Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma

MEA115588 A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma

This study will evaluate two dose regimens of mepolizumab [75mg intravenous (i.v.) or 100mg subcutaneous (SC) every 4 weeks] compared with placebo over a 32 week treatment period in subjects with severe refractory asthma with elevated blood eosinophils. Efficacy will be measured by a reduction in the frequency of asthma exacerbations. Additional efficacy assessments will include measurements of lung function, symptom scores, and quality of life. Safety will be assessed by clinical laboratory samples, ECGs, immunogenicity and adverse events.

This study is intended to replicate the Phase IIb/III study MEA112997. Subjects in MEA115588, who meet all eligibility criteria at screening visit, will enter the run-in period. Those subjects that are not able/eligible to be randomised at the end of the 6 week run-in period will be deemed run-in failures. Subjects will remain on their current maintenance therapy throughout the run-in, double-blind treatment administration and follow-up periods. Subjects who meet the randomisation eligibility criteria will be randomised in a 1:1:1 ratio to receive one of the following treatments every 4 weeks for a total of 8 doses: Mepolizumab 75 miligram (mg) i.v. and placebo SC, or Mepolizumab 100 mg SC and placebo i.v. or Placebo i.v. and placebo SC.

Subjects that receive all 8 doses of double-blind treatment, and meet the eligibility criteria for the Open-Label Extension (OLE) Study, will be offered the opportunity to participate in the OLE trial.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Mepolizumab IV; Drug: SC Placebo; Drug: Mepolizumab SC; Drug: IV Placebo

