Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Participants With Severe Eosinophilic Asthma on Markers of Asthma Control

A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre 24-week Study to Evaluate the Efficacy and Safety of Mepolizumab Adjunctive Therapy in Subjects With Severe Eosinophilic Asthma on Markers of Asthma Control

This is a multi-centre, placebo-controlled, double-blind, parallel-group study to evaluate the efficacy and safety of mepolizumab adjunctive therapy in participants with severe eosinophilic asthma on markers of asthma control. The overall intent of the current study is to more fully explore the impact of mepolizumab on health-related quality of life (HR-QoL) and other measures of asthma control, including lung function.

Participants who meet the predefined criteria will be randomised to receive either mepolizumab or placebo in addition to standard of care asthma treatment. Approximately 780 participants with severe eosinophilic asthma will be screened to ensure the randomisation of 544 participants (272 participants per treatment group) into the study.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Biological: Mepolizumab; Drug: SOC

• Study Type: Interventional
• Enrollment (Actual): 556
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1425BEN
    • GSK Investigational Site
  • Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
    • GSK Investigational Site
  • Mendoza, Argentina, 5500
    • GSK Investigational Site
  • Buenos Aires
    • La Plata, Buenos Aires, Argentina, 1900
      • GSK Investigational Site
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • GSK Investigational Site
  • Entre Ríos
    • Concepcion del Uruguay, Entre Ríos, Argentina, 3260
      • GSK Investigational Site
  • Mendoza
    • San Rafael, Mendoza, Argentina, 5600
      • GSK Investigational Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • GSK Investigational Site
• Belgium
  • Brussels, Belgium, 1000
    • GSK Investigational Site
  • Erpent, Belgium, 5101
    • GSK Investigational Site
  • Gent, Belgium, 9000
    • GSK Investigational Site
  • Leuven, Belgium, 3000
    • GSK Investigational Site
  • Liège, Belgium, 4000
    • GSK Investigational Site
• Bulgaria
  • Pleven, Bulgaria, 5800
    • GSK Investigational Site
  • Sofia, Bulgaria, 1431
    • GSK Investigational Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • 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
    • St-Charles-Borromée, Ontario, Canada, J6E 2B4
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M5T 3A9
      • GSK Investigational Site
    • Windsor, Ontario, Canada, N8X 5A6
      • GSK Investigational Site
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • GSK Investigational Site
    • Sainte-Foy, Quebec, Canada, G1V 4G5
      • GSK Investigational Site
    • Trois-Rivieres, Quebec, Canada, G8T 7A1
      • GSK Investigational Site
• Czechia
  • Brno, Czechia, 625 00
    • GSK Investigational Site
  • Hlucin, Czechia, 748 01
    • GSK Investigational Site
  • Hradec Kralove, Czechia, 500 05
    • GSK Investigational Site
  • Kralupy nad Vltavou, Czechia, 278 01
    • GSK Investigational Site
  • Olomouc, Czechia, 775 20
    • GSK Investigational Site
  • Plzen, Czechia, 305 99
    • GSK Investigational Site
  • Praha 4, Czechia, 140 59
    • GSK Investigational Site
• Estonia
  • Tallinn, Estonia, 13419
    • GSK Investigational Site
  • Tallinn, Estonia, 13619
    • GSK Investigational Site
  • Tartu, Estonia, 51014
    • GSK Investigational Site
• France
  • Brest Cedex, France, 29609
    • GSK Investigational Site
  • Dijon Cedex, France, 21079
    • 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
  • Nantes cedex 1, France, 44093
    • GSK Investigational Site
  • Paris Cedex 18, France, 75877
    • GSK Investigational Site
  • Pessac cedex, France, 33604
    • GSK Investigational Site
  • Reims Cedex, France, 51092
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 10717
    • GSK Investigational Site
  • Berlin, Germany, 12203
    • GSK Investigational Site
  • Berlin, Germany, 12157
    • GSK Investigational Site
  • Hamburg, Germany, 20354
    • GSK Investigational Site
  • Hamburg, Germany, 22299
    • GSK Investigational Site
  • Bayern
    • Bamberg, Bayern, Germany, 96049
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80539
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Witten, Nordrhein-Westfalen, Germany, 58452
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Koblenz, Rheinland-Pfalz, Germany, 56068
      • GSK Investigational Site
