Mepolizumab as Add-on Treatment IN Participants With COPD Characterized by Frequent Exacerbations and Eosinophil Level (MATINEE)

August 25, 2023 updated by: GlaxoSmithKline

A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Mepolizumab 100 mg SC as add-on Treatment in Participants With COPD Experiencing Frequent Exacerbations and Characterized by Eosinophil Levels (Study 208657)

This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study designed to confirm the benefits of mepolizumab treatment on moderate or severe exacerbations in chronic obstructive pulmonary disease (COPD) participants given as an add on to their optimized maintenance COPD therapy. The maximum duration of participant participation is approximately 109 weeks, consisting of 2 screening visits (up to 3 weeks), a run-in period (up to 2 weeks), and an intervention period of at least 52 weeks and up to 104 weeks. 800 participants will be randomized in a 1:1 ratio to receive mepolizumab 100 milligrams (mg) or placebo every 4 weeks for at least 13 doses (52 weeks treatment period) up to a maximum of 26 doses (104 weeks treatment period). The number of randomized participants may increase up to approximately 1400.

Study Overview

Status

Active, not recruiting

Conditions

Pulmonary Disease, Chronic Obstructive

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

806

Phase

Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Berazategui, Buenos Aires, Argentina, B1884AAC
    - GSK Investigational Site
  - Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
    - GSK Investigational Site
  - Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
    - GSK Investigational Site
  - Ciudad de Buenos Aires, Argentina, C1425AZE
    - GSK Investigational Site
  - La Plata, Argentina, B1902COS
    - GSK Investigational Site
  - Mendoza, Argentina, M5500CCG
    - GSK Investigational Site
  - Mendoza, Argentina, 5500
    - GSK Investigational Site
  - San Miguel de Tucumán, Argentina, 4000
    - GSK Investigational Site
- Buenos Aires
  - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1122AAK
    - GSK Investigational Site
  - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1414AIF
    - GSK Investigational Site
  - Lobos, Buenos Aires, Argentina, 7240
    - GSK Investigational Site
  - Mar Del Plata, Buenos Aires, Argentina, B7600DHK
    - GSK Investigational Site
  - Mar del Plata, Buenos Aires, Argentina, 7600
    - GSK Investigational Site
  - Quilmes, Buenos Aires, Argentina, B1878FNR
    - GSK Investigational Site
  - San Fernando, Buenos Aires, Argentina, 1646
    - GSK Investigational Site
- Córdova
  - Cordoba, Córdova, Argentina, X5003DCE
    - GSK Investigational Site
- Mendoza
  - San Rafael, Mendoza, Argentina, 5600
    - GSK Investigational Site
- Santa Fe
  - Rosario, Santa Fe, Argentina, 2000
    - GSK Investigational Site
  - Rosario, Santa Fe, Argentina, S2002OJN
    - GSK Investigational Site
- Tucumán
  - San Miguel de Tucumán, Tucumán, Argentina, T4000IHE
    - GSK Investigational Site
Australia
- New South Wales
  - Coffs Harbour, New South Wales, Australia, 2450
    - GSK Investigational Site
  - New Lambton, New South Wales, Australia, 2305
    - GSK Investigational Site
  - Sydney, New South Wales, Australia, 2010
    - GSK Investigational Site
  - Westmead, New South Wales, Australia, 2145
    - GSK Investigational Site
- South Australia
  - Kent Town, South Australia, Australia, 5067
    - GSK Investigational Site
  - Woodville South, South Australia, Australia, 5011
    - GSK Investigational Site
- Victoria
  - Frankston, Victoria, Australia, 3199
    - GSK Investigational Site
Austria
- - Wien, Austria, 1090
    - GSK Investigational Site
Belgium
- - Jambes, Belgium, 5100
    - GSK Investigational Site
  - Liège, Belgium, 4000
    - GSK Investigational Site
  - Yvoir, Belgium, 5530
    - GSK Investigational Site
Brazil
- - São Paulo, Brazil, 05403-000
    - GSK Investigational Site
- Rio Grande Do Sul
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90610000
    - GSK Investigational Site
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90035-074
    - GSK Investigational Site
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90430-000
    - GSK Investigational Site
- São Paulo
  - Santo Andre, São Paulo, Brazil, 09060-670
    - GSK Investigational Site
Canada
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 4E1
    - GSK Investigational Site
- Nova Scotia
  - Truro, Nova Scotia, Canada, B2N 1L2
    - GSK Investigational Site
- Ontario
  - Ajax, Ontario, Canada, L1S 2J5
    - GSK Investigational Site
  - Newmarket, Ontario, Canada, L3Y 5G8
    - GSK Investigational Site
  - Sarnia, Ontario, Canada, N7T 4X3
    - GSK Investigational Site
  - Windsor, Ontario, Canada, N8X 1T3
    - GSK Investigational Site
- Quebec
  - St. Charles-Borromee, Quebec, Canada, J6E 2B4
    - GSK Investigational Site
China
- - Beijing, China, 100044
    - GSK Investigational Site
  - Beijing, China, 100034
    - GSK Investigational Site
  - Beijing, China, 100029
    - GSK Investigational Site
  - Beijing, China, 100730
    - GSK Investigational Site
  - Beijing, China, 100020
    - GSK Investigational Site
  - Changsha, China, 410013
    - GSK Investigational Site
  - Changsha, China, 410008
    - GSK Investigational Site
  - Changsha, China, 410005
    - GSK Investigational Site
  - Hangzhou, China, 310009
    - GSK Investigational Site
  - Hangzhou, China, 310006
    - GSK Investigational Site
  - Hohehot, China, 010050
