A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (ARNASA)

May 19, 2026 updated by: Hoffmann-La Roche

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease

This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1290

Phase

  • Phase 3

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

      • Buenos Aires, Argentina, C1122AAK
        • Fundacion Faicep
      • Buenos Aires, Argentina, 12345
        • Consultorios Medicos Organizacion de Buen Ayre SRL
      • Buenos Aires, Argentina, C1025
        • Nexo Salud Investigacion Clinica - Riobamba 429
      • Buenos Aires, Argentina, C1027AAP
        • CINME S.A. ? Centro de Investigaciones Metabolicas - Rx Trials LLC
      • Buenos Aires, Argentina, C1425
        • Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias
      • Buenos Aires, Argentina, C1430
        • AES - AS - Glenny Corp. S.A. Buenos Aires
      • Concepción del Uruguay, Argentina, 3260
        • Centro de Medicina Respiratoria
      • Córdoba, Argentina, X5000BSQ
        • Sanatorio de la Cañada
      • La Plata, Argentina, 1900
        • Framingham Centro Medico
      • La Plata, Argentina, 1904
        • Centro Medico Capital
      • La Plata, Argentina, B1900BNN
        • Centro Platense en Investigaciones Respiratorias
      • Mendoza, Argentina, M5500AYB
        • Centro Medico Dharma
      • Paraná, Argentina, 3100
        • Centro Privado de Medicina Respiratoria
      • Ranelagh, Berazategui, Argentina, 1886
        • Sala de primeros auxilios Alberto Mignaburu
      • Rosario, Argentina, S2000DEJ
        • Instituto Medico de la Fundacion Estudios Clinicos
      • Rosario, Argentina, S2013JKR
        • Servicio de Investigacion de Patologias Alergicas-Instituto ABC
      • Rosario, Argentina, S2013KZD
        • Sanatorio Parque de Rosario
      • San Miguel de Tucumán, Argentina, 4000
        • Centro Modelo de Cardiología
      • San Nicolás de los Arroyos, Argentina, B2900
        • Centro Medico San Nicolas Grupo Orono
      • San Salvador, Argentina, E3218CHH
        • CEPROSS- Centro Profesional San Salvador
      • Santa Fe, Argentina, S3000ASF
        • Instituto Del Buen Aire
      • Santa Fe, Argentina, S3000
        • Centro de Diagnostico Y Rehabilitacion
    • South Australia
      • Midland, South Australia, Australia, 6056
        • Institute for Respiratory Health - Midland
      • Feldbach, Austria, 8330
        • Ordination Dr. Robert Voves
      • Linz, Austria, 4020
        • Ordination fur Lungenkrankheiten
      • Bruges, Belgium, 8000
        • AZ Sint-Jan Brugge-Oostende
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Brussels, Belgium, 1090
        • Universitair Ziekenhuis Brussel
      • Liège, Belgium, 4000
        • CHU de Liège
      • Rio de Janeiro, Brazil, 20241-180
        • IBPCLIN Instituto Brasil de Pesquisa Clinica
      • São Paulo, Brazil, 05403-000
        • Instituto do Coracao - HCFMUSP
    • Federal District
      • Brasília, Federal District, Brazil, 70200-730
        • L2IP ?Instituto de Pesquisas Clínicas Ltda.
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221
        • Santa Casa de Misericordia de Belo Horizonte - PPDS
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
      • Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
        • LMK Servicos Medicos SS
    • São Paulo
      • Santo André, São Paulo, Brazil, 09060-650
        • Faculdade de Medicina do ABC - FMABC
      • São Bernardo do Campo, São Paulo, Brazil, 09715-090
        • CEMEC - Centro Multidisciplinar de Estudos Clínicos
      • Blagoevgrad, Bulgaria, 2700
        • Multiprofile Hospital for Active Treatment Puls AD PPDS
      • Dimitrovgrad, Bulgaria, 6400
        • Multiprofile Hospital For Active Treatment Sveta Ekaterina - Dimitrovgrad EOOD
      • Gabrovo, Bulgaria, 5300
        • Multiprofile Hospital For Active Treatment Dr. Tota Venkova JSC
      • Montana, Bulgaria, 3400
        • Medical Center Hera EOOD
      • Plovdiv, Bulgaria, 4003
        • Multiprofile Hospital for Active Treatment Plovdiv
      • Razgrad, Bulgaria, 7200
        • Multiprofile Hospital for Active Treatment Sv. Ivan Rilski- Razgrad AD
      • Shumen, Bulgaria, 9700
        • Multiprofile Hospital for Active Treatment Shumen
      • Silistra, Bulgaria, 7500
        • Multiprofile Hospital for Active Treatment - Silistra AD
      • Smolyan, Bulgaria, 4700
        • Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
      • Sofia, Bulgaria, 1431
        • Diagnostic-Consultative Center Aleksandrovska EOOD
      • Sofia, Bulgaria, 1680
        • Diagnostic- Consultative Center Convex EOOD
      • Sofia, Bulgaria, 1233
        • Fifth Multiprofile Hospital for Active Treatment - Sofia EAD
