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The purpose of this study is to show whether mepolizumab given every 4 weeks intravenously (i.v.) can reduce the frequency of asthma exacerbations in subjects with severe asthma despite receiving high doses of standard asthma medications. The study will look at different doses of mepolizumab in comparison to a placebo.
A double-blind, placebo-controlled study to evaluate the efficacy, safety and pharmacodynamics of three doses (75 mg, 250 mg and 750 mg) of mepolizumab intravenous (i.v.) administered every 4 weeks compared with placebo over a 52-week treatment period in subjects with severe uncontrolled refractory asthma. Efficacy will be measured by the frequency of asthma exacerbations. In addition lung function, rescue medication usage, daily symptoms, asthma control score, asthma quality of life score and withdrawals due to asthma exacerbations will be assessed. Safety will be assessed by adverse events, clinical laboratory evaluations, ECGs, immunogenicity and vital signs. Pharmacodynamics will be assessed by eosinophil levels in blood, serum IL-5 and eosinophil levels in induced sputum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepolizumab 750mg | Active Comparator | Mepolizumab 750mcg i.v. every 4 weeks |
|
| Mepolizumab 250mg | Active Comparator | Mepolizumab 250mcg i.v. every 4 weeks |
|
| Mepolizumab 75mg | Active Comparator | Mepolizumab 75mcg i.v. every 4 weeks |
|
| Placebo | Placebo Comparator | Placebo saline every 4 weeks i.v. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepolizumab 750 | Biological | Mepolizumab 750mg every four weeks by i.v. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Clinically Significant Exacerbations of Asthma Per Year | Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance oral corticosteroids [OCS], an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or emergency department (ED) visit. The frequency of clinically significant exacerbations of asthma over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable | From randomization (Week 0) to Week 52 or early withdrawal (EW) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Clinically Significant Exacerbation Requiring Oral or Systemic Corticosteroid, Hospitalization and/ or ED Visit | Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance OCS, an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Long Beach | California | 90808 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22901886 | Background | Pavord ID, Korn S, Howarth P, Bleecker ER, Buhl R, Keene ON, Ortega H, Chanez P. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012 Aug 18;380(9842):651-9. doi: 10.1016/S0140-6736(12)60988-X. | |
| 37131185 | Derived | Chen W, Reddel HK, FitzGerald JM, Beasley R, Janson C, Sadatsafavi M. Can we predict who will benefit most from biologics in severe asthma? A post-hoc analysis of two phase 3 trials. Respir Res. 2023 May 2;24(1):120. doi: 10.1186/s12931-023-02409-2. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 112997 | Annotated Case Report Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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A total of 888 par. were enrolled, of these, 168 were screen failures and 720 entered the run-in phase. 99 participants were run-in failures and 621 completed the run-in phase and were randomized. Of these, 616 participants were randomized and received treatment and were included within the Intent-to-Treat (ITT) Population.
Participants (par.) who met the eligibility criteria at screening, entered the two week Run-in phase and par. who met the randomization eligibility criteria at the end of the Run-in phase entered into the 52-week Double-blind treatment period followed by a 4-week Follow-up phase. The total duration of participation in the study was 58 Weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo IV | Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). |
| FG001 | Mepolizumab 75 mg IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Mepolizumab 250 |
| Biological |
Mepolizumab 250mg every four weeks by i.v. |
|
| Mepolizumab 75 | Biological | Mepolizumab 75mg every four weeks by i.v. |
|
| Placebo saline | Drug | Placebo saline every four weeks by i.v. |
|
| From randomization (Week 0) to Week 52 or EW |
| Number of Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visit Per Year | The frequency of exacerbations of asthma requiring hospitalization (including intubation and admittance to an intensive care unit [ICU]) or ED visit over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable. | From randomization (Week 0) to Week 52 or EW |
| Time to First Exacerbation Requiring Hospitalization or ED Visit | Exacerbations of asthma requiring hospitalization or ED visit were assessed. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52). | From randomization (Week 0) to Week 52 or EW |
| Number of All Recorded Exacerbations Per Year | Clinically significant exacerbations (ex) of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for par. on maintenance OCS, an ex requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. In the case, an event described as an ex was not associated with a deterioration in >=1 of the objectives of eDiary parameters, the investigator (inv) provided an explanation to support the decision for defining the event as an ex. All recorded ex were defined as those recorded by inv, regardless of the outcome of the ex review process. Analysis was performed using Negative Binomial regression model with covariates of treatment group, BL maintenance OCS therapy (OCS vs. no OCS), region, ex in the year prior to the study (as an ordinal variable) and BL % predicted FEV1, and with logarithm of time on treatment as an offset variable. | From randomization (Week 0) to Week 52 or EW |
