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Cessation Versus Continuation of Long-term Mepolizumab in Severe Eosinophilic Asthma Patients

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: NCT02555371
Recruitment Status : Completed
First Posted : September 21, 2015
Results First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Biological: Mepolizumab 100mg
Drug: Placebo
Enrollment 306
Recruitment Details A multi-center, randomized, double-blind, placebo controlled, parallel group study to compare cessation versus continuation of long-term mepolizumab treatment. Participants (par.) who completed the Follow Up/Exit Visit or Early Withdrawal Visit from study MEA115666 (NCT01691859) or 201312 (NCT02135692) were eligible to participate in this study.
Pre-assignment Details This is a 3 period study including variable open-label (OL) run-in, double-blind (DB) treatment period and open-label treatment switch period. The study was conducted in 75 centers across 14 countries from 07-Jan-2016 to 24-Jul-2019.
Arm/Group Title Part A/B: Mepolizumab 100mg SC Part C: Placebo Part C: Mepolizumab 100mg SC Part D: Mepolizumab 100mg SC (Previous Placebo) Part D: Mepolizumab 100mg SC (Previous Mepolizumab)
Hide Arm/Group Description Participants with less than 3 years of mepolizumab treatment entered variable open-label run-in period-Part A in order to reach 3 years of exposure and received 100 mg of mepolizumab injected subcutaneously (SC) once every 4 weeks (W) up to 132 weeks. Upon achieving 3 years exposure, participants entered Part B. Participants with at least 3 years of mepolizumab treatment directly entered fixed open-label run-in period-Part B and received 100 mg of mepolizumab injected SC once every 4 weeks up to 8 weeks. Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received placebo SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization). Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received continued mepolizumab 100 mg SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization). Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization in Part C). Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization in Part C ).
Period Title: PartA(Upto 132W)+PartB(Upto 8W)
Started [1] 306 0 0 0 0
Completed 295 0 0 0 0
Not Completed 11 0 0 0 0
Reason Not Completed
Adverse Event             1             0             0             0             0
Failure to meet continuation criteria             2             0             0             0             0
Withdrawal by Subject             5             0             0             0             0
Physician Decision             1             0             0             0             0
Lack of Efficacy             2             0             0             0             0
[1]
Variable & fixed run-in periods have been combined since all par. received OL mepolizumab 100 mg SC
Period Title: Part C (DB Period: Up to 52W)
Started [1] 0 151 144 0 0
Completed 0 62 96 0 0
Not Completed 0 89 48 0 0
Reason Not Completed
Switched to Part D treatment             0             84             45             0             0
Withdrawal by Subject             0             2             2             0             0
Lack of Efficacy             0             1             0             0             0
Adverse Event             0             2             1             0             0
[1]
Double-blind Treatment Period
Period Title: PartD(OL: 52W Post-randomization PartC)
Started 0 0 0 84 45
Completed 0 0 0 80 42
Not Completed 0 0 0 4 3
Reason Not Completed
Withdrawal by Subject             0             0             0             1             0
Physician Decision             0             0             0             2             0
Lost to Follow-up             0             0             0             0             2
Lack of Efficacy             0             0             0             0             1
Adverse Event             0             0             0             1             0
Arm/Group Title Parts A/B: Mepolizumab 100mg SC
Hide Arm/Group Description Participants with less than 3 years of mepolizumab treatment entered variable open-label run-in period-Part A in order to reach 3 years of exposure and received 100 mg of mepolizumab injected subcutaneously (SC) once every 4 weeks up to 132 weeks. Upon achieving 3 years exposure, participants entered Part B. Participants with at least 3 years of mepolizumab treatment directly entered fixed open-label run-in period-Part B and received 100 mg of mepolizumab injected SC once every 4 weeks up to 8 weeks.
