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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02105961




Registration number
NCT02105961
Ethics application status
Date submitted
3/04/2014
Date registered
7/04/2014
Date last updated
16/08/2018

Titles & IDs
Public title
Efficacy and Safety of Mepolizumab as an Add-on Treatment in Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
Study MEA117113: Mepolizumab vs. Placebo as Add-on Treatment for Frequently Exacerbating COPD Patients Characterized by Eosinophil Level
Secondary ID [1] 0 0
117113
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mepolizumab
Treatment: Drugs - Placebo

Experimental: Arm 1 - Each subject will receive 100 mg mepolizumab SC injection every 4 weeks (13 administrations during 52 week treatment period) along with their baseline standard of care COPD medication

Experimental: Arm 2 - Each subject will receive 300 mg mepolizumab SC injection every 4 weeks (13 administrations during 52 week treatment period) along with their baseline standard of care COPD medication

Experimental: Arm 3 - Each subject will receive placebo (0.9percent sodium chloride) SC injection every 4 weeks (13 administrations during 52 week treatment period) their baseline standard of care COPD medication


Treatment: Drugs: Mepolizumab
Humanised 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.

Treatment: Drugs: Placebo
Sterile 0.9percent sodium chloride solution

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of Moderate or Severe Exacerbations - Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (>=24 hours) or result in death. Moderate and severe exacerbations occurring from the start of investigational product (IP) up to the Week 52 visit, including exacerbations reported after early discontinuation from IP by participants who remained in the study, were included in the analysis. The analysis was performed on the modified intent-to-treat (mITT) Population (all randomized participants who received at least one dose of study treatment).
Timepoint [1] 0 0
From randomization to Week 52
Secondary outcome [1] 0 0
Time to First Moderate/Severe Exacerbation - Kaplan Meier estimates of the probability of a moderate or severe exacerbation are expressed as the percentage of participants with an exacerbation over time (by Week 8, 16, 24, 32, 40, 48, 52). Analysis of time to first moderate/severe exacerbation was performed on the mITT population and included exacerbations reported on-treatment and those reported after early discontinuation from IP by participants who remained in the study.
Timepoint [1] 0 0
From randomization to Week 52
Secondary outcome [2] 0 0
Rate of COPD Exacerbations Requiring Emergency Department (ED) Visits and/or Hospitalizations (Hosp) - COPD exacerbations requiring an ED visit and/or hosp occurring from the start of IP up to the Week 52 visit, including exacerbations reported after early discontinuation from IP by participants who remained in the study, were included in the analysis. This analysis was performed on the mITT population.
Timepoint [2] 0 0
From randomization to Week 52
Secondary outcome [3] 0 0
Change From Baseline in Mean Total St. George's Respiratory Questionnaire (SGRQ) Score - The SGRQ for COPD is a 40-item questionnaire derived from the original SGRQ , designed to measure health impairment by addressing the frequency of respiratory symptoms and current state of the participant. SGRQ Total Scores range from 0 to 100 with higher scores indicating worse health-related quality of life and reductions indicating improvement. The Baseline value will be the last measurement collected prior to the first dose of investigational product.Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Mean change from Baseline in SGRQ score at Week 52 has been presented.
Timepoint [3] 0 0
Baseline and Week 52
Secondary outcome [4] 0 0
Change From Baseline in Mean COPD Assessment Test (CAT) Score - The CAT is an 8-item questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Each question is assessed on a 6-point scale ranging from 0 (no impairment) to 5 (maximum impairment) with the CAT score ranging from 0-40. Higher scores indicate greater disease impact with reductions indicating improvement. The Baseline value will be the last measurement collected prior to the first dose of investigational product. Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Mean change from Baseline in CAT score at Week 52 has been presented.
Timepoint [4] 0 0
Baseline and Week 52

Eligibility
Key inclusion criteria
- COPD diagnosis: Subjects with a clinically documented history of COPD for at least 1
year in accordance with the following definition by the American Thoracic
Society/European Respiratory Society