      • Sofia, Bulgaria, 1784
        • AES DRS Medical Center Synexus Sofia EOOD
      • Varna, Bulgaria, 9020
        • Diagnostic Consultative Centre Mladost?M OOD
      • Veliko Tarnovo, Bulgaria, 5000
        • Medical Center Tara OOD
      • Québec, Canada, G1V 4G5
        • Centre Hospitalier de l'Université Laval
    • Alberta
      • Edmonton, Alberta, Canada, T5J 3S9
        • Edmonton Respiratory Consultants
      • Sherwood Park, Alberta, Canada, T8H 0N2
        • Synergy Respiratory & Cardiac Care - Synergy Wellness Centre Location
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • Dynamic Drug Advancement Ltd.
      • Toronto, Ontario, Canada, M5T 3A9
        • Inspiration Research
      • Windsor, Ontario, Canada, N8X 1T3
        • Dr. Syed Anees Medicine Profession Corporation
      • Windsor, Ontario, Canada, N8X 5A6
        • Dr Anil Dhar Professional Medicine Corporation
    • Quebec
      • Montreal, Quebec, Canada, H1Y 3H5
        • Recherche GCP Research
      • Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
        • Clinique de pneumologie et du sommeil de Lanaudière
      • Pavie Gallegos, Chile, 2340000
        • Centro Respiratorio Integral LTDA. (CENRESIN)
      • Vitacura, Chile, 7630000
        • Fundacion Medica San Cristobal
      • Viña del Mar, Chile, 2520598
        • Oncocentro Apys
      • Beijing, China, 100730
        • Beijing Hospital
      • Beijing, China, 100029
        • China-Japan Friendship Hospital
      • Beijing, China
        • Peking University Shougang Hospital
      • Beijing, China, 100020
        • Beijing Chaoyang Hospital Capital Medical University
      • Beijing, China, 100042
        • Beijing Jingmei Group General Hospital
      • Changchun, China, 130021
        • The First Hospital of Jilin University
      • Changsha, China, 410005
        • The First Hospital of Changsha
      • Changsha, China
        • The Third Hospital of Changsha
      • Chengdu, China, 610041
        • West China Hospital, Sichuan University
      • Chengdu, China, 611130
        • Chengdu Fifth People's Hospital
      • Chongqing, China, 400042
        • Army Medical Center of PLA(Daping Hospital)
      • Chongqing, China, 400038
        • The Southwest Hospital of Army Medical University
      • Guangzhou, China, 510180
        • Guangzhou First People's Hospital
      • Hangzhou, China, 310006
        • Hangzhou First People's Hospital
      • Hefei, China, 230022
        • Anhui Chest Hospital
      • Huizhou, China, 516001
        • Huizhou Central People's Hospital
      • Linhai, China, 317000
        • Taizhou Hospital of Zhejiang Province
      • Nanchang, China, 330006
        • Jiangxi Provincial People's Hospital
      • Nanjing, China, 210009
        • Zhongda Hospital Southeast University
      • Pingxiang, China, 337055
        • Jiangxi Pingxiang People's Hospital
      • Shanghai, China, 200000
        • Huadong Hospital Affiliated to Fudan University
      • Shenyang, China, 110004
        • Shengjing Hospital of China Medical University
      • Tianjin, China, 300052
        • Tianjin Medical University General Hospital
      • Wuhan, China
        • Central Hospital of Wuhan
      • Wuxi, China, 214023
        • Wuxi People's Hospital
      • Wuxi, China, 214400
        • Jiangyin People's Hospital
      • Xi'an, China, 710100
        • Xi'an International Medical Center Hospital
      • Xiamen, China, 361004
        • Zhongshan Hospital Xiamen University
      • Xinxiang, China, 453000
        • Xinxiang First People's Hospital
      • Xuzhou, China
        • The Affiliated Hospital of Xuzhou Medical University
      • Yangzhou, China, 225001
        • Yangzhou First People?s Hospital
      • Zhuhai, China, 519001
        • The Fifth Affiliated Hospital Sun Yat-Sen University
      • Zigong, China, 643036
        • Zigong First People's Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510150
        • The Third Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, Guangdong, China, 510160
        • The First Affiliated Hospital of Guangzhou Medical University
      • Zhanjiang, Guangdong, China, 524001
        • Affiliated Hospital of Guangdong Medical University
    • Guizhou
      • Zunyi, Guizhou, China, 563000
        • Affiliated Hospital Of Zunyi Medical University
    • Jiangsu
      • Lianyungang, Jiangsu, China, 222061
        • The First People's Hospital of Lian Yun Gang
      • Brandýs nad Labem-Stará Boleslav, Czechia, 250 01
        • Plicní ambulance MUDr. I. Cierná Peterová s.r.o.
      • Hradec Králové, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Opava, Czechia, 746 01
        • Odborna plicni ambulance Opava s.r.o
      • Prague, Czechia, 110 00
        • Ordinace chorob plicních s.r.o.