Overall Number of Baseline Participants 306
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 306 participants
55.6  (11.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 306 participants
Female
180
  58.8%
Male
126
  41.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 306 participants
ASIAN - CENTRAL/SOUTH ASIAN HERITAGE
1
   0.3%
ASIAN - EAST ASIAN HERITAGE
28
   9.2%
ASIAN - JAPANESE HERITAGE
21
   6.9%
BLACK OR AFRICAN AMERICAN
8
   2.6%
WHITE - ARABIC/NORTH AFRICAN HERITAGE
3
   1.0%
WHITE - WHITE/CAUCASIAN/EUROPEAN HERITAGE
245
  80.1%
1.Primary Outcome
Title Percentage of Participants With First Clinically Significant Exacerbation in Part C
Hide Description Clinically significant exacerbation was defined as worsening of asthma which requires use of systemic corticosteroids (e.g., prednisone) for at least 3 days or a single intramuscular (IM) corticosteroid dose and/or hospitalization and/or emergency department (ED) visits. For participants on maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days is required. Percentage of participants with clinically significant exacerbation over time during the on-treatment period of Part C and 95% confidence interval were estimated using Kaplan-Meier estimates. Intent-to-Treat Population includes all randomized participants who received at least one dose of double-blind study medication within Part C.
Time Frame Weeks 12, 24, 36 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population.
Arm/Group Title Part C: Placebo Part C: Mepolizumab 100mg SC
Hide Arm/Group Description:
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received placebo SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received continued mepolizumab 100 mg SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
Overall Number of Participants Analyzed 151 144
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 12
31.8
(25.0 to 39.9)
20.2
(14.5 to 27.7)
Week 24
49.3
(41.5 to 57.6)
32.3
(25.3 to 40.7)
Week 36
56.0
(48.1 to 64.2)
40.3
(32.8 to 48.9)
Weeks 52
60.7
(52.7 to 68.8)
47.1
(39.2 to 55.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part C: Placebo, Part C: Mepolizumab 100mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.45 to 0.86
Estimation Comments Treatment comparison between mepolizumab 100 mg SC and placebo using hazards ratio and 95% confidence interval has been presented.
2.Secondary Outcome
Title Ratio to Baseline in Blood Eosinophil Count in Part C
Hide Description Blood samples were collected at specific time points to measure blood eosinophils level. Baseline was defined as the latest available assessment prior to first dose of double-blind treatment within Part C. Ratio to Baseline is defined as visit value divided by Baseline value and was analyzed using Mixed Model Repeated Measures with covariates of Baseline, region, exacerbations in the year prior to randomization (as an ordinal variable), Baseline maintenance oral corticosteroids (OCS) therapy (OCS versus no OCS), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group. The log transformation was applied to blood eosinophil counts prior to analysis. If a blood eosinophil count of zero was reported, a small value was added prior to log transforming the data. The dispersion measure used was log standard error.
Time Frame Baseline and Weeks 12, 24, 36 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. Only those participants available at the specified time points were analyzed for each treatment and represented as n=X in category titles
Arm/Group Title Part C: Placebo Part C: Mepolizumab 100mg SC
Hide Arm/Group Description:
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received placebo SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received continued mepolizumab 100 mg SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
Overall Number of Participants Analyzed 121 120
Least Squares Mean (Standard Error)
Unit of Measure: Ratio
Week 12, n=121, 120 Number Analyzed 121 participants 120 participants
6.03  (0.077) 1.16  (0.078)
Week 24, n= 79, 106 Number Analyzed 79 participants 106 participants
6.58  (0.095) 1.03  (0.084)
Week 36, n= 65, 99 Number Analyzed 65 participants 99 participants
6.48  (0.093) 1.20  (0.079)
Week 52, n=60, 92 Number Analyzed 60 participants 92 participants
6.17  (0.091) 1.00  (0.077)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part C: Placebo, Part C: Mepolizumab 100mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed model repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
0.15 to 0.24
Estimation Comments Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 12 has been presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part C: Placebo, Part C: Mepolizumab 100mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed model repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
0.12 to 0.20
Estimation Comments Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 24 has been presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part C: Placebo, Part C: Mepolizumab 100mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed model repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
0.15 to 0.24
Estimation Comments Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 36 has been presented.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part C: Placebo, Part C: Mepolizumab 100mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed model repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
0.13 to 0.20
Estimation Comments Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 52 has been presented.
