  (0.891)
Glucose; Week 48; n= 61, 64 Number Analyzed 61 participants 64 participants
0.32  (2.065) 0.21  (1.740)
Glucose; Week 52; n= 60, 65 Number Analyzed 60 participants 65 participants
-0.17  (1.650) 0.02  (1.258)
Glucose; Week 56; n= 61, 63 Number Analyzed 61 participants 63 participants
0.01  (1.718) 0.13  (1.852)
Glucose; Week 60; n= 60, 65 Number Analyzed 60 participants 65 participants
0.20  (1.664) 0.11  (1.483)
Absolute HDL cholesterol; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
1.837  (0.4540) 1.937  (0.5606)
HDL cholesterol; Week 8; n= 2, 0 Number Analyzed 2 participants 0 participants
-0.075  (0.0354)
HDL cholesterol; Week 12; n= 1, 0 Number Analyzed 1 participants 0 participants
-0.100 [2]   (NA)
HDL cholesterol; Week 16; n= 1, 1 Number Analyzed 1 participants 1 participants
0.400 [2]   (NA) -0.150 [2]   (NA)
HDL cholesterol; Week 20; n= 1, 1 Number Analyzed 1 participants 1 participants
0.000 [2]   (NA) -0.250 [2]   (NA)
HDL cholesterol; Week 24; n= 0, 1 Number Analyzed 0 participants 1 participants
-0.390 [1]   (NA)
HDL cholesterol; Week 36; n= 0, 1 Number Analyzed 0 participants 1 participants
0.400 [1]   (NA)
HDL cholesterol; Week 52; n= 60, 65 Number Analyzed 60 participants 65 participants
-0.045  (0.2832) -0.150  (0.3146)
HDL cholesterol; Week 56; n= 1, 0 Number Analyzed 1 participants 0 participants
-0.060 [1]   (NA)
Absolute LDL cholesterol; Baseline; n= 67, 68 Number Analyzed 67 participants 68 participants
3.261  (1.0808) 3.205  (1.0992)
LDL cholesterol; Week 8; n= 1, 0 Number Analyzed 1 participants 0 participants
-0.350 [1]   (NA)
LDL cholesterol; Week 12; n= 1, 0 Number Analyzed 1 participants 0 participants
0.190 [1]   (NA)
LDL cholesterol; Week 16; n= 1, 1 Number Analyzed 1 participants 1 participants
-0.730 [1]   (NA) -0.790 [1]   (NA)
LDL cholesterol; Week 20; n= 1, 1 Number Analyzed 1 participants 1 participants
-0.150 [1]   (NA) -0.540 [1]   (NA)
LDL cholesterol; Week 24; n= 0, 1 Number Analyzed 0 participants 1 participants
0.040 [1]   (NA)
LDL cholesterol; Week 36; n= 0, 1 Number Analyzed 0 participants 1 participants
0.250 [1]   (NA)
LDL cholesterol; Week 52; n= 58, 64 Number Analyzed 58 participants 64 participants
0.016  (0.7717) -0.215  (0.8079)
LDL cholesterol; Week 56; n= 1, 0 Number Analyzed 1 participants 0 participants
0.100 [1]   (NA)
Absolute Phosphate; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
1.068  (0.1797) 1.066  (0.1939)
Phosphate; Week 4; n= 68, 68 Number Analyzed 68 participants 68 participants
-0.027  (0.2183) 0.014  (0.1833)
Phosphate; Week 8; n= 67, 66 Number Analyzed 67 participants 66 participants
-0.004  (0.1577) 0.024  (0.2239)
Phosphate; Week 12; n= 65, 68 Number Analyzed 65 participants 68 participants
0.003  (0.1821) 0.019  (0.2181)
Phosphate; Week 16; n= 65, 68 Number Analyzed 65 participants 68 participants
0.016  (0.1819) 0.016  (0.2205)
Phosphate; Week 20; n= 63, 68 Number Analyzed 63 participants 68 participants
-0.001  (0.1611) 0.019  (0.2087)
Phosphate; Week 24; n= 63, 66 Number Analyzed 63 participants 66 participants
-0.042  (0.1565) 0.007  (0.2142)
Phosphate; Week 28; n= 62, 66 Number Analyzed 62 participants 66 participants
-0.025  (0.1819) 0.003  (0.2539)
Phosphate; Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
-0.018  (0.1975) 0.040  (0.2172)
Phosphate; Week 36; n= 60, 67 Number Analyzed 60 participants 67 participants
-0.038  (0.2159) 0.023  (0.2260)
Phosphate; Week 40; n= 61, 66 Number Analyzed 61 participants 66 participants
-0.029  (0.1822) 0.026  (0.2213)
Phosphate; Week 44; n= 61, 66 Number Analyzed 61 participants 66 participants
-0.018  (0.2104) 0.041  (0.2240)
Phosphate; Week 48; n= 61, 64 Number Analyzed 61 participants 64 participants
-0.053  (0.1931) -0.020  (0.2443)
Phosphate; Week 52; n= 60, 65 Number Analyzed 60 participants 65 participants
0.005  (0.1939) 0.053  (0.2988)
Phosphate; Week 56; n= 61, 63 Number Analyzed 61 participants 63 participants
0.019  (0.2962) 0.043  (0.3066)
Phosphate; Week 60; n= 60, 65 Number Analyzed 60 participants 65 participants
-0.035  (0.2125) -0.007  (0.2322)
Absolute Potassium; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
4.11  (0.348) 4.10  (0.359)
Potassium; Week 4; n= 68, 68 Number Analyzed 68 participants 68 participants
0.05  (0.378) -0.02  (0.345)
Potassium; Week 8; n= 67, 66 Number Analyzed 67 participants 66 participants
0.01  (0.309) 0.02  (0.323)
Potassium; Week 12; n= 65, 68 Number Analyzed 65 participants 68 participants
-0.04  (0.318) 0.01  (0.296)
Potassium; Week 16; n= 65, 68 Number Analyzed 65 participants 68 participants
0.06  (0.340) 0.05  (0.317)
Potassium; Week 20; n= 63, 68 Number Analyzed 63 participants 68 participants
0.08  (0.382) 0.01  (0.372)
Potassium; Week 24; n= 63, 66 Number Analyzed 63 participants 66 participants
-0.02  (0.298) 0.04  (0.350)
Potassium; Week 28; n= 61, 66 Number Analyzed 61 participants 66 participants
0.07  (0.338) 0.10  (0.382)
Potassium; Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