• Study Type: Interventional
• Enrollment (Actual): 580
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1424BSF
    • GSK Investigational Site
  • Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
    • GSK Investigational Site
  • Mendoza, Argentina, 5500
    • GSK Investigational Site
  • Buenos Aires
    • Mar del Plata, Buenos Aires, Argentina, B7600FZN
      • GSK Investigational Site
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • GSK Investigational Site
  • Mendoza
    • San Rafael, Mendoza, Argentina, 5600
      • GSK Investigational Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000DBS
      • GSK Investigational Site
• Australia
  • Parkville, Australia, 3052
    • GSK Investigational Site
  • New South Wales
    • New Lambton, New South Wales, Australia, 2305
      • GSK Investigational Site
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • GSK Investigational Site
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • GSK Investigational Site
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • GSK Investigational Site
• Belgium
  • Bruxelles, Belgium, 1020
    • GSK Investigational Site
  • Gent, Belgium, 9000
    • GSK Investigational Site
  • Leuven, Belgium, 3000
    • GSK Investigational Site
  • Liège, Belgium, 4000
    • GSK Investigational Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • GSK Investigational Site
    • Edmonton, Alberta, Canada, T6G2E1
      • GSK Investigational Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • GSK Investigational Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • GSK Investigational Site
  • Ontario
    • Burlington, Ontario, Canada, L7N 3V2
      • GSK Investigational Site
    • Hamilton, Ontario, Canada, L8N 3Z5
      • GSK Investigational Site
    • Windsor, Ontario, Canada, N8X 5A6
      • GSK Investigational Site
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • GSK Investigational Site
    • Montreal, Quebec, Canada, H2X 2P4
      • GSK Investigational Site
    • Montreal, Quebec, Canada, H2W 1T8
      • GSK Investigational Site
    • Quebec City, Quebec, Canada, G1V 4G5
      • GSK Investigational Site
    • St-Charles-Borromée, Quebec, Canada, J6E 2B4
      • GSK Investigational Site
    • Trois Rivieres, Quebec, Canada, G8T 7A1
      • GSK Investigational Site
• Chile
  • Santiago, Chile, 8380453
    • GSK Investigational Site
  • Talcahuano, Chile, 4270918
    • GSK Investigational Site
  • Reg Del Libert Bern Ohiggins
    • Rancagua, Reg Del Libert Bern Ohiggins, Chile, 2841959
      • GSK Investigational Site
• France
  • Le Kremlin-Bicêtre Cedex, France, 94275
    • GSK Investigational Site
  • Lille cedex, France, 59037
    • GSK Investigational Site
  • Lyon cedex 04, France, 69317
    • GSK Investigational Site
  • Marseille cedex 20, France, 13915
    • GSK Investigational Site
  • Montpellier cedex 5, France, 34295
    • GSK Investigational Site
  • Perpignan, France, 66000
    • GSK Investigational Site
  • Saint Pierre cedex, France, 97448
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 10367
    • GSK Investigational Site
  • Hamburg, Germany, 22299
    • GSK Investigational Site
  • Bayern
    • Aschaffenburg, Bayern, Germany, 63739
      • GSK Investigational Site
  • Brandenburg
    • Potsdam, Brandenburg, Germany, 14478
      • GSK Investigational Site
    • Ruedersdorf, Brandenburg, Germany, 15562
      • GSK Investigational Site
  • Hessen
    • Frankfurt, Hessen, Germany, 60596
      • GSK Investigational Site
    • Frankfurt, Hessen, Germany, 60389
      • GSK Investigational Site
    • Frankfurt am Main, Hessen, Germany, 60596
      • GSK Investigational Site
    • Gelnhausen, Hessen, Germany, 63571
      • GSK Investigational Site
    • Neu isenburg, Hessen, Germany, 63263
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • GSK Investigational Site
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39112
      • GSK Investigational Site
• Italy
  • Campania
    • Napoli, Campania, Italy, 80131
      • GSK Investigational Site
  • Emilia-Romagna
    • Parma, Emilia-Romagna, Italy, 43125
      • GSK Investigational Site
  • Liguria
    • Genova, Liguria, Italy, 16132
      • GSK Investigational Site
    • Pietra Ligure (SV), Liguria, Italy, 17027
      • GSK Investigational Site
  • Puglia
    • Foggia, Puglia, Italy, 71100
      • GSK Investigational Site
  • Toscana
    • Pisa, Toscana, Italy, 56124
      • GSK Investigational Site
  • Umbria
    • Perugia, Umbria, Italy, 06156
      • GSK Investigational Site
  • Veneto
    • Cittadella PD, Veneto, Italy, 35013
      • GSK Investigational Site
• Japan
  • Chiba, Japan, 296-8602
    • GSK Investigational Site
  • Fukuoka, Japan, 802-0052
    • GSK Investigational Site
  • Fukuoka, Japan, 811-1394
    • GSK Investigational Site
  • Fukuoka, Japan, 832-0059
    • GSK Investigational Site
  • Gunma, Japan, 370-0615
    • GSK Investigational Site
  • Hiroshima, Japan, 732-0052
    • GSK Investigational Site
  • Hokkaido, Japan, 070-8644
    • GSK Investigational Site
  • Hokkaido, Japan, 062-8618
    • GSK Investigational Site
  • Hyogo, Japan, 672-8064
    • GSK Investigational Site
  • Hyogo, Japan, 651-0072
    • GSK Investigational Site
  • Ibaraki, Japan, 319-1113
    • GSK Investigational Site
  • Kanagawa, Japan, 252-0392
    • GSK Investigational Site
  • Kumamoto, Japan, 861-1196
    • GSK Investigational Site
  • Mie, Japan, 515-8544
    • GSK Investigational Site
  • Okinawa, Japan, 901-2132
    • GSK Investigational Site
  • Okinawa, Japan, 904-2293