      • Prague, Czechia, 120 00
        • AES - DRS - Synexus Czech s.r.o.
      • Teplice, Czechia, 415 01
        • Plicni stredisko Teplice s.r.o.
      • Tábor, Czechia, 390 03
        • Nemocnice Tabor, a.s.
      • Næstved, Denmark, 4700
        • Naestved Sygehus
      • Roskilde, Denmark, 4000
        • Sjaellands Universitetshospital, Roskilde
      • Amiens, France, 80090
        • Sas Clinique De L Europe - Amiens
      • Lille, France, 59000
        • Hopital Calmette
      • Paris, France, 75014
        • Groupe Hospitalier Cochin St Vincent de Paul La Roche Guyon
      • Pessac, France, 33604
        • Hôpital Haut Levêque
      • Berlin, Germany, 12627
        • AES - DRS - Synexus Berlin Research Centre
      • Berlin, Germany, 10367
        • Praxis fur Kardiologie und Pneumologie Dr. med. Karin Forster
      • Berlin, Germany, 12157
        • Studienpraxis Berlin-Brandenburg, Berlin
      • Darmstadt, Germany, 64283
        • Lungenzentrum Darmstadt
      • Frankfurt, Germany, 60596
        • Universitaetsklinikum Frankfurt
      • Hamburg, Germany, 22299
        • Praxisgem. Dres. Schmoller und Ehlers
      • Hanover, Germany, 30173
        • Pneumologicum
      • Heidelberg, Germany, 69120
        • University Clinic Heidelberg
      • Immenhausen, Germany, 34376
        • Lungenfachklinik Immenhausen
      • Leipzig, Germany, 04299
        • BAG Prof. Dr. G. Hoheisel Dr. A. Bonitz
      • Magdeburg, Germany, 39120
        • SMO.MD GmbH
      • München, Germany, 80539
        • Praxis Dr. med. Jan Feimer
      • Neu-Isenburg, Germany, 63263
        • Institut fur klinische Forschung GmbH
      • Rheine, Germany, 48431
        • Framol-Med GmbH
      • Rosenheim, Germany, 83022
        • Klinikum Rosenheim
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23552
        • Velocity Clinical Research Leipzig GmbH
      • Athens, Greece, 106 76
        • Evangelismos General Hospital of Athens
      • Athens, Greece, 115 21
        • Navy Hospital of Athens
      • Heraklio, Greece, 711 10
        • University General Hospital of Heraklion
      • Ioannina, Greece, 455 00
        • University General Hospital of Ioannina
      • Palaió Fáliro, Greece, 175 62
        • Iatriko Palaiou Falirou
      • Thessaloniki, Greece, 570 10
        • Georgios Papanikolaou General Hospital of Thessaloniki
      • Budapest, Hungary, 1089
        • Benyovszky Medical Center
      • Csorna, Hungary, 9300
        • Omnimodus Elixír Kft.
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500018
        • Paarthiv Lung Care Center
      • Hyderabad, Andhra Pradesh, India, 500084
        • Yashoda Hospitals Hitec City
    • Gujarat
      • Ahmedabad, Gujarat, India, 380059
        • GMERS Medical College and Hospital, Sola
    • Haryana
      • Faridabad, Haryana, India, 121012
        • ESIC Medical College and Hospital - Faridabad
    • Karnataka
      • Hubballi, Karnataka, India, 580021
        • Karnataka Medical College and Research Institute, Hubballi;Department of Medicine
    • Maharashtra
      • Nagpur, Maharashtra, India, 044009
        • Shree Hospital And Critical Care Centre
      • Pune, Maharashtra, India, 411038
        • Kothrud Hospital
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • Sawai Man Singh Hospital and Medical College
      • Jaipur, Rajasthan, India, 302039
        • Maharaja Agrasen Super Speciality Hospital
    • Uttar Pradesh
      • Aligarh, Uttar Pradesh, India, 202002
        • Jawaharlal Nehru Medical College (JNMC)
      • Kanpur, Uttar Pradesh, India, 208001
        • Apollo Spectra Hospital
      • Lucknow, Uttar Pradesh, India, 226003
        • MV Hospital and Research Centre
      • Beersheba, Israel, 8410101
        • Soroka University Medical Centre
      • Haifa, Israel, 3436212
        • Lady Davis Carmel Medical Center
      • Haifa, Israel, 3109601
        • Rambam Medical Center - PPDS
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center
    • Campania
      • Battipaglia, Campania, Italy, 84091
        • Presidio Ospedaliero Santa Maria della Speranza
      • Naples, Campania, Italy, 80131
        • Azienda Ospedaliera dei Colli
    • Emilia-Romagna
      • Ferrara, Emilia-Romagna, Italy, 44121
        • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo di Pavia
    • Sicily
      • Catania, Sicily, Italy, 95123
        • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
      • Palermo, Sicily, Italy, 90127
        • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
      • Asahikawa-shi, Japan, 070-0901
        • Asahikawa Medical Center
      • Chikushino-shi, Japan, 818-8502
        • Fukuoka University Chikushi Hospital
      • Chuo-ku, Fukuoka-shi, Japan, 810-8563