0.04  (0.340) 0.11  (0.305)
Potassium; Week 36; n= 60, 67 Number Analyzed 60 participants 67 participants
0.02  (0.291) 0.01  (0.351)
Potassium; Week 40; n= 61, 66 Number Analyzed 61 participants 66 participants
0.08  (0.419) 0.14  (0.313)
Potassium; Week 44; n= 61, 66 Number Analyzed 61 participants 66 participants
0.08  (0.383) 0.09  (0.341)
Potassium; Week 48; n= 61, 64 Number Analyzed 61 participants 64 participants
0.09  (0.367) 0.05  (0.349)
Potassium; Week 52; n= 60, 65 Number Analyzed 60 participants 65 participants
0.05  (0.344) 0.01  (0.329)
Potassium; Week 56; n= 61, 63 Number Analyzed 61 participants 63 participants
0.08  (0.379) 0.08  (0.378)
Potassium; Week 60; n= 60, 65 Number Analyzed 60 participants 65 participants
0.00  (0.358) 0.10  (0.390)
Absolute Sodium; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
139.8  (2.03) 140.3  (1.83)
Sodium; Week 4; n= 68, 68 Number Analyzed 68 participants 68 participants
0.2  (1.86) 0.3  (2.03)
Sodium; Week 8; n= 67, 66 Number Analyzed 67 participants 66 participants
0.4  (2.06) 0.2  (1.89)
Sodium; Week 12; n= 65, 68 Number Analyzed 65 participants 68 participants
0.1  (1.99) -0.1  (2.28)
Sodium; Week 16; n= 65, 68 Number Analyzed 65 participants 68 participants
0.0  (1.46) -0.1  (1.91)
Sodium; Week 20; n= 63, 68 Number Analyzed 63 participants 68 participants
0.0  (1.88) 0.1  (2.09)
Sodium; Week 24; n= 63, 66 Number Analyzed 63 participants 66 participants
0.2  (1.94) 0.0  (1.95)
Sodium; Week 28; n= 62, 66 Number Analyzed 62 participants 66 participants
0.5  (1.71) 0.0  (2.23)
Sodium; Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
0.3  (1.92) 0.1  (2.13)
Sodium; Week 36; n= 60, 67 Number Analyzed 60 participants 67 participants
0.4  (2.10) 0.0  (1.95)
Sodium; Week 40; n= 61, 66 Number Analyzed 61 participants 66 participants
0.2  (2.42) 0.0  (2.18)
Sodium; Week 44; n= 61, 66 Number Analyzed 61 participants 66 participants
0.1  (1.77) -0.2  (2.02)
Sodium; Week 48; n= 61, 64 Number Analyzed 61 participants 64 participants
0.1  (2.03) -0.4  (1.97)
Sodium; Week 52; n= 60, 65 Number Analyzed 60 participants 65 participants
0.4  (1.79) -0.2  (2.17)
Sodium; Week 56; n= 61, 63 Number Analyzed 61 participants 63 participants
0.4  (2.15) -0.5  (2.08)
Sodium; Week 60; n= 60, 65 Number Analyzed 60 participants 65 participants
-0.1  (2.04) -0.3  (2.36)
Absolute Urea; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
5.94  (1.451) 5.79  (1.629)
Urea; Week 4; n= 68, 68 Number Analyzed 68 participants 68 participants
-0.08  (1.412) 0.09  (1.241)
Urea; Week 8; n= 67, 66 Number Analyzed 67 participants 66 participants
-0.23  (1.564) 0.20  (1.206)
Urea; Week 12; n= 65, 68 Number Analyzed 65 participants 68 participants
-0.15  (1.414) -0.10  (1.217)
Urea; Week 16; n= 65, 68 Number Analyzed 65 participants 68 participants
-0.07  (1.569) 0.00  (1.317)
Urea; Week 20; n= 63, 68 Number Analyzed 63 participants 68 participants
-0.21  (1.465) -0.23  (1.286)
Urea; Week 24; n= 63, 66 Number Analyzed 63 participants 66 participants
-0.28  (1.513) -0.12  (1.172)
Urea; Week 28; n= 62, 66 Number Analyzed 62 participants 66 participants
-0.21  (1.525) -0.22  (1.350)
Urea; Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
-0.11  (1.320) -0.23  (1.359)
Urea; Week 36; n= 60, 67 Number Analyzed 60 participants 67 participants
-0.27  (1.407) -0.32  (1.391)
Urea; Week 40; n= 61, 66 Number Analyzed 61 participants 66 participants
-0.44  (1.377) -0.23  (1.375)
Urea; Week 44; n= 61, 66 Number Analyzed 61 participants 66 participants
-0.32  (1.731) -0.19  (1.698)
Urea; Week 48; n= 61, 64 Number Analyzed 61 participants 64 participants
-0.36  (1.422) -0.09  (1.429)
Urea; Week 52; n= 60, 65 Number Analyzed 60 participants 65 participants
-0.19  (1.737) -0.18  (1.128)
Urea; Week 56; n= 61, 63 Number Analyzed 61 participants 63 participants
-0.11  (1.495) -0.13  (1.539)
Urea; Week 60; n= 60, 65 Number Analyzed 60 participants 65 participants
-0.09  (1.546) -0.10  (1.170)
Absolute VLDL cholesterol; Baseline; n= 67, 68 Number Analyzed 67 participants 68 participants
0.680  (0.2846) 0.646  (0.2841)
VLDL cholesterol; Week 8; n= 1, 0 Number Analyzed 1 participants 0 participants
0.100 [1]   (NA)
VLDL cholesterol; Week 12; n= 1, 0 Number Analyzed 1 participants 0 participants
-0.040 [1]   (NA)
VLDL cholesterol; Week 16; n= 1, 1 Number Analyzed 1 participants 1 participants
-0.070 [1]   (NA) 0.640 [1]   (NA)
VLDL cholesterol; Week 20; n= 1, 1 Number Analyzed 1 participants 1 participants
0.200 [1]   (NA) 0.490 [1]   (NA)
VLDL cholesterol; Week 24; n= 0, 1 Number Analyzed 0 participants 1 participants
-0.210 [1]   (NA)
VLDL cholesterol; Week 36; n= 0, 1 Number Analyzed 0 participants 1 participants
-0.230 [1]   (NA)
VLDL cholesterol; Week 52; n= 58, 64 Number Analyzed 58 participants 64 participants
-0.019  (0.3229) -0.051  (0.1927)
VLDL cholesterol; Week 56; n= 1, 0 Number Analyzed 1 participants 0 participants
-0.260 [1]   (NA)
[1]
NA indicates that data was not available.
