Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations (MIRANDA)

A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab in Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (MIRANDA)

The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab administered subcutaneously (SC) in adult participants with symptomatic COPD with a history of ≥ 2 moderate or ≥ 1 severe exacerbations of COPD in the 12 months prior to enrolment. Participants should be receiving optimised treatment with inhaled maintenance therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) throughout at least the last 3 months prior to enrolment.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: Tozorakimab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1454
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1121 ABE
    • Research Site
  • CABA, Argentina, C1025ABI
    • Research Site
  • CABA, Argentina, C1425BEN
    • Research Site
  • Ciudad de Buenos Aires, Argentina, C1414AIF
    • Research Site
  • Córdoba, Argentina, X5003DCE
    • Research Site
  • La Plata, Argentina, B1904
    • Research Site
  • Mar del Plata, Argentina, 7600
    • Research Site
  • Mar del Plata, Argentina, B7600GWV
    • Research Site
  • Mendoza, Argentina, M5500CCG
    • Research Site
  • Quilmes, Argentina, B1878FNR
    • Research Site
  • San Fernando, Argentina, B1646EBJ
    • Research Site
  • San Juan Bautista, Argentina, 1888
    • Research Site
  • San Miguel de Tucumán, Argentina, 4000
    • Research Site
• Belgium
  • Brussels, Belgium, 1070
    • Research Site
  • Edegem, Belgium, 2650
    • Research Site
  • Ghent, Belgium, 9000
    • Research Site
  • Kortrijk, Belgium, 8500
    • Research Site
  • Leuven, Belgium, 3000
    • Research Site
  • Mechelen, Belgium, 2800
    • Research Site
  • Namur, Belgium, 5101
    • Research Site
  • Roeselare, Belgium, 8800
    • Research Site
• Brazil
  • Barretos, Brazil, 14784-400
    • Research Site
  • Belo Horizonte, Brazil, 30150-221
    • Research Site
  • Blumenau, Brazil, 89030-101
    • Research Site
  • Campina Grande do Sul, Brazil, 83.430-000
    • Research Site
  • Campinas, Brazil, 13060-080
    • Research Site
  • Fortaleza, Brazil, 60430-270
    • Research Site
  • Porto Alegre, Brazil, 90610-000
    • Research Site
  • Porto Alegre, Brazil, 90035074
    • Research Site
  • Porto Alegre, Brazil, 91010-006
    • Research Site
  • São Bernardo do Campo, Brazil, 09715090
    • Research Site
  • São José do Rio Preto, Brazil, 15090-000
    • Research Site
  • São Paulo, Brazil, 05403-000
    • Research Site
  • Valinhos, Brazil, 13271-130
    • Research Site
• Bulgaria
  • Dupnitsa, Bulgaria, 2600
    • Research Site
  • Haskovo, Bulgaria, 6300
    • Research Site
  • Panagyurishte, Bulgaria, 4500
    • Research Site
  • Plovdiv, Bulgaria, 4003
    • Research Site
  • Sofia, Bulgaria, 1756
    • Research Site
  • Veliko Tanovo, Bulgaria, 5000
    • Research Site
  • Yambol, Bulgaria, 8600
    • Research Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3R 1W7
      • Research Site
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 4N7
      • Research Site
  • Ontario
    • Ajax, Ontario, Canada, L1S 2J5
      • Research Site
    • Burlington, Ontario, Canada, L7N 3V2
      • Research Site
    • Toronto, Ontario, Canada, M5T 3A9
      • Research Site
    • Winchester, Ontario, Canada, K0C 2K0
      • Research Site
  • Quebec
    • Lévis, Quebec, Canada, G6V 0C9
      • Research Site
    • Québec, Quebec, Canada, G1V 4G5
      • Research Site
    • Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
      • Research Site
• Chile
  • Chile, Chile, 7770484
    • Research Site
  • Concepción, Chile, 4070094
    • Research Site
  • Quillota, Chile, 2260000
    • Research Site
  • Santiago, Chile, 8380453
    • Research Site
  • Santiago, Chile, 7750495
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  • Santiago, Chile, 7501126
    • Research Site
  • Santiago, Chile, 7500010
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  • Viña del Mar, Chile, 2540488
    • Research Site
• China
  • Beijing, China, 100029
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  • Changchun, China, 130021
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  • Changsha, China, 410015
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  • Changsha, China, 430033
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  • Chengdu, China, 611130
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  • Chengdu, China, 610072
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  • Chengdu, China, 610014
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  • Chongqing, China, 400042
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  • Chongqing, China, 400037
    • Research Site
  • Guangzhou, China, 510515
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  • Guangzhou, China, 510145
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  • Guangzhou, China, 510163
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  • Hefei, China, 230061
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  • Hohhot, China, 750306
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  • Huizhou, China, 516002
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  • Jinan, China, 250001
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  • Lanzhou, China, 730030
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  • Liaocheng, China, 252000
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  • Linhai, China, 317000
    • Research Site
  • Nanchang, China, 330006
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  • Nanchong, China, 637000
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  • Nanjing, China, 210009
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  • Nanjing, China, 210006