    - GSK Investigational Site
  - Nanchang, China, 330006
    - GSK Investigational Site
  - Nanchang, China, 330038
    - GSK Investigational Site
  - Nanchang, China, 330200
    - GSK Investigational Site
  - Nanjing, China, 210009
    - GSK Investigational Site
  - Nanjing, China, 210029
    - GSK Investigational Site
  - Shanghai, China, 200040
    - GSK Investigational Site
  - Shanghai, China, 200032
    - GSK Investigational Site
  - Shanghai, China, 200120
    - GSK Investigational Site
  - Shanghai, China, 201100
    - GSK Investigational Site
  - Taizhou, China, 318000
    - GSK Investigational Site
  - Tianjin, China, 300052
    - GSK Investigational Site
  - Xining, China, 810007
    - GSK Investigational Site
  - Zhuhai, China, 519001
    - GSK Investigational Site
- Fujian
  - Xiamen, Fujian, China, 361004
    - GSK Investigational Site
- Guangdong
  - Guangzhou, Guangdong, China, 510080
    - GSK Investigational Site
  - Guangzhou, Guangdong, China, 510150
    - GSK Investigational Site
  - Guangzhou, Guangdong, China, 51080
    - GSK Investigational Site
- Guangxi
  - Nanning, Guangxi, China, 530021
    - GSK Investigational Site
- Hainan
  - Haikou, Hainan, China, 570311
    - GSK Investigational Site
- Hunan
  - Changsha, Hunan, China, 410004
    - GSK Investigational Site
- Inner Mongolia
  - Baotou, Inner Mongolia, China, 014010
    - GSK Investigational Site
- Jiangsu
  - Wuxi, Jiangsu, China, 214023
    - GSK Investigational Site
- Jilin
  - Changchun, Jilin, China, 130021
    - GSK Investigational Site
  - Changchun, Jilin, China, 130041
    - GSK Investigational Site
- Shandong
  - Jinan, Shandong, China, 250013
    - GSK Investigational Site
  - Qingdao, Shandong, China, 266071
    - GSK Investigational Site
- Shanxi
  - Taiyuan, Shanxi, China, 30000
    - GSK Investigational Site
- Xinjiang
  - Urumqi, Xinjiang, China, 830054
    - GSK Investigational Site
Denmark
- - Aalborg, Denmark, 9100
    - GSK Investigational Site
  - Hvidovre, Denmark, DK-2650
    - GSK Investigational Site
  - Kobenhavn NV, Denmark, 2400
    - GSK Investigational Site
  - København Ø, Denmark, 2100
    - GSK Investigational Site
  - Odense, Denmark, DK-5000
    - GSK Investigational Site
  - Rosklide, Denmark, 4000
    - GSK Investigational Site
  - Vejle, Denmark, 7100
    - GSK Investigational Site
France
- - Brest cedex, France, 29609
    - GSK Investigational Site
  - Cholet, France, 49300
    - GSK Investigational Site
  - Clermont-Ferrand, France, 63000
    - GSK Investigational Site
  - Le Mans, France, 72000
    - GSK Investigational Site
  - Lyon, France, 69004
    - GSK Investigational Site
  - Montpellier cedex 5, France, 34295
    - GSK Investigational Site
  - Mulhouse, France, 68100
    - GSK Investigational Site
  - Pringy Cedex, France, 74374
    - GSK Investigational Site
Germany
- - Berlin, Germany, 10367
    - GSK Investigational Site
  - Berlin, Germany, 10717
    - GSK Investigational Site
  - Berlin, Germany, 10119
    - GSK Investigational Site
  - Berlin, Germany, 10787
    - GSK Investigational Site
  - Berlin, Germany, 12627
    - GSK Investigational Site
  - Berlin, Germany, 12203
    - GSK Investigational Site
  - Berlin, Germany, 12157
    - GSK Investigational Site
  - Stuttgart, Germany, 70378
    - GSK Investigational Site
- Brandenburg
  - Cottbus, Brandenburg, Germany, 03050
    - GSK Investigational Site
- Hessen
  - Frankfurt, Hessen, Germany, 60596
    - GSK Investigational Site
  - Frankfurt, Hessen, Germany, 60389
    - GSK Investigational Site
  - Frankfurt, Hessen, Germany, 60313
    - GSK Investigational Site
  - Immenhausen, Hessen, Germany, 34376
    - GSK Investigational Site
  - Neu-Isenburg, Hessen, Germany, 63263
    - GSK Investigational Site
  - Rodgau, Hessen, Germany, 63110
    - GSK Investigational Site
- Niedersachsen
  - Peine, Niedersachsen, Germany, 31224
    - GSK Investigational Site
- Nordrhein-Westfalen
  - Gelsenkirchen, Nordrhein-Westfalen, Germany, 45879
    - GSK Investigational Site
  - Rheine, Nordrhein-Westfalen, Germany, 48431
    - GSK Investigational Site
- Rheinland-Pfalz
  - Koblenz, Rheinland-Pfalz, Germany, 56068
    - GSK Investigational Site
  - Mainz, Rheinland-Pfalz, Germany, 55131
    - GSK Investigational Site
- Sachsen
  - Leipzig, Sachsen, Germany, 04275
    - GSK Investigational Site
  - Leipzig, Sachsen, Germany, 04357
    - GSK Investigational Site
  - Leipzig, Sachsen, Germany, 04103
    - GSK Investigational Site
  - Leipzig, Sachsen, Germany, 04207
    - GSK Investigational Site
- Sachsen-Anhalt
  - Halle, Sachsen-Anhalt, Germany, 06108
    - GSK Investigational Site
- Schleswig-Holstein
  - Geesthacht, Schleswig-Holstein, Germany, 21502
    - GSK Investigational Site
  - Luebeck, Schleswig-Holstein, Germany, 23552
    - GSK Investigational Site
  - Schleswig, Schleswig-Holstein, Germany, 24837
    - GSK Investigational Site
Greece
- - Alexandroupolis, Greece, 68100
    - GSK Investigational Site
  - Athens, Greece, 106 76
    - GSK Investigational Site
  - Athina, Greece, 11527
    - GSK Investigational Site
  - Ioannina, Greece, 455 00
    - GSK Investigational Site
  - Patras, Greece, 26054
    - GSK Investigational Site
  - Thessaloniki, Greece, 57010
    - GSK Investigational Site
Hungary
- - Budapest, Hungary, 1036
    - GSK Investigational Site
  - Budapest, Hungary, 1125
    - GSK Investigational Site
  - Debrecen, Hungary, 4025
    - GSK Investigational Site
  - Debrecen, Hungary, 4032
    - GSK Investigational Site