[2]
NA indicates that data was not available
14.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameter of Troponin Levels
Hide Description Blood samples were collected to evaluate change from Baseline in troponin values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time Frame Baseline and up to Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Mepolizumab 300mg
Hide Arm/Group Description:
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Mean (Standard Deviation)
Unit of Measure: µg/L
Absolute Troponin; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
0.013  (0.0110) 0.013  (0.0092)
Troponin; Week 4; n= 68, 66 Number Analyzed 68 participants 66 participants
-0.001  (0.0106) 0.008  (0.0717)
Troponin; Week 8; n= 67, 67 Number Analyzed 67 participants 67 participants
-0.002  (0.0111) 0.001  (0.0089)
Troponin; Week 12; n= 64, 67 Number Analyzed 64 participants 67 participants
-0.002  (0.0108) -0.001  (0.0053)
Troponin; Week 16; n= 65, 68 Number Analyzed 65 participants 68 participants
-0.002  (0.0104) 0.002  (0.0272)
Troponin; Week 20; n= 61, 68 Number Analyzed 61 participants 68 participants
-0.002  (0.0105) -0.001  (0.0089)
Troponin; Week 24; n= 62, 67 Number Analyzed 62 participants 67 participants
-0.002  (0.0098) 0.004  (0.0535)
Troponin; Week 28; n= 63, 66 Number Analyzed 63 participants 66 participants
-0.003  (0.0102) -0.002  (0.0090)
Troponin; Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
-0.003  (0.0100) -0.002  (0.0092)
Troponin; Week 36; n= 61, 67 Number Analyzed 61 participants 67 participants
-0.002  (0.0107) 0.000  (0.0185)
Troponin; Week 40; n= 61, 66 Number Analyzed 61 participants 66 participants
-0.001  (0.0117) -0.002  (0.0090)
Troponin; Week 44; n= 61, 65 Number Analyzed 61 participants 65 participants
-0.000  (0.0068) -0.001  (0.0095)
Troponin; Week 48; n= 60, 65 Number Analyzed 60 participants 65 participants
0.017  (0.1479) -0.001  (0.0101)
Troponin; Week 52; n= 60, 65 Number Analyzed 60 participants 65 participants
-0.002  (0.0114) -0.001  (0.0111)
Troponin; Week 56; n= 61, 63 Number Analyzed 61 participants 63 participants
-0.003  (0.0112) -0.002  (0.0086)
Troponin; Week 60; n= 59, 65 Number Analyzed 59 participants 65 participants
-0.003  (0.0109) -0.001  (0.0093)
15.Secondary Outcome
Title Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels
Hide Description Blood samples were collected to evaluate change from Baseline in basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelet values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time Frame Baseline and up to Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Mepolizumab 300mg
Hide Arm/Group Description:
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/L
Absolute Basophils; Baselin; n= 68, 68 Number Analyzed 68 participants 68 participants
0.030  (0.0253) 0.028  (0.0236)
Basophils; Week 4; n= 66, 66 Number Analyzed 66 participants 66 participants
-0.002  (0.0302) -0.007  (0.0282)
Basophils; Week 8; n= 65, 66 Number Analyzed 65 participants 66 participants
0.005  (0.0285) -0.002  (0.0261)
Basophils; Week 12; n= 63, 65 Number Analyzed 63 participants 65 participants
0.007  (0.0351) -0.007  (0.0222)
Basophils; Week 16; n= 64, 68 Number Analyzed 64 participants 68 participants
0.005  (0.0333) -0.004  (0.0295)
Basophils; Week 20; n= 61, 66 Number Analyzed 61 participants 66 participants
0.005  (0.0338) -0.002  (0.0287)
Basophils; Week 24; n= 61, 66 Number Analyzed 61 participants 66 participants
0.004  (0.0341) -0.002  (0.0328)
Basophils; Week 28; n= 62, 65 Number Analyzed 62 participants 65 participants
0.006  (0.0411) -0.005  (0.0297)
Basophils; Week 32; n= 61, 66 Number Analyzed 61 participants 66 participants
0.010  (0.0467) 0.002  (0.0355)
Basophils; Week 36; n= 60, 66 Number Analyzed 60 participants 66 participants
0.009  (0.0321) 0.005  (0.0424)
Basophils; Week 40; n= 61, 65 Number Analyzed 61 participants 65 participants
0.005  (0.0357) -0.002  (0.0356)
Basophils; Week 44; n= 59, 61 Number Analyzed 59 participants 61 participants
0.008  (0.0328) 0.000  (0.0296)
Basophils; Week 48; n= 59, 64 Number Analyzed 59 participants 64 participants
0.003  (0.0408) -0.004  (0.0300)
Basophils; Week 52; n= 60, 64 Number Analyzed 60 participants 64 participants
0.004  (0.0289) -0.003  (0.0284)
Basophils; Week 56; n= 59, 61 Number Analyzed 59 participants 61 participants
0.009  (0.0381) -0.003  (0.0286)
Basophils; Week 60; n= 58, 64 Number Analyzed 58 participants 64 participants
0.002  (0.0316) -0.006  (0.0248)
Absolute Eosinophils; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
0.362  (0.5835) 0.398  (0.8415)
Eosinophils; Week 4; n= 66, 66 Number Analyzed 66 participants 66 participants
-0.054  (0.3309) -0.339  (0.6794)
Eosinophils; Week 8; n= 65, 66 Number Analyzed 65 participants 66 participants
0.103  (0.2921) -0.370  (0.8092)
Eosinophils; Week 12; n= 63, 65 Number Analyzed 63 participants 65 participants
0.027  (0.3515) -0.364  (0.8407)
Eosinophils; Week 16; n= 64, 68 Number Analyzed 64 participants 68 participants
0.058  (0.4092) -0.355  (0.8280)
Eosinophils; Week 20; n= 61, 66 Number Analyzed 61 participants 66 participants
0.162  (0.5900) -0.347  (0.8266)
Eosinophils; Week 24; n= 61, 66 Number Analyzed 61 participants 66 participants
0.136  (0.4044) -0.364  (0.8211)
Eosinophils; Week 28; n= 62, 65 Number Analyzed 62 participants 65 participants
0.172  (0.4365) -0.360  (0.8258)
Eosinophils; Week 32; n= 61, 66 Number Analyzed 61 participants 66 participants
0.079  (0.3759) -0.347  (0.8310)
Eosinophils; Week 36; n= 60, 66 Number Analyzed 60 participants 66 participants
0.086  (0.3758) -0.347  (0.8388)
Eosinophils; Week 40; n= 61, 65 Number Analyzed 61 participants 65 participants
0.022  (0.4448) -0.358  (0.8396)
Eosinophils; Week 44; n= 59, 61 Number Analyzed 59 participants 61 participants
0.051  (0.4472) -0.365  (0.8604)
Eosinophils; Week 48; n= 59, 64 Number Analyzed 59 participants 64 participants
0.109  (0.3873) -0.364  (0.8540)
Eosinophils; Week 52; n= 60, 64 Number Analyzed 60 participants 64 participants
0.055  (0.3764) -0.341  (0.8456)
Eosinophils; Week 56; n= 59, 61 Number Analyzed 59 participants 61 participants
0.071  (0.4137) -0.351  (0.8624)
Eosinophils; Week 60; n= 58, 64 Number Analyzed 58 participants 64 participants
0.111  (0.4666) -0.302  (0.8352)
