Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO). (PROSPERO)

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

Subjects who completed either OBERON or TITANIA will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo controlled, Parallel Group, Phase 3, extension study to evaluate the safety and efficacy of Tozorakimab in adult participants with symptomatic COPD.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Combination product: Tozorakimab 1; Combination product: Tozorakimab 2; Combination product: Placebo

Detailed Description

Participants who have completed the study treatment period and have not been prematurely discontinued from IP in one of the predecessor studies, OBERON or TITANIA, will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo-controlled, Parallel Group, Phase 3 extension study to evaluate the efficacy and safety of Tozorakimab versus placebo in adult (40 years and older) participants with symptomatic COPD and with a history of exacerbations

• Study Type: Interventional
• Enrollment (Actual): 1713
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1121 ABE
    • Research Site
  • CABA, Argentina, C1425BEN
    • Research Site
  • Ciudad de Buenos Aires, Argentina, C1414AIF
    • Research Site
  • Córdoba, Argentina, X5003DCE
    • 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, T4000IAR
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• Australia
  • Campbelltown, Australia, 2560
    • Research Site
  • Frankstown, Australia, 3199
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  • Macquarie University, Australia, 2109
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  • Melbourne, Australia, 3000
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  • Nedlands, Australia, 6009
    • Research Site
  • Southport, Australia, 4215
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  • Spearwood, Australia, 6163
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  • Wollongong, Australia, 2500
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  • Woodville South, Australia, 5011
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• Belgium
  • Brussels, Belgium, 1000
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  • Ghent, Belgium, 9000
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  • Leuven, Belgium, 3000
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  • Liège, Belgium, 4000
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  • Namur, Belgium, 5101
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• Brazil
  • Blumenau, Brazil, 89030-101
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  • Botucatu, Brazil, 18618-686
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  • Brasília, Brazil, 71681-603
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  • Curitiba, Brazil, 80440-220
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  • Porto Alegre, Brazil, 90035074
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  • Porto Alegre, Brazil, 9061-000
    • Research Site
  • Porto Alegre, Brazil, 91010-006
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  • Rio de Janeiro, Brazil, 22061-080
    • Research Site
  • São Bernardo do Campo, Brazil, 09750-420
    • Research Site
  • São Paulo, Brazil, 05403-000
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  • São Paulo, Brazil, 01409-001
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• Bulgaria
  • Dupnitsa, Bulgaria, 2600
    • Research Site
  • Kozloduy, Bulgaria, 3320
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  • Lovech, Bulgaria, 5500
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  • Petrich, Bulgaria, 2850
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  • Pleven, Bulgaria, 5800
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  • Rousse, Bulgaria, 7002
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  • Sliven, Bulgaria, 8800
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  • Sofia, Bulgaria, 1000
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  • Sofia, Bulgaria, 1606
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  • Vratsa, Bulgaria, 3000
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• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5A 4L8
      • Research Site
    • Sherwood Park, Alberta, Canada, T8L 0N2
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  • Ontario
    • Ajax, Ontario, Canada, L1S 2J5
      • Research Site
    • Guelph, Ontario, Canada, N1H 6J2
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    • Winchester, Ontario, Canada, K0C 2K0
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  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
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    • Québec, Quebec, Canada, G1V 4G5
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    • Québec, Quebec, Canada, G1G 5X1
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• Chile
  • Chile, Chile, 7770484
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  • Curicó, Chile, 3341643
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  • Santiago, Chile, 7500698
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  • Santiago, Chile, 7500010
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  • Santiago, Chile, 8150000
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  • Talca, Chile, 3465584
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• China
  • Baotou, China, 14010
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  • Beijing, China, 100144
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  • Beijing, China, 100057
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  • Changchun, China, 130021
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  • Changsha, China, 410015
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  • Chengdu, China, 610000
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  • Chengdu, China, 610014
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  • Chongqing, China, 400037
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  • Chongqing, China, 400013
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  • Guangzhou, China, 510120
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  • Guangzhou, China, 510180
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  • Haikou, China, 570311
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  • Hangzhou, China, 310006
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  • Hohhot, China, 010010
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  • Kunming, China, 650032
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  • Linhai, China, 317000
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  • Nanchang, China, 330006
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  • Nanjing, China, 210006
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  • Ningbo, China, 315010
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  • Shanghai, China, 201199
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  • Shanghai, China, 200002
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  • Shenyang, China, 110004