| Time to First All Recorded Exacerbation | All recorded exacerbations are defined as those recorded by investigators, regardless of the outcome of the exacerbation review process. In the case, an event described as an exacerbation was not associated with a deterioration in at least one of the objectives of eDiary parameters, the investigator provided an explanation to support the decision for defining the event as an exacerbation. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by week 16, week 32 and week 52). | From randomization (Week 0) to Week 52 or EW |
| Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period | FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at each clinic visit. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Analysis was performed using mixed model repeated measures with covariates of Baseline, region, Baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group. | From Baseline up to Week 52 or EW |
| Mean Change From Baseline in Clinic Post-bronchodilator FEV1 Over the 52-week Treatment Period | FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Post-bronchodilator FEV1 measurements were taken by spirometry at Baseline, Week 16, Week 32 and Week 52. Post bronchodilator values were recorded following reversibility testing, using the maximum post bronchodilator method. Participants unable to achieve >=12% reversibility and 200 mL change at Visit 1, reversibility test was repeated at Visit 2. These procedures to achieve the maximum post-bronchodilator are generated by the Asthma Clinical Research Network. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Analysis was performed using mixed model repeated measures with covariates of Baseline, region, Baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment | From Baseline up to Week 52 or EW |
| Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period | The ACQ-6 is a six-item questionnaire. The six questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze) and use of short-acting bronchodilator over the previous week. The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 6 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). Change from BL is defined as the difference between the value of the endpoint at the time point of interest and BL value. Analysis was performed using mixed model repeated measures with covariates of BL, region, BL maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), BL % predicted FEV1, treatment and visit, plus interaction terms for visit by BL and visit by treatment group. | From Baseline up to Week 52 or EW |
| Los Angeles |
| California |
| 90095 |
| United States |
| GSK Investigational Site | Riverside | California | 92506 | United States |
| GSK Investigational Site | San Diego | California | 92103-8415 | United States |
| GSK Investigational Site | Denver | Colorado | 80206 | United States |
| GSK Investigational Site | New Haven | Connecticut | 06510 | United States |
| GSK Investigational Site | Albany | Georgia | 31707 | United States |
| GSK Investigational Site | Columbus | Georgia | 31904 | United States |
| GSK Investigational Site | Lexington | Kentucky | 40508 | United States |
| GSK Investigational Site | St Louis | Missouri | 63110 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| GSK Investigational Site | Canton | Ohio | 44718 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44195 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73103 | United States |
| GSK Investigational Site | Hershey | Pennsylvania | 17033 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | PA 15213 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29406 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203 | United States |
| GSK Investigational Site | Boerne | Texas | 78006 | United States |
| GSK Investigational Site | Houston | Texas | 77054 | United States |
| GSK Investigational Site | Madison | Wisconsin | 53792 | United States |
| GSK Investigational Site | Mar del Plata | Buenos Aires | B7600FZN | Argentina |
| GSK Investigational Site | Buenos Aires | 1425 | Argentina |
| GSK Investigational Site | Buenos Aires | C1426ABP | Argentina |
| GSK Investigational Site | Mendoza | M5500CCG | Argentina |
| GSK Investigational Site | San Miguel de Tucumán | 4000 | Argentina |
| GSK Investigational Site | New Lambton | New South Wales | 2305 | Australia |
| GSK Investigational Site | Adelaide | South Australia | 5000 | Australia |
| GSK Investigational Site | Clayton | Victoria | 3168 | Australia |
| GSK Investigational Site | Melbourne | Victoria | 3004 | Australia |
| GSK Investigational Site | Nedlands | Western Australia | 6009 | Australia |
| GSK Investigational Site | Calgary | Alberta | T2N 4Z6 | Canada |
| GSK Investigational Site | Vancouver | British Columbia | V5Z 1M9 | Canada |
| GSK Investigational Site | Mississauga | Ontario | L5A 3V4 | Canada |
| GSK Investigational Site | Mississauga | Ontario | L5M 2V8 | Canada |
| GSK Investigational Site | Québec | Quebec | G1V 4G5 | Canada |
| GSK Investigational Site | Puente Alto - Santiago | Región Metro de Santiago | 8207257 | Chile |
| GSK Investigational Site | Valparaíso | Valparaiso | 2341131 | Chile |
| GSK Investigational Site | Santiago | 8380453 | Chile |
| GSK Investigational Site | Talcahuano | 4270918 | Chile |
