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A Safety and Efficacy Study of Mepolizumab in Subjects With Severe Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Mepolizumab 100 milligrams
Placebo
Salbutamol
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Eosinophilic inflammation, Mepolizumab, Asthma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects who will be able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials.
  • Subjects with at least 12 years of age at Visit 0 and a minimum weight of 40 kilograms.
  • Persistent airflow obstruction as indicated by: For subjects >=18 years of age at visit 1, a pre-bronchodilator FEV1 <80 percent predicted (National Health and Nutrition Examination Survey [NHANES] III).;For subjects 12 to 17 years of age at Visit 1: A pre-bronchodilator FEV1 <90 percent predicted (NHANES III) recorded at Visit 1 or FEV1: Forced vital capacity (FVC) ratio <0.8 recorded at Visit 1.
  • Prior documentation of eosinophilic asthma or high likelihood of eosinophilic asthma as per Randomization Criteria 1 (Documented peripheral blood eosinophil count of >=300 cells per microliters that is related to asthma in the past 12 months prior to Visit 1 or a peripheral blood eosinophil count of >=150 cells per microliters at Visit 1 that is related to asthma).
  • Regular treatment with high dose inhaled corticosteroid (ICS) in the 12 months prior to Visit 1, of which at least 9 months accumulated documented is required, the 3 months prior to Visit 1 is mandatory. With or without maintenance oral corticosteroids (OCS). ICS dose must be >=500 microgram per day fluticasone propionate (FP) or equivalent daily (for ICS/long-acting beta-2-agonists combination preparations, Seretide 50/250 micrograms twice daily and above or equivalent will meet this ICS criteria). (Maintenance OCS is defined as a prescribed regimen of a minimum average daily dose of prednisone 5 milligrams [or equivalent]).
  • Current treatment with an additional controller medication, besides ICS, for at least 3 months. (Example given [e.g.], long-acting beta-2-agonist, leukotriene receptor antagonist [LTRA], or theophylline).
  • Previously confirmed history of two or more exacerbations requiring treatment with systemic corticosteroid (intramuscular [IM], intravenous, or oral), in the 12 months prior to Visit 1, despite the use of high-dose ICS. For subjects receiving maintenance corticosteroid, the corticosteroid treatment for the exacerbations must have been a two-fold increase or greater in the dose for at least 3 days is required.
  • A female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1 percent, during the intervention period and for at least 4 months after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.

A WOCBP must have a negative highly sensitive pregnancy test before the first dose of study intervention. If urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the subject must be excluded from participation if the serum pregnancy result is positive. Follicle-stimulating hormone will be assessed to confirm child-bearing status as needed in non WOCBP.

Exclusion Criteria:

  • 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 subject who quit smoking at least 6 months prior to Visit 1.
  • Presence of a known pre-existing, clinically significant lung condition other than asthma, in the opinion of the Investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study. This includes current bacterial or viral infection of the upper or lower respiratory tract, 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. Clinically Significant is defined as any disease/condition that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
  • A chest X-ray that reveals evidence of clinically significant abnormalities not believed to be due to the presence of asthma.
  • Bronchial Thermoplasty and Radiotherapy are excluded for 12 months prior to visit 1 and throughout the study.
  • A current malignancy or previous history of cancer in remission for less than 12 months prior to screening (Subjects that had localized carcinoma of the skin which was resected for cure will not be excluded).
  • Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice or cirrhosis. Subjects with ALT >2 times Upper Limit of Normal (ULN), bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent)
  • Subjects who have known, pre-existing severe or clinically significant cardiovascular disease uncontrolled with standard treatment. Including but not limited to: known ejection fraction of <30 percent or severe heart failure meeting New York Heart Association Class IV classification or hospitalized in the 12 months prior to Visit 1 for severe heart failure meeting New York Heart Association Class III or angina diagnosed less than 3 months prior to Visit 1 or at Visit 1.
  • QT interval corrected by Fridericia's formula (QTc[F]) >450 milliseconds (msec) or QTc(F) >480 msec for subjects with Bundle Branch Block at Visit 1 is exclusive.
  • Subjects who have known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, hematological or any other system abnormalities that are uncontrolled with standard treatment. Current malignancy except for basal and squamous skin cancer.
  • Subjects with other conditions that could lead to elevated eosinophils such as Hypereosiniophilic Syndromes, including Churg-Strauss Syndrome, or Eosinophilic Esophagitis.
  • Subjects with a known, pre-existing parasitic infestation within 6 months prior to Visit 1 are also excluded.
  • A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Visit 1. Alcohol abuse is defined as: an average weekly intake of greater than 21 units or an average daily intake of greater than three units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than two units (females). One unit was equivalent to a half-pint (220 milliliters) of beer or one (25 milliliters) measure of spirits or one glass (125 milliliters) of wine.
  • A known immunodeficiency (e.g., human immunodeficiency virus - HIV), other than that explained by the use of corticosteroids taken as therapy for asthma.
  • Subjects who have received omalizumab (Xolair) within 130 days of Visit 1.
  • Subjects who have received any monoclonal antibodies (other than Xolair) to treat inflammatory disease within 5 half-lives of Visit 1.
  • Use of herbals within 7 days prior to visit 1, unless in the opinion of the Investigator and GlaxoSmithKline (GSK) Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
  • 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, prior to visit 1 (this also includes investigational formulations of marketed products).
  • Subjects with allergy/intolerance to a monoclonal antibody or biologic.
  • Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnant during the time of study participation.
  • 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).
  • A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
  • Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study. Re-screening of subjects will be allowed only upon approval by the medical monitor.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Subjects receiving Mepolizumab