3.Secondary Outcome
Title Percentage of Participants With 0.5 Point or More Increase in Asthma Control Questionnaire (ACQ)-5 Score From Baseline in Part C
Hide Description The ACQ-5 is a five-item, self-completed questionnaire. Five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response ranges from zero (no impairment/limitation) to six (total impairment/ limitation) scale. Increase in score of >= 0.5 units from Baseline indicates decrease in asthma control. Baseline is the latest available assessment prior to first dose of double-blind treatment within Part C. Percentage of participants with a 0.5 point or more increase in ACQ-5 score from Baseline over time during the on-treatment period of Part C and its 95% confidence interval were estimated using Kaplan-Meier estimates.
Time Frame Baseline and Weeks 12, 24, 36 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population.
Arm/Group Title Part C: Placebo Part C: Mepolizumab 100mg SC
Hide Arm/Group Description:
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received placebo SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received continued mepolizumab 100 mg SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
Overall Number of Participants Analyzed 151 144
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 12
44.5
(36.9 to 52.8)
39.3
(31.8 to 47.8)
Week 24
69.5
(61.6 to 77.1)
49.3
(41.3 to 57.9)
Week 36
74.9
(67.1 to 82.1)
56.0
(47.8 to 64.6)
Weeks 52
79.0
(71.3 to 85.7)
63.1
(54.8 to 71.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part C: Placebo, Part C: Mepolizumab 100mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
0.49 to 0.88
Estimation Comments Treatment comparison between mepolizumab 100 mg SC and placebo using hazards ratio and 95% confidence interval has been presented.
4.Secondary Outcome
Title Percentage of Participants With Time to First Exacerbation Requiring Hospitalization or ED Visit in Part C
Hide Description Exacerbations of asthma requiring hospitalization or ED visit were assessed. The analysis was performed from Cox Proportional Hazards Model with covariates of treatment group, region, exacerbations in the year prior to randomization (as an ordinal variable) and Baseline maintenance OCS therapy (OCS versus no OCS). Percentage of participants with an exacerbation over time and its 95% confidence intervals were estimated using Kaplan-Meier estimates
Time Frame Weeks 12, 24, 36 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population.
Arm/Group Title Part C: Placebo Part C: Mepolizumab 100mg SC
Hide Arm/Group Description:
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received placebo SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received continued mepolizumab 100 mg SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
Overall Number of Participants Analyzed 151 144
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 12
2.9
(1.1 to 7.5)
2.8
(1.1 to 7.2)
Week 24
5.7
(2.7 to 11.8)
5.1
(2.4 to 10.3)
Week 36
5.7
(2.7 to 11.8)
5.9
(3.0 to 11.6)
Weeks 52
5.7
(2.7 to 11.8)
7.9
(4.3 to 14.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part C: Placebo, Part C: Mepolizumab 100mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.570
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.33
Confidence Interval (2-Sided) 95%
0.50 to 3.51
Estimation Comments Treatment comparison between mepolizumab 100 mg SC and placebo using hazards ratio and 95% confidence interval has been presented.
Time Frame Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
Adverse Event Reporting Description AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
 
Arm/Group Title Part A/B: Mepolizumab 100mg SC Part C: Placebo Part C: Mepolizumab 100mg Part D: Mepolizumab 100mg SC (Previous Placebo) Part D: Mepolizumab 100mg SC (Previous Mepolizumab)
Hide Arm/Group Description Participants with less than 3 years of mepolizumab treatment entered variable open-label run-in period-Part A in order to reach 3 years of exposure and received 100 mg of mepolizumab injected subcutaneously (SC) once every 4 weeks (W) up to 132 weeks. Upon achieving 3 years exposure, participants entered Part B. Participants with at least 3 years of mepolizumab treatment directly entered fixed open-label run-in period-Part B and received 100 mg of mepolizumab injected SC once every 4 weeks up to 8 weeks. Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received placebo SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization). Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received continued mepolizumab 100 mg SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization). Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization in Part C). Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization in Part C).