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  • Nanning, China, 530021
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  • Ningbo, China, 315010
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  • Pingxiang, China, 337055
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  • Qingdao, China, 266000
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  • Shanghai, China, 200433
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  • Shanghai, China, 201199
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  • Shanghai, China, 200040
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  • Shanghai, China, 200240
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  • Shenyang, China, 110016
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  • Shenyang, China, 110004
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  • Shenzhen, China, 518020
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  • Shijiazhuang, China, 050051
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  • Shijiazhuang, China, 50051
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  • Taizhou, China, 318000
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  • Wuhan, China, 430022
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  • Wuhan, China, 430030
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  • Xi'an, China, 710006
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  • Xuzhou, China, 221009
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  • Xuzhou, China, 221000
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  • Yinchuan, China, 750004
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  • Zigong, China, 643000
    • Research Site
• Denmark
  • Aalborg, Denmark, 9000
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  • Aarhus, Denmark, 8200
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  • Hvidovre, Denmark, 2650
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  • København NV, Denmark, 2400
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  • Næstved, Denmark, 4700
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  • Roskilde, Denmark, 4000
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  • Vejle, Denmark, 7100
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• France
  • Aix-en-Provence, France, 13100
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  • Brest, France, 29609
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  • Colmar, France, 68024
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  • Epagny Metz-Tessy, France, 74370
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  • La Tronche, France, 38700
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  • Lyon, France, 69317
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  • Marseille, France, 13015
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  • Montpellier, France, 34295
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  • Quimper, France, 29000
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  • Reims, France, 51092
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  • Villefranche-sur-Saône, France, 69655
    • Research Site
• Germany
  • Augsburg, Germany, 86150
    • Research Site
  • Berlin, Germany, 10717
    • Research Site
  • Berlin, Germany, 10119
    • Research Site
  • Berlin, Germany, 10787
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  • Berlin, Germany, 12157
    • Research Site
  • Berlin, Germany, 12203
    • Research Site
  • Berlin, Germany, 13187
    • Research Site
  • Berlin, Germany, 12159
    • Research Site
  • Berlin, Germany, 10961
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  • Cologne, Germany, 51069
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  • Darmstadt, Germany, 64283
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  • Essen, Germany, 45127
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  • Frankfurt, Germany, 60596
    • Research Site
  • Frankfurt am Main, Germany, 60389
    • Research Site
  • Großhansdorf, Germany, 22927
    • Research Site
  • Halle, Germany, 06120
    • Research Site
  • Halle, Germany, 06108
    • Research Site
  • Hanover, Germany, 30159
    • Research Site
  • Leipzig, Germany, 04299
    • Research Site
  • Marburg, Germany, 35037
    • Research Site
  • Moers, Germany, 47441
    • Research Site
  • München, Germany, 80335
    • Research Site
  • München-Pasing, Germany, 81241
    • Research Site
  • Nuremberg, Germany, 90419
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  • Peine, Germany, 31224
    • Research Site
  • Solingen, Germany, 42699
    • Research Site
• Greece
  • Athens, Greece, 11521
    • Research Site
  • Athens, Greece, 17562
    • Research Site
  • Heraklion, Greece, 71409
    • Research Site
  • Thessaloniki, Greece, 57010
    • Research Site
• Hungary
  • Budapest, Hungary, 1203
    • Research Site
  • Debrecen, Hungary, 4032
    • Research Site
  • Edelény, Hungary, 3780
    • Research Site
  • Encs, Hungary, 3860
    • Research Site
  • Gödöllő, Hungary, 2100
    • Research Site
  • Hajdúnánás, Hungary, 4080
    • Research Site
  • Mosonmagyaróvár, Hungary, 9200
    • Research Site
  • Pécs, Hungary, 7635
    • Research Site
  • Szolnok, Hungary, 5000
    • Research Site
  • Százhalombatta, Hungary, 2440
    • Research Site
• India
  • Ajmer, India, 305001
    • Research Site
  • Calicut, India, 673 008
    • Research Site
  • Dehradun, India, 248001
    • Research Site
  • Delhi, India, 110029
    • Research Site
  • Dwārka, India, 110075
    • Research Site
  • Hyderabad, India, 500035
    • Research Site
  • Hyderabad, India, 500038
    • Research Site
  • Jaipur, India, 302039
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  • Jaipur, India, 302012