- Severity of COPD: Subjects must present with the following: a measured pre and
post-salbutamol Forced expiratory volume in one second/ Forced vital capacity
(FEV1/FVC) ratio of <0.70 at Visit 1 to confirm the diagnosis of COPD; a measured
post-salbutamol FEV1> 20 percent and <=80 percent of predicted normal values
calculated using National Health and Nutrition Examination Survey (NHANES) III
reference equations at Visit 1

- History of exacerbations: A well documented history (e.g., medical record
verification) in the 12 months prior to Visit 1 of ; at least two moderate COPD
exacerbations. Moderate is defined as the use of systemic corticosteroids
(intramuscular (IM), intravenous, or oral) and/or treatment with antibiotics or; at
least one severe COPD exacerbation. Severe is defined as having required
hospitalization. Note: At least one exacerbation must have occurred while the subject
was taking Inhaled corticosteroid (ICS) plus long acting beta2-agonist (LABA) plus
long acting muscarinic antagonist (LAMA). Prior use of antibiotics alone does not
qualify as a moderate exacerbation unless the use was specifically for the treatment
of worsening symptoms of COPD.

- Concomitant COPD therapy: A well documented requirement for optimized standard of care
background therapy that includes Inhaled corticosteroid (ICS) plus 2 additional COPD
medications (i.e., triple therapy) for the 12 months prior to Visit 1 and meets the
following criteria: Immediately prior to Visit 1, minimum of 3 months of use of an;
Inhaled corticosteroid at a dose >= 500 micrograms (mcg)/day fluticasone propionate
dose equivalent plus; LABA and LAMA.

For subjects who are not continually maintained on ICS plus LABA plus LAMA for the entire
12 months prior to Visit 1 use of following is allowed (but not in the 3 months immediately
prior to Visit 1); inhaled corticosteroid at a dose >=500 mcg/day fluticasone propionate
dose equivalent plus; a LABA or a LAMA and; use of at least one other class of COPD
medication (i.e., phosphodiesterase-4-inhibitors, methylxanthines, or a combination of
short acting beta2-agonist and short acting muscarinic antagonist).

- Informed Consent: 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.

- Gender: Male or Eligible Female; To be eligible for entry into the study females of
child bearing potential must commit to consistent and correct use of an acceptable
method of birth control from the time of consent, for the duration of the trial, and
for 4 months after last study drug administration.

- Age: At least 40 years of age at Visit 1

- Smoking status: Subject with confirmed COPD are eligible to participate independent of
their smoking status and smoking history, i.e. current smokers, never smokers or
ex-smokers can be enrolled into the study. Current smokers are defined as those with a
history of cigarette smoking of >=10 pack-years [number of pack years = (number of
cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10
years, or 10 cigarettes per day for 20 years)]. Former smokers are defined as those
who meet the definition of a current smoker but have stopped smoking for at least 6
months prior to Visit 1. Never smokers are those that do not meet the definition of a
current or former smoker.

- French subjects: In France, a subject will be eligible for inclusion in this study
only if either affiliated to or a beneficiary of a social security category.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects with Asthma: Current and Former Smokers: Subjects with a current diagnosis of
asthma (those with a prior history are eligible if they meet inclusion criteria for a
current diagnosis of COPD); Never-Smokers: Subjects with any history of asthma.

- Other respiratory disorders: The investigator must judge that COPD is the primary
diagnosis accounting for the clinical manifestations of the lung disease. Subjects
with alpha1-antitrypsin deficiency as the underlying cause of COPD are excluded. Also,
excluded are subjects with active tuberculosis, lung cancer, bronchiectasis,
sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung diseases
or other active pulmonary diseases. Subjects are also excluded if maintenance use of
bi-level positive airway pressure is required for the treatment of respiratory
disorder.

- COPD stability: Subjects with pneumonia, exacerbation, lower respiratory infection
within the 4 weeks prior to Visit 1.

- Lung resection: Subjects with lung volume reduction surgery within the 12 months prior
to Visit 1.