Subjects receiving Placebo

Arm Description

Eligible subjects will randomized in 1:1 ratio to Mepolizumab group or Placebo group. Subjects in Mepolizumab group will receive Mepolizumab 100mg subcutaneously into the upper arm or thigh every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC of asthma treatment. Subjects will be provided with salbutamol MDIs as a rescue medication to be used on an needed basis in this study.

Eligible subjects in placebo group will receive placebo (0.9 percent sodium chloride) matching to Mepolizumab administered subcutaneously into the upper arm or thigh every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC of asthma treatment. Subjects will be provided with salbutamol MDIs as a rescue medication to be used on an as needed basis in this study.

Outcomes

Primary Outcome Measures

Number of clinically significant exacerbations of asthma
Clinically significant exacerbations are defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalizations and/or Emergency Department (ED) visits.

Secondary Outcome Measures

Time to first clinically significant exacerbations
Clinically significant exacerbations are defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalizations and/or ED visits.
Mean change from Baseline in St. George's Respiratory Questionnaire (SGRQ) at Week 52
The SGRQ Questionnaire is a well-established, self-completed tool, comprising of 50 questions with 76 weighted responses designed to measure Quality of Life in subjects with diseases of airway obstruction. It consists of two parts; Part 1 produces the symptom score and Part 2 produces the activity and impact score. A Total score is also calculated which summarizes the impact of the disease on overall health status. Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and zero indicates best possible health status.
Number of exacerbations requiring hospitalization or ED visits
An exacerbation is defined as worsening of asthma requiring the use of systemic corticosteroids and/or emergency department visit, or hospitalization. The number of exacerbations requiring hospitalization including intubation and admittance to an Intensive care unit (ICU) or ED visits will be evaluated.
Number of exacerbations requiring hospitalization
An exacerbation is defined as worsening of asthma requiring the use of systemic corticosteroids and/or emergency department visit, or hospitalization.
Mean change from Baseline in clinic prebronchodilator forced expiratory volume in 1 second (FEV1) at Week 52
FEV1 is the volume of air that can be forced out in one second after taking a deep breath. FEV1 will be measured via spirometer at Baseline and Week 52.
Number of subjects with adverse events including systemic (i.e., allergic [type I hypersensitivity] and other systemic) and injection site reactions
AE is any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of subjects with adverse events including systemic and injection site reactions will be reported.
Number of subjects with abnormal hematology parameters
Hematology parameters which will be assessed include platelet count, red blood cell (RBC) count, hemoglobin, hematocrit; RBC indices: mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH); white blood cell (WBC) count with differential: neutrophils, lymphocytes, monocytes, eosinophils and basophils.
Number of subjects with abnormal clinical chemistry parameters
Clinical chemistry parameters which will be assessed include blood urea nitrogen, potassium, aspartate amino transferase (serum glutamic oxaloacetic transaminase), total and direct bilirubin, creatinine, sodium, alanine amino transferase (serum glutamic pyruvic transaminase), total protein, glucose, calcium, alkaline phosphatase and albumin.
Number of subjects with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)
SBP and DBP will be measured in a sitting position after 5 minutes rest.
Number of subjects with abnormal pulse rate
Pulse rate measurement will be measured in a sitting position after 5 minutes rest.
Number of subjects with abnormal electrocardiogram (ECG) findings
Twelve-lead ECG measurements will be obtained after the subject has rested in the supine position for 5 minutes.
Number of subjects with anti-mepolizumab antibody positive results
Number of subjects with positive anti-mepolizumab antibody results will be determined.
Change from Baseline in blood eosinophil ratio
Blood eosinophil counts will be recorded as part of standard hematological assessments.

