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Trial record 37 of 154 for:    Dermatitis, Atopic, 8

Efficacy and Safety Study of Mepolizumab in Subjects With Moderate to Severe Atopic Dermatitis

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: NCT03055195
Recruitment Status : Terminated (Study reached pre-determined futility criteria following interim analysis. No safety concerns were noted.)
First Posted : February 16, 2017
Results First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Dermatitis, Atopic
Interventions Drug: Mepolizumab 100 mg
Drug: Placebo matching mepolizumab
Enrollment 34
Recruitment Details This study investigated the efficacy and safety of mepolizumab administered subcutaneously (SC) in adults with moderate to severe atopic dermatitis. A total of 34 participants were enrolled at different centers in Canada and United States.
Pre-assignment Details This study was terminated early, as this study reached pre-determined futility criteria following interim analysis.
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks. Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Period Title: Overall Study
Started 16 18
Completed 4 4
Not Completed 12 14
Reason Not Completed
Lack of Efficacy             1             0
Withdrawal by Subject             6             7
Study Terminated by Sponsor             2             6
Protocol Violation             2             1
Physician Decision             1             0
Arm/Group Title Placebo SC Mepolizumab 100 mg SC Total
Hide Arm/Group Description Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks. Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks. Total of all reporting groups
Overall Number of Baseline Participants 16 18 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 18 participants 34 participants
30.8  (9.95) 34.6  (13.99) 32.8  (12.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 18 participants 34 participants
Female
7
  43.8%
6
  33.3%
13
  38.2%
Male
9
  56.3%
12
  66.7%
21
  61.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 18 participants 34 participants
Asian - Central/South Asian Heritage
1
   6.3%
1
   5.6%
2
   5.9%
Asian - East Asian Heritage
5
  31.3%
4
  22.2%
9
  26.5%
Asian - Japanese Heritage
1
   6.3%
0
   0.0%
1
   2.9%
Asian - South East Asian Heritage
2
  12.5%
2
  11.1%
4
  11.8%
Black Or African American
2
  12.5%
1
   5.6%
3
   8.8%
White - White/Caucasian/European Heritage
5
  31.3%
10
  55.6%
15
  44.1%
1.Primary Outcome
Title Number of Participants With an Investigator’s Global Assessment (IGA) Score of 0 or 1 and at Least a 2- Grade Improvement at Week 16
Hide Description The IGA is a clinical tool for assessing the current state/severity of a participant's atopic dermatitis . It is a static 5-point morphological assessment of overall disease severity determined by the investigator, sub-investigator, or trained healthcare professional with required qualifications on a scale of 0 to 4 where, 0-clear, 1-almost clear, 2-mild, 3-moderate, and 4- severe. Higher score indicates severity of disease. A responder is defined as a participant who had an IGA score of 0 or 1 and a minimum 2-grade improvement from Baseline. Number of participants with IGA score of 0 or 1 and at least a 2- grade improvement at Week 16 was presented.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population comprised of all participants who were randomized and who received at least one dose of study treatment.
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 16 18
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2
  11.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo SC, Mepolizumab 100 mg SC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportions Difference
Estimated Value 11
Confidence Interval (2-Sided) 90%
-1.1 to 23.3
Estimation Comments Difference in Proportions between Mepolizumab 100 mg SC versus Placebo SC has been presented.
2.Secondary Outcome
Title Mean Percentage Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Study Visit
Hide Description EASI scoring system is a standardized clinical tool for the assessment of atopic dermatitis that takes into account overall extent of the percent body surface area (% BSA) involved and severity scores for each clinical signs (erythema, induration/papulation, excoriation, and lichenification). Severity scores were graded on a 4-point scale, 0(absent) to 3(severe) for each body regions (head and neck, upper extremities, lower extremities, and trunk). The severity scores for each signs were summed for each region and multiplied by the % BSA area score and by the appropriate proportionality multiplier (for participants >=8 years of age, 0.1 for head, 0.2 upper extremities, 0.3 for trunk and 0.4 for lower extremities) to generate a regional EASI score. The regional EASI scores were then summed to yield the final EASI score. Baseline is defined as latest pre-dose assessment. Percent change from Baseline is Post-Baseline Visit Value minus Baseline, divided by Baseline and multiplied by 100.