    • GSK Investigational Site
  • Osaka, Japan, 596-8501
    • GSK Investigational Site
  • Osaka, Japan, 560-8552
    • GSK Investigational Site
  • Tokyo, Japan, 102-0083
    • GSK Investigational Site
  • Tokyo, Japan, 103-0027
    • GSK Investigational Site
  • Tokyo, Japan, 187-0024
    • GSK Investigational Site
  • Tokyo, Japan, 171-0014
    • GSK Investigational Site
• Korea, Republic of
  • Anyang-Si, Korea, Republic of, 431-070
    • GSK Investigational Site
  • Bucheon-si,, Korea, Republic of, 420-767
    • GSK Investigational Site
  • Cheongju, Chungcheongbuk-do, Korea, Republic of, 361-711
    • GSK Investigational Site
  • Daegu, Korea, Republic of, 705-717
    • GSK Investigational Site
  • Donggu Gwangju, Korea, Republic of, 501757
    • GSK Investigational Site
  • Incheon, Korea, Republic of, 405-760
    • GSK Investigational Site
  • Jeonju-si, Jeollabuk-Do, Korea, Republic of, 561-712
    • GSK Investigational Site
  • Kangwon-do, Korea, Republic of, 220-701
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 120-752
    • GSK Investigational Site
  • Seoul, Korea, Republic of
    • GSK Investigational Site
  • Suwon, Kyonggi-do, Korea, Republic of, 443-721
    • GSK Investigational Site
• Mexico
  • México DF, Mexico, 14050
    • GSK Investigational Site
  • Jalisco
    • Zapopan, Jalisco, Mexico, 45040
      • GSK Investigational Site
    • Zapopan, Jalisco, Mexico, 45200
      • GSK Investigational Site
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64020
      • GSK Investigational Site
• Russian Federation
  • Chelyabinsk, Russian Federation, 454106
    • GSK Investigational Site
  • Moscow, Russian Federation, 123182
    • GSK Investigational Site
  • Saint-Petersburg, Russian Federation, 194354
    • GSK Investigational Site
  • St. Petersburg, Russian Federation, 194356
    • GSK Investigational Site
• Spain
  • Alicante, Spain, 03004
    • GSK Investigational Site
  • Barcelona, Spain, 08036
    • GSK Investigational Site
  • Barcelona, Spain, 08041
    • GSK Investigational Site
  • Barcelona, Spain, 08208
    • GSK Investigational Site
  • Pozuelo De Alarcón/Madrid, Spain, 28223
    • GSK Investigational Site
• Ukraine
  • Kharkiv, Ukraine, 61124
    • GSK Investigational Site
  • Kiev, Ukraine, 03680
    • GSK Investigational Site
  • Mykolayiv, Ukraine, 54003
    • GSK Investigational Site
  • Vinnytsia, Ukraine, 21018
    • GSK Investigational Site
• United Kingdom
  • Bradford, United Kingdom, BD9 6RJ
    • GSK Investigational Site
  • Glasgow, United Kingdom, G11 6NT
    • GSK Investigational Site
  • London, United Kingdom, EC1M 6BQ
    • GSK Investigational Site
  • Plymouth, United Kingdom, PL6 8DH
    • GSK Investigational Site
  • Southampton, United Kingdom, SO16 6YD
    • GSK Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • GSK Investigational Site
  • California
    • Newport Beach, California, United States, 92663
      • GSK Investigational Site
    • Riverside, California, United States, 92506
      • GSK Investigational Site
    • Rolling Hills Estates, California, United States, 90274
      • GSK Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80206
      • GSK Investigational Site
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • GSK Investigational Site
  • Georgia
    • Albany, Georgia, United States, 31707
      • GSK Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60612
      • GSK Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • GSK Investigational Site
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • GSK Investigational Site
  • New York
    • New York, New York, United States, 10029
      • GSK Investigational Site
    • Rochester, New York, United States, 14642
      • GSK Investigational Site
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • GSK Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • GSK Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • GSK Investigational Site
    • Cincinnati, Ohio, United States, 45229
      • GSK Investigational Site
    • Cleveland, Ohio, United States, 44195
      • GSK Investigational Site
    • Columbus, Ohio, United States, 43221
      • GSK Investigational Site
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • GSK Investigational Site
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • GSK Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84132-2409
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able to give written informed consent prior to participation in the study
• At least 12 years of age at visit 1 and a minimum weight of 45 kilogram (kg)
• A well-documented requirement for regular treatment with high dose inhaled corticosteroid (ICS) in the 12 months prior to Visit 1 with or without maintenance oral corticosteroids (OCS)
• Current treatment with an additional controller medication, besides ICS, for at least 3 months or a documented failure in the past 12 months of an additional controller medication for at least 3 successive months
• Prior documentation of eosinophilic asthma or high likelihood of eosinophilic asthma
• At Visit 1, a pre-bronchodilator FEV1 <80% (for subjects >= 18 years of age), a pre-bronchodilator FEV1 <90% or FEV1:FVC ratio <0.8 (for subjects 12-17 years of age).
• Previously confirmed history of two or more exacerbations requiring treatment with systemic CS
• Male or Eligible Female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control)
• French subjects will be included only if either affiliated to or a beneficiary of a social security category.