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  • Shenyang, China, 110000
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  • Shenzhen, China, 518053
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  • Shenzhen, China, 518020
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  • Shijiazhuang, China, 50051
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  • Suzhou, China, 215002
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  • Taiyuan, China, 030001
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  • Wuhan, China, 430022
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  • Wuxi, China, 214023
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  • Xiamen, China, 361004
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  • Xuzhou, China, 221009
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  • Xuzhou, China, 221000
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  • Yangzhou, China, 225001
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  • Yinchuan, China, 750004
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  • Zhanjiang, China, 524004
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  • Zunyi, China, 563100
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• Colombia
  • Barranquilla, Colombia, 80007
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  • Ibagué, Colombia, 730006
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  • Rionegro, Colombia, 054047
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  • Zipaquirá, Colombia, 200251
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• Czechia
  • Brno, Czechia, 625 00
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  • Jindřichův Hradec, Czechia, 377 01
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  • Liberec, Czechia, 460 63
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  • Olomouc, Czechia, 779 00
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  • Rokycany, Czechia, 337 01
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• Denmark
  • Aalborg, Denmark, 9000
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  • Copenhagen, Denmark, 2400
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  • Hvidovre, Denmark, 2650
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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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• Finland
  • Helsinki, Finland, 00290
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  • Hämeenlinna, Finland, 13530
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  • Kuopio, Finland, 70210
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  • Turku, Finland, 20520
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• France
  • Bordeaux, France, 33076
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  • Brest, France, 29609
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  • La Tronche, France, 38700
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  • Lyon, France, 69317
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  • Marseille, France, 13326
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  • Montpellier, France, 34295
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  • Nantes, France, 44093
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  • Toulouse, France, 31300
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• Germany
  • Ahrensburg, Germany, 22926
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  • Bamberg, Germany, 96049
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  • Berlin, Germany, 10717
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  • Berlin, Germany, 12157
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  • Cologne, Germany, 51069
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  • Darmstadt, Germany, 64283
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  • Halle, Germany, 06108
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  • Marburg, Germany, 35037
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  • Peine, Germany, 31224
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• Greece
  • Alexandroupoli, Greece, 68100
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  • Athens, Greece, 11527
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  • Exohi Thessaloniki, Greece, 57010
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  • Ioannina, Greece, 45500
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  • Pátrai, Greece, 26500
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  • Thessaloniki, Greece, 57010
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• Hungary
  • Budapest, Hungary, 1036
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  • Debrecen, Hungary, 4032
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  • Edelény, Hungary, 3780
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  • Encs, Hungary, 3860
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  • Mosonmagyaróvár, Hungary, 9200
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  • Nyíregyháza-Sóstóhegy, Hungary, 4481
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  • Százhalombatta, Hungary, 2440
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• India
  • Belagavi, India, 590010
    • Research Site
  • Coimbatore, India, 641028
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  • Dehradun, India, 248001
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  • Jaipur, India, 302039
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  • Nagpur, India, 440012
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  • Nashik, India, 422007
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  • New Delhi, India, 110029
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  • Thane, India, 401107
    • Research Site
• Israel
  • Ashkelon, Israel, 78278
    • Research Site
  • Beersheba, Israel, 8410101
    • Research Site
  • Jerusalem, Israel, 9103102
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  • Kfar Saba, Israel, 4428164
    • Research Site
  • Rehovot, Israel, 76100
    • Research Site
  • Tel Aviv, Israel, 6423906
    • Research Site
• Italy
  • Bari, Italy, 70124
    • Research Site
  • Carrara, Italy, 54033
    • Research Site
  • Milan, Italy, 20157
    • Research Site
  • Milan, Italy, 20142
    • Research Site
  • Napoli, Italy, 80131
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  • Roma, Italy, 00168
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  • Salerno, Italy, 84131
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  • Sassari, Italy, 07100
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  • Statte, Italy, 74010
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  • Telese Terme, Italy, 82037
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  • Tradate, Italy, 21049
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  • Vercelli, Italy, 13100
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  • Verona, Italy, 37124
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• Japan
  • Asahikawa-shi, Japan, 078-8510
    • Research Site