Time Frame Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 16 18
Mean (Standard Deviation)
Unit of Measure: Percent change
Week 4, n=16, 17 Number Analyzed 16 participants 17 participants
-22.508  (30.2511) -24.556  (45.4823)
Week 8,n=15, 16 Number Analyzed 15 participants 16 participants
-30.497  (29.0671) -43.904  (43.4749)
Week 12, n= 11, 11 Number Analyzed 11 participants 11 participants
-22.372  (31.7156) -42.464  (49.2445)
Week 16, n=8, 6 Number Analyzed 8 participants 6 participants
-32.269  (27.8121) -31.921  (50.0658)
Week 20, n=4, 4 Number Analyzed 4 participants 4 participants
1.327  (32.5577) -63.938  (34.2710)
3.Secondary Outcome
Title Number of Participants With an IGA Score of 0 or 1 and at Least a 2-grade Improvement at Each Study Visit
Hide Description The IGA is a clinical tool for assessing the current state/severity of a participant's atopic dermatitis . It is a static 5-point morphological assessment of overall disease severity determined by the investigator, sub-investigator, or trained healthcare professional with required qualifications on a scale of 0 to 4 where, 0-clear, 1-almost clear, 2-mild, 3-moderate, and 4- severe. Higher score indicates severity of disease. A Responder is defined as a participant who had an IGA score of 0 or 1 and a minimum 2-grade improvement from Baseline. Participants withdrawn early from the study were assigned to be a non-responder for all weeks after withdrawal. Number of participants with IGA score of 0 or 1 and at least a 2- grade improvement at each study visit (Weeks 4, 8, 12, 16 and 20) is presented.
Time Frame Weeks 4, 8, 12, 16 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 16 18
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4
1
   6.3%
1
   5.6%
Week 8
0
   0.0%
2
  11.1%
Week 12
0
   0.0%
2
  11.1%
Week 16
0
   0.0%
2
  11.1%
Week 20
0
   0.0%
1
   5.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo SC, Mepolizumab 100 mg SC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion Difference
Estimated Value -1
Confidence Interval (2-Sided) 90%
-14.0 to 12.6
Estimation Comments Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 4 has been presented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo SC, Mepolizumab 100 mg SC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion Difference
Estimated Value 11
Confidence Interval (2-Sided) 90%
-1.1 to 23.3
Estimation Comments Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 8 has been presented.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo SC, Mepolizumab 100 mg SC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion Difference
Estimated Value 11
Confidence Interval (2-Sided) 90%
-1.1 to 23.3
Estimation Comments Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 12 has been presented.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo SC, Mepolizumab 100 mg SC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion Difference
Estimated Value 11
Confidence Interval (2-Sided) 90%
-1.1 to 23.3
Estimation Comments Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 16 has been presented.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo SC, Mepolizumab 100 mg SC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion Difference
Estimated Value 6
Confidence Interval (2-Sided) 90%
-3.3 to 14.4
Estimation Comments Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 20 has been presented.
4.Secondary Outcome
Title Number of Participants With On-treatment Adverse Events (AEs), Serious Adverse Events (SAEs) and Non-serious Adverse Events (nSAEs)
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. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. On-treatment AES were reported on or after treatment start date and on or before treatment stop date (plus 28 days). Number of participants with AEs, SAEs and nSAEs is presented.
Time Frame Up to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population comprised of all participants who received at least one dose of a study treatment. One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 15 19
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE
7
  46.7%
1
   5.3%
Any SAE
0
   0.0%
0
   0.0%
Any nSAE
7
  46.7%
1
   5.3%
5.Secondary Outcome