  - Gyula, Hungary, 5700
    - GSK Investigational Site
  - Hajdunanas, Hungary, 4080
    - GSK Investigational Site
  - Hatvan, Hungary, 3000
    - GSK Investigational Site
  - Pécs, Hungary, 7635
    - GSK Investigational Site
  - Siófok, Hungary, 8600
    - GSK Investigational Site
  - Törökbálint, Hungary, 2045
    - GSK Investigational Site
  - Zalaegerszeg, Hungary, 8900
    - GSK Investigational Site
India
- - Ahmedabad, India, 380052
    - GSK Investigational Site
  - Ahmedabad, India, 380060
    - GSK Investigational Site
  - Aligarh, India, 202002
    - GSK Investigational Site
  - Hyderabad, India, 500018
    - GSK Investigational Site
  - Jaipur, India, 302023
    - GSK Investigational Site
  - Kanpur, India, 208001
    - GSK Investigational Site
  - Lucknow, India, 226003
    - GSK Investigational Site
  - Madurai, India, 625107
    - GSK Investigational Site
  - Nagpur, India, 440012
    - GSK Investigational Site
  - Nagpur, India, 44009
    - GSK Investigational Site
  - New Delhi, India, 110060
    - GSK Investigational Site
  - New Delhi, India, 110005
    - GSK Investigational Site
  - Secunderabad, India, 500003
    - GSK Investigational Site
Ireland
- - Drogheda, Ireland, A92 VW28
    - GSK Investigational Site
  - Dublin, Ireland, D09 V2N0
    - GSK Investigational Site
  - Dublin, Ireland, D24 NR0A
    - GSK Investigational Site
  - Dublin, Ireland, DO4T6F4
    - GSK Investigational Site
  - Dublin 15, Ireland, D15 X40D
    - GSK Investigational Site
  - Galway, Ireland, H53 T971
    - GSK Investigational Site
  - Limerick, Ireland, V94 F858
    - GSK Investigational Site
Israel
- - Ashkelon, Israel, 78278
    - GSK Investigational Site
  - Beer-Yaakov, Israel, 703000
    - GSK Investigational Site
  - Haifa, Israel, 34362
    - GSK Investigational Site
  - Holon, Israel, 58100
    - GSK Investigational Site
  - Jerusalem, Israel, 91031
    - GSK Investigational Site
  - Jerusalem, Israel, 91120
    - GSK Investigational Site
  - Kfar Saba, Israel, 44281
    - GSK Investigational Site
  - Petah Tikva, Israel, 49100
    - GSK Investigational Site
  - Ramat Gan, Israel, 52621
    - GSK Investigational Site
  - Rehovot, Israel, 76100
    - GSK Investigational Site
Italy
- Campania
  - Telese Terme (BN), Campania, Italy, 82037
    - GSK Investigational Site
- Emilia-Romagna
  - Ferrara, Emilia-Romagna, Italy, 44123
    - GSK Investigational Site
- Lazio
  - Roma, Lazio, Italy, 00128
    - GSK Investigational Site
- Veneto
  - Verona, Veneto, Italy, 37134
    - GSK Investigational Site
Japan
- - Fukuoka, Japan, 802-0052
    - GSK Investigational Site
  - Fukuoka, Japan, 811-1394
    - GSK Investigational Site
  - Gifu, Japan, 509-6134
    - GSK Investigational Site
  - Gunma, Japan, 371-0048
    - GSK Investigational Site
  - Gunma, Japan, 372-0831
    - GSK Investigational Site
  - Gunma, Japan, 373-0807
    - GSK Investigational Site
  - Gunma, Japan, 371-0054
    - GSK Investigational Site
  - Hokkaido, Japan, 062-0931
    - GSK Investigational Site
  - Hokkaido, Japan, 064-0804
    - GSK Investigational Site
  - Kagoshima, Japan, 890-8520
    - GSK Investigational Site
  - Kanagawa, Japan, 210-0852
    - GSK Investigational Site
  - Mie, Japan, 515-8544
    - GSK Investigational Site
  - Osaka, Japan, 591-8555
    - GSK Investigational Site
  - Shizuoka, Japan, 438-8550
    - GSK Investigational Site
Korea, Republic of
- - Daegu, Korea, Republic of, 42415
    - GSK Investigational Site
  - Incheon, Korea, Republic of, 21565
    - GSK Investigational Site
  - Incheon, Korea, Republic of, 21431
    - GSK Investigational Site
  - Jeonju-si, Jeollabuk-do, Korea, Republic of, 54907
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 143-729
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 06591
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 07061
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 02559
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 02447
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 02841
    - GSK Investigational Site
Mexico
- - Chihuahua, Mexico, 31217
    - GSK Investigational Site
  - Chihuahua, Mexico, 31203
    - GSK Investigational Site
  - Jalisco, Mexico, 44130
    - GSK Investigational Site
  - Mexico City, Mexico, 06760
    - GSK Investigational Site
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44100
    - GSK Investigational Site
  - Guadalajara, Jalisco, Mexico, 44160
    - GSK Investigational Site
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64460
    - GSK Investigational Site
  - Monterrey, Nuevo León, Mexico, 64020
    - GSK Investigational Site
Netherlands
- - Alkmaar, Netherlands, 1815 JD
    - GSK Investigational Site
  - Breda, Netherlands, 4818 CK
    - GSK Investigational Site
  - Den Haag, Netherlands, 2545 AA
    - GSK Investigational Site
  - Groningen, Netherlands, 9728 NT
    - GSK Investigational Site
  - Heerlen, Netherlands, 6419 PC
    - GSK Investigational Site
  - Rotterdam, Netherlands, 3045 PM
    - GSK Investigational Site
  - Zutphen, Netherlands, 7207 AE
    - GSK Investigational Site
New Zealand
- - Auckland, New Zealand, 1051
    - GSK Investigational Site
  - Hamilton, New Zealand, 3240
    - GSK Investigational Site
  - Havelock North, New Zealand, 4130
    - GSK Investigational Site
  - Rotorua, New Zealand, 3010
    - GSK Investigational Site
  - Wellington, New Zealand, 6021
    - GSK Investigational Site
Poland
- - Bialystok, Poland, 15-044
    - GSK Investigational Site