        • National Hospital Organization Kyushu Medical Center
      • Chūōku, Japan, 104-0031
        • Fukuwa Clinic
      • Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital
      • Fukuoka-Shi Nishi-Ku, Japan, 819-0055
        • Nishi Fukuoka Hospital
      • Himeji, Japan, 670-0849
        • Terada Respiratory and Internal Clinic
      • Hiroshima, Japan, 734-8530
        • Hiroshima Prefectural Hospital
      • Ishikawa, Japan, 920-8530
        • Ishikawa Prefectural Central Hospital
      • Jōyō, Japan, 610-0113
        • National Hospital Organization Minami Kyoto Hospital
      • Kagoshima, Japan, 890-8520
        • Kagoshima University Hospital
      • Kagoshima, Japan, 890-0062
        • Kagoshima Kouseiren Hospital
      • Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center
      • Kawachinagano-Shi, Japan, 586-8521
        • Osaka-Minami Medical Center
      • Kiryū, Japan, 376-0024
        • Kiryu Kosei General Hospital
      • Kishiwada, Japan, 596-0822
        • Kishiwada City Hospital
      • Kitakyushu-shi, Japan, 807-8556
        • Hospital of the University of Occupational and Environmental Health,Japan
      • Kumamoto, Japan, 861-4101
        • Saiseikai Kumamoto Hospital
      • Kyoto, Japan, 607-8062
        • Rakuwakai Otowa Hospital
      • Kyoto, Japan, 612-8555
        • National Hospital Organization Kyoto Medical Center
      • Kōtō City, Japan, 136-0075
        • Juntendo Tokyo Koto Geriatric Medical Center
      • Machida-shi, Japan, 194-0023
        • Machida Municipal Hospital
      • Mibu-Machi, Japan, 321-0293
        • Dokkyo Medical University Hospital
      • Miyagi, Japan, 960-1295
        • Fukushima Medical University Hospital
      • Nagoya, Japan, 454-8502
        • Nagoya Ekisaikai Hospital
      • Nagoya-shi Minami-ku, Japan, 457-8511
        • Kojunkai Social Medical Corporation Daido Clinic
      • Naka-gun, Japan, 319-1113
        • National Hospital Organization Ibarakihigashi National Hospital
      • Niigata, Japan, 950-11977
        • Niigata City General Hospital
      • Okayama, Japan, 701-1192
        • National Hospital Organization Okayama Medical Center
      • Okayama-Shi Minami-ku, Japan, 702-8055
        • Okayama Rosai Hospital
      • Omuta, Japan, 837-0911
        • Omuta National Hospital
      • Osaka, Japan, 594-0073
        • Izumi City General Hospital
      • Sagamihara-shi Minami-ku, Japan, 252-0392
        • National Hospital Organization - Sagamihara National Hospital
      • Sakaidechō, Japan, 762-0043
        • Sakaide City Hospital
      • Sakaishi, Japan, 591-8555
        • NHO Kinki-Chuo Chest Medical Center
      • Sapporo, Japan, 062-8618
        • Japan Community Health care Organization Hokkaido Hospital
      • Sapporo-shi Chuo-ku, Japan, 064-0804
        • Idaimae Minami 4-Jo Internal Medicine
      • Shizuoka, Japan, 424-0911
        • Shizuoka City Shizuoka Hospital
      • Shizuoka, Japan, 438?8550
        • Iwata City Hospital
      • Takamatsu, Japan, 761-8073
        • Kamei Internal medicine and Respiratory Clinic
      • Takasaki, Japan, 370-0829
        • National Hospital Organization Takasaki General Medical Center
      • Tanabe, Japan, 646-8558
        • Minami Wakayama Medical Center
      • Tokyo, Japan, 103-0027
        • Tokyo-Eki Center-building Clinic
      • Tokyo, Japan, 173-8610
        • Nihon University Itabashi Hospital
      • Tokyo, Japan
        • Japanese Red Cross Medical Center
      • Toyama, Japan, 930-8550
        • Toyama Prefectural Central Hospital
      • Yamagata, Japan, 990-9585
        • Yamagata University Hospital
      • Yanagawa, Japan, 832-0059
        • Nagata Hospital
      • Yokohama-Shi Totsuka-Ku, Japan, 245-8575
        • National Hospital Organization - Yokohama Medical Center
      • Yokohama-shi Aoba-ku, Japan, 227-8501
        • Showa University Fujigaoka Hospital
      • Yokohama-shi Kanazawa-ku, Japan, 236-0051
        • Kanagawa Cardiovascular and Respiratory Center
      • Yonezawa, Japan, 992-0033
        • Sanyudo Hospital
      • Ōita, Japan, 870-0263
        • Oita Medical Center
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 001-0901
        • Makita Hospital
    • Kanagawa
      • Miura-shi, Kanagawa, Japan, 238-0111
        • Miura Medical Clinic
      • Sagamihara-shi, Kanagawa, Japan, 252-0375
        • Kitasato University Hospital
      • Yokohama, Kanagawa, Japan, 221-0835
        • Yokohama Front Clinic
      • Yokohama, Kanagawa, Japan, 232-0066
        • Yokohama-Gumyouji Kokyuukinaika Naika Clinic
    • Mie-ken
      • Matsusaka-Shi, Mie-ken, Japan, 515-8544
        • Matsusaka City Hospital
    • Okinawa
      • Ginowan-shi, Okinawa, Japan, 901-2725