Exclusion Criteria:

• Current smokers or former smokers with a smoking history of >=10 pack years
• Presence of a known pre-existing, clinically important lung condition other than asthma
• A current malignancy or previous history of malignancy in less than 12 months
• Known, pre-existing, unstable liver disease cirrhosis and known biliary abnormalities
• Known, pre-existing severe or clinically significant cardiovascular disease
• known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment
• Subjects with any eosinophilic diseases
• QTc(F) ≥450msec or QTc(F) ≥480 msec
• A history of alcohol/substance abuse
• Subject with known immunodeficiency
• Subjects who have received omalizumab within 130 days of Visit 1 or any monoclonal antibody (other than Xolair) to treat inflammatory disease within 5 half-lives of Visit 1
• Subjects who have received treatment with an investigational drug within the past 30 days or five terminal phase half-lives of the drug whichever is longer
• Subjects with allergy/intolerance to a monoclonal antibody or biologic.
• Subjects who are pregnant or breastfeeding
• Subjects who have known evidence of lack of adherence to controller medications and/or ability to follow physician's recommendations
• Previously participated in any study with mepolizumab and received investigational product (including placebo)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mepolizumab IV; Mepolizumab 75 mg will be administered intravenously approximately every 4 weeks with the last dose at week 32. Subjects in the Mepolizumab IV arm will receive mepolizumab 75 mg intravenously and placebo SC once every 4 weeks with the last dose at Week 28 (total of 8 doses)	Drug: Mepolizumab IV; Mepolizumab 75 mg IV will be administered every 4 weeks with the last dose at Week 28; Drug: SC Placebo; Normal saline (placebo) will be administered SC every 4 weeks with the last dose at Week 28
EXPERIMENTAL: Mepolizumab SC; Subjects in the Mepolizumab SC arm will receive mepolizumab 100 mg SC and placebo IV once every 4 weeks with the last dose at Week 28 (total of 8 doses)	Drug: Mepolizumab SC; Mepolizumab 100 mg SC will be administered every 4 weeks with the last dose at Week 28; Drug: IV Placebo; Normal saline (placebo) will be administered IV every 4 weeks with the last dose at Week 28
PLACEBO_COMPARATOR: Placebo; Subjects in the Placebo arm will receive matching placebo SC and placebo IV once every 4 weeks with the last dose at Week 28 (total of 8 doses)	Drug: SC Placebo; Normal saline (placebo) will be administered SC every 4 weeks with the last dose at Week 28; Drug: IV Placebo; Normal saline (placebo) will be administered IV every 4 weeks with the last dose at Week 28

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits. The frequency of clinically significant exacerbations of asthma over the 32-week treatment period is expressed as the number of exacerbations per year. Analysis of the number of exacerbations performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.	From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Clinically Significant Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visits Per Year	Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits. The frequency of clinically significant exacerbations of asthma over the 32-week treatment period is expressed as the number of exacerbations per year. Analysis of the number of exacerbations performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.	From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose
Number of Clinically Significant Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an ICU) Per Year	Clinically significant exacerbations of asthma is defined as worsening of asthma which required use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization. The frequency of clinically significant exacerbations of asthma over the 32-week treatment period is expressed as the number of exacerbations per year. Analysis of the number of exacerbations performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.	From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose
Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 32	FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry. 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 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.	Baseline, Week 32
Mean Change From Baseline in the St. George's Respiratory Questionnaire Total Score at Week 32	The St. George's Respiratory Questionnaire is an established instrument, comprising 50 questions, evaluating symptoms, activity, and impacts; to measure Quality of Life in participants with diseases of airway obstruction and to elicit the participant's opinion of his/her health. The lowest possible value is zero and the highest possible value is 100. The higher values correspond to greater impairment in quality of life. The questionnaire was administered at Baseline (Visit 2) and at the Exit Visit (approximately 4 weeks after the last dose of study treatment). 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 performed using analysis of covariance 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), baseline % predicted FEV1, and treatment.	Baseline, Week 32