  - Bydgoszcz, Poland, 85-796
    - GSK Investigational Site
  - Czestochowa, Poland, 42202
    - GSK Investigational Site
  - Elblag, Poland, 82-300
    - GSK Investigational Site
  - Gdansk, Poland, 80-382
    - GSK Investigational Site
  - Gdynia, Poland, 81-537
    - GSK Investigational Site
  - Katowice, Poland, 40-040
    - GSK Investigational Site
  - Katowice, Poland, 40-081
    - GSK Investigational Site
  - Kielce, Poland, 25-751
    - GSK Investigational Site
  - Krakow, Poland, 30-033
    - GSK Investigational Site
  - Krakow, Poland, 31-209
    - GSK Investigational Site
  - Lodz, Poland, 90-127
    - GSK Investigational Site
  - Lodz, Poland, 90-141
    - GSK Investigational Site
  - Lublin, Poland, 20-954
    - GSK Investigational Site
  - Ostrow Wilekopolski, Poland, 63-400
    - GSK Investigational Site
  - Ostrowiec Swietokrzyski, Poland, 27-400
    - GSK Investigational Site
  - Poznan, Poland, 60-214
    - GSK Investigational Site
  - Poznan, Poland, 60-702
    - GSK Investigational Site
  - Rzeszow, Poland, 35-051
    - GSK Investigational Site
  - Rzeszow, Poland, 35-205
    - GSK Investigational Site
  - Sopot, Poland, 81-741
    - GSK Investigational Site
  - Sosnowiec, Poland, 41-200
    - GSK Investigational Site
  - Warszawa, Poland, 02-777
    - GSK Investigational Site
  - Warszawa, Poland, ?01-192
    - GSK Investigational Site
  - Wroclaw, Poland, 50-088
    - GSK Investigational Site
  - Wroclaw, Poland, 53-301
    - GSK Investigational Site
  - Zamosc, Poland, 22-400
    - GSK Investigational Site
Spain
- - Alzira/Valencia, Spain, 46600
    - GSK Investigational Site
  - Barcelona, Spain, 08035
    - GSK Investigational Site
  - Barcelona, Spain, 08003
    - GSK Investigational Site
  - Benalmadena Costa, Spain, 29630
    - GSK Investigational Site
  - Caceres, Spain, 10003
    - GSK Investigational Site
  - Cádiz, Spain, 10009
    - GSK Investigational Site
  - Galdakano, Spain, 48960
    - GSK Investigational Site
  - Granada, Spain, 18014
    - GSK Investigational Site
  - Guadalajara, Spain, 19002
    - GSK Investigational Site
  - L'Hospitalet de Llobregat, Spain, 08907
    - GSK Investigational Site
  - Lleida, Spain, 25198
    - GSK Investigational Site
  - Logroño, Spain, 26006
    - GSK Investigational Site
  - Loja/ Granada, Spain, 18300
    - GSK Investigational Site
  - Pamplona, Spain, 31008
    - GSK Investigational Site
  - Pozuelo De Alarcón/Madrid, Spain, 28223
    - GSK Investigational Site
  - Sagunto/Valencia, Spain, 46520
    - GSK Investigational Site
  - Santiago de Compostela, Spain, 15706
    - GSK Investigational Site
  - Zaragoza, Spain, 50009
    - GSK Investigational Site
- Andalucia
  - Marbella - Málaga, Andalucia, Spain, 29603
    - GSK Investigational Site
- Castilla Y Leon
  - Salamanca, Castilla Y Leon, Spain, 37007
    - GSK Investigational Site
Sweden
- - Härnösand, Sweden, SE-871 31
    - GSK Investigational Site
  - Malmö, Sweden, SE-211 52
    - GSK Investigational Site
  - Uppsala, Sweden, SE-752 37
    - GSK Investigational Site
Taiwan
- - Taipei, Taiwan, 10002
    - GSK Investigational Site
United Kingdom
- - Birmingham, United Kingdom, B15 2SQ
    - GSK Investigational Site
  - Cardiff, United Kingdom, CF159SS
    - GSK Investigational Site
  - Dundee, United Kingdom, DD2 4BF
    - GSK Investigational Site
  - Glasgow, United Kingdom, G20 0SP
    - GSK Investigational Site
  - Gwaelod-y-Garth, Cardiff, United Kingdom, CF15 9SS
    - GSK Investigational Site
  - Hexham, United Kingdom, NE46 1QJ
    - GSK Investigational Site
  - London, United Kingdom, W1G 8HU
    - GSK Investigational Site
  - Manchester, United Kingdom, M15 6SE
    - GSK Investigational Site
  - Norwich, United Kingdom, NR4 7UY
    - GSK Investigational Site
  - Stockton On Tees, United Kingdom, TS19 8PE
    - GSK Investigational Site
- Lanarkshire
  - Wishaw, Lanarkshire, United Kingdom, ML2 0DP
    - GSK Investigational Site
- Lancashire
  - Buckshaw Village, Chorley, Lancashire, United Kingdom, PR7 7NA
    - GSK Investigational Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35211
    - GSK Investigational Site
  - Dothan, Alabama, United States, 36305
    - GSK Investigational Site
  - Jasper, Alabama, United States, 35501
    - GSK Investigational Site
  - Sheffield, Alabama, United States, 35660
    - GSK Investigational Site
- Arizona
  - Chandler, Arizona, United States, 85224
    - GSK Investigational Site
  - Gilbert, Arizona, United States, 85296
    - GSK Investigational Site
  - Glendale, Arizona, United States, 85306
    - GSK Investigational Site
  - Mesa, Arizona, United States, 85206
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85020
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85050
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85018
    - GSK Investigational Site
  - Tucson, Arizona, United States, 85741
    - GSK Investigational Site
- Arkansas
  - Conway, Arkansas, United States, 72032
    - GSK Investigational Site
- California
  - Cerritos, California, United States, 90703
    - GSK Investigational Site
  - Newport Beach, California, United States, 92663
    - GSK Investigational Site
  - Palm Springs, California, United States, 92262
    - GSK Investigational Site
  - Riverside, California, United States, 92506
    - GSK Investigational Site
  - San Diego, California, United States, 92120
    - GSK Investigational Site
  - Torrance, California, United States, 90503-4818
    - GSK Investigational Site