        • University of the Ryukyus Hospital
    • Shizuoka
      • Fujieda-Shi, Shizuoka, Japan, 426-8677
        • Fujieda Municipal General Hospital
    • Yamaguchi
      • Ube-shi, Yamaguchi, Japan, 755-8505
        • Yamaguchi University Hospital
      • Machakos, Kenya, 90100
        • Clinical Research Health Network (CREA-N)
      • Nairobi, Kenya, 00100
        • KEMRI CRDR Clinical Research Clinic Nairobi
      • Nairobi, Kenya
        • University of Nairobi Clinical Research Centre
      • Thika, Kenya, 01000
        • Center for Research In Tropical Medicine and community development
    • Coast
      • Kilifi, Coast, Kenya, 80108
        • KEMRI-MTWAPA Clinical Trial Site
      • Daugavpils, Latvia, LV-5417
        • Daugavpils Regional Hospital
      • R?ga, Latvia, LV-1002
        • Pauls Stradins Clinical University Hospital
      • Riga, Latvia, LV-1001
        • Riga 1st Hospital
      • Riga, Latvia, LV-1010
        • ConsiliumMedicum
      • Riga, Latvia, LV-1011
        • Postgraduate Medical Training Institute University of Latvia
      • Amersfoort, Netherlands, 3813 TZ
        • Meander Medisch Centrum
      • Groningen, Netherlands, 9728 MG
        • Martini Ziekenhuis
      • Heerlen, Netherlands, 6419PC
        • Zuyderland Medisch Centrum - Heerlen
      • Auckland, New Zealand, 1051
        • Greenlane Clinical Centre
      • Dunedin, New Zealand, 9016
        • Dunedin Hospital
      • Hamilton, New Zealand, 3248
        • Waikato Hospital
      • Waikanae Beach, New Zealand, 05036
        • P3 Research - Kapiti - PPDS
      • Caloocan, Philippines, 1442
        • Manila Central University-Filemon D Tanchoco Medical Foundation
      • Dasmariñas, Philippines, 4114
        • CARE CT Group Inc.
      • Iloilo City, Philippines, 5000
        • West Visayas State University Medical Center
      • Iloilo City, Philippines, 5000
        • Healthlink Medicalsurgicaldental Clinic and Diagnostic Center
      • Lipa City, Philippines, 4217
        • Mary Mediatrix Medical Center
      • Quezon City, Philippines, 1109
        • Quirino Memorial Medical Center
      • Quezon City, Philippines, 1100
        • Philippine Heart Center
      • Bia?ystok, Poland, 15-044
        • Centrum Medycyny Oddechowej Mroz sp. j.
      • Bydgoszcz, Poland, 85-079
        • Vitamed Galaj I Cichomski sp.j.
      • Bydgoszcz, Poland, 85-231
        • Medical Center Kermed
      • Chojnice, Poland, 89-600
        • Centrum Medyczne Lukamed Joanna Luka-Wendrowska
      • Gdynia, Poland, 81-537
        • Synexus Polska Sp. z o.o. Oddzial w Gdyni
      • Grudzadz, Poland, 86-300
        • Centrum Medyczne CLW-med Aneta Cichomska , Joanna Luka -Wendrowska
      • Grudziądz, Poland, 86-300
        • Prywatny Gabinet Pulmonologiczny Joanna Nowacka-Apiyo
      • Katowice, Poland, 40-081
        • Centrum Medyczne Katowice - PRATIA - PPDS
      • Ksawerów, Poland, 95-054
        • Prywatna Praktyka Lekarska Adam Smialowski
      • Lodz, Poland, 90-127
        • AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi
      • Lublin, Poland, 20-078
        • Clinical Best Solutions - Lublin
      • Lublin, Poland, 20-089
        • NZOZ Przychodnia Alergologiczno-pulmonologiczna
      • Radom, Poland, 26-600
        • ABC-Pulmo NZOZ Agnieszka Dobielska, Jaroslaw Dobie
      • Sopot, Poland, 81-741
        • Centrum Medyczne KARDIOTEL
      • Sosnowiec, Poland, 41-200
        • Kiepury Clinic
      • Szczecin, Poland, 70-111
        • Gabinet Pulmonologii i Diagnostyki Chorob Alergicznych Dorota Malosek
      • Słupsk, Poland, 76-200
        • NZOZ Poradnia Chorob Pluc i Alergologii
      • Trzebnica, Poland, 55-100
        • Viltis Medica Specjalistyczna Praktyka Lekarska Lek. Med. Agata Kot
      • Warsaw, Poland, 01-192
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
      • Wroc?aw, Poland, 50-381
        • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
      • Wroc?aw, Poland, 51-162
        • Centrum Badan Klinicznych Piotr Napora lekarze spolka partnerska
      • Wroc?aw, Poland, 54-239
        • Lekarze Specjalisci J. Malolepszy i Partnerzy
      • Zabrze, Poland, 41-807
        • Medical Center Clinhouse
    • Lesser Poland Voivodeship
      • Tarnów, Lesser Poland Voivodeship, Poland, 33-100
        • CenterMed Sp. z o.o.
    • Lódzkie
      • Lodz, Lódzkie, Poland, 90-349
        • Appletreeclinics Network Sp. z o.o.
      • Guaynabo, Puerto Rico, 00968
        • Allianze Pulmonary Research LLC
      • Centurion, South Africa, 1692
        • Johese Clinical Research
      • City of Cape Town, South Africa, 7764
        • Dr. Ismail Abdullah Private Practice
      • Kempton Park, South Africa, 1619
        • CLINRESCO, ARWYP Medical Suites
      • Pretoria, South Africa, 0184