All-Cause Mortality
Part A/B: Mepolizumab 100mg SC Part C: Placebo Part C: Mepolizumab 100mg Part D: Mepolizumab 100mg SC (Previous Placebo) Part D: Mepolizumab 100mg SC (Previous Mepolizumab)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/306 (0.00%)      0/151 (0.00%)      0/144 (0.00%)      1/84 (1.19%)      0/45 (0.00%)    
Hide Serious Adverse Events
Part A/B: Mepolizumab 100mg SC Part C: Placebo Part C: Mepolizumab 100mg Part D: Mepolizumab 100mg SC (Previous Placebo) Part D: Mepolizumab 100mg SC (Previous Mepolizumab)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/306 (2.29%)      10/151 (6.62%)      9/144 (6.25%)      10/84 (11.90%)      4/45 (8.89%)    
Gastrointestinal disorders           
Abdominal hernia  1  1/306 (0.33%)  1 0/151 (0.00%)  0 0/144 (0.00%)  0 0/84 (0.00%)  0 0/45 (0.00%)  0
Diarrhoea  1  0/306 (0.00%)  0 0/151 (0.00%)  0 1/144 (0.69%)  1 0/84 (0.00%)  0 0/45 (0.00%)  0
Inguinal hernia  1  0/306 (0.00%)  0 0/151 (0.00%)  0 0/144 (0.00%)  0 1/84 (1.19%)  1 0/45 (0.00%)  0
Salivary gland calculus  1  0/306 (0.00%)  0 0/151 (0.00%)  0 0/144 (0.00%)  0 0/84 (0.00%)  0 1/45 (2.22%)  1
General disorders           
Device related thrombosis  1  0/306 (0.00%)  0 1/151 (0.66%)  1 0/144 (0.00%)  0 0/84 (0.00%)  0 0/45 (0.00%)  0
Non-cardiac chest pain  1  0/306 (0.00%)  0 0/151 (0.00%)  0 1/144 (0.69%)  1 0/84 (0.00%)  0 0/45 (0.00%)  0
Hepatobiliary disorders           
Cholelithiasis  1  0/306 (0.00%)  0 1/151 (0.66%)  1 0/144 (0.00%)  0 0/84 (0.00%)  0 0/45 (0.00%)  0
Infections and infestations           
Cytomegalovirus infection  1  1/306 (0.33%)  1 0/151 (0.00%)  0 0/144 (0.00%)  0 0/84 (0.00%)  0 0/45 (0.00%)  0
Influenza  1  1/306 (0.33%)  1 0/151 (0.00%)  0 0/144 (0.00%)  0 0/84 (0.00%)  0 0/45 (0.00%)  0
Pharyngeal abscess  1  1/306 (0.33%)  1 0/151 (0.00%)  0 0/144 (0.00%)  0 0/84 (0.00%)  0 0/45 (0.00%)  0
Urinary tract infection  1  1/306 (0.33%)  1 0/151 (0.00%)  0 0/144 (0.00%)  0 0/84 (0.00%)  0 0/45 (0.00%)  0
Appendicitis  1  0/306 (0.00%)  0 0/151 (0.00%)  0 1/144 (0.69%)  1 0/84 (0.00%)  0 0/45 (0.00%)  0
Bronchitis  1  0/306 (0.00%)  0 1/151 (0.66%)  1 0/144 (0.00%)  0 0/84 (0.00%)  0 0/45 (0.00%)  0
Diverticulitis  1  0/306 (0.00%)  0 0/151 (0.00%)  0 1/144 (0.69%)  1 0/84 (0.00%)  0 0/45 (0.00%)  0
Escherichia pyelonephritis  1  0/306 (0.00%)  0 1/151 (0.66%)  1 0/144 (0.00%)  0 0/84 (0.00%)  0 0/45 (0.00%)  0
Atypical pneumonia  1  0/306 (0.00%)  0 0/151 (0.00%)  0 0/144 (0.00%)  0 1/84 (1.19%)  1 0/45 (0.00%)  0
Sinusitis fungal  1  0/306 (0.00%)  0 0/151 (0.00%)  0 0/144 (0.00%)  0 1/84 (1.19%)  1 0/45 (0.00%)  0
Injury, poisoning and procedural complications           
Hip fracture  1  0/306 (0.00%)  0 1/151 (0.66%)  1 0/144 (0.00%)  0 0/84 (0.00%)  0 0/45 (0.00%)  0