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  • Kolkata, India, 700053
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  • Nagpur, India, 440012
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  • Vijayawada, India, 520 008
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  • Visakhapatnam, India, 530017
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• Ireland
  • Cork, Ireland, T12 DV56
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  • Dublin, Ireland, D24 NR0A
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  • Galway, Ireland, H91 YR71
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  • Moneymore, Ireland, A92 VW28
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• Italy
  • Cona, Italy, 44124
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  • Foggia, Italy, 71100
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  • Modena, Italy, 41124
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  • Napoli, Italy, 80131
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  • Padua, Italy, 35128
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  • Pavia, Italy, 27100
    • Research Site
  • Pisa, Italy, 56100
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  • Roma, Italy, 161
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• Japan
  • Aomori, Japan, 030-8553
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  • Asahikawa-shi, Japan, 070-8644
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  • Chikushino-shi, Japan, 818-8502
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  • Chūōku, Japan, 104-0031
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  • Fujieda-shi, Japan, 426-8677
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  • Fukuoka, Japan, 814-0180
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  • Ginowan-shi, Japan, 901-2214
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  • Habikino-shi, Japan, 583-8588
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  • Hakodate-shi, Japan, 041-8680
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  • Hamamatsu, Japan, 430-8525
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  • Itabashi-ku, Japan, 173-8610
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  • Izumi-shi, Japan, 594-0073
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  • Kagoshima, Japan, 892-0847
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  • Kobe, Japan, 650-0047
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  • Kusatsu-shi, Japan, 525-8585
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  • Kyoto, Japan, 612-8555
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  • Matsusaka-shi, Japan, 515-8544
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  • Minoh, Japan, 562-0003
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  • Minokamo Shi, Japan, 505-8510
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  • Mizunami-shi, Japan, 509-6134
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  • Morioka, Japan, 020-0066
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  • Nagoya, Japan, 457-8511
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  • Nankoku-shi, Japan, 783-8505
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  • Nankoku-shi, Japan, 783-8509
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  • Omuta-shi, Japan, 837-0911
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  • Sagamihara-shi, Japan, 252-0315
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  • Sagamihara-shi, Japan, 252-0143
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  • Sakaide-shi, Japan, 762-8550
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  • Sapporo, Japan, 006-8555
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  • Sapporo, Japan, 064-0804
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  • Shizuoka, Japan, 420-8630
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  • Tachikawa-shi, Japan, 190-8531
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  • Toon-shi, Japan, 791-0281
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  • Toshima-ku, Japan, 171-0014
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  • Toyonaka-shi, Japan, 560-8552
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  • Ube, Japan, 755-8505
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  • Yanagawa-shi, Japan, 832-0059
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  • Yokohama, Japan, 232-0066
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  • Yokohama, Japan, 232-0024
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  • Yokohama, Japan, 221-0855
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  • Yokohama, Japan, 236-0037
    • Research Site
• Malaysia
  • Alor Star, Malaysia, 5460
    • Research Site
  • Kajang, Malaysia, 43000
    • Research Site
  • Kota Bharu, Malaysia, 15586
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  • Kuala Lumpur, Malaysia, 59100
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  • Kuantan, Malaysia, 25100
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  • Seremban, Malaysia, 70300
    • Research Site
• Mexico
  • Mexico City, Mexico, 03310
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• Netherlands
  • 's-Hertogenbosch, Netherlands, 5223 GZ
    • Research Site
  • Arnhem, Netherlands, 6815 AD
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  • Breda, Netherlands, 4818 CK
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  • Heerlen, Netherlands, 6419 PC
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  • Roermond, Netherlands, 6043 CV
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  • Rotterdam, Netherlands, 3045 PM
    • Research Site
  • Rotterdam, Netherlands, 3083 AN
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  • Zutphen, Netherlands, 7207 AE