  • Sachsen
    • Leipzig, Sachsen, Germany, 04357
      • GSK Investigational Site
    • Leipzig, Sachsen, Germany, 04103
      • GSK Investigational Site
  • Schleswig-Holstein
    • Schleswig, Schleswig-Holstein, Germany, 24837
      • GSK Investigational Site
• Greece
  • Athens, Greece, 11527
    • GSK Investigational Site
  • Athens, Greece, 106 76
    • GSK Investigational Site
  • Haidari / Athens, Greece, 124 62
    • GSK Investigational Site
  • Rethymnon, Crete, Greece, 74100
    • GSK Investigational Site
  • Thessaloniki, Greece, 57010
    • GSK Investigational Site
  • Thessaloniki, Greece, 56429
    • GSK Investigational Site
  • Thessaloniki, Greece, 56403
    • GSK Investigational Site
• Italy
  • Abruzzo
    • Chieti, Abruzzo, Italy, 66100
      • GSK Investigational Site
  • Emilia-Romagna
    • Parma, Emilia-Romagna, Italy, 43100
      • GSK Investigational Site
    • Reggio Emilia, Emilia-Romagna, Italy, 42100
      • GSK Investigational Site
  • Puglia
    • Bari, Puglia, Italy, 70124
      • GSK Investigational Site
    • Foggia, Puglia, Italy, 71100
      • GSK Investigational Site
  • Toscana
    • Firenze, Toscana, Italy, 50134
      • GSK Investigational Site
    • Pisa, Toscana, Italy, 56124
      • GSK Investigational Site
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • GSK Investigational Site
  • Breda, Netherlands, 4818 CK
    • GSK Investigational Site
  • Leeuwarden, Netherlands, 8934 AD
    • GSK Investigational Site
  • Leiden, Netherlands, 2333 ZA
    • GSK Investigational Site
  • Rotterdam, Netherlands, 3045 PM
    • GSK Investigational Site
• Norway
  • Bergen, Norway, 5021
    • GSK Investigational Site
  • Oslo, Norway, 0405
    • GSK Investigational Site
  • Stavanger, Norway, 4011
    • GSK Investigational Site
  • Trondheim, Norway, 7006
    • GSK Investigational Site
• Peru
  • Lima, Peru, Lima 1
    • GSK Investigational Site
  • Lima, Peru, Lima 32
    • GSK Investigational Site
  • Lima
    • Lima 27, Lima, Peru, Lima 27
      • GSK Investigational Site
    • San Martin de Porres, Lima, Peru, Lima 31
      • GSK Investigational Site
    • San Miguel, Lima, Peru, Lima 32
      • GSK Investigational Site
• Russian Federation
  • Ekaterinburg, Russian Federation, 620109
    • GSK Investigational Site
  • Irkutsk, Russian Federation, 664043
    • GSK Investigational Site
  • Moscow, Russian Federation, 115211
    • GSK Investigational Site
  • Novosibirsk, Russian Federation, 630102
    • GSK Investigational Site
  • Saint Petesburg, Russian Federation, 195030
    • GSK Investigational Site
  • Sestroretsk, Russian Federation, 197706
    • GSK Investigational Site
  • St. Petersburg, Russian Federation, 198216
    • GSK Investigational Site
  • Stavropol, Russian Federation, 355030
    • GSK Investigational Site
  • Voronezh, Russian Federation, 394066
    • GSK Investigational Site
• Slovakia
  • Bojnice, Slovakia, 972 01
    • GSK Investigational Site
  • Sala, Slovakia, 927 01
    • GSK Investigational Site
  • Spisska Nova Ves, Slovakia, 052 01
    • GSK Investigational Site
  • Vrable, Slovakia, 952 01
    • GSK Investigational Site
• Spain
  • Alcorcón (Madrid), Spain, 28922
    • GSK Investigational Site
  • Alicante, Spain, 03004
    • GSK Investigational Site
  • Barcelona, Spain, 08041
    • GSK Investigational Site
  • Madrid, Spain, 28041
    • GSK Investigational Site
  • Pozuelo De Alarcón/Madrid, Spain, 28223
    • GSK Investigational Site
  • Santander, Spain, 39008
    • GSK Investigational Site
  • Santiago de Compostela, Spain, 15706
    • GSK Investigational Site
  • Valencia, Spain, 46026
    • GSK Investigational Site
• Ukraine
  • Dnepropetrovsk, Ukraine, 49074
    • GSK Investigational Site
  • Kharkiv, Ukraine, 61124
    • GSK Investigational Site
  • Kharkiv, Ukraine, 61093
    • GSK Investigational Site
  • Kyiv, Ukraine, 03680
    • GSK Investigational Site
  • Kyiv, Ukraine, 03038
    • GSK Investigational Site
  • Kyiv, Ukraine, 03049
    • GSK Investigational Site
  • Odesa, Ukraine, 65025
    • GSK Investigational Site
  • Vinnytsia, Ukraine, 21018
    • GSK Investigational Site
  • Vinnytsia, Ukraine, 21029
    • GSK Investigational Site
  • Zaporizhia, Ukraine, 69076
    • GSK Investigational Site
• United Kingdom
  • Bradford, United Kingdom, BD9 6RJ
    • GSK Investigational Site
  • Oxford, United Kingdom, OX3 7LE
    • GSK Investigational Site
  • Plymouth, United Kingdom, PL6 8DH
    • GSK Investigational Site
  • Swansea, United Kingdom, SA2 8PP
    • GSK Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • GSK Investigational Site