        • AES - DRS - Synexus Watermeyer Clinical Research Centre
      • Pretoria, South Africa, 183
        • Medicross Pretoria West, Jongaie Research
      • Somerset West, South Africa, 7130
        • AES - DRS - Synexus - Helderberg Clinical Research Centre
      • Welkom, South Africa, 9459
        • Dr Yacoob AK Private Practice
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Iatros International
    • Gauteng
      • City of Johannesburg, Gauteng, South Africa, Hillbrow 2001
        • Newtown Clinical Research Centre
      • Bucheon-si, South Korea, 420-767
        • Soon Chun Hyang University Hospital Bucheon
      • Daegu, South Korea, 42415
        • Yeungnam University Hospital
      • Gyeonggi-do, South Korea, 13496
        • CHA Bundang Medical Center
      • Seoul, South Korea, 03181
        • Kangbuk Samsung Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center - PPDS
      • Seoul, South Korea, 06351
        • Samsung Medical Center - PPDS
      • Seoul, South Korea, 06973
        • Chung-Ang University Hospital
      • Seoul, South Korea, 137-701
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Wŏnju, South Korea, 220-701
        • Yonsei University Wonju Severance Christian Hospital
      • Barcelona, Spain, 8041
        • Hospital Universitario La Paz - PPDS
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
      • Valencia, Spain, 46600
        • Hospital de la Ribera
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 07010
        • Hospital Universitario Son Espases
    • LEON
      • Ponferrada, LEON, Spain, 24411
        • Hospital El Bierzo
    • Madrid
      • Torrejón de Ardoz, Madrid, Spain, 28850
        • Hospital Universitario De Torrejon
    • Malaga
      • Benalmádena Costa, Malaga, Spain, 29630
        • Vithas Xanit International Hospital
      • Gothenburg, Sweden, 413 45
        • Sahlgrenska Universitetssjukhuset
      • Stockholm, Sweden, 117 27
        • Akardo AB
    • Uppsala County
      • Uppsala, Uppsala County, Sweden, 752 37
        • Clinical Trial Consultants - Linkoping
      • Zurich, Switzerland
        • Zurcher Reha Zentren Wald
      • Chang-hua, Taiwan, 500
        • Changhua Christian Hospital
      • Kaoshiung City, Taiwan, 807
        • Kaohsiung Medical University Hospital
      • New Taipei City, Taiwan, 220
        • Far East Memorial Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 11031
        • Taipei Medical University Hospital
      • Taipei, Taiwan, 11490
        • TRI-Service General Hospital
      • Khon Kaen, Thailand, 40002
        • Srinagarind Hospital, Khon Kaen University
      • Muang, Thailand, 11000
        • Central Chest Institute of Thailand
      • Kirikkale, Turkey (Türkiye), 71100
        • Kirikkale Universitesi Tip Fakultesi Hastanesi
      • Rize Merkez, Turkey (Türkiye), 53020
        • Rize Recep Tayyip Erdogan University Training and Research Hospital
      • Sarıçam, Turkey (Türkiye), 01250
        • Cukurova Universitesi Tip Fakultesi Balcali Hastanesi
      • Bellshill, United Kingdom, ML4 3NJ
        • AES - DRS - Synexus Scotland Clinical Research Centre
      • Birmingham, United Kingdom, B15 2SQ
        • AES - DRS - Synexus Midlands Clinical Research Centre
      • Cardiff, United Kingdom, CF15 9SS
        • AES - DRS - Synexus Wales Clinical Research Centre
      • Chesterfield, United Kingdom, S40 4AA
        • Royal Primary Care - Ashgate Manor
      • Chorley, United Kingdom, PR7 7NA
        • AES - DRS - NW Consortium Lancashire
      • Edinburgh, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh
      • Hexham, United Kingdom, NE46 1QJ
        • AES - DRS - Synexus Hexham Clinical Research Centre
      • Lancaster, United Kingdom, LA1 4RP
        • Royal Lancaster Infirmary
      • Leeds, United Kingdom, LS9 7TF
        • St James University Hospital
      • Liverpool, United Kingdom, L32 2AN
        • AES - DRS - NW Consortium Merseyside
      • London, United Kingdom, SE1 7EH
        • St Thomas' Hospital
      • London, United Kingdom, N12 8BU
        • Velocity Clinical Research North London - Percy Road - PPDS
    • Yorkshire
      • Cottingham, Yorkshire, United Kingdom, HU16 5JQ
        • Castle Hill Hospital
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
      • Dothan, Alabama, United States, 36305
        • SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
    • Arizona
      • Glendale, Arizona, United States, 85306-4669
        • Pulmonary Associates PA
      • Tucson, Arizona, United States, 85741-3118
        • AES - DRS - Synexus Clinical Research US, Inc. - Tucson
    • California
      • Bakersfield, California, United States, 93301
        • Kern Research