    • Research Site
• Peru
  • Lima, Peru, 15046
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  • Lima, Peru, 15102
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  • Lima, Peru, LIMA 21
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  • Piura, Peru, 20001
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  • Santa Beatriz, Peru, LIMA 14
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• Poland
  • Bialystok, Poland, 15-044
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  • Bydgoszcz, Poland, 85-796
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  • Chrzanów, Poland, 32-500
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  • Kielce, Poland, 25-426
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  • Krakow, Poland, 30-033
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  • Krakow, Poland, 31-513
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  • Pruszków, Poland, 05-800
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  • Płock, Poland, 09-407
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  • Rzeszów, Poland, 35-205
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• South Korea
  • Anyang-si, South Korea, 14068
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  • Daegu, South Korea, 42415
    • Research Site
  • Incheon, South Korea, 21565
    • Research Site
  • Jeonju, South Korea, 54907
    • Research Site
  • Seoul, South Korea, 04763
    • Research Site
  • Seoul, South Korea, 06351
    • Research Site
  • Seoul, South Korea, 06591
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  • Seoul, South Korea, 05030
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  • Seoul, South Korea, 06973
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  • Wŏnju, South Korea, 26426
    • Research Site
• Spain
  • Badalona(Barcelona), Spain, 08916
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  • Barcelona, Spain, 08035
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  • Cáceres, Spain, 10003
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  • Madrid, Spain, 28850
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  • Málaga, Spain, 29010
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  • Mérida, Spain, 06800
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  • Santander, Spain, 39008
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  • Zaragoza, Spain, 50009
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• Thailand
  • Hat Yai, Thailand, 90110
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  • Khlong Luang, Thailand, 12120
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  • Muang, Thailand, 40002
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  • Muang, Thailand, 22000
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  • Mueang, Thailand, 20000
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  • Nakhon Ratchasima, Thailand, 30000
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• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 1330
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  • Istanbul, Turkey (Türkiye), 34722
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  • Mersin, Turkey (Türkiye), 33343
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• Ukraine
  • Chernivtsi, Ukraine, 58022
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  • Ivano-Frankivsk, Ukraine, 76019
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  • Kyiv, Ukraine, 02002
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  • Kyiv, Ukraine, 03037
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  • Kyiv, Ukraine, 03680
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  • Kyiv, Ukraine, 02081
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  • Tarasove Village, Ukraine, 45634
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  • Ternopil, Ukraine, 46001
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  • Uzhhorod, Ukraine, 88018
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  • Vinnytsia, Ukraine, 21029
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  • Vinnytsia, Ukraine, 21001
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  • Zhytomyr, Ukraine, 100002
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• United Kingdom
  • Bradford, United Kingdom, BD9 6RJ
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  • Cottingham, United Kingdom, HU16 5JQ
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  • Glasgow, United Kingdom, G4 0SF
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  • Leeds, United Kingdom, LS9 7TF
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  • Liverpool, United Kingdom, L7 8XP
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  • London, United Kingdom, NW3 2QG
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  • London, United Kingdom, EC1M 6BQ
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  • Macclesfield, United Kingdom, SK10 3BL
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  • Newcastle upon Tyne, United Kingdom, NE7 7AF
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  • Portsmouth, United Kingdom, PO6 3LY
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  • Wakefield, United Kingdom, WF1 4DG
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• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
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    • Decatur, Alabama, United States, 35603
      • Research Site
    • Sheffield, Alabama, United States, 35660
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  • Arizona
    • Phoenix, Arizona, United States, 85027
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    • Tucson, Arizona, United States, 85704
      • Research Site
    • Yuma, Arizona, United States, 85365