Absolute Leukocytes; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
9.91  (2.714) 9.54  (3.130)
Leukocytes; Week 4; 66, 66 Number Analyzed 66 participants 66 participants
-0.11  (2.109) -0.77  (2.356)
Leukocytes; Week 8; n= 65, 66 Number Analyzed 65 participants 66 participants
-0.18  (2.562) -0.83  (2.511)
Leukocytes; Week 12; n= 63, 65 Number Analyzed 63 participants 65 participants
-0.53  (1.765) -1.24  (2.716)
Leukocytes; ; Week 16; n= 64, 68 Number Analyzed 64 participants 68 participants
0.01  (2.567) -1.16  (2.827)
Leukocytes; Week 20; n= 61, 66 Number Analyzed 61 participants 66 participants
-0.13  (2.269) -1.43  (2.649)
Leukocytes; Week 24; n= 61, 66 Number Analyzed 61 participants 66 participants
-0.73  (2.110) -1.47  (2.738)
Leukocytes; Week 28; n= 62, 65 Number Analyzed 62 participants 65 participants
-0.01  (2.297) -1.66  (2.804)
Leukocytes; week 32; n= 61, 66 Number Analyzed 61 participants 66 participants
-0.33  (2.218) -1.54  (2.725)
Leukocytes; Week 36; n= 60, 66 Number Analyzed 60 participants 66 participants
-0.17  (2.501) -1.37  (2.578)
Leukocytes; Week 40; n= 61, 65 Number Analyzed 61 participants 65 participants
0.17  (2.912) -1.28  (3.284)
Leukocytes; Week 44; n= 59, 61 Number Analyzed 59 participants 61 participants
0.25  (3.166) -1.57  (2.198)
Leukocytes; Week 48; n= 59, 64 Number Analyzed 59 participants 64 participants
-0.10  (3.092) -1.46  (2.546)
Leukocytes; Week 52; n= 60, 64 Number Analyzed 60 participants 64 participants
-0.12  (3.114) -1.50  (2.521)
Leukocytes; Week 56; n= 59, 61 Number Analyzed 59 participants 61 participants
-0.05  (3.357) -1.50  (2.840)
Leukocytes; Week 60; n= 58, 64 Number Analyzed 58 participants 64 participants
0.19  (3.533) -1.20  (2.396)
Absolute Lymphocytes; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
1.638  (0.9375) 1.508  (0.8230)
Lymphocytes; Week 4; n= 66, 66 Number Analyzed 66 participants 66 participants
0.031  (0.8990) 0.145  (0.7485)
Lymphocytes; Week 8; n= 65, 66 Number Analyzed 65 participants 66 participants
0.245  (0.8804) -0.048  (0.6388)
Lymphocytes; Week 12; n= 63, 65 Number Analyzed 63 participants 65 participants
0.160  (0.9043) -0.071  (0.7665)
Lymphocytes; Week 16; n= 64, 68 Number Analyzed 64 participants 68 participants
0.078  (1.0337) 0.079  (0.7254)
Lymphocytes; Week 20; n= 61, 66 Number Analyzed 61 participants 66 participants
0.137  (0.7984) 0.127  (0.7096)
Lymphocytes; Week 24; n= 61, 66 Number Analyzed 61 participants 66 participants
0.056  (0.8778) 0.011  (0.8077)
Lymphocytes; Week 28; n= 62, 65 Number Analyzed 62 participants 65 participants
0.261  (1.0966) 0.004  (0.7328)
Lymphocytes; Week 32; n= 61, 66 Number Analyzed 61 participants 66 participants
0.244  (0.9633) 0.031  (0.7986)
Lymphocytes; Week 36; n= 60, 66 Number Analyzed 60 participants 66 participants
0.156  (1.0399) 0.031  (0.5939)
Lymphocytes; Week 40; n= 61, 65 Number Analyzed 61 participants 65 participants
0.064  (1.0537) 0.037  (0.6391)
Lymphocytes; Week 44; n= 59, 61 Number Analyzed 59 participants 61 participants
0.130  (0.8773) 0.059  (0.6471)
Lymphocytes; Week 48; n=59, 64 Number Analyzed 59 participants 64 participants
0.106  (0.8396) 0.035  (0.7368)
Lymphocytes; Week 52; n= 60, 64 Number Analyzed 60 participants 64 participants
0.144  (0.9262) 0.031  (0.6244)
Lymphocytes; Week 56; n= 59, 61 Number Analyzed 59 participants 61 participants
0.200  (0.8356) 0.128  (0.7824)
Lymphocytes; Week 60; n= 58, 64 Number Analyzed 58 participants 64 participants
0.076  (0.8821) -0.101  (0.6848)
Absolute Monocytes; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
0.377  (0.2126) 0.405  (0.2376)
Monocytes; week 4; n= 66, 66 Number Analyzed 66 participants 66 participants
0.038  (0.2444) 0.014  (0.2127)
Monocytes; Week 8; n= 65, 66 Number Analyzed 65 participants 66 participants
0.052  (0.2271) 0.039  (0.1988)
Monocytes; Week 12; n= 63, 65 Number Analyzed 63 participants 65 participants
0.077  (0.2468) -0.004  (0.1985)
Monocytes; Week 16; n= 64, 68 Number Analyzed 64 participants 68 participants
0.086  (0.2790) 0.031  (0.2157)
Monocytes; Week 20; n= 61, 66 Number Analyzed 61 participants 66 participants
0.132  (0.2684) 0.030  (0.1967)
Monocytes; Week 24; n= 61, 66 Number Analyzed 61 participants 66 participants
0.061  (0.2290) 0.013  (0.2412)
Monocytes; Week 28; n= 62, 65 Number Analyzed 62 participants 65 participants
0.107  (0.2363) 0.035  (0.2350)
Monocytes; Week 32; n= 61, 66 Number Analyzed 61 participants 66 participants
0.108  (0.2839) 0.057  (0.2069)
Monocytes; Week 36; n= 60, 66 Number Analyzed 60 participants 66 participants
0.089  (0.2992) 0.072  (0.2416)
Monocytes; Week 40; n= 61, 65 Number Analyzed 61 participants 65 participants
0.084  (0.2495) 0.050  (0.2096)
Monocytes; Week 44; n= 59, 61 Number Analyzed 59 participants 61 participants
0.090  (0.2494) 0.077  (0.2176)
Monocytes; Week 48; n= 59, 64 Number Analyzed 59 participants 64 participants
0.078  (0.2261) 0.025  (0.2235)
Monocytes; Week 52; n= 60, 64 Number Analyzed 60 participants 64 participants
0.075  (0.2407) 0.024  (0.2098)
Monocytes; Week 56; n= 59, 61 Number Analyzed 59 participants 61 participants
0.051  (0.2104) 0.037  (0.2303)
Monocytes; Week 60; n= 58, 64 Number Analyzed 58 participants 64 participants
0.052  (0.2600) 0.001  (0.2165)
Absolute Neutrophils; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
7.500  (2.7424) 7.198  (2.9732)
Neutrophils; Week 4; n= 66, 66 Number Analyzed 66 participants 66 participants
-0.124  (2.6170) -0.583  (2.2703)
Neutrophils; Week 8; n= 65, 66 Number Analyzed 65 participants 66 participants
-0.572  (2.6791) -0.443  (2.56476)
Neutrophils; Week 12; n= 63, 65 Number Analyzed 63 participants 65 participants
-0.797  (2.2948) -0.799  (2.6278)
Neutrophils; Week 16; n= 64, 68 Number Analyzed 64 participants 68 participants
-0.222  (2.7666) -0.914  (2.6034)
Neutrophils; Week 20; n= 61, 66 Number Analyzed 61 participants 66 participants
-0.560  (2.3679) -1.243  (2.6857)
Neutrophils; Week 24; n= 61, 66 Number Analyzed 61 participants 66 participants
-0.980  (2.3151) -1.120  (2.8349)
Neutrophils; Week 28; n= 62, 65 Number Analyzed 62 participants 65 participants
-0.555  (2.3719) -1.335  (2.9428)
Neutrophils; Week 32; n= 61, 66 Number Analyzed 61 participants 66 participants
-0.762  (2.4952) -1.286  (2.6995)
