Efficacy and Safety of Mepolizumab as an Add-on Treatment in Chronic Obstructive Pulmonary Disease (COPD)

NCT02105961 | Completed Phase 3 Results DMC

• 1 other identifier: 117113
• Study Type: interventional
• Target: 674
• Locations: 15 countries
• Sites: 169

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Disease; exacerbations; SB240563; mepolizumab; eosinophils

Outcome Measures

Primary Outcomes (1)

• 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).

  From randomization to Week 52

Secondary Outcomes (4)

• Time to First Moderate/Severe Exacerbation

  From randomization to Week 52

• Rate of COPD Exacerbations Requiring Emergency Department (ED) Visits and/or Hospitalizations (Hosp)

  From randomization to Week 52

• Change From Baseline in Mean Total St. George's Respiratory Questionnaire (SGRQ) Score

  Baseline and Week 52

• Change From Baseline in Mean COPD Assessment Test (CAT) Score

  Baseline and Week 52

Study Arms (3)

Arm 1

EXPERIMENTAL

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

Drug: Mepolizumab

Arm 2

EXPERIMENTAL

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

Drug: Mepolizumab

Arm 3

EXPERIMENTAL

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

Drug: Placebo

Interventions

Mepolizumab DRUG

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.

Arm 1; Arm 2

Placebo DRUG

Sterile 0.9percent sodium chloride solution

Arm 3

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (169)

GSK Investigational Site

Birmingham, Alabama, 35294, United States

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GSK Investigational Site

Mobile, Alabama, 36608, United States

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GSK Investigational Site

Riverside, California, 92506, United States

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GSK Investigational Site

Upland, California, 91786, United States

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Broomfield, Colorado, 80023, United States

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Stamford, Connecticut, 06902, United States

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Boynton Beach, Florida, 33436, United States

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DeLand, Florida, 32720, United States

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Edgewater, Florida, 32132, United States

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Gainesville, Florida, 32608, United States

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GSK Investigational Site

Orlando, Florida, 32825, United States

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GSK Investigational Site

St. Petersburg, Florida, 33704, United States

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GSK Investigational Site

Adairsville, Georgia, 30103, United States

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GSK Investigational Site

Duluth, Georgia, 30096, United States

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Woodstock, Georgia, 30189, United States

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Coeur d'Alene, Idaho, 83814, United States

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Bowling Green, Kentucky, 42101, United States

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Albuquerque, New Mexico, 87108, United States

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Charlotte, North Carolina, 28207, United States

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Gastonia, North Carolina, 28054, United States

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Huntersville, North Carolina, 28078, United States

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Columbus, Ohio, 43213, United States

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Portland, Oregon, 97220, United States

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Hershey, Pennsylvania, 17033, United States

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Oaks, Pennsylvania, 19456, United States

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Philadelphia, Pennsylvania, 19140, United States

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Charleston, South Carolina, 29406-7108, United States

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Easley, South Carolina, 29640, United States

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Greenville, South Carolina, 29615, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Rock Hill, South Carolina, 29732, United States

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Fort Worth, Texas, 76104, United States

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Richmond, Virginia, 23225, United States

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Richmond, Virginia, 23249, United States

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Morgantown, West Virginia, 26505, United States

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Bahía Blanca, Buenos Aires, B8000AAK, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1414AIF, Argentina

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La Plata, Buenos Aires, 1900, Argentina

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Mar del Plata, Buenos Aires, 7600, Argentina

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Berazategui, 1886, Argentina

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Buenos Aires, C1121ABE, Argentina

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Buenos Aires, C1425BEN, Argentina

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Mendoza, 5500, Argentina

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Mendoza, M5500CCG, Argentina

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Coffs Harbour, New South Wales, 2450, Australia

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Maroubra, New South Wales, 2035, Australia

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Murdoch, Western Australia, 6150, Australia

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Truro, Nova Scotia, B2N 1L2, Canada

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Burlington, Ontario, L7N 3V2, Canada

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Toronto, Ontario, M5T 3A9, Canada

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Windsor, Ontario, N8X 5A6, Canada

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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

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Trois-Rivières, Quebec, G8T 7A1, Canada

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Talca, Maule Region, 3460001, Chile