- Pulmonary rehabilitation program: Participation in the acute phase of a pulmonary
rehabilitation program within 4 weeks prior to Visit 1. Subjects who are in the
maintenance phase of a pulmonary rehabilitation program are not excluded.

- Oxygen: Subjects receiving treatment with oxygen more than 4.0 liters/minute (L/min).
While breathing supplemental oxygen, subjects should demonstrate an oxyhemoglobin
saturation greater than or equal to 89 percent.

- 12-lead Electrocardiography (ECG) finding: An abnormal and significant ECG finding
from the 12-lead ECG conducted at Visit 1, if considered to be clinically significant
by the Investigator. 12-lead ECGs will be over-read by a centralized independent
cardiologist to assist in consistent evaluation of subject eligibility. Results from
the 12-lead ECG over-read must be received prior to assessing eligibility at Visit 2.

- Unstable or life threatening cardiac disease: Subjects with any of the following would
be excluded: Myocardial infarction or unstable angina in the last 6 months ; Unstable
or life threatening cardiac arrhythmia requiring intervention in the last 3 months ;
New York Heart Association (NYHA) Class IV Heart failure

- Other diseases/abnormalities: Subjects with (historical or) current evidence of
clinically significant, neurological, psychiatric, renal, hepatic, immunological,
endocrine (including uncontrolled diabetes or thyroid disease) or haematological
abnormalities that are uncontrolled. Significant is defined as any disease 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.

- Eosinophilic disease: Subjects with other conditions that could lead to elevated
eosinophils such as Hypereosinophilic syndromes including Eosinophilic Granulomatosis
with Polyangiitis (EGPA, also known as Churg-Strauss Syndrome), or Eosinophilic
Esophagitis.

- Parasitic infection: Subjects with a pre-existing helminthes infestation within 6
months prior to Visit 1 are also excluded.

- Malignancy: A current malignancy or previous history of cancer in remission for less
than 12 months prior to Visit 1 (Subjects that had localized carcinoma of the skin or
cervix which was resected for cure will not be excluded). South Korea subjects with a
diagnosis of malignancy within 5 years of Visit 1 are excluded.

- Immunodeficiency: A known immunodeficiency (e.g. human immunodeficiency virus HIV),
other than that explained by the use of corticosteroids taken for COPD.

- Liver disease: 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). Chronic stable hepatitis B and C
are acceptable if subject otherwise meets entry criteria (e.g., presence of hepatitis
B surface antigen or positive hepatitis C test result within 3 months of screening)

- Monoclonal antibodies: Subjects who have received any monoclonal antibody within 5
half-lives of Visit 1.

- Investigational medications: Subjects who have received an investigational drug within
30 days of Visit 1, or within 5 drug half-lives of the investigational drug, whichever
is longer (this also includes investigational formulations of a marketed product).

- Hypersensitivity: Subjects with a known allergy or intolerance to another monoclonal
antibody or biologic including history of anaphylaxis to another biologic

- Inability to read: In the opinion of the investigator, any subject who is unable to
read and/or would not be able to complete study related materials.

- Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study
procedures. Any infirmity, disability, or geographic location that would limit
compliance for scheduled visits.

- Questionable validity of consent: 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.

- Drug or alcohol abuse: A known or suspected history of alcohol or drug abuse within 2
years prior to Visit 1.

- Previous participation: Subjects who have previously participated in any study of
mepolizumab.

- Affiliation with Investigator Site: Is an investigator, sub-investigator, study
coordinator, employee of a participating investigator or study site, or immediate
family member of the aforementioned that is involved in this study.

Randomization Criteria

In order to be randomized to study drug the subject must meet the following randomization
criteria at Visit 2:

- Blood eosinophils: Documented elevated peripheral blood eosinophil count of >=300
cells/microliter within the past 12 months prior to Visit 1; OR A peripheral baseline
blood eosinophil count of >=150 cells/microliter from haematology conducted at Visit 1

- Electronic Diary Compliance: Compliance with completion of the eDiary defined as
completion of all questions on 5 or more days out of the 7 days immediately preceding
Visit 2.