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  • California
    • Los Angeles, California, United States, 90027
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    • Newport Beach, California, United States, 92663
      • Research Site
    • San Francisco, California, United States, 94109
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    • Westminster, California, United States, 92683
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  • Colorado
    • Aurora, Colorado, United States, 80014
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    • Boulder, Colorado, United States, 80301
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  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20037
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  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Research Site
    • Cape Coral, Florida, United States, 33990
      • Research Site
    • Lakeland, Florida, United States, 33805
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    • Lakeland, Florida, United States, 33813
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    • Naples, Florida, United States, 34102
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    • Ocala, Florida, United States, 34470
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    • Ormond Beach, Florida, United States, 32174
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  • Georgia
    • Atlanta, Georgia, United States, 30344
      • Research Site
    • Lithonia, Georgia, United States, 30038
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  • Illinois
    • Champaign, Illinois, United States, 61820
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    • Chicago, Illinois, United States, 60607
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    • Chicago, Illinois, United States, 60616
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  • Kansas
    • Andover, Kansas, United States, 67002
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  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
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    • Lexington, Kentucky, United States, 40503
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  • Maryland
    • Towson, Maryland, United States, 21286
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  • Michigan
    • Detroit, Michigan, United States, 48202
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  • Minnesota
    • Minneapolis, Minnesota, United States, 55425
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  • Missouri
    • Chesterfield, Missouri, United States, 63017
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    • Chesterfield, Missouri, United States, 63005
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    • Hannibal, Missouri, United States, 63401
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  • Nebraska
    • Papillion, Nebraska, United States, 68046
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  • Nevada
    • Las Vegas, Nevada, United States, 89102
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  • New Jersey
    • Toms River, New Jersey, United States, 08755
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  • New York
    • The Bronx, New York, United States, 10451
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  • North Carolina
    • Charlotte, North Carolina, United States, 28273
      • Research Site
    • Greenville, North Carolina, United States, 27834
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    • Huntersville, North Carolina, United States, 28078
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    • Winston-Salem, North Carolina, United States, 27103
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  • Ohio
    • Dayton, Ohio, United States, 45439
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    • Lima, Ohio, United States, 45801
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  • Oregon
    • Grants Pass, Oregon, United States, 97527
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  • South Carolina
    • Gaffney, South Carolina, United States, 29340
      • Research Site
    • Union, South Carolina, United States, 29379
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  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
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    • Elizabethton, Tennessee, United States, 37643
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    • Jackson, Tennessee, United States, 38305
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  • Texas
    • Dallas, Texas, United States, 75254
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    • El Paso, Texas, United States, 79902
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    • Houston, Texas, United States, 77008
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    • McKinney, Texas, United States, 75069
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    • San Antonio, Texas, United States, 78258
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  • Utah
    • Roy, Utah, United States, 84067
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  • Wisconsin
    • Kenosha, Wisconsin, United States, 53142
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• Vietnam
  • Hanoi, Vietnam, 100000
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  • Hanoi, Vietnam, 10000
    • Research Site
  • Ho Chi Minh City, Vietnam, 700000
    • Research Site
  • Ho Chi Minh City, Vietnam, 70000
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  • Hochiminh, Vietnam, 70000
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  • Hà Nội, Vietnam, 100000
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participant must be ≥ 40 years of age and capable of giving signed informed consent.