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Valparaíso, Región de Valparaíso, 2341131, Chile

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Santiago, Región Metro de Santiago, 7500692, Chile

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Santiago, Región Metro de Santiago, 7860406, Chile

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Santiago, Región Metro de Santiago, 8242238, Chile

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Santiago, 7500698, Chile

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Santiago, 8380453, Chile

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Aarhus C, 8000, Denmark

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Hvidovre, 2650, Denmark

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København NV, 2400, Denmark

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Odense C, 5000, Denmark

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Stuttgart, Baden-Wurttemberg, 70378, Germany

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Rüdersdorf, Brandenburg, 15562, Germany

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Frankfurt am Main, Hesse, 60389, Germany

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Frankfurt am Main, Hesse, 60596, Germany

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Neu-Isenburg, Hesse, 63263, Germany

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Hanover, Lower Saxony, 30173, Germany

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Mainz, Rhineland-Palatinate, 55131, Germany

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Dresden, Saxony, 01307, Germany

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Leipzig, Saxony, 04357, Germany

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Magdeburg, Saxony-Anhalt, 39112, Germany

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Lübeck, Schleswig-Holstein, 23552, Germany

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Berlin, 10717, Germany

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Berlin, 12157, Germany

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Berlin, 12203, Germany

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Hamburg, 22299, Germany

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GSK Investigational Site

Ehime, 791-0281, Japan

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Fukui, 910-1193, Japan

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Fukuoka, 811-1394, Japan

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Fukushima, 960-1295, Japan

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Gifu, 509-6134, Japan

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Hiroshima, 722-8503, Japan

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Hiroshima, 734-8530, Japan

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Hokkaido, 053-8506, Japan

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Hyōgo, 650-0047, Japan

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Kagawa, 762-8550, Japan

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Kanagawa, 227-8501, Japan

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Kumamoto, 861-1196, Japan

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Mie, 515-8544, Japan

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Miyagi, 980-8574, Japan

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Miyagi, 983-8520, Japan

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Miyagi, 986-8522, Japan

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Okayama, 702-8055, Japan

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Okayama, 711-0921, Japan

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Okinawa, 901-2121, Japan

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Osaka, 573-0153, Japan

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Osaka, 589-8511, Japan

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Osaka, 591-8555, Japan

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Ōita, 876-0813, Japan

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GSK Investigational Site

Shimane, 693-8501, Japan

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GSK Investigational Site

Shizuoka, 436-0022, Japan

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Shizuoka, 438-8550, Japan

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Tokyo, 103-0027, Japan

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Tokyo, 104-8560, Japan

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Tokyo, 136-0075, Japan

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Tokyo, 142-8666, Japan

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Tokyo, 152-0021, Japan

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Tokyo, 204-8585, Japan

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's-Hertogenbosch, 5223 GZ, Netherlands

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Almelo, 7609 PP, Netherlands

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Breda, 4818 CK, Netherlands

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Groningen, 9713 GZ, Netherlands

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Hoofddorp, 2134 TM, Netherlands

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Horn, 6085 NM, Netherlands

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Leiden, 2333 ZA, Netherlands

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Sittard-geleen, 6162 BG, Netherlands

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Utrecht, 3584 CX, Netherlands

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Zutphen, 7207 AE, Netherlands

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GSK Investigational Site

Bucharest, 020125, Romania

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Bucharest, 050159, Romania

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Cluj-Napoca, 400371, Romania

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Codlea, 505100, Romania

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Craiova, 200642, Romania

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GSK Investigational Site

Focşani, 620043, Romania

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Iași, 700115, Romania

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GSK Investigational Site

Piteşti, 110084, Romania

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GSK Investigational Site

Ploieşti, 100024, Romania

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Timișoara, 300310, Romania

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Humenné, 066 01, Slovakia

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Poprad, 058 01, Slovakia

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GSK Investigational Site

Spišská Nová Ves, 052 01, Slovakia

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GSK Investigational Site

Šaľa, 927 01, Slovakia

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GSK Investigational Site

Vráble, 952 01, Slovakia

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GSK Investigational Site

Anyang-Si Gyeonggi-do, 431-070, South Korea

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GSK Investigational Site

Bucheon City, Gyenggi-do, 420-767, South Korea

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GSK Investigational Site

Busan, 602-715, South Korea

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Cheongju, Chungcheongbuk-do, 361-711, South Korea