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.
• Khurana S, Brusselle GG, Bel EH, FitzGerald JM, Masoli M, Korn S, Kato M, Albers FC, Bradford ES, Gilson MJ, Price RG, Humbert M. Long-term Safety and Clinical Benefit of Mepolizumab in Patients With the Most Severe Eosinophilic Asthma: The COSMEX Study. Clin Ther. 2019 Oct;41(10):2041-2056.e5. doi: 10.1016/j.clinthera.2019.07.007. Epub 2019 Aug 22.
• 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.
• Lemiere C, Taille C, Lee JK, Smith SG, Mallett S, Albers FC, Bradford ES, Yancey SW, Liu MC. Impact of baseline clinical asthma characteristics on the response to mepolizumab: a post hoc meta-analysis of two Phase III trials. Respir Res. 2021 Jun 22;22(1):184. doi: 10.1186/s12931-021-01767-z.
• Best N, Price RG, Pouliquen IJ, Keene ON. Assessing efficacy in important subgroups in confirmatory trials: An example using Bayesian dynamic borrowing. Pharm Stat. 2021 May;20(3):551-562. doi: 10.1002/pst.2093. Epub 2021 Jan 21.
• Wardlaw A, Howarth PH, Israel E, Taille C, Quirce S, Mallett S, Bates S, Albers FC, Kwon N. Fungal sensitization and its relationship to mepolizumab response in patients with severe eosinophilic asthma. Clin Exp Allergy. 2020 Jul;50(7):869-872. doi: 10.1111/cea.13680. Epub 2020 Jun 25. No abstract available.
• 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.
• Khurana S, Lyness JM, Mallett S, Nelsen LM, Prazma CM, Albers FC, Forshag M, Llanos JP, Yancey SW, Ortega HG. Association of depressive symptoms with health status and markers of uncontrolled severe asthma. Allergy Asthma Proc. 2019 Jul 1;40(4):230-239. doi: 10.2500/aap.2019.40.4229.
• Nelsen LM, Cockle SM, Gunsoy NB, Jones P, Albers FC, Bradford ES, Mullerova H. Impact of exacerbations on St George's Respiratory Questionnaire score in patients with severe asthma: post hoc analyses of two clinical trials and an observational study. J Asthma. 2020 Sep;57(9):1006-1016. doi: 10.1080/02770903.2019.1630640. Epub 2019 Jun 28.
• Yancey SW, Bradford ES, Keene ON. Disease burden and efficacy of mepolizumab in patients with severe asthma and blood eosinophil counts of >/=150-300 cells/muL. Respir Med. 2019 May;151:139-141. doi: 10.1016/j.rmed.2019.04.008. Epub 2019 Apr 8.
• Ortega H, Menzies-Gow A, Llanos JP, Forshag M, Albers F, Gunsoy N, Bradford ES, Yancey SW, Kraft M. Rapid and Consistent Improvements in Morning PEF in Patients with Severe Eosinophilic Asthma Treated with Mepolizumab. Adv Ther. 2018 Jul;35(7):1059-1068. doi: 10.1007/s12325-018-0727-8. Epub 2018 Jun 15.
• 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.
• 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.
• Albers FC, Price RG, Smith SG, Yancey SW. Mepolizumab efficacy in patients with severe eosinophilic asthma receiving different controller therapies. J Allergy Clin Immunol. 2017 Nov;140(5):1464-1466.e4. doi: 10.1016/j.jaci.2017.06.010. Epub 2017 Jul 4. No abstract available.
• Magnan A, Bourdin A, Prazma CM, Albers FC, Price RG, Yancey SW, Ortega H. Treatment response with mepolizumab in severe eosinophilic asthma patients with previous omalizumab treatment. Allergy. 2016 Sep;71(9):1335-44. doi: 10.1111/all.12914. Epub 2016 May 24.
• Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, Chetta A, Humbert M, Katz LE, Keene ON, Yancey SW, Chanez P; MENSA Investigators. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014 Sep 25;371(13):1198-207. doi: 10.1056/NEJMoa1403290. Epub 2014 Sep 8. Erratum In: N Engl J Med. 2015 Apr 30;372(18):1777.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: October 8, 2012
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): January 18, 2014

Study Registration Dates

• First Submitted: September 20, 2012
• First Submitted That Met QC Criteria: September 20, 2012
• First Posted (ESTIMATE): September 24, 2012

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2018
• Last Update Submitted That Met QC Criteria: August 2, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: safety; placebo; mepolizumab; efficacy; SB-240563; eosinophils; Severe refractory asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 115588

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Informed Consent Form
   Information identifier: 115588
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Annotated Case Report Form
   Information identifier: 115588
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Statistical Analysis Plan
   Information identifier: 115588
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Clinical Study Report
   Information identifier: 115588
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Individual Participant Data Set
   Information identifier: 115588
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Study Protocol
   Information identifier: 115588
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Dataset Specification
   Information identifier: 115588
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register