  • Fujieda-shi, Japan, 426-8677
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  • Fukuoka, Japan, 819-8555
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  • Hamamatsu, Japan, 430-8525
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  • Hiroshima, Japan, 734-8530
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  • Iizuka-shi, Japan, 820-8505
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  • Itabashi-ku, Japan, 173-8610
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  • Iwata-shi, Japan, 438-8550
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  • Kanazawa, Japan, 920-8650
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  • Kawachinagano-shi, Japan, 586-8521
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  • Kobe, Japan, 651-0072
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  • Matsusaka-shi, Japan, 515-8544
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  • Mizunami-shi, Japan, 509-6134
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  • Nagoya, Japan, 460-0001
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  • Obihiro, Japan, 080-0017
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  • Okayama, Japan, 700-8558
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  • Osaka, Japan, 545-8586
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  • Osaka, Japan, 543-8555
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  • Osaka, Japan, 531-0073
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  • Shinjuku-ku, Japan, 162-8655
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  • Shizuoka, Japan, 420-8630
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  • Toshima-ku, Japan, 170-0003
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  • Toyonaka-shi, Japan, 560-8552
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  • Yokohama, Japan, 232-0024
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  • Yokohama, Japan, 223-0059
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  • Yokohama, Japan, 221-0855
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• Mexico
  • Benito Juárez, Mexico, 03650
    • Research Site
  • Chihuahua City, Mexico, 31000
    • Research Site
  • Guadalajara, Mexico, 44200
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  • Guadalajara, Mexico, 44100
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  • Monterrey, Mexico, 64460
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  • Morelia, Mexico, 58000
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  • México, Mexico, 01710
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  • Oaxaca City, Mexico, 68020
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  • Veracruz, Mexico, 91910
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• Netherlands
  • Eindhoven, Netherlands, 5623EJ
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  • Groningen, Netherlands, 9713 GZ
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  • Harderwijk, Netherlands, 3844 DG
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  • Heerlen, Netherlands, 6419 PC
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  • Zutphen, Netherlands, 7207 AE
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• Norway
  • Lørenskog, Norway, 1478
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  • Oslo, Norway, 450
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  • Tønsberg, Norway, 3103
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• Peru
  • Lima, Peru, 15046
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  • Lima, Peru, 15036
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  • Lima, Peru, 15088
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  • Lima, Peru, LIMA 21
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• Philippines
  • Baguio City, Philippines, 2600
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  • Cebu City, Philippines, 6000
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  • Iloilo City, Philippines, 5000
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• Poland
  • Bialystok, Poland, 15-044
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  • Bydgoszcz, Poland, 85-796
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  • Katowice, Poland, 40-648
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  • Krakow, Poland, 30-033
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  • Lublin, Poland, 20-412
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  • Ostrowiec Świętokrzyski, Poland, 27-400
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  • Ostróda, Poland, 14-100
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  • Poznan, Poland, 60-693
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  • Rzeszów, Poland, 35-205
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  • Sosnowiec, Poland, 41-208
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  • Wroclaw, Poland, 53-301
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• Portugal
  • Guimarães, Portugal, 4835-235
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  • Lisbon, Portugal, 1649-035
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  • Lisbon, Portugal, 1998-018
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  • Matosinhos Municipality, Portugal, 4454-509
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  • Vila Franca de Xira, Portugal, 2600-009
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• Romania
  • Brasov, Romania, 500283
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  • Bucharest, Romania, 050159
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  • Cluj-Napoca, Romania, 400371
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  • Timișoara, Romania, 300002
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• South Korea
  • Daegu, South Korea, 42415
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  • Incheon, South Korea, 21431
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  • Jeonju, South Korea, 54907
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  • Seoul, South Korea, 06591
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  • Seoul, South Korea, 05030
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  • Seoul, South Korea, 07061
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• Spain
  • Galdakao, Spain, 48960
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  • Madrid, Spain, 28040
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  • Málaga, Spain, 29010
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  • Mérida, Spain, 06800
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  • Pozuelo de Alarcón, Spain, 28223
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  • Santander, Spain, 39008
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  • Valencia, Spain, 46010
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  • Zaragoza, Spain, 50009
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• Sweden
  • Gothenburg, Sweden, 41345
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  • Gothenburg, Sweden, 413 46