      • Walnut Creek, California, United States, 94598
        • Allergy & Asthma Medical Group of the Bay Area
    • Florida
      • Greenacres City, Florida, United States, 33467-2979
        • Finlay Medical Research Corporation
      • Miami, Florida, United States, 33014
        • San Marcus Research Clinic Inc.
      • Miami, Florida, United States, 33173
        • Research Institute of South Florida Inc
      • Miami, Florida, United States, 33144-2155
        • Oceane7 Medical & Research Center, Inc.
      • Miami, Florida, United States, 33155-3265
        • Avantis Clinical Research, LLC
      • Miami, Florida, United States, 33175-3434
        • Diverse Clinical Research, LLC
      • Orlando, Florida, United States, 32803
        • Central Florida Pulmonary Group, PA
      • The Villages, Florida, United States, 32162-7116
        • AES - DRS - Synexus Clinical Research US, Inc. - The Villages
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • AES - DRS - Synexus Clinical Research US, Inc. - Atlanta
      • Columbus, Georgia, United States, 31904-2954
        • Allergy Center at Brookstone Research - Centricity Research - HyperCore - PPD
      • Stonecrest, Georgia, United States, 30038-2649
        • Pivotal Research Solutions
    • Indiana
      • Hammond, Indiana, United States, 46324-2213
        • ASHA Clinical Research - ClinEdge - PPDS
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • The Research Group of Lexington, LLC
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Best Clinical Trials
    • Maine
      • Bangor, Maine, United States, 04401-5691
        • Paul A. Shapero, MD, PA
    • Michigan
      • Farmington Hills, Michigan, United States, 48336-2817
        • Pulmonary Research Institute of Southeast Michigan
      • Flint, Michigan, United States, 48504-4730
        • Flushing Road Internal Medicine and Pediatrics - F
      • Lathrup Village, Michigan, United States, 48076
        • Revive Research Institute
      • Troy, Michigan, United States, 48085-5524
        • Oakland Medical Research Center
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine in St. Louis
    • Nebraska
      • Bellevue, Nebraska, United States, 68123-4318
        • Nebraska Medical Research Institute, Inc. - CRN
    • Nevada
      • Las Vegas, Nevada, United States, 89104-3953
        • Machuca Family Medicine
      • Reno, Nevada, United States, 89502-1576
        • Renown Regional Medical Center Hospital
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Hassman Research Institute - HRI - Berlin - CenExel - PPDS
    • New York
      • New York, New York, United States, 10017-4008
        • AES - DRS - Synexus Clinical Research US, Inc. - New York
    • North Carolina
      • Denver, North Carolina, United States, 28037-7929
        • Research Carolina Elite
      • Greensboro, North Carolina, United States, 27403
        • PulmonIx LLC
      • Huntersville, North Carolina, United States, 28078
        • Advanced Respiratory and Sleep Medicine, PLLC
      • Winston-Salem, North Carolina, United States, 27103-4029
        • Southeastern Research Center
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034-3258
        • OK Clinical Research
    • Oregon
      • Portland, Oregon, United States, 97213
        • The Oregon Clinic
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Clinical Research Associates Of Central Pa , Llc
      • Pittsburgh, Pennsylvania, United States, 15241
        • Allergy & Clinical Immun Assoc
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Medtrial, LLC
      • Gaffney, South Carolina, United States, 29340-4737
        • Velocity Clinical Research - Gaffney - PPDS
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • ClinSearch, LLC
      • Franklin, Tennessee, United States, 37067-5603
        • Clinical Trials Center of Middle Tennessee
      • Hendersonville, Tennessee, United States, 37075-3085
        • Tennessee Comprehensive Lung & Sleep Center
    • Texas
      • Boerne, Texas, United States, 78006
        • TTS Research
      • Corsicana, Texas, United States, 75110-2471
        • Corsicana Medical Research
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine Medical Center
      • Houston, Texas, United States, 77008
        • Trio Clinical Trials
      • Houston, Texas, United States, 77084
        • Biopharma Informatic - Park Row - PPDS
      • Katy, Texas, United States, 77494-2031
        • R & H Clinical Research
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center
    • Washington
      • Everett, Washington, United States, 98208
        • Western Washington Medical Group
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228-3467
        • Allergy Asthma and Sinus Center-Greenfield