Title Number of Participants With On-treatment AEs of Special Interest Reported as Local Site Injection Reaction and Systemic Reactions
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. Number of participants with local site injection reaction and systemic reactions were reported.
Time Frame Up to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 15 19
Measure Type: Count of Participants
Unit of Measure: Participants
Local site injection reaction
0
   0.0%
0
   0.0%
Systemic reaction
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Hide Description Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 15 19
Mean (Standard Deviation)
Unit of Measure: Billion cells per liter (10^9/L)
Basophils, Week 4, n=15,17 Number Analyzed 15 participants 17 participants
0.000  (0.0146) -0.021  (0.0293)
Basophils, Week 8, n=12,17 Number Analyzed 12 participants 17 participants
0.013  (0.0234) -0.018  (0.0282)
Basophils, Week 12, n=10,11 Number Analyzed 10 participants 11 participants
0.007  (0.0164) -0.010  (0.0219)
Basophils, Week 16, n=7,7 Number Analyzed 7 participants 7 participants
-0.006  (0.0190) -0.001  (0.0195)
Basophils, Week 20, n=3,4 Number Analyzed 3 participants 4 participants
0.000  (0.0100) -0.008  (0.0150)
Eosinophils, Week 4, n=15,17 Number Analyzed 15 participants 17 participants
-0.028  (0.5179) -0.567  (0.2498)
Eosinophils, Week 8, n=12,17 Number Analyzed 12 participants 17 participants
-0.193  (0.3991) -0.601  (0.2820)
Eosinophils, Week 12, n=10,11 Number Analyzed 10 participants 11 participants
-0.086  (0.2866) -0.605  (0.3668)
Eosinophils, Week 16, n=7,7 Number Analyzed 7 participants 7 participants
0.000  (0.3354) -0.517  (0.4007)
Eosinophils, Week 20, n=3,4 Number Analyzed 3 participants 4 participants
0.173  (0.7247) -0.438  (0.3721)
Leukocytes, Week 4, n=15,17 Number Analyzed 15 participants 17 participants
-0.01  (1.307) -0.75  (1.471)
Leukocytes, Week 8, n=12,17 Number Analyzed 12 participants 17 participants
-0.23  (1.393) -0.77  (1.162)
Leukocytes, Week 12, n=10,11 Number Analyzed 10 participants 11 participants
0.68  (1.466) -0.59  (2.257)
Leukocytes, Week 16, n=7,7 Number Analyzed 7 participants 7 participants
0.37  (1.053) -0.44  (1.427)
Leukocytes, Week 20, n=3,4 Number Analyzed 3 participants 4 participants
-0.10  (0.866) -1.12  (1.372)
Lymphocytes, Week 4, n=15,17 Number Analyzed 15 participants 17 participants
0.001  (0.3654) -0.104  (0.4309)
Lymphocytes, Week 8, n=12,17 Number Analyzed 12 participants 17 participants
0.046  (0.5113) -0.140  (0.4461)
Lymphocytes, Week 12, n=10,11 Number Analyzed 10 participants 11 participants
-0.127  (0.5121) -0.057  (0.3453)
Lymphocytes, Week 16, n=7,7 Number Analyzed 7 participants 7 participants
0.409  (0.8914) -0.051  (0.2543)
Lymphocytes, Week 20, n=3,4 Number Analyzed 3 participants 4 participants
0.240  (0.4251) -0.095  (0.1638)
Monocytes, Week 4, n=15,17 Number Analyzed 15 participants 17 participants
0.057  (0.1247) -0.011  (0.1508)
Monocytes, Week 8, n=12,17 Number Analyzed 12 participants 17 participants
0.028  (0.1207) -0.090  (0.1634)
Monocytes, Week 12, n=10,11 Number Analyzed 10 participants 11 participants
0.029  (0.1347) -0.070  (0.1532)
Monocytes, Week 16, n=7,7 Number Analyzed 7 participants 7 participants
0.039  (0.1206) 0.017  (0.0939)
Monocytes, Week 20, n=3,4 Number Analyzed 3 participants 4 participants
0.073  (0.2641) 0.010  (0.1268)
Neutrophils, Week 4, n=15,17 Number Analyzed 15 participants 17 participants
-0.029  (1.2133) -0.062  (1.3958)
Neutrophils, Week 8, n=12,17 Number Analyzed 12 participants 17 participants
-0.103  (1.3031) 0.068  (0.8773)
Neutrophils, Week 12, n=10,11 Number Analyzed 10 participants 11 participants
0.864  (1.8011) 0.130  (1.9898)
Neutrophils, Week 16, n=7,7 Number Analyzed 7 participants 7 participants
-0.089  (1.2211) 0.104  (1.0966)
Neutrophils, Week 20, n=3,4 Number Analyzed 3 participants 4 participants
-0.577  (0.5387) -0.587  (1.3189)
Platelets, Week 4, n=15,18 Number Analyzed 15 participants 18 participants
2.6  (30.86) -4.8  (35.02)
Platelets, Week 8, n=12,17 Number Analyzed 12 participants 17 participants
1.3  (45.31) 7.5  (36.83)
Platelets, Week 12, n=10,11 Number Analyzed 10 participants 11 participants
-4.5  (36.92) -16.8  (23.34)