- 12-lead ECG: No evidence of an abnormal and significant ECG finding from the 12-lead
ECG conducted at Visit 1 as indicated on the over-read provided by the centralized
independent cardiologist. Subjects with a QT interval corrected with Fridericia's
formulas (QTcF)>=450 msec are not eligible. For subjects with a QRS interval
>=120msec, those with QTcF>=480 msec are not eligible. Specific ECG findings that
preclude subject eligibility are listed in the protocol.

- Abnormal chest X-ray (or Computerized Tomography [CT] scan): No chest X-ray (or CT
scan) that reveals evidence of clinically significant abnormalities not believed to be
due to the presence of COPD. If a chest X-ray or CT scan is not available within 6
months prior to Visit 1, then a chest X-ray must be taken at Visit 1 and the results
reviewed prior to randomization. For sites in Germany: If a chest X-ray (or CT scan)
within 6 months prior to Screening (Visit 1) is not available, the subject will not be
eligible for the study.

- Laboratory abnormality: No evidence of clinically significant abnormality in the
haematological, biochemical, or urinalysis screen at Visit 1, as judged by the
investigator.

- Hepatitis B: Subjects who are HBsAg positive or HBcAb positive must not have a HBV DNA
level >=2000 International Units (IU)/millilitre (mL).

- Liver function test: Subjects must meet the following based on results from sample
taken at Visit 1: Alanine aminotransferase (ALT) <2x ULN (upper limit of normal);
Alkaline Phosphatase (Alk Phos) <=2x ULN; Bilirubin <=1.5x ULN (isolated
bilirubin>1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35
percent)

- Pregnancy: No subjects who are pregnant or breastfeeding. Subjects should not be
enrolled if they plan to become pregnant during the time of study participation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Coffs Harbour
Recruitment hospital [2] 0 0
GSK Investigational Site - Maroubra
Recruitment hospital [3] 0 0
GSK Investigational Site - Murdoch
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2035 - Maroubra
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
Recruitment outside Australia
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Pitesti
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Romania
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Ploiesti
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Romania
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Vrable
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Taiwan
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Kaohsiung
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Taichung
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Taipei
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Tau-Yuan County
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Ukraine
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Dnipropetrovsk
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Ukraine
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Kharkiv
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Ukraine
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Kiev
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Ukraine
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Kyiv
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Ukraine
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Mykolayiv
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Ukraine
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Vinnytsia
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United Kingdom
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Bradford
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United Kingdom
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Cambridge
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United Kingdom
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Oxford
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United Kingdom
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Plymouth
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United Kingdom
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Sheffield
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United Kingdom
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Stevenage

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a multi-centered, randomized, placebo-controlled, double-blind, parallel group, trial
evaluating 2 doses of mepolizumab against placebo given every 4 weeks through subcutaneous
(SC) injection. In severe COPD subjects, sputum eosinophils levels are elevated to similar
levels as those seen in severe asthmatics. It is hypothesized that the reduction of
eosinophils with mepolizumab in COPD subjects would translate into a reduction of COPD
exacerbations. The study will evaluate the efficacy and safety of mepolizumab, in subjects
who are at or above the baseline blood eosinophil count of at least 150 cells/microliters who
exacerbate despite regular use of maximal tolerated therapy, appropriate for severe COPD
subjects, in the 12 months prior to study start. In total, 660 subjects will be randomized in
1:1:1 ratio to receive mepolizumab 300 mg, mepolizumab 100mg, or placebo administered SC. The
total duration of subject participation will be approximately 62 weeks, consisting of a 1 to
2 week screening period, 52-week treatment period and 8-week follow-up period.
Trial website
https://clinicaltrials.gov/show/NCT02105961
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Public notes

Contacts
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GSK Clinical Trials
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GlaxoSmithKline
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Summary results
Other publications