2. Documented diagnosis of COPD for at least one year prior to enrolment.
3. Post BD FEV1/FVC < 0.70 and post-BD FEV1 >20% of predicted normal value
4. Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.
5. Documented optimised inhaled dual or triple therapy for at least 3 months prior to enrolment.
6. Smoking history of ≥ 10 pack-years.
7. CAT total score ≥ 10, with each of the phlegm (sputum) and cough items with a score ≥ 2

Exclusion Criteria:

1. Clinically important pulmonary disease other than COPD.
2. Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms. Radiological findings of pulmonary nodules suspicious for lung cancer, as per applicable guidances, without appropriate follow up prior to randomisation. Radiological findings suggestive of acute infection.
3. Current diagnosis of asthma, prior history of asthma, or asthma-COPD overlap. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18
4. Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment that could affect safety, study findings or participants ability to complete the study.
5. COPD exacerbation, within 2 weeks prior to randomization, that was treated with systemic corticosteroids and/or antibiotics, and/or led to hospitalization.
6. Active significant infection within the 4 weeks prior to randomization, pneumonia within 6 weeks prior to randomization, or medical condition that predisposes the participant to infection.
7. Suspicion of, or confirmed, ongoing SARS-CoV-2 infection.
8. Significant COVID-19 illness within the 6 months prior to enrolment.
9. Unstable cardiovascular disorder.
10. Diagnosis of cor pulmonale, pulmonary arterial hypertension and/or right ventricular failure.
11. History of active severe inflammatory bowel disease or colitis within one year prior to enrolment, or unexplained diarrhoea within the 4 weeks prior to randomisation.
12. History of known immunodeficiency disorder, including a positive test for HIV-1 or HIV 2.
13. History of positive test or treatment for hepatitis B or hepatitis C (except for cured hepatitis C)
14. Evidence of active liver disease, including jaundice during screening.
15. Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than one year prior to enrolment. Suspected malignancy or undefined neoplasms.
16. Participants who have evidence of active TB.
17. History of partial or total lung resection.
18. Scheduled major surgical procedure during the course of the study.
19. Participants that have previously received tozorakimab.
20. Any clinically significant abnormal findings in physical examination, vital signs, ECG, or laboratory testing during the screening period, which in the opinion of the investigator may put the participant at risk because of their participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Dosing subcutaneously with equivalent volume to tozorakimab	Drug: Placebo; Placebo administered subcutaneously, equivalent volume to tozorakimab throughout the study.