Platelets, Week 16, n=7,7 Number Analyzed 7 participants 7 participants
1.4  (29.73) -27.7  (38.87)
Platelets, Week 20, n=3,4 Number Analyzed 3 participants 4 participants
11.3  (15.57) -14.0  (35.07)
7.Secondary Outcome
Title Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Hide Description Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 15 19
Mean (Standard Deviation)
Unit of Measure: Picograms
Week 4,n=15,18 Number Analyzed 15 participants 18 participants
0.05  (0.582) 0.13  (0.407)
Week 8,n=12,17 Number Analyzed 12 participants 17 participants
-0.08  (0.564) 0.09  (0.578)
Week 12,n=10,11 Number Analyzed 10 participants 11 participants
0.08  (0.461) 0.15  (0.670)
Week 16,n=7,7 Number Analyzed 7 participants 7 participants
0.46  (0.336) 0.11  (0.708)
Week 20,n=3,4 Number Analyzed 3 participants 4 participants
0.33  (0.252) 0.55  (0.926)
8.Secondary Outcome
Title Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Hide Description Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Volume. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 15 19
Mean (Standard Deviation)
Unit of Measure: Femtoliter
Week 4,n=15,18 Number Analyzed 15 participants 18 participants
0.2  (2.08) 0.3  (2.45)
Week 8,n=12,17 Number Analyzed 12 participants 17 participants
-0.4  (1.56) -0.4  (2.58)
Week 12,n=10,11 Number Analyzed 10 participants 11 participants
-1.1  (1.60) -0.7  (2.90)
Week 16,n=7,7 Number Analyzed 7 participants 7 participants
-0.7  (0.76) -1.7  (3.25)
Week 20,n=3,4 Number Analyzed 3 participants 4 participants
-0.3  (1.53) 0.3  (2.63)
9.Secondary Outcome
Title Change From Baseline in Hematology Parameter: Erythrocytes
Hide Description Blood samples were collected to analyze the hematology parameter: Erythrocytes. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 15 19
Mean (Standard Deviation)
Unit of Measure: Trillion cells/liter (10^12 cell/L)
Week 4, n=15,18 Number Analyzed 15 participants 18 participants
0.02  (0.262) 0.01  (0.226)
Week 8, n=12,17 Number Analyzed 12 participants 17 participants
0.06  (0.294) -0.02  (0.283)
Week 12, n=10,11 Number Analyzed 10 participants 11 participants
0.08  (0.210) 0.06  (0.234)
Week 16, n=7,7 Number Analyzed 7 participants 7 participants
-0.01  (0.204) 0.10  (0.153)
Week 20, n=3,4 Number Analyzed 3 participants 4 participants
0.13  (0.252) 0.07  (0.096)
10.Secondary Outcome
Title Change From Baseline in Hematology Parameter: Hematocrit
Hide Description Blood samples were collected to analyze the hematology parameter: Hematocrit. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 15 19
Mean (Standard Deviation)
Unit of Measure: Percentage of red blood cells in blood
Week 4, n=15,18 Number Analyzed 15 participants 18 participants
0.0030  (0.02071) 0.0021  (0.02555)
Week 8, n=12,17 Number Analyzed 12 participants 17 participants
0.0024  (0.02171) -0.0042  (0.02357)
Week 12, n=10,11 Number Analyzed 10 participants 11 participants
0.0011  (0.01813) 0.0005  (0.01873)
Week 16, n=7,7 Number Analyzed 7 participants 7 participants
-0.0057  (0.01616) 0.0007  (0.01701)
Week 20, n=3,4 Number Analyzed 3 participants 4 participants
0.0130  (0.01400) 0.0082  (0.00967)
11.Secondary Outcome
Title Change From Baseline in Hematology Parameter: Hemoglobin
Hide Description Blood samples were collected to analyze the hematology parameter: Hemoglobin. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 15 19
Mean (Standard Deviation)
Unit of Measure: Grams per liter
Week 4, n=15,18 Number Analyzed 15 participants 18 participants
1.0  (7.29) 0.9  (6.82)
Week 8, n=12,17 Number Analyzed 12 participants 17 participants
1.0  (7.48) 0.0  (6.76)
Week 12, n=10,11 Number Analyzed 10 participants 11 participants
2.6  (5.44) 2.3  (5.55)
Week 16, n=7,7 Number Analyzed 7 participants 7 participants
1.7  (6.32) 3.7  (4.19)
Week 20, n=3,4 Number Analyzed 3 participants 4 participants
6.7  (6.51) 5.0  (2.45)
12.Secondary Outcome
Title Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST)
Hide Description Blood samples were collected to analyze the chemistry parameters: ALT, ALP and AST . Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 12, and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 15 19
Mean (Standard Deviation)
Unit of Measure: International units per liter (IU/L)