| GSK Investigational Site | Clamart | 92140 | France |
| GSK Investigational Site | Marseille | 13915 | France |
| GSK Investigational Site | Montpellier | 34295 | France |
| GSK Investigational Site | Nantes | 44093 | France |
| GSK Investigational Site | Saint-Pierre | 97448 | France |
| GSK Investigational Site | Rüdersdorf | Brandenburg | 15562 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60596 | Germany |
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55131 | Germany |
| GSK Investigational Site | Magdeburg | Saxony-Anhalt | 39112 | Germany |
| GSK Investigational Site | Lübeck | Schleswig-Holstein | 23552 | Germany |
| GSK Investigational Site | Berlin | 10367 | Germany |
| GSK Investigational Site | Berlin | 10717 | Germany |
| GSK Investigational Site | Berlin | 12203 | Germany |
| GSK Investigational Site | Berlin | 14050 | Germany |
| GSK Investigational Site | Bialystok | 15-276 | Poland |
| GSK Investigational Site | Lodz | 90-153 | Poland |
| GSK Investigational Site | Warsaw | 01-138 | Poland |
| GSK Investigational Site | Wroclaw | 54-239 | Poland |
| GSK Investigational Site | Zawadzkie | 47-120 | Poland |
| GSK Investigational Site | Zgierz | 95-100 | Poland |
| GSK Investigational Site | Bucharest | 050159 | Romania |
| GSK Investigational Site | Bucharest | 70000 | Romania |
| GSK Investigational Site | Iași | 700115 | Romania |
| GSK Investigational Site | Târgu Mureş | 540143 | Romania |
| GSK Investigational Site | Barnaul | 656 045 | Russia |
| GSK Investigational Site | Chelyabinsk | 454106 | Russia |
| GSK Investigational Site | Kazan' | 420015 | Russia |
| GSK Investigational Site | Moscow | 105 077 | Russia |
| GSK Investigational Site | Moscow | 115478 | Russia |
| GSK Investigational Site | Moscow | 123 182 | Russia |
| GSK Investigational Site | Saint Petersburg | 194354 | Russia |
| GSK Investigational Site | Saint Petersburg | 198216 | Russia |
| GSK Investigational Site | Tomsk | 634001 | Russia |
| GSK Investigational Site | Bucheon-si | 420-767 | South Korea |
| GSK Investigational Site | Cheongju, Chungcheongbuk-do | 361-711 | South Korea |
| GSK Investigational Site | Seoul | 133--792 | South Korea |
| GSK Investigational Site | Seoul | 152-703 | South Korea |
| GSK Investigational Site | Suwon, Kyonggi-do | 443-721 | South Korea |
| GSK Investigational Site | Cherkassy | 18009 | Ukraine |
| GSK Investigational Site | Dnipropetrovsk | 49006 | Ukraine |
| GSK Investigational Site | Dnipropetrovsk | 49027 | Ukraine |
| GSK Investigational Site | Dnipropetrovsk | 49051 | Ukraine |
| GSK Investigational Site | Donetsk | 83003 | Ukraine |
| GSK Investigational Site | Donetsk | 83099 | Ukraine |
| GSK Investigational Site | Kharkiv | 61035 | Ukraine |
| GSK Investigational Site | Kiev | 03680 | Ukraine |
| GSK Investigational Site | Kyiv | 03038 | Ukraine |
| GSK Investigational Site | Kyiv | 03115 | Ukraine |
| GSK Investigational Site | Mykolayiv | 54003 | Ukraine |
| GSK Investigational Site | Leicester | Leicestershire | LE3 9QP | United Kingdom |
| GSK Investigational Site | London | E1 2AT | United Kingdom |
| GSK Investigational Site | London | SW3 6HP | United Kingdom |
| GSK Investigational Site | Manchester | M23 9LT | United Kingdom |
| GSK Investigational Site | Southampton | SO16 6YD | United Kingdom |
| 34098955 | Derived | Gibson PG, Prazma CM, Chupp GL, Bradford ES, Forshag M, Mallett SA, Yancey SW, Smith SG, Bel EH. Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions. Respir Res. 2021 Jun 7;22(1):171. doi: 10.1186/s12931-021-01746-4. |
| 32450626 | Derived | Kim MK, Park HS, Park CS, Min SJ, Albers FC, Yancey SW, Mayer B, Kwon N. Efficacy and safety of mepolizumab in Korean patients with severe eosinophilic asthma from the DREAM and MENSA studies. Korean J Intern Med. 2021 Mar;36(2):362-370. doi: 10.3904/kjim.2019.198. Epub 2020 May 26. |
| 30954640 | Derived | Ortega HG, Meyer E, Brusselle G, Asano K, Prazma CM, Albers FC, Mallett SA, Yancey SW, Gleich GJ. Update on immunogenicity in severe asthma: Experience with mepolizumab. J Allergy Clin Immunol Pract. 2019 Sep-Oct;7(7):2469-2475.e1. doi: 10.1016/j.jaip.2019.03.042. Epub 2019 Apr 5. No abstract available. |
| 29398640 | Derived | Ortega H, Yancey SW, Keene ON, Gunsoy NB, Albers FC, Howarth PH. Asthma Exacerbations Associated with Lung Function Decline in Patients with Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):980-986.e1. doi: 10.1016/j.jaip.2017.12.019. Epub 2018 Feb 15. |
| 29258789 | Derived | Gunsoy NB, Cockle SM, Yancey SW, Keene ON, Bradford ES, Albers FC, Pavord ID. Evaluation of Potential Continuation Rules for Mepolizumab Treatment of Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):874-882.e4. doi: 10.1016/j.jaip.2017.11.026. Epub 2017 Dec 16. |
| 24983709 | Derived | Ortega H, Li H, Suruki R, Albers F, Gordon D, Yancey S. Cluster analysis and characterization of response to mepolizumab. A step closer to personalized medicine for patients with severe asthma. Ann Am Thorac Soc. 2014 Sep;11(7):1011-7. doi: 10.1513/AnnalsATS.201312-454OC. |
| 24834924 | Derived | Prazma CM, Wenzel S, Barnes N, Douglass JA, Hartley BF, Ortega H. Characterisation of an OCS-dependent severe asthma population treated with mepolizumab. Thorax. 2014 Dec;69(12):1141-2. doi: 10.1136/thoraxjnl-2014-205581. Epub 2014 May 16. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 112997 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112997 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112997 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112997 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112997 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112997 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Participants received mepolizumab 75 milligrams (mg) IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