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  • Lund, Sweden, 222 22
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  • Stockholm, Sweden, 11239
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• Taiwan
  • Hsinchu, Taiwan, 300
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  • Kaohsiung City, Taiwan, 80756
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  • Taichung, Taiwan, 40705
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  • Taichung, Taiwan, 40447
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  • Taipei, Taiwan, 10002
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  • Taipei, Taiwan, 110
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  • Taoyuan District, Taiwan, 333
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  • Yunlin, Taiwan, 640
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• Thailand
  • Bang Kra So, Thailand, 11000
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  • Hat Yai, Thailand, 90110
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  • Khon Kaen, Thailand, 40002
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  • Muang, Thailand, 22000
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  • Muang,, Thailand, 55000
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  • Mueang, Thailand, 20000
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  • Nakhon Ratchasima, Thailand, 30000
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• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06620
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  • Istanbul, Turkey (Türkiye), 34854
    • Research Site
  • Mersin, Turkey (Türkiye), 33343
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• United Kingdom
  • Bradford, United Kingdom, BD9 6RJ
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  • Corby, United Kingdom, NN17 2UR
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  • Corby, United Kingdom, NN18 9EZ
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  • High Wycombe, United Kingdom, HP11 2QW
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  • Northwood, United Kingdom, HA6 2RN
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  • Preston, United Kingdom, PR2 9QB
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  • Shipley, United Kingdom, BD18 3SA
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• United States
  • Alabama
    • Sheffield, Alabama, United States, 35660
      • Research Site
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Research Site
  • California
    • Lincoln, California, United States, 95648
      • Research Site
    • Newport Beach, California, United States, 92663
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    • Northridge, California, United States, 91324
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  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Research Site
    • Cape Coral, Florida, United States, 33990
      • Research Site
    • Ormond Beach, Florida, United States, 32174
      • Research Site
    • Pensacola, Florida, United States, 32503
      • Research Site
    • Plantation, Florida, United States, 33324
      • Research Site
    • Tampa, Florida, United States, 33607
      • Research Site
    • Winter Park, Florida, United States, 32789
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  • Illinois
    • Evergreen Park, Illinois, United States, 60805
      • Research Site
    • Normal, Illinois, United States, 61761
      • Research Site
  • Indiana
    • Greenwood, Indiana, United States, 46143
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  • Kansas
    • Kansas City, Kansas, United States, 66160
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  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
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  • Louisiana
    • Baton Rouge, Louisiana, United States, 70836
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    • Zachary, Louisiana, United States, 70791
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  • Maryland
    • Baltimore, Maryland, United States, 21224
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    • White Marsh, Maryland, United States, 21162
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  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
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  • Michigan
    • Farmington Hills, Michigan, United States, 48336
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    • Grand Rapids, Michigan, United States, 49546
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  • Minnesota
    • Rochester, Minnesota, United States, 55905
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  • Missouri
    • St Louis, Missouri, United States, 63110
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  • New York
    • Buffalo, New York, United States, 14203
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  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Research Site
    • Gastonia, North Carolina, United States, 28054
      • Research Site
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Research Site
  • Ohio
    • Toledo, Ohio, United States, 43617
      • Research Site
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
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  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19140
      • Research Site
    • Pittsburgh, Pennsylvania, United States, 15213
      • Research Site
    • Sayre, Pennsylvania, United States, 18840
      • Research Site
  • South Carolina
    • Rock Hill, South Carolina, United States, 29732
      • Research Site
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Research Site
  • Texas
    • Amarillo, Texas, United States, 79106
      • Research Site
    • Boerne, Texas, United States, 78006
      • Research Site
    • Kingwood, Texas, United States, 77339
      • Research Site
    • McKinney, Texas, United States, 75069
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    • Tomball, Texas, United States, 77375
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  • Vermont
    • Colchester, Vermont, United States, 05446
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  • Virginia
    • Williamsburg, Virginia, United States, 23188
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  • Wisconsin
    • Cudahy, Wisconsin, United States, 53110
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• Vietnam
  • Hanoi, Vietnam, 100000
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  • Hanoi, Vietnam, 10000
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  • Ho Chi Minh City, Vietnam, 700000
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participants who have completed the treatment period and have not been prematurely discontinued from IP in the predecessor studies.
2. Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.
3. FOCBP (female(s) of childbearing potential) must have a negative urine pregnancy test at Visit 1.
4. Participants who are willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies.
5. Capable of giving signed informed consent.