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GSK Investigational Site

Daegu, 705-703, South Korea

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Incheon, 403-720, South Korea

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GSK Investigational Site

Jeonju, 561-712, South Korea

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GSK Investigational Site

Seoul, 120-752, South Korea

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Seoul, 130-709, South Korea

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GSK Investigational Site

Seoul, 130-872, South Korea

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GSK Investigational Site

Seoul, 138-736, South Korea

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GSK Investigational Site

Seoul, 140-743, South Korea

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GSK Investigational Site

Seoul, South Korea

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GSK Investigational Site

Wonju-si, Kanwon-do, 220-701, South Korea

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GSK Investigational Site

Kaohsiung City, 824, Taiwan

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GSK Investigational Site

Taichung, 404, Taiwan

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GSK Investigational Site

Taipei, 220, Taiwan

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GSK Investigational Site

Taipei, Taiwan

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GSK Investigational Site

Tau-Yuan County, 333, Taiwan

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Dnipropetrovsk, 49051, Ukraine

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GSK Investigational Site

Kharkiv, 61035, Ukraine

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Kharkiv, 61124, Ukraine

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GSK Investigational Site

Kiev, 03680, Ukraine

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GSK Investigational Site

Kyiv, 03038, Ukraine

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GSK Investigational Site

Kyiv, 03680, Ukraine

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GSK Investigational Site

Mykolayiv, 54003, Ukraine

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GSK Investigational Site

Vinnytsia, 21018, Ukraine

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Bradford, BD9 6RJ, United Kingdom

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Cambridge, CB2 0QQ, United Kingdom

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Oxford, OX3 7LE, United Kingdom

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GSK Investigational Site

Plymouth, PL6 8DH, United Kingdom

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Sheffield, S5 7AU, United Kingdom

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GSK Investigational Site

Stevenage, SG1 4AB, United Kingdom

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Related Publications (4)

• Pavord ID, Chapman KR, Bafadhel M, Sciurba FC, Bradford ES, Schweiker Harris S, Mayer B, Rubin DB, Yancey SW, Paggiaro P. Mepolizumab for Eosinophil-Associated COPD: Analysis of METREX and METREO. Int J Chron Obstruct Pulmon Dis. 2021 Jun 16;16:1755-1770. doi: 10.2147/COPD.S294333. eCollection 2021.

  PMID: 34163157 DERIVED

• Condreay LD, Gao C, Bradford E, Yancey SW, Ghosh S. No genetic associations with mepolizumab efficacy in COPD with peripheral blood eosinophilia. Respir Med. 2019 Aug;155:26-28. doi: 10.1016/j.rmed.2019.07.004. Epub 2019 Jul 5.

  PMID: 31295674 DERIVED

• Roger JH, Bratton DJ, Mayer B, Abellan JJ, Keene ON. Treatment policy estimands for recurrent event data using data collected after cessation of randomised treatment. Pharm Stat. 2019 Jan;18(1):85-95. doi: 10.1002/pst.1910. Epub 2018 Nov 8.

  PMID: 30406948 DERIVED

• Pavord ID, Chanez P, Criner GJ, Kerstjens HAM, Korn S, Lugogo N, Martinot JB, Sagara H, Albers FC, Bradford ES, Harris SS, Mayer B, Rubin DB, Yancey SW, Sciurba FC. Mepolizumab for Eosinophilic Chronic Obstructive Pulmonary Disease. N Engl J Med. 2017 Oct 26;377(17):1613-1629. doi: 10.1056/NEJMoa1708208. Epub 2017 Sep 11.

  PMID: 28893134 DERIVED

Related Links

• IPD for this study will be made available via the Clinical Study Data Request site.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2014
• First Posted: April 7, 2014
• Study Start: April 24, 2014
• Primary Completion: January 16, 2017
• Study Completion: January 16, 2017
• Last Updated: August 16, 2018
• Results First Posted: April 6, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• 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.

Locations

CL (7); DK (4); SL (5); NL (10); AR (9); TW (5); RO (10); KR (14); AU (3); GB (6); DE (15); UA (8); JP (32); CA (6); US (35)