ALT, Week 4, n=15,18 Number Analyzed 15 participants 18 participants
1.4  (5.45) 0.3  (27.10)
ALT, Week 8, n=11,16 Number Analyzed 11 participants 16 participants
5.9  (22.31) -6.3  (21.96)
ALT, Week 12, n=7,11 Number Analyzed 7 participants 11 participants
-2.0  (10.00) -3.5  (11.01)
ALT, Week 16, n=5,7 Number Analyzed 5 participants 7 participants
2.4  (6.69) 1.7  (8.40)
ALP, Week 4, n=15,18 Number Analyzed 15 participants 18 participants
-2.3  (5.85) -1.9  (10.06)
ALP, Week 8, n=11,16 Number Analyzed 11 participants 16 participants
0.3  (6.89) 0.4  (13.86)
ALP, Week 12, n=7,11 Number Analyzed 7 participants 11 participants
3.9  (3.85) -3.8  (7.43)
ALP, Week 16, n=5,7 Number Analyzed 5 participants 7 participants
3.2  (7.26) -2.6  (6.48)
AST, Week 4, n=15,18 Number Analyzed 15 participants 18 participants
0.6  (4.00) -3.0  (11.60)
AST, Week 8, n=11,16 Number Analyzed 11 participants 16 participants
-0.1  (8.87) -4.9  (11.11)
AST, Week 12, n=7,11 Number Analyzed 7 participants 11 participants
-2.1  (5.27) -6.0  (13.34)
AST, Week 16, n=5,7 Number Analyzed 5 participants 7 participants
0.4  (5.13) -1.0  (8.64)
13.Secondary Outcome
Title Change From Baseline in Chemistry Parameters: Albumin and Protein
Hide Description Blood samples were collected to analyze the chemistry parameters: Albumin and Protein. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 12, and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 15 19
Mean (Standard Deviation)
Unit of Measure: Grams per liter
Albumin, Week 4, n=15,18 Number Analyzed 15 participants 18 participants
-0.5  (2.75) 0.3  (3.31)
Albumin, Week 8, n=11,16 Number Analyzed 11 participants 16 participants
-0.6  (2.42) 0.7  (3.46)
Albumin, Week 12, n=7,11 Number Analyzed 7 participants 11 participants
-0.6  (2.23) 1.1  (2.77)
Albumin, Week 16, n=5,7 Number Analyzed 5 participants 7 participants
-1.4  (3.13) 1.9  (1.86)
Protein, Week 4, n=15,18 Number Analyzed 15 participants 18 participants
-0.5  (3.02) 1.3  (3.41)
Protein, Week 8, n=11,16 Number Analyzed 11 participants 16 participants
0.8  (4.02) 1.6  (4.59)
Protein, Week 12, n=7,11 Number Analyzed 7 participants 11 participants
0.4  (2.70) 1.6  (2.54)
Protein, Week 16, n=5,7 Number Analyzed 5 participants 7 participants
-1.2  (4.32) 2.7  (3.64)
14.Secondary Outcome
Title Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin
Hide Description Blood samples were collected to analyze the chemistry parameters: Bilirubin, Creatinine and Direct Bilirubin. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 12, and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 15 19
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter
Bilirubin, Week 4, n=15,18 Number Analyzed 15 participants 18 participants
1.2  (3.53) 2.0  (3.82)
Bilirubin, Week 8, n=11,16 Number Analyzed 11 participants 16 participants
-0.4  (3.32) 1.6  (4.27)
Bilirubin, Week 12, n=7,11 Number Analyzed 7 participants 11 participants
-0.9  (2.54) 0.7  (3.93)
Bilirubin, Week 16, n=5,7 Number Analyzed 5 participants 7 participants
-1.2  (1.79) 2.3  (5.59)
Creatinine, Week 4, n=15,18 Number Analyzed 15 participants 18 participants
2.77  (10.027) 0.74  (8.097)
Creatinine, Week 8, n=11,16 Number Analyzed 11 participants 16 participants
0.74  (7.250) -0.81  (5.150)
Creatinine, Week 12, n=7,11 Number Analyzed 7 participants 11 participants
0.63  (2.799) 1.62  (6.693)
Creatinine, Week 16, n=5,7 Number Analyzed 5 participants 7 participants
1.24  (5.379) -1.63  (11.755)
Direct Bilirubin, Week 4, n=15,18 Number Analyzed 15 participants 18 participants
0.3  (1.28) 0.2  (1.17)
Direct Bilirubin, Week 8, n=11,16 Number Analyzed 11 participants 16 participants
-0.5  (1.29) 0.0  (1.26)
Direct Bilirubin, Week 12, n=7,11 Number Analyzed 7 participants 11 participants
-0.6  (0.98) 0.2  (1.08)
Direct Bilirubin, Week 16, n=5,7 Number Analyzed 5 participants 7 participants
0.0  (0.00) 0.3  (0.76)
15.Secondary Outcome
Title Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Urea
Hide Description Blood samples were collected to analyze the chemistry parameters: Calcium, Glucose, Potassium, Sodium and Urea. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 12, and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 15 19