Neutrophils; Week 36; n= 60, 66 Number Analyzed 60 participants 66 participants
-0.509  (2.8231) -1.131  (2.4261)
Neutrophils; Week 40; n= 61, 65 Number Analyzed 61 participants 65 participants
-0.009  (3.0467) -1.010  (3.3999)
Neutrophils; Week 44; n= 59, 61 Number Analyzed 59 participants 61 participants
-0.020  (3.3497) -1.344  (2.1031)
Neutrophils; Week 48; n= 59, 64 Number Analyzed 59 participants 64 participants
-0.403  (3.2656) -1.151  (2.5806)
Neutrophils; Week 52; n= 60, 64 Number Analyzed 60 participants 64 participants
-0.391  (3.4463) -1.211  (2.2815)
Neutrophils; Week 56; n= 59, 61 Number Analyzed 59 participants 61 participants
-0.381  (3.4297) -1.311  (3.0024)
Neutrophils; Week 60; n= 58, 64 Number Analyzed 58 participants 64 participants
-0.048  (3.5724) -0.795  (2.6501)
Absolute Platelets; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
259.8  (61.16) 270.3  (60.86)
Platelets; Week 4; n= 66, 67 Number Analyzed 66 participants 67 participants
4.5  (38.14) -1.4  (33.79)
Platelets; Week 8; n= 66, 66 Number Analyzed 66 participants 66 participants
5.0  (43.97) 4.1  (26.48)
Platelets; Week 12; n= 63, 65 Number Analyzed 63 participants 65 participants
3.1  (50.60) -4.3  (37.89)
Platelets; Week 16; n= 64, 68 Number Analyzed 64 participants 68 participants
15.4  (71.20) 1.8  (40.25)
Platelets; Week 20; n= 61, 68 Number Analyzed 61 participants 68 participants
12.3  (49.92) 6.1  (52.76)
Platelets; Week 24; n= 62, 65 Number Analyzed 62 participants 65 participants
10.9  (50.38) -4.2  (40.07)
Platelets; Week 28; n= 62, 66 Number Analyzed 62 participants 66 participants
13.3  (55.12) 5.4  (41.57)
Platelets; Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
12.1  (45.36) 0.7  (43.85)
Platelets; Week 36; n= 60, 66 Number Analyzed 60 participants 66 participants
9.3  (42.64) 0.6  (37.87)
Platelets; Week 40; n= 61, 65 Number Analyzed 61 participants 65 participants
14.7  (45.63) 2.0  (42.12)
Platelets; Week 44; n= 60, 63 Number Analyzed 60 participants 63 participants
19.3  (48.88) 4.9  (40.27)
Platelets; Week 48; n= 59, 64 Number Analyzed 59 participants 64 participants
14.2  (53.93) 5.4  (44.80)
Platelets; Week 52; n= 60, 64 Number Analyzed 60 participants 64 participants
14.7  (48.19) -3.7  (46.34)
Platelets; Week 56; n= 59, 61 Number Analyzed 59 participants 61 participants
20.3  (47.35) -1.0  (48.51)
Platelets; Week 60; n= 59, 64 Number Analyzed 59 participants 64 participants
13.0  (50.07) -2.0  (41.32)
16.Secondary Outcome
Title Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels
Hide Description Blood samples were collected to evaluate change from Baseline in MCHC and hemoglobin values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time Frame Baseline and up to Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Mepolizumab 300mg
Hide Arm/Group Description:
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Mean (Standard Deviation)
Unit of Measure: g/L
Absolute MCHC; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
324.9  (7.53) 324.4  (7.37)
MCHC; Week 4; n= 66, 67 Number Analyzed 66 participants 67 participants
-1.2  (6.02) -1.1  (5.92)
MCHC; Week 8; n= 66, 66 Number Analyzed 66 participants 66 participants
-1.5  (6.69) -1.5  (6.86)
MCHC; Week 12; n= 63, 65 Number Analyzed 63 participants 65 participants
-1.3  (7.73) 0.3  (6.60)
MCHC; Week 16; n= 64, 68 Number Analyzed 64 participants 68 participants
-2.3  (7.11) -2.1  (7.88)
MCHC; Week 20; n= 61, 68 Number Analyzed 61 participants 68 participants
-2.2  (6.65) -1.2  (7.88)
MCHC; Week 24; n= 62, 66 Number Analyzed 62 participants 66 participants
-3.2  (10.19) -2.6  (7.39)
MCHC; Week 28; n= 62, 66 Number Analyzed 62 participants 66 participants
-4.3  (7.07) -2.6  (7.33)
MCHC; Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
-6.6  (8.19) -3.6  (7.56)
MCHC; Week 36; n= 60, 66 Number Analyzed 60 participants 66 participants
-4.7  (8.05) -3.3  (8.37)
MCHC; Week 40; n= 61, 65 Number Analyzed 61 participants 65 participants
-4.5  (8.04) -3.2  (8.96)
MCHC; Week 44; n= 60, 64 Number Analyzed 60 participants 64 participants
-4.7  (8.51) -4.5  (9.40)
MCHC; Week 48; n= 59, 64 Number Analyzed 59 participants 64 participants
-6.0  (8.03) -4.8  (10.56)
MCHC; Week 52; n= 60, 64 Number Analyzed 60 participants 64 participants
-5.2  (7.79) -5.3  (7.72)
MCHC; Week 56; n= 59, 61 Number Analyzed 59 participants 61 participants
-6.9  (7.74) -5.3  (7.47)
MCHC; Week 60; n= 59, 64 Number Analyzed 59 participants 64 participants
-7.5  (7.41) -4.7  (9.90)
Absolute Hemoglobin; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
141.6  (12.67) 140.6  (12.99)
Hemoglobin; Week 4; n= 66, 67 Number Analyzed 66 participants 67 participants
-2.3  (6.86) -1.8  (6.43)
Hemoglobin; Week 8; n= 66, 66 Number Analyzed 66 participants 66 participants
-2.5  (7.56) -1.1  (6.28)
Hemoglobin; Week 12; n= 63, 65 Number Analyzed 63 participants 65 participants
-1.6  (8.28) -2.2  (7.17)
Hemoglobin; Week 16; n= 64, 68 Number Analyzed 64 participants 68 participants
-1.6  (8.24) -1.9  (7.64)
Hemoglobin; Week 20; n= 61, 68 Number Analyzed 61 participants 68 participants
-0.3  (6.85) -1.4  (7.64)
Hemoglobin; Week 24; n= 62, 66 Number Analyzed 62 participants 66 participants
-1.1  (8.06) -1.6  (8.51)
Hemoglobin; Week 28; n= 62, 66 Number Analyzed 62 participants 66 participants
-1.3  (7.48) -1.3  (8.94)
Hemoglobin; Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
-1.3  (8.03) -1.6  (9.22)
Hemoglobin; Week 36; n= 60, 66 Number Analyzed 60 participants 66 participants
-0.2  (8.50) -0.4  (10.23)
Hemoglobin; Week 40; n= 61, 65 Number Analyzed 61 participants 65 participants
0.1  (8.35) -0.9  (9.74)
Hemoglobin; Week 44; n= 60, 64 Number Analyzed 60 participants 64 participants
0.7  (9.59) -1.9  (10.47)
Hemoglobin; Week 48; n= 59, 64 Number Analyzed 59 participants 64 participants
0.5  (8.20) -1.9  (11.07)
Hemoglobin; Week 52; n= 60, 64 Number Analyzed 60 participants 64 participants
0.1  (8.57) -1.9  (10.36)
Hemoglobin; Week 56; n= 59, 61 Number Analyzed 59 participants 61 participants
-1.5  (9.92) -1.9  (11.48)
Hemoglobin; Week 60; n= 59, 64 Number Analyzed 59 participants 64 participants
-1.8  (9.86) -2.4  (11.36)
17.Secondary Outcome
Title Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels
Hide Description Blood samples were collected to evaluate change from Baseline in MCV values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time Frame Baseline and up to Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Mepolizumab 300mg
Hide Arm/Group Description:
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Mean (Standard Deviation)
Unit of Measure: femtoliter (fL)
Absolute, Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
94.8  (9.02) 94.8  (6.14)
Week 4; n= 66, 67 Number Analyzed 66 participants 67 participants
0.4  (1.67) 0.0  (2.33)
Week 8; n= 66, 66 Number Analyzed 66 participants 66 participants
0.3  (2.50) 0.0  (2.58)
Week 12; n= 63, 65 Number Analyzed 63 participants 65 participants
0.2  (2.00) -0.7  (2.30)
Week 16; n= 64, 68 Number Analyzed 64 participants 68 participants
0.0  (2.22) -0.4  (2.94)
Week 20; n= 61, 68 Number Analyzed 61 participants 68 participants
-0.3  (1.87) -0.9  (2.66)
Week 24; n= 62, 66 Number Analyzed 62 participants 66 participants
-0.5  (2.21) -1.0  (2.92)
Week 28; n= 62, 66 Number Analyzed 62 participants 66 participants
-0.4  (2.86) -1.4  (3.48)
Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
-0.2  (3.01) -1.7  (3.56)
Week 36; n= 60, 66 Number Analyzed 60 participants 66 participants
-0.5  (3.55) -1.9  (3.74)
Week 40; n= 61, 65 Number Analyzed 61 participants 65 participants
-0.9  (4.09) -1.4  (3.73)
Week 44; n= 60, 64 Number Analyzed 60 participants 64 participants
-1.2  (5.06) -1.5  (3.91)
Week 48; n= 59, 64 Number Analyzed 59 participants 64 participants
-1.1  (5.96) -1.5  (4.04)
Week 52; n= 60, 64 Number Analyzed 60 participants 64 participants
-0.8  (6.52) -1.3  (4.29)
Week 56; n= 59, 61 Number Analyzed 59 participants 61 participants
-0.5  (6.47) -1.0  (4.15)
Week 60; n= 59, 64 Number Analyzed 59 participants 64 participants
-0.6  (6.57) -1.0  (4.49)
18.Secondary Outcome
Title Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels
Hide Description Blood samples were collected to evaluate change from Baseline in MCH values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time Frame Baseline and up to Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Mepolizumab 300mg
Hide Arm/Group Description:
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Mean (Standard Deviation)
Unit of Measure: Picogram (pg)
Absolute, Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
30.77  (2.902) 30.77  (2.255)
Week 4; n= 66, 67 Number Analyzed 66 participants 67 participants
0.04  (0.331) -0.12  (0.785)
Week 8; n= 66, 66 Number Analyzed 66 participants 66 participants
-0.02  (0.950) -0.16  (0.653)
Week 12; n= 63, 65 Number Analyzed 63 participants 65 participants
-0.04  (0.550) -0.17  (0.769)
Week 16; n= 64, 68 Number Analyzed 64 participants 68 participants
-0.21  (0.845) -0.34  (0.769)
Week 20; n= 61, 68 Number Analyzed 61 participants 68 participants
-0.28  (0.665) -0.41  (0.851)
Week 24; n= 62, 66 Number Analyzed 62 participants 66 participants
-0.45  (1.270) -0.59  (0.959)
Week 28; n= 62, 66 Number Analyzed 62 participants 66 participants
-0.51  (0.618) -0.70  (1.184)
Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
-0.66  (0.764) -0.88  (1.368)
Week 36; n= 60, 66 Number Analyzed 60 participants 66 participants
-0.60  (0.910) -0.90  (1.395)
Week 40; n= 61, 65 Number Analyzed 61 participants 65 participants
-0.67  (1.171) -0.79  (1.390)
Week 44; n= 60, 64 Number Analyzed 60 participants 64 participants
-0.78  (1.566) -0.95  (1.484)
Week 48; n= 59, 64 Number Analyzed 59 participants 64 participants
-0.87  (1.745) -0.96  (1.654)
Week 52; n= 60, 64 Number Analyzed 60 participants 64 participants
-0.69  (1.908) -0.95  (1.585)
Week 56; n= 59, 61 Number Analyzed 59 participants 61 participants
-0.79  (2.056) -0.83  (1.713)
Week 60; n= 59, 64 Number Analyzed 59 participants 64 participants
-0.86  (2.094) -0.80  (1.818)
19.Secondary Outcome
Title Change From Baseline in Hematology Parameters of Erythrocytes Levels
Hide Description Blood samples were collected to evaluate change from Baseline in erythrocytes values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time Frame Baseline and up to Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Mepolizumab 300mg
Hide Arm/Group Description:
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Mean (Standard Deviation)
Unit of Measure: 10^12 cells/L
Absolute, Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
4.64  (0.511) 4.58  (0.456)
Week 4; n= 66, 67 Number Analyzed 66 participants 67 participants
-0.07  (0.228) -0.03  (0.226)
Week 8; n= 66, 66 Number Analyzed 66 participants 66 participants
-0.07  (0.278) -0.01  (0.211)
Week 12; n= 63, 65 Number Analyzed 63 participants 65 participants
-0.04  (0.273) -0.04  (0.252)
Week 16; n= 64, 68 Number Analyzed 64 participants 68 participants
-0.02  (0.266) -0.01  (0.243)
Week 20; n= 61, 68 Number Analyzed 61 participants 68 participants
0.03  (0.243) 0.03  (0.252)
Week 24; n= 62, 66 Number Analyzed 62 participants 66 participants
0.02  (0.252) 0.05  (0.265)
Week 28; n= 62, 66 Number Analyzed 62 participants 66 participants
0.03  (0.286) 0.08  (0.264)
Week 32; n= 61, 67 Number Analyzed 61 participants 67 participants
0.06  (0.300) 0.09  (0.273)
Week 36; n= 60, 66 Number Analyzed 60 participants 66 participants
0.08  (0.314) 0.14  (0.299)
Week 40; n= 61, 65 Number Analyzed 61 participants 65 participants
0.09  (0.274) 0.09  (0.270)
Week 44; n= 60, 64 Number Analyzed 60 participants 64 participants
0.13  (0.332) 0.08  (0.260)
Week 48; n= 59, 64 Number Analyzed 59 participants 64 participants
0.14  (0.293) 0.10  (0.271)
Week 52; n= 60, 64 Number Analyzed 60 participants 64 participants
0.10  (0.309) 0.09  (0.251)
Week 56; n= 59, 61 Number Analyzed 59 participants 61 participants
0.06  (0.365) 0.07  (0.284)
Week 60; n= 59, 64 Number Analyzed 59 participants 64 participants
0.07  (0.384) 0.05  (0.318)
20.Secondary Outcome
Title Number of Participants With Anti-Mepolizumab Antibodies
Hide Description Blood samples were collected for the determination of anti-Mepolizumab antibodies. Participants who showed presence of anti-Mepolizumab antibody were termed as 'positive' and those who did not have anti-Mepolizumab antibody in blood sample were termed as 'negative'. Participants who did not have a positive ADA assay prior to the first dose of investigational product were included in the analysis.