| FG002 | Mepolizumab 250 mg IV | Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). |
| FG003 | Mepolizumab 750 mg IV | Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo IV | Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). |
| BG001 | Mepolizumab 75 mg IV | Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). |
| BG002 | Mepolizumab 250 mg IV | Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). |
| BG003 | Mepolizumab 750 mg IV | Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Clinically Significant Exacerbations of Asthma Per Year | Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance oral corticosteroids [OCS], an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or emergency department (ED) visit. The frequency of clinically significant exacerbations of asthma over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable | Intent-to-Treat (ITT) Population: all participants who were randomized and who received at least one dose of study medication. | Posted | Number | Exacerbations per year | From randomization (Week 0) to Week 52 or early withdrawal (EW) |
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| Secondary | Time to First Clinically Significant Exacerbation Requiring Oral or Systemic Corticosteroid, Hospitalization and/ or ED Visit | Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance OCS, an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52). | ITT Population | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization (Week 0) to Week 52 or EW |
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| Secondary | Number of Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visit Per Year | The frequency of exacerbations of asthma requiring hospitalization (including intubation and admittance to an intensive care unit [ICU]) or ED visit over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable. | ITT Population | Posted | Number | Exacerbations per year | From randomization (Week 0) to Week 52 or EW |
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| Secondary | Time to First Exacerbation Requiring Hospitalization or ED Visit | Exacerbations of asthma requiring hospitalization or ED visit were assessed. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52). | ITT Population | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization (Week 0) to Week 52 or EW |
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| Secondary | Number of All Recorded Exacerbations Per Year | Clinically significant exacerbations (ex) of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for par. on maintenance OCS, an ex requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. In the case, an event described as an ex was not associated with a deterioration in >=1 of the objectives of eDiary parameters, the investigator (inv) provided an explanation to support the decision for defining the event as an ex. All recorded ex were defined as those recorded by inv, regardless of the outcome of the ex review process. Analysis was performed using Negative Binomial regression model with covariates of treatment group, BL maintenance OCS therapy (OCS vs. no OCS), region, ex in the year prior to the study (as an ordinal variable) and BL % predicted FEV1, and with logarithm of time on treatment as an offset variable. | ITT Population | Posted | Number | Exacerbations per year | From randomization (Week 0) to Week 52 or EW |
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| Secondary | Time to First All Recorded Exacerbation | All recorded exacerbations are defined as those recorded by investigators, regardless of the outcome of the exacerbation review process. In the case, an event described as an exacerbation was not associated with a deterioration in at least one of the objectives of eDiary parameters, the investigator provided an explanation to support the decision for defining the event as an exacerbation. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by week 16, week 32 and week 52). | ITT Population | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization (Week 0) to Week 52 or EW |
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| Secondary | Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period | FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at each clinic visit. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Analysis was performed using mixed model repeated measures with covariates of Baseline, region, Baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group. | ITT Population. Only those participants available at the specified time points were analyzed for each treatment and represented as n=X, X, X, X respectively. | Posted | Least Squares Mean | Standard Error | Milliliters (mL) | From Baseline up to Week 52 or EW |