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Documented COPD diagnosis for ≥ 12 months
  • History of frequent exacerbations, defined as having had 2 or more moderate or severe COPD exacerbations within 12 months prior to screening
  • Post-bronchodilator FEV1 ≥ 20% and < 80% of predicted at screening
  • Post-bronchodilator FEV1/FVC < 0.70 at screening
  • Modified Medical Research Council (dyspnea scale) (mMRC) score ≥ 2
  • Current tobacco smoker or former smoker with a history of smoking ≥ 10 pack-years
  • On optimized COPD maintenance therapy as defined below for ≥ 12 months prior to screening, and stable on current therapy for at least 4 weeks prior to screening: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA), Long-acting muscarinic antagonist (LAMA) plus LABA, ICS plus LAMA plus LABA
  • Chest X-ray or computed tomography (CT) scan within 6 months prior to screening or chest X-ray during the screening period that confirms the absence of clinically significant lung disease besides COPD

Exclusion Criteria

  • Current documented diagnosis of asthma
  • History of clinically significant pulmonary disease other than COPD
  • Diagnosis of 1-antitrypsin deficiency
  • History of long-term treatment with oxygen at > 4.0 liters/minute
  • Lung volume reduction surgery or procedure within 12 months prior to screening
  • Individuals participating in, or scheduled for, an intensive COPD rehabilitation program (participants who are in the maintenance phase of a rehabilitation program are eligible)
  • History of lung transplant
  • Any infection that resulted in hospital admission for ≥ 24 hours and/or treatment with oral, IV, or IM antibiotics within 4 weeks prior to or during screening
  • Upper or lower respiratory tract infection within 4 weeks prior to or during screening
  • Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
  • Initiation of or change in non-biologic immunomodulatory or immunosuppressive therapy within 3 months prior to screening
  • Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Astegolimab SC Q2W
Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W)
Participants will receive SC astegolimab Q2W or Q4W
Experimental: Astegolimab SC Q4W
Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving SC astegolimab Q4W.
Participants will receive SC astegolimab Q2W or Q4W
Placebo Comparator: Placebo SC Q2W
Participants will receive SC placebo Q2W
Participants will receive SC placebo Q2W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to first moderate or severe COPD exacerbation during the 52-week treatment period
Time Frame: 52 weeks
52 weeks
Absolute change from baseline in health-related quality of life (HRQoL) at Week 52 as assessed through the St. George's Respiratory Questionnaire-COPD (SGRQ-C) total score
Time Frame: Week 52
Week 52
Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Week 52
Time Frame: Week 52
Week 52
Absolute change from baseline in the Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) total score at Week 52
Time Frame: Week 52
Week 52
Proportion of participants with improvement in HRQoL at Week 52
Time Frame: Week 52
Week 52
Annualized rate of severe COPD exacerbations over the 52-week treatment period
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

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

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

December 29, 2022

Primary Completion (Actual)

June 24, 2025

Study Completion (Estimated)

September 24, 2027

Study Registration Dates

First Submitted

October 24, 2022

First Submitted That Met QC Criteria

October 24, 2022

First Posted (Actual)

October 27, 2022

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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