  - Vista, California, United States, 92083
    - GSK Investigational Site
- Colorado
  - Colorado Springs, Colorado, United States, 80907
    - GSK Investigational Site
- Florida
  - Boynton Beach, Florida, United States, 33472-2952
    - GSK Investigational Site
  - Clearwater, Florida, United States, 33765
    - GSK Investigational Site
  - Daytona Beach, Florida, United States, 32117
    - GSK Investigational Site
  - Doral, Florida, United States, 33172-1604
    - GSK Investigational Site
  - Fort Pierce, Florida, United States, 34950-4832
    - GSK Investigational Site
  - Gainesville, Florida, United States, 32608
    - GSK Investigational Site
  - Homestead, Florida, United States, 33032
    - GSK Investigational Site
  - Melbourne, Florida, United States, 32934
    - GSK Investigational Site
  - Miami, Florida, United States, 33144
    - GSK Investigational Site
  - Miami, Florida, United States, 33174
    - GSK Investigational Site
  - Miami, Florida, United States, 33186
    - GSK Investigational Site
  - Miami, Florida, United States, 33155
    - GSK Investigational Site
  - Miami, Florida, United States, 33144-257
    - GSK Investigational Site
  - Miami, Florida, United States, 33173-3259
    - GSK Investigational Site
  - Miami Lakes, Florida, United States, 33016
    - GSK Investigational Site
  - Miami Lakes, Florida, United States, 33014-2473
    - GSK Investigational Site
  - New Port Richey, Florida, United States, 34653
    - GSK Investigational Site
  - Orlando, Florida, United States, 32806
    - GSK Investigational Site
  - Orlando, Florida, United States, 32825
    - GSK Investigational Site
  - Pinellas Park, Florida, United States, 33781
    - GSK Investigational Site
  - Plantation, Florida, United States, 33324
    - GSK Investigational Site
  - Port Orange, Florida, United States, 32127
    - GSK Investigational Site
  - Saint Petersburg, Florida, United States, 33704
    - GSK Investigational Site
  - Tampa, Florida, United States, 33603
    - GSK Investigational Site
  - Tampa, Florida, United States, 33615-3219
    - GSK Investigational Site
  - The Villages, Florida, United States, 32162
    - GSK Investigational Site
- Georgia
  - Adairsville, Georgia, United States, 30103
    - GSK Investigational Site
  - Johns Creek, Georgia, United States, 30022-7484
    - GSK Investigational Site
  - Lawrenceville, Georgia, United States, 30046
    - GSK Investigational Site
  - Woodstock, Georgia, United States, 30189
    - GSK Investigational Site
- Illinois
  - Chicago, Illinois, United States, 60602
    - GSK Investigational Site
- Indiana
  - Evansville, Indiana, United States, 47714
    - GSK Investigational Site
  - Valparaiso, Indiana, United States, 46383
    - GSK Investigational Site
- Iowa
  - Iowa City, Iowa, United States, 52246-2209
    - GSK Investigational Site
- Kentucky
  - Lexington, Kentucky, United States, 40503
    - GSK Investigational Site
- Louisiana
  - Natchitoches, Louisiana, United States, 71457-6215
    - GSK Investigational Site
- Maryland
  - Baltimore, Maryland, United States, 21224-2141
    - GSK Investigational Site
  - Columbia, Maryland, United States, 21044
    - GSK Investigational Site
- Michigan
  - Lathrup Village, Michigan, United States, 48076
    - GSK Investigational Site
- Missouri
  - Saint Louis, Missouri, United States, 63141
    - GSK Investigational Site
- Nevada
  - Henderson, Nevada, United States, 89014
    - GSK Investigational Site
  - Las Vegas, Nevada, United States, 89106
    - GSK Investigational Site
- New Jersey
  - Toms River, New Jersey, United States, 08755
    - GSK Investigational Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87108
    - GSK Investigational Site
- New York
  - Bronx, New York, United States, 10455
    - GSK Investigational Site
- North Carolina
  - Gastonia, North Carolina, United States, 28054
    - GSK Investigational Site
  - Hickory, North Carolina, United States, 28601
    - GSK Investigational Site
  - Shelby, North Carolina, United States, 28150
    - GSK Investigational Site
  - Wilmington, North Carolina, United States, 28401
    - GSK Investigational Site
  - Winston-Salem, North Carolina, United States, 27103
    - GSK Investigational Site
- Ohio
  - Cincinnati, Ohio, United States, 45236
    - GSK Investigational Site
  - Columbus, Ohio, United States, 43215
    - GSK Investigational Site
  - Columbus, Ohio, United States, 43016
    - GSK Investigational Site
  - Kettering, Ohio, United States, 45439-2201
    - GSK Investigational Site
- Oklahoma
  - Norman, Oklahoma, United States, 73072
    - GSK Investigational Site
  - Oklahoma City, Oklahoma, United States, 73111
    - GSK Investigational Site
- Oregon
  - Portland, Oregon, United States, 97220
    - GSK Investigational Site
- Pennsylvania
  - DuBois, Pennsylvania, United States, 15801
    - GSK Investigational Site
  - Philadelphia, Pennsylvania, United States, 19140
    - GSK Investigational Site
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - GSK Investigational Site
  - Charleston, South Carolina, United States, 29406-7108
    - GSK Investigational Site
  - Clinton, South Carolina, United States, 29325
    - GSK Investigational Site
  - Fort Mill, South Carolina, United States, 29707
    - GSK Investigational Site
  - Gaffney, South Carolina, United States, 29340
    - GSK Investigational Site
  - Greenville, South Carolina, United States, 29615
    - GSK Investigational Site
  - Lancaster, South Carolina, United States, 29720-1709