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| Secondary | Mean Change From Baseline in Clinic Post-bronchodilator FEV1 Over the 52-week Treatment Period | FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Post-bronchodilator FEV1 measurements were taken by spirometry at Baseline, Week 16, Week 32 and Week 52. Post bronchodilator values were recorded following reversibility testing, using the maximum post bronchodilator method. Participants unable to achieve >=12% reversibility and 200 mL change at Visit 1, reversibility test was repeated at Visit 2. These procedures to achieve the maximum post-bronchodilator are generated by the Asthma Clinical Research Network. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Analysis was performed using mixed model repeated measures with covariates of Baseline, region, Baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment | ITT Population. Only those participants available at the specified time points were analyzed for each treatment and represented as n=X, X, X, X respectively. | Posted | Least Squares Mean | Standard Error | mL | From Baseline up to Week 52 or EW |
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| Secondary | Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period | The ACQ-6 is a six-item questionnaire. The six questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze) and use of short-acting bronchodilator over the previous week. The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 6 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). Change from BL is defined as the difference between the value of the endpoint at the time point of interest and BL value. Analysis was performed using mixed model repeated measures with covariates of BL, region, BL maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), BL % predicted FEV1, treatment and visit, plus interaction terms for visit by BL and visit by treatment group. | ITT Population. Only those participants available at the specified time points were analyzed for each treatment and represented as n=X, X, X, X respectively. | Posted | Least Squares Mean | Standard Error | Scores on a scale | From Baseline up to Week 52 or EW |
|
On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks.
SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo IV | Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). | 25 | 155 | 106 | 155 | ||
| EG001 | Mepolizumab 75 mg IV | Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). | 20 | 153 | 113 | 153 | ||
| EG002 | Mepolizumab 250 mg IV | Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). | 24 | 152 | 113 | 152 | ||
| EG003 | Mepolizumab 750 mg IV | Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). | 19 | 156 | 112 | 156 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Haematoma infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes zoster ophthalmic | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lung infection pseudomonal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery thrombosis | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery insufficiency | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Peritoneal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Thrombosis mesenteric vessel | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cervicobrachial syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cranial nerve disorder | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Distributive shock | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Malignant hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Microlithiasis | General disorders | MedDRA | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Reticulocyte count decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| American Indian or Alaska Native |
|
| Asian - Central/South Asian Heritage |
|
| Asian - East Asian Heritage |
|
| Asian - South East Asian Heritage |
|
| Native Hawaiian or other Pacific Islander |
|
| White - Arabic/North African Heritage |
|
| White - White/Caucasian/European Heritage |
|
| Mixed Race |
|
| Negative Binomial regression model |
| <0.001 |
Hochberg testing procedure with a one-sided alpha of 2.5% used for controlling multiplicity |
| Rate Ratio |
| 0.61 |
| 2-Sided |
| 95 |
| 0.46 |
| 0.81 |
Number of exacerbations per year in the mepolizumab 250 mg IV arm divided by the number of exacerbations per year in the placebo arm. |
| Superiority or Other |
| Negative Binomial regression model | <0.001 | Hochberg testing procedure with a one-sided alpha of 2.5% used for controlling multiplicity | Rate Ratio | 0.48 | 2-Sided | 95 | 0.36 | 0.64 | Number of exacerbations per year in the mepolizumab 750 mg IV arm divided by the number of exacerbations per year in the placebo arm. | Superiority or Other |
| OG003 | Mepolizumab 750 mg IV | Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). |
|
|
Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
| OG003 | Mepolizumab 750 mg IV | Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). |
|
|
Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
|
|
| OG002 | Mepolizumab 250 mg IV | Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). |
| OG003 | Mepolizumab 750 mg IV | Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). |
|
|
| OG003 | Mepolizumab 750 mg IV | Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). |
|
|
| Mepolizumab 250 mg IV |
Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). |
| OG003 | Mepolizumab 750 mg IV | Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). |
|
|
Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). |
| OG002 | Mepolizumab 250 mg IV | Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). |
| OG003 | Mepolizumab 750 mg IV | Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). |
|
|
Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). |
| OG002 | Mepolizumab 250 mg IV | Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). |
| OG003 | Mepolizumab 750 mg IV | Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product). |
|
|