Exclusion Criteria:

1. Any clinically significant disorder or abnormal findings (clinical, laboratory, instrumental, etc) or major physical and/or cognitive impairment - which, in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study or impact the interpretation of the study results, or otherwise make the participation of the participant inappropriate.
2. Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.
3. Concurrent enrolment in other interventional clinical studies or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies.

4. Known history of:

   1. Severe allergic reaction to any monoclonal and polyclonal antibody.
   2. Allergy or reaction to any component of the IP formulation.
5. Chronic use (or expected need for chronic use during the study) of immunosuppressive medications (including, but not limited to, systemic corticosteroids), marketed or investigational biologic, or another prohibited medication.
6. Involvement in the planning and/or conduct of the study (applies to both staff employed by the Sponsor and/or staff at the study site).
7. Participants who are not able to comply with the study requirements, procedures, and restrictions.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tozorakimab Dose 2; Injection subcutaneously Tozorakimab via pre-filled syringe.	Combination product: Tozorakimab 2; Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study.
Placebo Comparator: Placebo; Injection subcutaneously with equivalent volume to Tozorakimab via pre-filled syringe.	Combination product: Placebo; Participants previously randomised to placebo in one of the predecessor studies will be re-randomised in a 1:1 ratio to the active dose of Tozorakimab or placebo.
Experimental: Tozorakimab Dose 1; Injection subcutaneously Tozorakimab via pre-filled syringe.	Combination product: Tozorakimab 1; Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualised rate of severe COPD exacerbations in former smokers.	The primary efficacy endpoint is the rate of severe COPD exacerbations.	Up to 104 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first moderate-to-severe COPD exacerbation.	To explore the extent to which treatment with each dose of Tozorakimab delays the time to first exacerbation compared with placebo.	Up to 104 weeks.
Annualised rate of moderate to severe COPD exacerbations.	To evaluate the effect of Tozorakimab as an add on to SoC compared with SoC plus placebo on the rate of moderate to severe COPD exacerbations.	Up to 104 weeks.
Time to all-cause death.	To evaluate the effect of Tozorakimab as an add on to SoC compared with SoC plus placebo on time to all-cause death.	Up to 104 weeks.
Incidence of anti-drug antibodies.	Immunogenicity: presence of Tozorakimab anti-drug antibodies in blood serum.	Up to 104 weeks.
The annualised rate of severe COPD exacerbations	To be analyzed as a key secondary endpoint in the Overall Population in former or current smokers.	Up to 104 weeks.
Time to First Severe COPD Exacerbations	Time to first severe COPD exacerbation over the treatment period. Analyses will be conducted in the former smoker population, followed by the Overall Population in former or current smokers.	Up to 104 weeks.
Annualised rate of COPD exacerbations requiring hospitalisation and/or ER/ED visits.	To evaluate the long-term effect of Tozorakimab as an add on to SoC compared to with SoC plus placebo on COPD related health care utilisation. Analyses will be conducted in the former smoker population, followed by the Overall Population in former or current smokers.	Up to 104 weeks.
Trough serum concentrations of Tozorakimab over the treatment period.	Pharmacokinetics: concentrations of Tozorakimab in trough serum.	Up to 104 weeks.

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Actual): February 26, 2026
• Study Completion (Estimated): May 28, 2026

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: COPD; exacerbations; Chronic Obstructive Pulmonary Disease; MEDI3506; ICS; LABA/LAMA; Tozorakimab
• 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; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: D9180C00008; 2022-501063-41-00 (Registry Identifier: EU CT number)

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 Pharma Data Sharing Principles. For details of our timelines, please rerefer 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 deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• 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