    - GSK Investigational Site
  - Rock Hill, South Carolina, United States, 29732
    - GSK Investigational Site
  - Spartanburg, South Carolina, United States, 29303
    - GSK Investigational Site
- Tennessee
  - Knoxville, Tennessee, United States, 37909
    - GSK Investigational Site
- Texas
  - Corsicana, Texas, United States, 75110
    - GSK Investigational Site
  - Dallas, Texas, United States, 75225-6301
    - GSK Investigational Site
  - Houston, Texas, United States, 77042-4643
    - GSK Investigational Site
  - Lampasas, Texas, United States, 76550
    - GSK Investigational Site
  - McAllen, Texas, United States, 78503
    - GSK Investigational Site
  - McKinney, Texas, United States, 75069
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78229
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78258
    - GSK Investigational Site
  - Sherman, Texas, United States, 75092
    - GSK Investigational Site
  - Sugar Land, Texas, United States, 77479
    - GSK Investigational Site
  - Webster, Texas, United States, 77598
    - GSK Investigational Site
- Vermont
  - Rutland, Vermont, United States, 05701
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Participant must be at least 40 years of age at Screening Visit 1.
Participants with a peripheral blood eosinophil count of >=300 cells per microliter (μL) from the hematology sample collected at Screening Visit 0 AND a documented historical blood eosinophil count of >=150 cells per μL in the 12 months prior to Screening Visit 0 that meets the following: It must have been measured between 12 months and 1 month prior to Screening Visit 0, and it must not have been measured within 14 days of a COPD exacerbation. Participants with no documented historical blood eosinophil count of >=150 cells per µL must meet this threshold at the Screening Visit 1 assessment.
Participants with a clinically documented history of COPD for at least 1 year in accordance with the definition by the American Thoracic Society or European Respiratory Society.
Participants must present with a measured pre- and post-salbutamol Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio of <0.70 at Screening Visit 1 to confirm the diagnosis of COPD and with a measured post-salbutamol FEV1>20% and <=80% of predicted normal values calculated using NHANES III reference equations at Screening Visit 1.
Participants must have a well-documented history (for example, medical record verification) in the 12 months prior to Screening Visit 1 of two or more moderate COPD exacerbations that were treated with systemic corticosteroids (intramuscular [IM], intravenous, or oral) with or without antibiotics or at least one severe COPD exacerbation requiring hospitalization.
Participants must have a well-documented requirement for optimized standard of care background therapy that includes inhaled corticosteroids (ICS) plus 2 additional COPD medications (ICS-based triple therapy) for the 12 months prior to Screening Visit 1 and meets the following criteria: immediately prior to Screening Visit 1, minimum of 3 months of use of an 1) inhaled corticosteroid at a dose >=500 microgram (mcg) per day fluticasone propionate dose equivalent plus 2) Long acting beta2-agonist (LABA) and 3) Long acting muscarinic antagonist (LAMA) unless documentation of safety or intolerance issues related to LABA or LAMA. For participants who are not continually maintained on ICS plus LABA plus LAMA for the entire 12 months prior to Visit 1 use of the following is allowed (but not in the 3 months immediately prior to Visit 1); inhaled corticosteroid at a dose >=500 mcg per day fluticasone propionate dose equivalent plus inhaled LABA or inhaled LAMA and Phosphodiesterase-4-inhibitors, methylxanthines, or scheduled daily use of short acting beta2-agonist (SABA) and/or short acting muscarinic antagonist (SAMA).
Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at Screening (Visit 1) calculated as (number of pack years = [number of cigarettes per day/20] multiplied by number of years smoked [For example, 20 cigarettes per day for 10 years or 10 cigarettes per day for 20 years]).
Contraceptive use for female participant should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: She is not a woman of childbearing potential (WOCBP) or she is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%, during the intervention period and for at least 16 weeks after the last dose of study intervention. The principal investigator (PI) should evaluate the effectiveness of the contraceptive method in relation to the first dose of study intervention.
A WOCBP must have a negative highly sensitive pregnancy urine test within 24 hours before the first dose of study intervention. If a urine test cannot be confirmed as negative (For example, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
Participants capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Participants must meet following randomization inclusion criteria at Visit 2 to be randomized and commence the study intervention period: a) Participants that do not have documented historical blood eosinophil count of ≥150 cells/μL prior to Screening Visit must meet this threshold based on the Screening Visit 1 assessment, b) Participants must have eosinophil count of ≥300 cells/μL from the hematology sample collected at Screening Visit 0, c) Compliance with completion of the e-diary defined as completion of all questions on 5 or more days out of the 7 days immediately preceding Visit 2.