Experimental: Tozorakimab; Dosing subcutaneously tozorakimab	Drug: Tozorakimab; Administered subcutaneously tozorakimab and placebo throughout the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers.	The primary endpoint will be assessed in the primary population (former smokers with symptomatic COPD and a history of exacerbations, on optimised treatment with maintenance inhaled therapy [triple therapy, or dual therapy if triple is not considered appropriate]).	Over 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized rate of moderate to severe COPD exacerbations in former or current smokers.	The annualized rate will be assessed in the overall population of participants including current and former smokers with symptomatic COPD and history of exacerbations, on optimised treatment with maintenance inhaled therapy.	Over 52 weeks
Change from baseline in SGRQ total score from in former smokers	Difference in mean change from baseline in SGRQ total score in former smokers.	Over 52 weeks
Change from baseline in SGRQ total score from in the overall population of current and former smokers.	Difference in mean change from baseline in SGRQ total score in the overall population of current and former smokers.	Over 52 weeks
Change from baseline in E-RS:COPD total score in former smokers	Difference in mean change in E-RS:COPD total score from baseline in former smokers.	Over 52 weeks
Change from baseline in E-RS:COPD total score in former or current smokers	Difference in mean change in E-RS:COPD total score from baseline in the overall population of current and former smokers.	Over 52 weeks
Time to first moderate to severe COPD exacerbation	Time to first moderate to severe COPD exacerbation compared with placebo.	Over 52 weeks
Change from baseline in CAT total score	Change from baseline in CAT total score compared with placebo.	Week 52
Proportion of participants achieving MCID in CAT score	Proportion of participants achieving MCID in CAT score (percentage of participants with a decrease in CAT total score of ≥ 2 points from baseline).	Week 52
Proportion of participants achieving MCID in SGRQ total score	Proportion of participants achieving MCID in SGRQ score (percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline).	Week 52
Proportion of participants achieving MCID in E-RS:COPD total score	Proportion of participants achieving MCID in E-RS:COPD total score (percentage of participants with a decrease in E-RS:COPD total score of ≥ 2 points from baseline).	Week 52
Change from baseline in rescue medication	Change from baseline (difference in mean number of puffs/day) in rescue medication use.	Over 52 weeks
Trough serum concentrations of tozorakimab	Pharmacokinetics: concentrations of tozorakimab in trough serum.	Over 52 weeks
Presence of anti-drug antibodies	Immunogenicity: presence of tozorakimab anti-drug antibodies in blood serum.	Over 52 weeks
Annualized rate of severe COPD exacerbations in former smokers	The rate ratio of severe COPD exacerbations will be assessed in former smokers.	Variable duration period up to study completion, approximately 3 years
Annualized rate of severe COPD exacerbations in former or current smokers	The rate ratio of severe COPD exacerbations will be assessed in the overall population of current and former smokers.	Variable duration period up to study completion, approximately 3 years
Time to first severe COPD exacerbation	Time to first severe COPD exacerbation compared with placebo.	Variable duration period up to study completion, approximately 3 years
Annualized rate of healthcare resource utilization	Annualized rate of healthcare resource utilization.	Variable duration period up to study completion, approximately 3 years
Time to death	Time to death (all-cause mortality)	Variable duration period up to study completion, approximately 3 years
Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in former smokers	Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in former smokers.	Over 52 weeks
Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in former or current smokers	Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in the overall population of current and former smokers.	Over 52 weeks
Change from baseline in post-bronchodilator FEV1 (mL) in former smokers	Change from baseline in post-bronchodilator FEV1 (mL) in former smokers.	Week 52
Change from baseline in post-bronchodilator FEV1 (mL) in former smokers or current smokers	Change from baseline in post-bronchodilator FEV1 (mL) in former smokers or current smokers.	Week 52
Annualised rate of COPD exacerbations requiring hospitalisations and/or Emergency Room (ER)/Emergency Department (ED) visits in former smokers	The rate ratio of COPD exacerbations requiring hospitalisations and/or Emergency Room (ER)/Emergency Department (ED) visits in former smokers.	Variable duration period up to study completion, approximately 3 years
Annualised rate of COPD exacerbations requiring hospitalisations and/or Emergency Room (ER)/Emergency Department (ED) visits in former or current smokers	The rate ratio of COPD exacerbations requiring hospitalisations and/or Emergency Room (ER)/Emergency Department (ED) visits in former or current smokers.	Variable duration period up to study completion, approximately 3 years
Change from baseline in pre-BD, pre-dose trough FEV1 (mL)	Change from baseline in pre-BD, pre-dose trough FEV1 (mL).	52 weeks
Change from baseline in post-BD FEV1 (mL)	Change from baseline in post-BD FEV1 (mL).	Over 52 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2023
• Primary Completion (Actual): March 6, 2026
• Study Completion (Estimated): May 22, 2026

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: COPD; exacerbations; Biologic; Chronic Obstructive Pulmonary Disease; MEDI3506; ICS; tozorakimab; LABA/LAMA; Biologic Treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: D9180C00012; 2023-505543-39-00 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at :

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No