Time Frame Up to Week 60
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Safety Population
Arm/Group Title Placebo Mepolizumab 300mg
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Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 67 66
Measure Type: Number
Unit of Measure: Participants
Negative 66 65
Positive 1 1
21.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels
Hide Description SBP and DBP were measured from Baseline throughout follow-up (till Week 60) before injection with the participant sitting, having rested in this position for at least 5 minutes before reading. The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time Frame Baseline up to Week 60
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Safety Population
Arm/Group Title Placebo Mepolizumab 300mg
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Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mm of Hg)
Absolute SBP; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
127.46  (17.794) 122.46  (14.134)
SBP; Week 4; n= 68, 68 Number Analyzed 68 participants 68 participants
0.47  (15.865) 0.93  (12.370)
SBP; Week 8; n= 67, 68 Number Analyzed 67 participants 68 participants
0.07  (14.192) 1.29  (11.066)
SBP; Week 12; n= 66, 68 Number Analyzed 66 participants 68 participants
-1.12  (14.380) -1.41  (12.071)
SBP; Week 16; n= 64, 68 Number Analyzed 64 participants 68 participants
-0.97  (16.630) -0.41  (11.579)
SBP; Week 20; n= 63, 68 Number Analyzed 63 participants 68 participants
-0.97  (15.028) -0.85  (12.019)
SBP; Week 24; n= 63, 67 Number Analyzed 63 participants 67 participants
-1.54  (15.449) -1.57  (12.824)
SBP; Week 28; n= 63, 67 Number Analyzed 63 participants 67 participants
-0.06  (14.337) -0.15  (13.240)
SBP; Week 32; n= 62, 67 Number Analyzed 62 participants 67 participants
-2.35  (14.027) 0.04  (11.181)
SBP; Week 36; n= 62, 67 Number Analyzed 62 participants 67 participants
1.02  (14.663) 0.48  (14.397)
SBP; Week 40; n= 62, 66 Number Analyzed 62 participants 66 participants
0.90  (14.202) 1.27  (12.075)
SBP; Week 44; n= 61, 66 Number Analyzed 61 participants 66 participants
1.41  (16.143) -0.36  (13.694)
SBP; Week 48; n= 61, 65 Number Analyzed 61 participants 65 participants
-0.41  (17.140) -0.22  (12.351)
SBP: Week 52; n= 61, 65 Number Analyzed 61 participants 65 participants
-1.03  (13.200) -0.32  (13.091)
SBP; Week 56; n= 62, 63 Number Analyzed 62 participants 63 participants
0.06  (15.216) 1.02  (13.559)
SBP; Week 60; n= 61, 65 Number Analyzed 61 participants 65 participants
0.61  (15.627) -0.63  (11.656)
Absolute DBP; Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
80.21  (10.127) 76.22  (9.646)
DBP; Week 4; n= 68, 68 Number Analyzed 68 participants 68 participants
-2.26  (10.046) 1.01  (10.130)
DBP; Week 8; n= 67, 68 Number Analyzed 67 participants 68 participants
-2.04  (8.461) -0.34  (10.078)
DBP; Week 12; n= 66, 68 Number Analyzed 66 participants 68 participants
-1.92  (10.115) -0.37  (9.167)
DBP; Week 16; n= 64, 68 Number Analyzed 64 participants 68 participants
-1.36  (10.237) 0.46  (9.824)
DBP; Week 20; n= 63, 68 Number Analyzed 63 participants 68 participants
-1.25  (8.092) -1.19  (9.214)
DBP; Week 24; n= 63, 67 Number Analyzed 63 participants 67 participants
-2.24  (8.751) -1.16  (9.629)
DBP; Week 28; n= 63, 67 Number Analyzed 63 participants 67 participants
-2.02  (9.939) 0.36  (10.071)
DBP; Week 32; n= 62, 67 Number Analyzed 62 participants 67 participants
-4.27  (9.313) -0.49  (10.652)
DBP; Week 36; n= 62, 67 Number Analyzed 62 participants 67 participants
-1.97  (10.995) 0.16  (10.988)
DBP; Week 40; n= 62, 66 Number Analyzed 62 participants 66 participants
-0.48  (9.625) -0.03  (8.868)
DBP; Week 44; n= 61, 66 Number Analyzed 61 participants 66 participants
-0.79  (9.930) -1.03  (9.595)
DBP; Week 48; n= 61, 65 Number Analyzed 61 participants 65 participants
-3.26  (10.466) -1.71  (9.239)
DBP; Week 52; n= 61, 65 Number Analyzed 61 participants 65 participants
-3.66  (10.628) -0.06  (9.236)
DBP; Week 56; n= 62, 63 Number Analyzed 62 participants 63 participants
-3.48  (10.570) 0.11  (8.899)
DBP; Week 60; n= 61, 65 Number Analyzed 68 participants 68 participants
-2.54  (11.278) -0.45  (9.836)
22.Secondary Outcome
Title Change From Baseline in Pulse Rate
Hide Description Pulse rate was measured from Baseline throughout follow-up (till Week 60) before injection with the participant sitting, having rested in this position for at least 5 minutes before reading. The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time Frame Baseline and up to Week 60
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Safety Population
Arm/Group Title Placebo Mepolizumab 300mg
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Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Mean (Standard Deviation)
Unit of Measure: beats per minute (bpm)
Absolute Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
77.38  (13.763) 75.75  (10.404)
Week 4; n= 68, 68 Number Analyzed 68 participants 68 participants
2.01  (12.294) 1.87  (10.543)
Week 8; n= 67, 68 Number Analyzed 67 participants 68 participants
0.97  (10.718) -1.01  (10.304)
Week 12; n= 66, 68 Number Analyzed 66 participants 68 participants
1.52  (12.393) -0.12  (10.855)
Week 16; n= 64, 68 Number Analyzed 64 participants 68 participants
0.59  (11.287) 0.44  (11.411)
Week 20; n= 63, 68 Number Analyzed 63 participants 68 participants
1.03  (11.521) -0.56  (9.687)
Week 24; n= 63, 67 Number Analyzed 63 participants 67 participants
0.79  (12.134) 0.37  (10.057)
Week 28; n= 62, 67 Number Analyzed 62 participants 67 participants
1.29  (10.439) 0.16  (10.093)
Week 32; n= 62, 67 Number Analyzed 62 participants 67 participants
1.60  (11.703) -0.31  (10.530)
Week 36; n= 62, 67 Number Analyzed 62 participants 67 participants
3.47  (12.538) -0.57  (11.422)
Week 40; n= 62, 66 Number Analyzed 62 participants 66 participants
2.65  (12.297) 0.74  (11.669)
Week 44; n= 61, 66 Number Analyzed 61 participants 66 participants
3.10  (12.195) 0.15  (12.763)
Week 48; n= 61, 65 Number Analyzed 61 participants 65 participants
3.85  (12.383) -1.12  (10.315)
Week 52; n= 61, 65 Number Analyzed 61 participants 65 participants
1.85  (11.987) -2.17  (9.596)
Week 56; n= 62, 63 Number Analyzed 62 participants 63 participants
2.60  (14.041) -0.35  (9.986)
Week 60; n= 61, 65 Number Analyzed 61 participants 65 participants
1.51  (12.793) 0.09  (10.280)
23.Secondary Outcome
Title Change From Baseline in Body Temperature
Hide Description Body temperature was measured from Baseline throughout follow-up (till Week 60). The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. The analysis was performed on Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time Frame Baseline and up to Week 60
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Safety Population
Arm/Group Title Placebo Mepolizumab 300mg
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Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Mean (Standard Deviation)
Unit of Measure: Degree celsius
Absolute Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
36.52  (0.385) 36.51  (0.462)
Week 4; n= 68, 68 Number Analyzed 68 participants 68 participants
0.05  (0.439) -0.04  (0.411)
Week 8; n= 67,68 Number Analyzed 67 participants 68 participants
-0.01  (0.379) -0.02  (0.425)
Week 12; n= 66, 68 Number Analyzed 66 participants 68 participants
0.05  (0.410) -0.03  (0.447)
Week 16; n= 64, 68 Number Analyzed 64 participants 68 participants