Full Information

First Posted
May 22, 2018
Last Updated
October 20, 2022
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT03562195
Brief Title
A Safety and Efficacy Study of Mepolizumab in Subjects With Severe Asthma
Official Title
A Randomized, Double Blind, Parallel Group Study of the Efficacy and Safety of Mepolizumab as Adjunctive Therapy in Patients With Severe Asthma With Eosinophilic Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 29, 2018 (Actual)
Primary Completion Date
September 7, 2022 (Actual)
Study Completion Date
September 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Mepolizumab, a humanized monoclonal antibody, has been developed as an add-on treatment for subjects with severe asthma with eosinophilic inflammation. Current asthma treatment guidelines offer minimal options for the severe asthmatic subjects on intensive therapy with frequent exacerbations. There is a significant unmet medical need to provide better treatment options for this segment of the asthma population. Thus, this study is designed to evaluate the efficacy and safety of mepolizumab in Chinese severe asthmatic subjects with eosinophilic inflammation. A total number of 300 subjects will be randomized in 1:1 ratio to receive either mepolizumab or placebo along with existing standard of care therapy. The maximum study duration will be 56 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Eosinophilic inflammation, Mepolizumab, Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Eligible subjects will be randomized in 1:1 ratio to receive either mepolizumab or placebo along with existing standard of care therapy during the treatment period.
Masking
ParticipantInvestigator
Masking Description
This will be a double blind study. Subjects and investigator will be masked.
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects receiving Mepolizumab
Arm Type
Experimental
Arm Description
Eligible subjects will randomized in 1:1 ratio to Mepolizumab group or Placebo group. Subjects in Mepolizumab group will receive Mepolizumab 100mg subcutaneously into the upper arm or thigh every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC of asthma treatment. Subjects will be provided with salbutamol MDIs as a rescue medication to be used on an needed basis in this study.
Arm Title
Subjects receiving Placebo
Arm Type
Placebo Comparator
Arm Description
Eligible subjects in placebo group will receive placebo (0.9 percent sodium chloride) matching to Mepolizumab administered subcutaneously into the upper arm or thigh every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC of asthma treatment. Subjects will be provided with salbutamol MDIs as a rescue medication to be used on an as needed basis in this study.
Intervention Type
Drug
Intervention Name(s)
Mepolizumab 100 milligrams
Intervention Description
Mepolizumab will be given as a lyophilized cake in sterile vials for individual use. The vial will be reconstituted with Sterile Water for Injection, just prior to use.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be given as 0.9 percent sodium chloride solution.
Intervention Type
Drug
Intervention Name(s)
Salbutamol
Intervention Description
Salbutamol MDI will be given as a rescue medication to be used on an as needed basis in this study.
Primary Outcome Measure Information:
Title
Number of clinically significant exacerbations of asthma
Description
Clinically significant exacerbations are defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalizations and/or Emergency Department (ED) visits.
Time Frame
Up to Week 52
Secondary Outcome Measure Information:
Title
Time to first clinically significant exacerbations
Description
Clinically significant exacerbations are defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalizations and/or ED visits.
Time Frame
Up to Week 52
Title
Mean change from Baseline in St. George's Respiratory Questionnaire (SGRQ) at Week 52
Description
The SGRQ Questionnaire is a well-established, self-completed tool, comprising of 50 questions with 76 weighted responses designed to measure Quality of Life in subjects with diseases of airway obstruction. It consists of two parts; Part 1 produces the symptom score and Part 2 produces the activity and impact score. A Total score is also calculated which summarizes the impact of the disease on overall health status. Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and zero indicates best possible health status.
Time Frame
Baseline and Week 52
Title
Number of exacerbations requiring hospitalization or ED visits
Description
An exacerbation is defined as worsening of asthma requiring the use of systemic corticosteroids and/or emergency department visit, or hospitalization. The number of exacerbations requiring hospitalization including intubation and admittance to an Intensive care unit (ICU) or ED visits will be evaluated.
Time Frame
Up to Week 52
Title
Number of exacerbations requiring hospitalization
Description
An exacerbation is defined as worsening of asthma requiring the use of systemic corticosteroids and/or emergency department visit, or hospitalization.
Time Frame
Up to Week 52
Title
Mean change from Baseline in clinic prebronchodilator forced expiratory volume in 1 second (FEV1) at Week 52
Description
FEV1 is the volume of air that can be forced out in one second after taking a deep breath. FEV1 will be measured via spirometer at Baseline and Week 52.
Time Frame
Baseline and Week 52
Title
Number of subjects with adverse events including systemic (i.e., allergic [type I hypersensitivity] and other systemic) and injection site reactions
Description
AE is any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of subjects with adverse events including systemic and injection site reactions will be reported.
Time Frame
Up to Week 52
Title
Number of subjects with abnormal hematology parameters
Description