Exclusion Criteria:

Participants with a past history or concurrent diagnosis of asthma are excluded regardless of whether they have active or inactive disease.
The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease. Participants with alpha1-antitrypsin deficiency as the underlying cause of COPD are excluded. Also, excluded are participants with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1.
Participants with lung volume reduction surgery within the 12 months prior to Screening Visit 1.
Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1. Participants who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.
Participants receiving treatment with oxygen more than 2 liter (L) per minute at rest over 24 hours. For participants receiving oxygen treatment, participants should demonstrate an oxyhemoglobin saturation greater than or equal to 89% while breathing supplemental oxygen.
Participants with a QT interval, from the electrocardiogram (ECG) conducted at Screening Visit 1, corrected with Fridericia's formula (QTcF) >450 millisecond (msec) (or QTcF >480 msec in participants with bundle branch block). Fridericia's formula must be used to determine eligibility and discontinuation for an individual participant. Participants are excluded if an abnormal ECG finding from the 12-lead ECG conducted at Screening Visit 1 is considered to be clinically significant and would impact the participant's participation during the study, based on the evaluation of the Investigator.
Participants with any of the following would be excluded: myocardial infarction or unstable angina in the 6 months prior to Screening Visit 1; unstable or life threatening cardiac arrhythmia requiring intervention in the 3 months prior to Screening Visit 1; New York Heart Association (NYHA) Class IV Heart failure.
Participants with (historical or) current evidence of clinically significant, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
Participants 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.
Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening Visit 1.
A current malignancy or previous history of cancer in remission for less than 12 months prior to Screening Visit 1 (participants that had localized carcinoma of the skin or cervix which was resected for cure will not be excluded).
Participants with a known immunodeficiency (For example, human immunodeficiency virus [HIV]), other than that explained by the use of corticosteroids taken for COPD.
Participants with cirrhosis or current unstable liver disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice. Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B or C -e.g., presence of hepatitis B surface antigen [HbsAg] or positive hepatitis C antibody test result) is acceptable if the participant otherwise meets entry criteria.
Participants who have received interventional product in previous mepolizumab studies are excluded.
Participants who have received any monoclonal antibody within 5 half-lives of Screening Visit 1.
Participants 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).
Participants who have received short term use of oral corticosteroids within 30 days of Visit 1.
Participants with a known allergy or sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study or intolerance to another monoclonal antibody or biologic including history of anaphylaxis to another biologic.
Participants 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.
Participants with conditions that will limit the validity of informed consent to participate in the study, for example, uncontrolled psychiatric disease or intellectual deficiency.
Participants with a known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1.
Participant 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.
Participants with a current active COVID-19 infection, either laboratory confirmed or according to the investigator's medical judgement and who are known to be in contact with active COVID-19 positive individuals within the past 14 days.
Participant will not be randomized if they meet any of the following randomization exclusion criteria at Visit 2: a) Participants who have pneumonia, exacerbation, lower respiratory infection during the Run-in period. b) Evidence of clinically significant abnormality in the hematological or biochemical screen at Visit 1, as judged by the Investigator. c) Participants who meet the following based on results from sample taken at Screening Visit 1: Alanine aminotransferase (ALT) >2x upper limit of normal (ULN), bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%), cirrhosis or current unstable liver or biliary disease per Investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice. d) Participants who are pregnant or breastfeeding. Participants should not be randomized if they plan to become pregnant during the time of study participation. e) Participants that had an active COVID-19 infection during the Run-in period, either laboratory confirmed or according to the investigator's medical judgment or known to be in contact with active COVID-19 positive individuals within the past 14 days. f) Participants with a QT interval, from the ECG conducted at Visit 2, corrected with Fridericia's formula (QTcF) >450 msec (or QTcF >480 msec in participants with bundle branch block).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Participants will receive placebo subcutaneously once every 4 weeks over a treatment period of at least 52 weeks up to a maximum of 104 weeks.	Drug: Placebo Placebo is a 0.9% sodium chloride solution. It will be administered as a subcutaneous (SC) injection delivered once every 4 weeks using a pre-filled safety syringe.
Experimental: Mepolizumab Participants will receive mepolizumab subcutaneously once every 4 weeks over a treatment period of at least 52 weeks up to a maximum of 104 weeks.	Biological: Mepolizumab Mepolizumab is a sterile liquid formulation. It will be administered as a SC injection (100 mg/mL) delivered once every 4 weeks using a pre-filled safety syringe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized rate of moderate or severe exacerbations Time Frame: Up to Week 104	Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral or systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (>=24 hours) or result in death. The frequency of moderate or severe exacerbations expressed as an annualized exacerbation rate will be evaluated.	Up to Week 104