    • Birmingham, Alabama, United States, 35243
      • GSK Investigational Site
  • California
    • Fresno, California, United States, 93720
      • GSK Investigational Site
    • Long Beach, California, United States, 90808
      • GSK Investigational Site
    • 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
    • Upland, California, United States, 91786
      • GSK Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80206
      • GSK Investigational Site
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • GSK Investigational Site
  • Florida
    • Aventura, Florida, United States, 33180
      • GSK Investigational Site
    • Orlando, Florida, United States, 32825
      • GSK Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21236
      • GSK Investigational Site
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • GSK Investigational Site
  • New York
    • Rochester, New York, United States, 14642
      • GSK Investigational Site
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • GSK Investigational Site
    • Gastonia, North Carolina, United States, 28054
      • GSK Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • GSK Investigational Site
  • Pennsylvania
    • Upland, Pennsylvania, United States, 19013
      • GSK Investigational Site
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • GSK Investigational Site
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • GSK Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • GSK Investigational Site
  • Virginia
    • Richmond, Virginia, United States, 23229
      • GSK Investigational Site
    • Williamsburg, Virginia, United States, 23188
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age: At least 12 years of age at the time of signing the informed consent/assent (For those countries where local regulations permit enrolment of adults only, participant recruitment will be restricted to those who are >=18 years of age)
• Inhaled Corticosteroid: 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). For participants >=18 years old: ICS dose must be >=880 micrograms (mcg)/day fluticasone propionate (FP) (exactuator) or equivalent daily. For ICS/long-acting beta-2-agonist (LABA) combination preparations, the highest approved maintenance dose in the local country will meet this ICS criterion. For participants >=12 to <=17 years old: ICS dose must be >=440 mcg/day FP (ex-actuator) or equivalent daily. For ICS/LABA combination preparations, the mid-strength approved maintenance dose in the local country will meet this ICS criterion
• Controller Medication: 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 (e.g. LABA, leukotriene receptor antagonist [LTRA], or theophylline)
• Eosinophilic asthma: Prior documentation of eosinophilic asthma or high likelihood of eosinophilic asthma as per Randomisation Criteria 1 and 2
• FEV1: Persistent airflow obstruction as indicated by : For participants >=18 years of age at visit 1, a pre-bronchodilator FEV1 <80% predicted (National Health and Nutrition Examination Survey [NHANES III]) recorded at Visit 1. For participants 12-17 years of age at Visit 1: A pre-bronchodilator FEV1 <90% predicted (NHANES III) recorded at Visit 1 OR FEV1:FVC ratio <0.8 recorded at Visit 1
• Exacerbation history: Previously confirmed history of two or more exacerbations requiring treatment with systemic Corticosteroid (CS) (intramuscular, intravenous, or oral), in the 12 months prior to visit 1, despite the use of high-dose inhaled corticosteroids (ICS). For participants receiving maintenance CS, the CS treatment for the exacerbations must have been a two-fold dose increase or greater.
• Gender: Male or Eligible Female. To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control listed in the protocol for the duration of the trial and for 4 months after the last study drug administration.
• Informed Consent/Assent: Able to give written informed consent/assent prior to participation in the core study, which will include the ability to comply with the requirements and restrictions listed in the consent/assent form and in this protocol. Participants must be able to read, comprehend, and write at a level sufficient to complete study related materials. Written informed consent must be obtained from ALL patients/legally authorized representative(s); for patients 12-17 years old, written informed assent must be obtained in addition to the legally authorized representative(s)' consent.
• French participants: In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Exclusion Criteria:

• Smoking history: Current smokers or former smokers with a smoking history of >=10 pack years (number of pack years = (number of cigarettes per day/20) x number of years smoked). A former smoker is defined as a participant who quit smoking at least 6 months prior to Visit 1.
• Concurrent Respiratory Disease: Presence of a known pre-existing, clinically important lung condition other than asthma. This includes current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer.
• Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior to screening (Participants that had localized carcinoma of the skin which was resected for cure will not be excluded).
• Liver Disease: Known, pre-existing, unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice), cirrhosis, and known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• Cardiovascular: Participants who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment. Including but not limited to: (a) known ejection fraction of <30% OR (b) severe heart failure meeting New York Heart Association Class IV classification OR (c) hospitalised in the 12 months prior to Visit 1 for severe heart failure meeting New York Heart Association Class III OR (d) angina diagnosed less than 3 months prior to Visit 1 or at Visit 1.
• Other Concurrent Medical Conditions: Participants who have known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment.
• Eosinophilic Diseases: Participants with other conditions that could lead to elevated eosinophils such as Hypereosinophilic Syndromes, including Churg-Strauss Syndrome (Eosinophilic Granulomatosis with Polyangiitis [EGPA]), or Eosinophilic Esophagitis. Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1 are also to be excluded.
• Electrocardiogram (ECG) Assessment: QT interval corrected for heart rate by Fridericia's formula (QTc(F)) >=450 milliseconds (msec) or QTc(F) >=480 msec for participants with Bundle Branch Block at Visit 1.
• Alcohol/Substance Abuse: A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Visit 1.
• Immunodeficiency: A known immunodeficiency (e.g. human immunodeficiency virus [HIV]), other than that explained by the use of corticosteroids taken as therapy for asthma.
• Xolair: Participants who have received omalizumab (Xolair) within 130 days of Visit 1.
• Other Monoclonal Antibodies: Participants who have received any monoclonal antibody (other than Xolair) to treat inflammatory disease within 5 half-lives of Visit 1.
• Investigational Medications: Participants 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, prior to Visit 1 (this also includes investigational formulations of marketed products).
• Hypersensitivity: Participants with allergy/intolerance to a monoclonal antibody or biologic.
• Pregnancy: Participants who are pregnant or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the time of study participation. A urine pregnancy test is required of all women of child bearing potential. This test will be performed at the time points specified in the Time and Events Schedule in protocol.
• Adherence: Participants who have known evidence of lack of adherence to controller medications and/or ability to follow physician's recommendations.
• Previous participation: 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 Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mepolizumab SC; Participants will receive Mepolizumab 100 mg subcutaneously (SC) into the upper arm or thigh every 4 weeks for a period of 24 weeks (total of 6 doses) along with their respective standard care of treatment	Biological: Mepolizumab; Humanised Immunoglobulin G (IgG) antibody (IgG1, kappa) with human heavy and light chain frameworks, provided as a lyophilised cake in sterile vial. Vial to be reconstituted with sterile water for injection, just prior to use; Drug: SOC; Standard of Care (SOC) will differ by participants, however it will include high dose ICS with at least one other controller, e.g. LABA, with or without maintenance OCS
Placebo Comparator: Placebo SC; Participants will receive placebo (0.9% sodium chloride) subcutaneously into the upper arm or thigh every 4 weeks for a period of 24 weeks (total of 6 doses) along with their respective standard care of treatment	Drug: Placebo; Sterile 0.9% sodium chloride solution; Drug: SOC; Standard of Care (SOC) will differ by participants, however it will include high dose ICS with at least one other controller, e.g. LABA, with or without maintenance OCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline (BL) in St. George's Respiratory Questionnaire (SGRQ) Score at Week 24	SGRQ consisted of 50 questions (scored from 0 to 100 where 0 indicates best and 100 indicates worst health) designed to measure Quality of Life in par. with diseases of airway obstruction, measuring symptoms, impact, and activity. Questions were completed by the par. with a recall over the past 4 weeks. SGRQ Total Score was calculated by summing the pre-assigned weights of answers, dividing by the sum of the maximum weights for items in SGRQ and multiplying by 100 to get a %. Change from BL in SGRQ was calculated as value at Week 24 minus value at BL for each par. and was analyzed using mixed model repeated measures allowing for covariates of BL value, region, BL maintenance oral corticosteroid (OCS) therapy, exacerbations in the year prior to the study (as an ordinal variable), BL % predicted FEV1 and visit, plus interaction terms for visit by BL and visit by treatment group. Modified Intent-to-Treat (mITT) Population consisted of all randomized par. who received >= 1 dose of drug.	Baseline and Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Week 24	FEV1 is the volume of air that can be forced out in one second after taking a deep breath. The change from Baseline in pre-bronchodilator FEV1 was calculated as the value at Week 24 minus the value at Baseline for each subject and was analyzed using a mixed model repeated measures adjusting for Baseline absolute pre-bronchodilator FEV1, region, Baseline maintenance OCS therapy, exacerbations in the year prior to the study and visit, plus interaction terms for visit by Baseline and visit by treatment group.	Baseline and Week 24
Percentage of Participants Achieving a 4 Point or Greater Reduction From Baseline in SGRQ Score at Week 24	The percentage of participants achieving a 4 point or greater reduction from Baseline in SGRQ (scored from 0-100 with lower scores indicating better outcome) at Week 24 was compared between treatment groups using a logistic regression model with covariates of Baseline value, region, Baseline maintenance OCS therapy, exacerbations in the year prior to the study (as an ordinal variable) and Baseline % predicted FEV1.	Baseline (Visit 2-latest pre-dose assessment) and Week 24
Mean Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 24	The ACQ-5 is a five-item questionnaire, designed to be self-completed by the participants. ACQ-5 score is the mean score of 5 questions, each assessed on a 0-6 point scale to give a mean ranging between 0-6 with lower scores indicating better outcome. The five questions inquired about the frequency and/or severity of symptoms over the previous week. The response options for all these questions consisted of a zero (no impairment/limitation) to six (total impairment/limitation) scale. The mean change from Baseline was calculated as the value at Week 24 minus the Baseline value for each participant and analyzed using a mixed model repeated measures allowing for covariates of Baseline value, region, Baseline maintenance OCS therapy, exacerbations in the year prior to the study (as an ordinal variable), Baseline % predicted FEV1 and visit, plus interaction terms for visit by Baseline and visit by treatment group.	Baseline and Week 24