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter (mmol/L)
Calcium, Week 4, n=15,18 Number Analyzed 15 participants 18 participants
-0.003  (0.0692) -0.004  (0.1130)
Calcium, Week 8, n=11,16 Number Analyzed 11 participants 16 participants
0.007  (0.1093) 0.001  (0.1097)
Calcium, Week 12, n=7,11 Number Analyzed 7 participants 11 participants
0.031  (0.1232) -0.005  (0.1110)
Calcium, Week 16, n=5,7 Number Analyzed 5 participants 7 participants
-0.076  (0.1126) 0.043  (0.0941)
Glucose, Week 4, n=15,18 Number Analyzed 15 participants 18 participants
-0.13  (0.841) 0.20  (0.707)
Glucose, Week 8, n=11,16 Number Analyzed 11 participants 16 participants
-0.56  (1.267) 0.53  (0.846)
Glucose, Week 12, n=7,11 Number Analyzed 7 participants 11 participants
0.90  (2.653) 0.14  (1.002)
Glucose, Week 16, n=5,7 Number Analyzed 5 participants 7 participants
0.26  (0.783) 0.21  (0.857)
Potassium, Week 4, n=15,18 Number Analyzed 15 participants 18 participants
-0.02  (0.265) -0.01  (0.252)
Potassium, Week 8, n=11,16 Number Analyzed 11 participants 16 participants
0.07  (0.290) -0.03  (0.272)
Potassium, Week 12, n=7,11 Number Analyzed 7 participants 11 participants
0.19  (0.254) -0.06  (0.191)
Potassium, Week 16, n=5,7 Number Analyzed 5 participants 7 participants
0.04  (0.288) -0.09  (0.363)
Sodium, Week 4, n=15,18 Number Analyzed 15 participants 18 participants
0.3  (1.88) -0.9  (1.94)
Sodium, Week 8, n=11,16 Number Analyzed 11 participants 16 participants
1.0  (1.34) -0.2  (1.76)
Sodium, Week 12, n=7,11 Number Analyzed 7 participants 11 participants
0.0  (1.83) 0.1  (1.04)
Sodium, Week 16, n=5,7 Number Analyzed 5 participants 7 participants
-1.2  (1.30) 0.4  (2.30)
Urea, Week 4, n=15,18 Number Analyzed 15 participants 18 participants
0.23  (1.015) -0.25  (1.204)
Urea, Week 8, n=11,16 Number Analyzed 11 participants 16 participants
0.41  (1.114) -0.78  (1.722)
Urea, Week 12, n=7,11 Number Analyzed 7 participants 11 participants
-0.07  (1.813) -0.59  (1.998)
Urea, Week 16, n=5,7 Number Analyzed 5 participants 7 participants
0.30  (1.304) -0.50  (2.255)
16.Secondary Outcome
Title Number of Participants With Worst Post Baseline Potential Clinical Importance (PCI) Value for Hematology Parameters
Hide Description Blood samples were collected from participants for analysis of following hematology parameters; hematocrit, hemoglobin, leukocytes and platelets. PCI ranges were < 0.201 or >0.599 proportion of red blood cells in blood for hematocrit, <71 or >199 grams per liter for hemoglobin, <31 or >1499 Giga cells per liter for platelets and for leukocytes < 1.1 Giga cells per liter. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants with laboratory value category "To Low" and "To High" were presented. Only those parameters having worst post-Baseline PCI values were presented. Day 1 was considered as Baseline.
Time Frame Up to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with available data at the specified time points were analyzed. One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 15 18
Measure Type: Count of Participants
Unit of Measure: Participants
Hematocrit, To Low
0
   0.0%
0
   0.0%
Hematocrit, To High
0
   0.0%
0
   0.0%
Hemoglobin, To Low
0
   0.0%
0
   0.0%
Hemoglobin, To High
0
   0.0%
0
   0.0%
Leukocytes, To Low
0
   0.0%
0
   0.0%
Leukocytes, To High
0
   0.0%
0
   0.0%
Platelets, To Low
0
   0.0%
0
   0.0%
Platelets, To High
0
   0.0%
0
   0.0%
17.Secondary Outcome
Title Number of Participants With Worst Post Baseline PCI Value for Chemistry Parameters
Hide Description Blood samples were collected from participants for analysis of following clinical chemistry parameters: ALT, Calcium, glucose, Potassium and sodium. PCI ranges were >143 units per liter (U/L) for ALT (Age category: 3-12 years) and >239 U/L for ALT (Age category: 13+ years), <1.50 or >3.24 mmol/L for calcium, < 2.2 or > 27.8 mmol/L for glucose, <2.8 or >6.5 mmoL/L for potassium , and <120 or >160 mmoL/L for sodium. Participants were counted in the worst case category that their value changes to (low, normal , or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the "To within Range or No Change" category. Only those parameters having worst post-Baseline PCI values were presented. Day 1 was considered as Baseline.