-0.01  (0.421) -0.03  (0.432)
Week 20; n= 63, 68 Number Analyzed 63 participants 68 participants
-0.08  (0.351) -0.13  (0.376)
Week 24; n= 62, 67 Number Analyzed 62 participants 67 participants
-0.06  (0.449) -0.06  (0.389)
Week 28; n= 63, 67 Number Analyzed 63 participants 67 participants
-0.06  (0.499) -0.14  (0.411)
Week 32; n= 62, 67 Number Analyzed 62 participants 67 participants
-0.09  (0.392) -0.07  (0.355)
Week 36; n= 62, 67 Number Analyzed 62 participants 67 participants
-0.05  (0.431) 0.03  (0.468)
Week 40; n= 62, 66 Number Analyzed 62 participants 66 participants
-0.03  (0.530) -0.13  (0.406)
Week 44; n= 61, 65 Number Analyzed 61 participants 65 participants
-0.03  (0.550) -0.08  (0.396)
Week 48; n= 61, 64 Number Analyzed 61 participants 64 participants
-0.04  (0.452) -0.09  (0.414)
Week 52; n= 60, 65 Number Analyzed 60 participants 65 participants
-0.04  (0.423) -0.12  (0.541)
Week 56; n= 61, 63 Number Analyzed 61 participants 63 participants
-0.08  (0.530) -0.00  (0.402)
Week 60; n= 61, 64 Number Analyzed 61 participants 64 participants
0.03  (0.467) -0.02  (0.479)
24.Secondary Outcome
Title Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values
Hide Description Single measurements of 12-lead electrocardiogram (ECGs) were obtained after 5 minutes rest in a supine position at Baseline throughout the 52 weeks treatment period and 8 weeks follow-up period using an ECG machine. Mean change from Baseline in QTcF and QTcB values were measured. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Baseline and up to Week 60
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Safety Population
Arm/Group Title Placebo Mepolizumab 300mg
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Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Mean (Standard Deviation)
Unit of Measure: milliseconds (msec)
QTcF; Week 8; n= 66, 66 Number Analyzed 66 participants 66 participants
0.1  (17.90) 1.0  (15.03)
QTcF; Week 16; n= 64, 66 Number Analyzed 64 participants 66 participants
0.8  (15.26) 0.2  (14.05)
QTcF; Week 24; n= 60, 66 Number Analyzed 60 participants 66 participants
2.8  (14.43) 1.9  (16.66)
QTcF; Week 32; n= 61, 66 Number Analyzed 61 participants 66 participants
6.2  (25.19) 1.5  (17.16)
QTcF; Week 40; n= 61, 65 Number Analyzed 61 participants 65 participants
-0.5  (15.25) -0.3  (17.53)
QTcF; Week 52; n= 58, 64 Number Analyzed 58 participants 64 participants
2.0  (15.96) 3.0  (16.04)
QTcF; Week 60; n= 58, 63 Number Analyzed 58 participants 63 participants
3.0  (14.30) 2.9  (14.97)
QTcF; Any time post Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
16.9  (23.74) 15.4  (13.79)
QTcB; Week 8; n= 66, 66 Number Analyzed 66 participants 66 participants
-0.8  (19.05) 0.9  (17.31)
QTcB; Week 16; n= 64, 66 Number Analyzed 64 participants 66 participants
-0.1  (18.33) -0.9  (14.76)
QTcB; Week 24; n= 60, 66 Number Analyzed 60 participants 66 participants
1.4  (17.89) 1.0  (18.10)
QTcB; Week 32; n= 61, 66 Number Analyzed 61 participants 66 participants
5.2  (29.63) 0.0  (19.63)
QTcB; Week 40; n= 61, 65 Number Analyzed 61 participants 65 participants
-0.6  (17.83) -1.4  (18.88)
QTcB; Week 52; n= 58, 64 Number Analyzed 58 participants 64 participants
1.8  (17.64) 0.7  (18.27)
QTcB; Week 60; n= 58, 63 Number Analyzed 58 participants 63 participants
1.2  (16.56) 2.7  (17.27)
QTcB; Any time post Baseline; n= 68, 68 Number Analyzed 68 participants 68 participants
18.8  (26.46) 18.1  (15.28)
25.Secondary Outcome
Title Maximum Change From Baseline in QTcF and QTcB Values
Hide Description Single measurements of 12-lead ECGs were obtained after 5 minutes rest in a supine position at Baseline throughout the 52 weeks treatment period and 8 weeks follow-up period using an ECG machine. Maximum change from Baseline in QTcF and QTcB values were measured.
Time Frame Baseline and up to Week 60
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Safety Population
Arm/Group Title Placebo Mepolizumab 300mg
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Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Overall Number of Participants Analyzed 68 68
Mean (Standard Deviation)
Unit of Measure: msec
QTcB interval 18.8  (26.46) 18.1  (15.28)
QTcF interval 16.9  (23.74) 15.4  (13.79)
Time Frame On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
Adverse Event Reporting Description AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
 
Arm/Group Title Placebo Mepolizumab 300mg
Hide Arm/Group Description Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48. Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
All-Cause Mortality
Placebo Mepolizumab 300mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/68 (0.00%)   1/68 (1.47%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Mepolizumab 300mg
Affected / at Risk (%) Affected / at Risk (%)
Total   18/68 (26.47%)   12/68 (17.65%) 
Cardiac disorders     
Cardiac arrest  1  0/68 (0.00%)  1/68 (1.47%) 
Coronary artery disease  1  1/68 (1.47%)  0/68 (0.00%) 
Stress cardiomyopathy  1  1/68 (1.47%)  0/68 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  0/68 (0.00%)  1/68 (1.47%) 
General disorders     
Hernia  1  0/68 (0.00%)  1/68 (1.47%) 
Pyrexia  1  1/68 (1.47%)  0/68 (0.00%) 
Immune system disorders     
Allergic granulomatous angiitis  1  1/68 (1.47%)  0/68 (0.00%) 
Hypersensitivity  1  0/68 (0.00%)  1/68 (1.47%) 
Infections and infestations     
Influenza  1  2/68 (2.94%)  0/68 (0.00%) 
Pneumonia  1  2/68 (2.94%)  0/68 (0.00%) 
Appendicitis  1  1/68 (1.47%)  0/68 (0.00%) 
Bronchitis  1  1/68 (1.47%)  0/68 (0.00%) 
Cellulitis  1  1/68 (1.47%)  0/68 (0.00%) 
Corona virus infection  1  1/68 (1.47%)  0/68 (0.00%) 
Enterococcal infection  1  0/68 (0.00%)  1/68 (1.47%) 
Gastroenteritis  1  1/68 (1.47%)  0/68 (0.00%) 
Herpes zoster  1  1/68 (1.47%)  0/68 (0.00%) 
Lower respiratory infection  1  2/68 (2.94%)  0/68 (0.00%) 
Parainfluenzae virus infection  1  0/68 (0.00%)  1/68 (1.47%) 
Perirectal abscess  1  0/68 (0.00%)  1/68 (1.47%) 
Pneumonia bacterial  1  1/68 (1.47%)  0/68 (0.00%) 
Respiratory tract infection  1  0/68 (0.00%)  1/68 (1.47%) 
Urinary tract infection  1  0/68 (0.00%)  1/68 (1.47%) 
Injury, poisoning and procedural complications     
Road traffic accident  1  1/68 (1.47%)  0/68 (0.00%) 
Spinal fracture  1  1/68 (1.47%)  0/68 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/68 (0.00%)  1/68 (1.47%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Testis cancer  1  1/68 (1.47%)  0/68 (0.00%) 
Nervous system disorders     
Cerebellar ischaemia  1  0/68 (0.00%)  1/68 (1.47%) 
Dizziness  1  0/68 (0.00%)  1/68 (1.47%) 
Facial paralysis  1  1/68 (1.47%)  0/68 (0.00%) 
Facial paresis  1  0/68 (0.00%)  1/68 (1.47%) 
Lacunar infarction  1  0/68 (0.00%)  1/68 (1.47%) 
Nystagmus  1  0/68 (0.00%)  1/68 (1.47%) 
Pachymeningitis  1  0/68 (0.00%)  1/68 (1.47%) 
Toxic encephalopathy  1  1/68 (1.47%)  0/68 (0.00%) 
Psychiatric disorders     
Mental status changes  1  1/68 (1.47%)  0/68 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  1/68 (1.47%)  0/68 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  4/68 (5.88%)  2/68 (2.94%) 
Acute respiratory failure  1  2/68 (2.94%)  0/68 (0.00%) 
Lung infiltration  1  1/68 (1.47%)  0/68 (0.00%) 
Pneumonia aspiration  1  1/68 (1.47%)  0/68 (0.00%) 
Respiratory failure  1  1/68 (1.47%)  0/68 (0.00%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Placebo Mepolizumab 300mg