Spinal fracture  1  0/306 (0.00%)  0 0/151 (0.00%)  0 1/144 (0.69%)  1 0/84 (0.00%)  0 0/45 (0.00%)  0
Meniscus injury  1  0/306 (0.00%)  0 0/151 (0.00%)  0 0/144 (0.00%)  0 1/84 (1.19%)  1 0/45 (0.00%)  0
Rib fracture  1  0/306 (0.00%)  0 0/151 (0.00%)  0 0/144 (0.00%)  0 1/84 (1.19%)  1 0/45 (0.00%)  0
Traumatic haemothorax  1  0/306 (0.00%)  0 0/151 (0.00%)  0 0/144 (0.00%)  0 1/84 (1.19%)  1 0/45 (0.00%)  0
Metabolism and nutrition disorders           
Decreased appetite  1  1/306 (0.33%)  1 0/151 (0.00%)  0 0/144 (0.00%)  0 0/84 (0.00%)  0 0/45 (0.00%)  0
Hypoglycaemia  1  0/306 (0.00%)  0 0/151 (0.00%)  0 0/144 (0.00%)  0 1/84 (1.19%)  1 0/45 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Malignant polyp  1  1/306 (0.33%)  1 0/151 (0.00%)  0 0/144 (0.00%)  0 0/84 (0.00%)  0 0/45 (0.00%)  0
Benign ovarian tumour  1  0/306 (0.00%)  0 1/151 (0.66%)  1 0/144 (0.00%)  0 0/84 (0.00%)  0 0/45 (0.00%)  0
Colon cancer stage 0  1  0/306 (0.00%)  0 0/151 (0.00%)  0 1/144 (0.69%)  1 0/84 (0.00%)  0 0/45 (0.00%)  0
Intraductal papillary mucinous neoplasm  1  0/306 (0.00%)  0 0/151 (0.00%)  0 1/144 (0.69%)  1 0/84 (0.00%)  0 0/45 (0.00%)  0
Prostate cancer  1  0/306 (0.00%)  0 0/151 (0.00%)  0 1/144 (0.69%)  1 0/84 (0.00%)  0 0/45 (0.00%)  0
Uterine leiomyoma  1  0/306 (0.00%)  0 1/151 (0.66%)  1 0/144 (0.00%)  0 0/84 (0.00%)  0 0/45 (0.00%)  0
Nervous system disorders           
Myasthenia gravis  1  0/306 (0.00%)  0 0/151 (0.00%)  0 1/144 (0.69%)  1 0/84 (0.00%)  0 0/45 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Asthma  1  3/306 (0.98%)  4 6/151 (3.97%)  6 2/144 (1.39%)  2 4/84 (4.76%)  4 4/45 (8.89%)  6
Acute respiratory failure  1  0/306 (0.00%)  0 0/151 (0.00%)  0 0/144 (0.00%)  0 1/84 (1.19%)  1 0/45 (0.00%)  0
Paranasal cyst  1  0/306 (0.00%)  0 0/151 (0.00%)  0 0/144 (0.00%)  0 1/84 (1.19%)  1 0/45 (0.00%)  0
Pneumonia aspiration  1  0/306 (0.00%)  0 0/151 (0.00%)  0 0/144 (0.00%)  0 1/84 (1.19%)  1 0/45 (0.00%)  0
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Part A/B: Mepolizumab 100mg SC Part C: Placebo Part C: Mepolizumab 100mg Part D: Mepolizumab 100mg SC (Previous Placebo) Part D: Mepolizumab 100mg SC (Previous Mepolizumab)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/306 (4.58%)      69/151 (45.70%)      82/144 (56.94%)      44/84 (52.38%)      32/45 (71.11%)    
Gastrointestinal disorders           
Abdominal pain  1  0/306 (0.00%)  0 0/151 (0.00%)  0 0/144 (0.00%)  0 1/84 (1.19%)  1 2/45 (4.44%)  2
Diarrhoea  1  0/306 (0.00%)  0 0/151 (0.00%)  0 0/144 (0.00%)  0 3/84 (3.57%)  3 0/45 (0.00%)  0
Large intestine polyp  1  0/306 (0.00%)  0 0/151 (0.00%)  0 0/144 (0.00%)  0 0/84 (0.00%)  0 2/45 (4.44%)  2
Infections and infestations           
Nasopharyngitis  1  14/306 (4.58%)  23 26/151 (17.22%)  44 27/144 (18.75%)  36 16/84 (19.05%)  22 9/45 (20.00%)  12