Time Frame Up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with available data at the specified time points were analyzed. One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 15 18
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, To Low
0
   0.0%
0
   0.0%
ALT, To High
0
   0.0%
0
   0.0%
Calcium, To Low
0
   0.0%
0
   0.0%
Calcium, To High
0
   0.0%
0
   0.0%
Glucose, To Low
0
   0.0%
0
   0.0%
Glucose, To High
0
   0.0%
0
   0.0%
Potassium, To Low
0
   0.0%
0
   0.0%
Potassium, To High
0
   0.0%
0
   0.0%
Sodium, To Low
0
   0.0%
0
   0.0%
Sodium, To High
0
   0.0%
0
   0.0%
18.Secondary Outcome
Title Change From Baseline in PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia’s Formula (QTcF)
Hide Description Triplicate 12-lead electrocardiograms (ECG) were obtained to measure PR Interval, QRS Duration, QT Interval and QTcF Interval. Screening was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time Frame Baseline (Screening) and Weeks 4, 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 15 19
Mean (Standard Deviation)
Unit of Measure: Milliseconds
PR Interval; Week 4, n=15,18 Number Analyzed 15 participants 18 participants
9.1  (9.91) -0.5  (10.62)
PR Interval; Week 16,n=12,16 Number Analyzed 12 participants 16 participants
-1.3  (15.43) 1.5  (12.54)
QRS duration; Week 4; n=15,18 Number Analyzed 15 participants 18 participants
-0.9  (5.93) 3.1  (7.71)
QRS duration; Week 16,n=12,16 Number Analyzed 12 participants 16 participants
-2.2  (6.51) 0.9  (8.27)
QT Interval; Week 4; n=15,18 Number Analyzed 15 participants 18 participants
-5.8  (17.65) -4.7  (16.32)
QT Interval; Week 16,n=12,16 Number Analyzed 12 participants 16 participants
-10.8  (18.05) -4.1  (23.42)
QTc F Interval; Week 4; n=15,18 Number Analyzed 15 participants 18 participants
-2.4  (11.69) -6.4  (14.30)
QTcF Interval; Week 16,n=12,16 Number Analyzed 12 participants 16 participants
-2.1  (18.20) -5.8  (17.68)
19.Secondary Outcome
Title Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Hide Description SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 15 19
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
DBP, Week 4,n=15,18 Number Analyzed 15 participants 18 participants
1.3  (8.22) 4.5  (9.73)
DBP, Week 8,n=14,17 Number Analyzed 14 participants 17 participants
1.6  (7.76) 3.4  (7.90)
DBP, Week 12,n=10,12 Number Analyzed 10 participants 12 participants
-1.0  (5.16) 3.4  (7.01)
DBP, Week 16,n=7,7 Number Analyzed 7 participants 7 participants
0.7  (7.30) 1.9  (9.56)
DBP, Week 20,n=3,5 Number Analyzed 3 participants 5 participants
4.0  (0.00) 5.6  (5.37)
SBP, Week 4,n=15,18 Number Analyzed 15 participants 18 participants
2.0  (8.99) 2.6  (8.11)
SBP, Week 8,n=14,17 Number Analyzed 14 participants 17 participants
0.6  (8.65) 4.9  (11.24)
SBP, Week 12,n=10,12 Number Analyzed 10 participants 12 participants
-0.6  (6.62) 2.8  (12.22)
SBP, Week 16,n=7,7 Number Analyzed 7 participants 7 participants
1.1  (5.76) 3.3  (10.70)
SBP, Week 20,n=3,5 Number Analyzed 3 participants 5 participants
0.7  (5.51) 11.2  (6.14)
20.Secondary Outcome
Title Change From Baseline in Vital Signs: Pulse Rate
Hide Description Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 15 19
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Week 4,n=15,18 Number Analyzed 15 participants 18 participants
0.3  (6.81) 0.8  (9.80)
Week 8,n=14,17 Number Analyzed 14 participants 17 participants
2.4  (9.57) -1.4  (9.28)
Week 12,n=10,12 Number Analyzed 10 participants 12 participants
0.6  (11.27) 1.0  (12.41)
Week 16,n=7,7 Number Analyzed 7 participants 7 participants
3.7  (12.54) -1.7  (15.68)
Week 20,n=3,5 Number Analyzed 3 participants 5 participants
2.7  (5.86) 0.8  (9.88)
21.Secondary Outcome
Title Change From Baseline in Vital Signs: Temperature
Hide Description Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time Frame Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 15 19
Mean (Standard Deviation)
Unit of Measure: Celsius
Week 4,n=15,18 Number Analyzed 15 participants 18 participants
0.01  (0.474) -0.02  (0.345)
Week 8,n=14,17 Number Analyzed 14 participants 17 participants
0.06  (0.334) 0.02  (0.281)
Week 12,n=10,12 Number Analyzed 10 participants 12 participants
0.06  (0.357) -0.29  (0.640)
Week 16,n=7,7 Number Analyzed 7 participants 7 participants
0.14  (0.162) -0.27  (0.309)
Week 20,n=3,5 Number Analyzed 3 participants 5 participants
-0.17  (0.153) -0.08  (0.370)
22.Secondary Outcome
Title Number of Participants With Worst Post Baseline PCI Value for Vital Signs
Hide Description Blood samples were collected from participants for analysis of following vital signs parameters: DBP, Pulse rate and SBP. PCI ranges were <85 or >160 mmHg for SBP, <45 or >100 mmHg for DBP and < 40 or > 110 beats per minute for Pulse rate. Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants with vital signs value category "To Low" and "To High" were presented. Only those parameters having worst post-Baseline PCI values are presented. Day 1 was considered as Baseline.