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first moderate or severe exacerbation Time Frame: Up to Week 104	Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral or systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (>=24 hours) or result in death.	Up to Week 104
Number of COPD assessment test (CAT) responders Time Frame: Week 52	The proportion of CAT score responders with reduction of >=2 units in CAT score from Baseline will be assessed.	Week 52
Number of St. George's Respiratory Questionnaire (SGRQ) total score responders Time Frame: Week 52	The proportion of SGRQ total score responders with reduction of >=4 units in SGRQ total score from Baseline will be assessed. It will be calculated using St. George's Respiratory Questionnaire for COPD (SGRQ-C).	Week 52
Number of Evaluating Respiratory Symptoms in COPD (E-RS: COPD) responders Time Frame: Week 52	The proportion of E-RS: COPD responders with reduction of >=2 units in E-RS: COPD total score from Baseline will be assessed.	Week 52
Annualized rate of exacerbations requiring Emergency Department (ED) visit or hospitalization Time Frame: Up to Week 104	Annualized rate of exacerbations requiring ED visit or hospitalization will be evaluated.	Up to Week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Collaborators

PPD

Investigators

Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2019

Primary Completion (Estimated)

August 19, 2024

Study Completion (Estimated)

August 19, 2024

Study Registration Dates

First Submitted

October 18, 2019

First Submitted That Met QC Criteria

October 18, 2019

First Posted (Actual)

October 21, 2019

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

208657

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

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 Supporting Information Type

STUDY_PROTOCOL
SAP
ICF
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Expanded Access

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Pulmonary Disease, Chronic Obstructive

Clinical Trials on Placebo

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