Upper respiratory tract infection  1  0/306 (0.00%)  0 14/151 (9.27%)  18 12/144 (8.33%)  14 5/84 (5.95%)  5 3/45 (6.67%)  3
Sinusitis  1  0/306 (0.00%)  0 9/151 (5.96%)  10 13/144 (9.03%)  14 7/84 (8.33%)  11 5/45 (11.11%)  8
Bronchitis  1  0/306 (0.00%)  0 5/151 (3.31%)  5 14/144 (9.72%)  14 7/84 (8.33%)  8 8/45 (17.78%)  13
Respiratory tract infection viral  1  0/306 (0.00%)  0 2/151 (1.32%)  2 6/144 (4.17%)  11 0/84 (0.00%)  0 0/45 (0.00%)  0
Viral upper respiratory tract infection  1  0/306 (0.00%)  0 5/151 (3.31%)  7 3/144 (2.08%)  3 0/84 (0.00%)  0 0/45 (0.00%)  0
Influenza  1  0/306 (0.00%)  0 1/151 (0.66%)  1 5/144 (3.47%)  5 1/84 (1.19%)  1 2/45 (4.44%)  2
Urinary tract infection  1  0/306 (0.00%)  0 0/151 (0.00%)  0 0/144 (0.00%)  0 4/84 (4.76%)  6 0/45 (0.00%)  0
Chronic sinusitis  1  0/306 (0.00%)  0 0/151 (0.00%)  0 0/144 (0.00%)  0 1/84 (1.19%)  1 2/45 (4.44%)  4
Pneumonia  1  0/306 (0.00%)  0 0/151 (0.00%)  0 0/144 (0.00%)  0 3/84 (3.57%)  3 0/45 (0.00%)  0
Oral candidiasis  1  0/306 (0.00%)  0 0/151 (0.00%)  0 0/144 (0.00%)  0 0/84 (0.00%)  0 2/45 (4.44%)  2
Tooth infection  1  0/306 (0.00%)  0 0/151 (0.00%)  0 0/144 (0.00%)  0 0/84 (0.00%)  0 2/45 (4.44%)  2
Metabolism and nutrition disorders           
Hyperglycaemia  1  0/306 (0.00%)  0 0/151 (0.00%)  0 0/144 (0.00%)  0 1/84 (1.19%)  1 2/45 (4.44%)  2
Musculoskeletal and connective tissue disorders           
Back pain  1  0/306 (0.00%)  0 6/151 (3.97%)  12 6/144 (4.17%)  8 3/84 (3.57%)  4 2/45 (4.44%)  2
Arthralgia  1  0/306 (0.00%)  0 3/151 (1.99%)  3 6/144 (4.17%)  6 0/84 (0.00%)  0 0/45 (0.00%)  0
Neck pain  1  0/306 (0.00%)  0 0/151 (0.00%)  0 0/144 (0.00%)  0 2/84 (2.38%)  2 2/45 (4.44%)  2
Nervous system disorders           
Headache  1  0/306 (0.00%)  0 9/151 (5.96%)  11 9/144 (6.25%)  12 6/84 (7.14%)  7 4/45 (8.89%)  7
Respiratory, thoracic and mediastinal disorders           
Asthma  1  0/306 (0.00%)  0 14/151 (9.27%)  16 10/144 (6.94%)  14 7/84 (8.33%)  7 4/45 (8.89%)  12
Cough  1  0/306 (0.00%)  0 6/151 (3.97%)  7 1/144 (0.69%)  1 0/84 (0.00%)  0 0/45 (0.00%)  0
Oropharyngeal pain  1  0/306 (0.00%)  0 0/151 (0.00%)  0 0/144 (0.00%)  0 3/84 (3.57%)  3 1/45 (2.22%)  1
Vascular disorders           
Hypertension  1  0/306 (0.00%)  0 1/151 (0.66%)  1 5/144 (3.47%)  6 0/84 (0.00%)  0 0/45 (0.00%)  0
1
Term from vocabulary, MedDRA 22.0
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
Layout table for Results Point of Contact information
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: NCT02555371    
Other Study ID Numbers: 201810
2015-002361-32 ( EudraCT Number )
First Submitted: September 17, 2015
First Posted: September 21, 2015
Results First Submitted: January 23, 2020
Results First Posted: February 5, 2020
Last Update Posted: February 5, 2020