Time Frame Up to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with available data at the specified time points were analyzed. One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 15 18
Measure Type: Count of Participants
Unit of Measure: Participants
DBP,To Low
0
   0.0%
0
   0.0%
DBP,To High
0
   0.0%
0
   0.0%
Pulse rate, To Low
0
   0.0%
0
   0.0%
Pulse rate, To High
0
   0.0%
1
   5.6%
SBP,To Low
0
   0.0%
0
   0.0%
SBP,To High
0
   0.0%
0
   0.0%
23.Secondary Outcome
Title Number of Participants With Abnormal Findings for ECG Parameters
Hide Description Triplicate 12-lead ECG were obtained to measure ECG parameters. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Time Frame Week 4 and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 15 19
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4; NCS; n=15, 18 Number Analyzed 15 participants 18 participants
4
  26.7%
7
  38.9%
Week 4; CS; n=15, 18 Number Analyzed 15 participants 18 participants
0
   0.0%
0
   0.0%
Week 16; NCS; n= 12, 16 Number Analyzed 12 participants 16 participants
3
  25.0%
6
  37.5%
Week 16; CS; n=12, 16 Number Analyzed 12 participants 16 participants
0
   0.0%
0
   0.0%
24.Secondary Outcome
Title Number of Participants With Any Time Post Baseline Anti-mepolizumab Binding Antibodies and Neutralizing Antibodies Response
Hide Description Blood samples were collected for the determination of anti-mepolizumab antibodies at the specified visits. The number of participants with anti-mepolizumab binding antibodies and neutralizing antibodies response at Any Time Post Baseline has been presented. Neutralizing antibodies response assay result have been only presented for participants with positive anti-drug antibody assay. Day 1 was considered as Baseline.
Time Frame Up to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description:
Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
Overall Number of Participants Analyzed 15 19
Measure Type: Count of Participants
Unit of Measure: Participants
Binding Antibody, Negative, n=15,18 Number Analyzed 15 participants 18 participants
15
 100.0%
17
  94.4%
Binding Antibody, Positive, n=15,18 Number Analyzed 15 participants 18 participants
0
   0.0%
1
   5.6%
Neutralizing Antibody, Negative, n=0,1 Number Analyzed 0 participants 1 participants
0
1
 100.0%
Neutralizing Antibody, Positive, n=0,1 Number Analyzed 0 participants 1 participants
0
0
   0.0%
Time Frame On-treatment serious Adverse events (SAEs) and nSAEs were collected from the start of study treatment Up to 20 weeks
Adverse Event Reporting Description Safety Population was used. Safety Population comprised of all participants who received at least one dose of a study treatment. One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.
 
Arm/Group Title Placebo SC Mepolizumab 100 mg SC
Hide Arm/Group Description Participants received placebo (0.9 percent sodium chloride solution) SC injection administered into the upper arm, abdomen, or thigh every 4 weeks. Participants received 100 milligram (mg) of Mepolizumab SC injection administered into the upper arm, abdomen, or thigh every 4 weeks.
All-Cause Mortality
Placebo SC Mepolizumab 100 mg SC
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/19 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo SC Mepolizumab 100 mg SC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/19 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Placebo SC Mepolizumab 100 mg SC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/15 (46.67%)      1/19 (5.26%)    
Gastrointestinal disorders     
Diarrhoea  1  2/15 (13.33%)  2 0/19 (0.00%)  0
Infections and infestations     
Furuncle  1  1/15 (6.67%)  1 0/19 (0.00%)  0
Herpes simplex  1  1/15 (6.67%)  1 0/19 (0.00%)  0
Hordeolum  1  1/15 (6.67%)  1 0/19 (0.00%)  0
Impetigo  1  0/15 (0.00%)  0 1/19 (5.26%)  1
Localised infection  1  1/15 (6.67%)  1 0/19 (0.00%)  0
Staphylococcal infection  1  1/15 (6.67%)  1 0/19 (0.00%)  0
Staphylococcal skin infection  1  1/15 (6.67%)  1 0/19 (0.00%)  0
Streptococcal infection  1  1/15 (6.67%)  1 0/19 (0.00%)  0
Upper respiratory tract infection  1  1/15 (6.67%)  2 0/19 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/15 (6.67%)  1 0/19 (0.00%)  0
Nervous system disorders     
Dizziness  1  1/15 (6.67%)  1 0/19 (0.00%)  0
Skin and subcutaneous tissue disorders     
Skin plaque  1  1/15 (6.67%)  1 0/19 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03055195     History of Changes
Other Study ID Numbers: 205050
First Submitted: February 13, 2017
First Posted: February 16, 2017
Results First Submitted: December 3, 2018
Results First Posted: December 25, 2018
Last Update Posted: December 25, 2018