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Yancey SW, Ortega HG, Keene ON, Bradford ES. Efficacy of add-on mepolizumab in adolescents with severe eosinophilic asthma. Allergy Asthma Clin Immunol. 2019 Sep 3;15:53. doi: 10.1186/s13223-019-0366-x. eCollection 2019.
• 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.
• 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.
• Chupp GL, Bradford ES, Albers FC, Bratton DJ, Wang-Jairaj J, Nelsen LM, Trevor JL, Magnan A, Ten Brinke A. Efficacy of mepolizumab add-on therapy on health-related quality of life and markers of asthma control in severe eosinophilic asthma (MUSCA): a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 3b trial. Lancet Respir Med. 2017 May;5(5):390-400. doi: 10.1016/S2213-2600(17)30125-X. Epub 2017 Apr 5.

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 (Actual): December 11, 2014
• Primary Completion (Actual): June 10, 2016
• Study Completion (Actual): June 10, 2016

Study Registration Dates

• First Submitted: October 30, 2014
• First Submitted That Met QC Criteria: October 30, 2014
• First Posted (Estimate): November 2, 2014

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: Mepolizumab; Lung function; Health-related quality of life; Asthma control; Severe Eosinophilic asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Leukocyte Disorders; Eosinophilia; Hypereosinophilic Syndrome; Asthma; Pulmonary Eosinophilia
• Other Study ID Numbers: 200862

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. Dataset Specification
   Information identifier: 200862
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Clinical Study Report
   Information identifier: 200862
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Annotated Case Report Form
   Information identifier: 200862
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Individual Participant Data Set
   Information identifier: 200862
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Study Protocol
   Information identifier: 200862
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Informed Consent Form
   Information identifier: 200862
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Statistical Analysis Plan
   Information identifier: 200862
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register