Hematology parameters which will be assessed include platelet count, red blood cell (RBC) count, hemoglobin, hematocrit; RBC indices: mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH); white blood cell (WBC) count with differential: neutrophils, lymphocytes, monocytes, eosinophils and basophils.
Time Frame
Up to Week 52
Title
Number of subjects with abnormal clinical chemistry parameters
Description
Clinical chemistry parameters which will be assessed include blood urea nitrogen, potassium, aspartate amino transferase (serum glutamic oxaloacetic transaminase), total and direct bilirubin, creatinine, sodium, alanine amino transferase (serum glutamic pyruvic transaminase), total protein, glucose, calcium, alkaline phosphatase and albumin.
Time Frame
Up to Week 52
Title
Number of subjects with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Description
SBP and DBP will be measured in a sitting position after 5 minutes rest.
Time Frame
Up to Week 52
Title
Number of subjects with abnormal pulse rate
Description
Pulse rate measurement will be measured in a sitting position after 5 minutes rest.
Time Frame
Up to Week 52
Title
Number of subjects with abnormal electrocardiogram (ECG) findings
Description
Twelve-lead ECG measurements will be obtained after the subject has rested in the supine position for 5 minutes.
Time Frame
Up to Week 52
Title
Number of subjects with anti-mepolizumab antibody positive results
Description
Number of subjects with positive anti-mepolizumab antibody results will be determined.
Time Frame
Up to Week 52
Title
Change from Baseline in blood eosinophil ratio
Description
Blood eosinophil counts will be recorded as part of standard hematological assessments.
Time Frame
Baseline and Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who will be able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials. Subjects with at least 12 years of age at Visit 0 and a minimum weight of 40 kilograms. Persistent airflow obstruction as indicated by: For subjects >=18 years of age at visit 1, a pre-bronchodilator FEV1 <80 percent predicted (National Health and Nutrition Examination Survey [NHANES] III).;For subjects 12 to 17 years of age at Visit 1: A pre-bronchodilator FEV1 <90 percent predicted (NHANES III) recorded at Visit 1 or FEV1: Forced vital capacity (FVC) ratio <0.8 recorded at Visit 1. Prior documentation of eosinophilic asthma or high likelihood of eosinophilic asthma as per Randomization Criteria 1 (Documented peripheral blood eosinophil count of >=300 cells per microliters that is related to asthma in the past 12 months prior to Visit 1 or a peripheral blood eosinophil count of >=150 cells per microliters at Visit 1 that is related to asthma). Regular treatment with high dose inhaled corticosteroid (ICS) in the 12 months prior to Visit 1, of which at least 9 months accumulated documented is required, the 3 months prior to Visit 1 is mandatory. With or without maintenance oral corticosteroids (OCS). ICS dose must be >=500 microgram per day fluticasone propionate (FP) or equivalent daily (for ICS/long-acting beta-2-agonists combination preparations, Seretide 50/250 micrograms twice daily and above or equivalent will meet this ICS criteria). (Maintenance OCS is defined as a prescribed regimen of a minimum average daily dose of prednisone 5 milligrams [or equivalent]). Current treatment with an additional controller medication, besides ICS, for at least 3 months. (Example given [e.g.], long-acting beta-2-agonist, leukotriene receptor antagonist [LTRA], or theophylline). Previously confirmed history of two or more exacerbations requiring treatment with systemic corticosteroid (intramuscular [IM], intravenous, or oral), in the 12 months prior to Visit 1, despite the use of high-dose ICS. For subjects receiving maintenance corticosteroid, the corticosteroid treatment for the exacerbations must have been a two-fold increase or greater in the dose for at least 3 days is required. A female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1 percent, during the intervention period and for at least 4 months after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive pregnancy test before the first dose of study intervention. If urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the subject must be excluded from participation if the serum pregnancy result is positive. Follicle-stimulating hormone will be assessed to confirm child-bearing status as needed in non WOCBP. Exclusion Criteria: 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 subject who quit smoking at least 6 months prior to Visit 1. Presence of a known pre-existing, clinically significant lung condition other than asthma, in the opinion of the Investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study. This includes current bacterial or viral infection of the upper or lower respiratory tract, 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. Clinically Significant is defined as any disease/condition that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. A chest X-ray that reveals evidence of clinically significant abnormalities not believed to be due to the presence of asthma. Bronchial Thermoplasty and Radiotherapy are excluded for 12 months prior to visit 1 and throughout the study. A current malignancy or previous history of cancer in remission for less than 12 months prior to screening (Subjects that had localized carcinoma of the skin which was resected for cure will not be excluded). Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice or cirrhosis. Subjects with ALT >2 times Upper Limit of Normal (ULN), bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent) Subjects who have known, pre-existing severe or clinically significant cardiovascular disease uncontrolled with standard treatment. Including but not limited to: known ejection fraction of <30 percent or severe heart failure meeting New York Heart Association Class IV classification or hospitalized in the 12 months prior to Visit 1 for severe heart failure meeting New York Heart Association Class III or angina diagnosed less than 3 months prior to Visit 1 or at Visit 1. QT interval corrected by Fridericia's formula (QTc[F]) >450 milliseconds (msec) or QTc(F) >480 msec for subjects with Bundle Branch Block at Visit 1 is exclusive. Subjects who have known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, hematological or any other system abnormalities that are uncontrolled with standard treatment. Current malignancy except for basal and squamous skin cancer. Subjects with other conditions that could lead to elevated eosinophils such as Hypereosiniophilic Syndromes, including Churg-Strauss Syndrome, or Eosinophilic Esophagitis. Subjects with a known, pre-existing parasitic infestation within 6 months prior to Visit 1 are also excluded. A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Visit 1. Alcohol abuse is defined as: an average weekly intake of greater than 21 units or an average daily intake of greater than three units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than two units (females). One unit was equivalent to a half-pint (220 milliliters) of beer or one (25 milliliters) measure of spirits or one glass (125 milliliters) of wine. A known immunodeficiency (e.g., human immunodeficiency virus - HIV), other than that explained by the use of corticosteroids taken as therapy for asthma. Subjects who have received omalizumab (Xolair) within 130 days of Visit 1. Subjects who have received any monoclonal antibodies (other than Xolair) to treat inflammatory disease within 5 half-lives of Visit 1. Use of herbals within 7 days prior to visit 1, unless in the opinion of the Investigator and GlaxoSmithKline (GSK) Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. 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, prior to visit 1 (this also includes investigational formulations of marketed products). Subjects with allergy/intolerance to a monoclonal antibody or biologic. Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnant during the time of study participation. 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). A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator. Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study. Re-screening of subjects will be allowed only upon approval by the medical monitor.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
GSK Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
GSK Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
GSK Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510150
Country
China
Facility Name
GSK Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
GSK Investigational Site
City
Shen Zhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Facility Name
GSK Investigational Site
City
Zhanjiang
State/Province
Guangdong
ZIP/Postal Code
524001
Country
China
Facility Name
GSK Investigational Site
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550002
Country
China
Facility Name
GSK Investigational Site
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
GSK Investigational Site
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
GSK Investigational Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
GSK Investigational Site
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
421000
Country
China
Facility Name
GSK Investigational Site
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010050
Country
China
Facility Name
GSK Investigational Site
City
Huhhot
State/Province
Inner Mongolia
ZIP/Postal Code
010017
Country
China
Facility Name
GSK Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Facility Name
GSK Investigational Site
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Facility Name
GSK Investigational Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
GSK Investigational Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Facility Name
GSK Investigational Site
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
GSK Investigational Site
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110015
Country
China
Facility Name
GSK Investigational Site
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750001
Country
China
Facility Name
GSK Investigational Site
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
GSK Investigational Site
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266071
Country
China
Facility Name
GSK Investigational Site
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Facility Name
GSK Investigational Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
GSK Investigational Site
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Facility Name
GSK Investigational Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Name
GSK Investigational Site
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
323027
Country
China
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100144
Country
China
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
GSK Investigational Site
City
Changsha
ZIP/Postal Code
410013
Country
China
Facility Name
GSK Investigational Site
City
Guangzhou
ZIP/Postal Code
511400
Country
China
Facility Name
GSK Investigational Site
City
Hang Zhou
ZIP/Postal Code
310005
Country
China
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
200233
Country
China
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
GSK Investigational Site
City
Suzhou
ZIP/Postal Code
215004
Country
China
Facility Name
GSK Investigational Site
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
GSK Investigational Site
City
Tianjin
ZIP/Postal Code
300211
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site URL http://clinicalstudydatarequest
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints of the study
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months
IPD Sharing URL
http://clinicalstudydatarequest

Learn more about this trial

A Safety and Efficacy Study of Mepolizumab in Subjects With Severe Asthma

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