Chronic Obstructive Pulmonary DiseasePhase 3NCT05878769
A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing Astegolimab in people with Chronic Obstructive Pulmonary Disease, run by Hoffmann-La Roche at 481 sites in 40 countries.
Trial summary
The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Astegolimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 481 sitesin 40 countries
- Study dates
- 28 Jun 2023to 30 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completion of the 52-week treatment period in either parent GB43311 or GB44332
Who cannot join
- Withdrawal of consent and/or premature discontinuation from parent study
- Any permanent discontinuation of study drug in parent study
- Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator's judgment
- Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study
- Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study
- Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study
Trial locations and contacts
481 sites in 40 countries.
481 sites in 40 countries
United States68 sites
Kern Allergy and Medical Research
Bakersfield, California, 93301-4205
Paul A. Shapero, MD, PA
Bangor, Maine, 04401-5691
UAB Lung Health Center
Birmingham, Alabama, 35205-2610
South Texas Medical Research Institute, Inc., dba TTS Research ? ClinEdge ? PPDS
Boerne, Texas, 78006-1993
American Health Research Inc.
Charlotte, North Carolina, 28277
University of Virginia Health System
Charlottesville, Virginia, 22903
ClinSearch, LLC
Chattanooga, Tennessee, 37421
The Lung Research Center
Chesterfield, Missouri, 63017-3625
Northwestern Center for Clinical Research
Chicago, Illinois, 60611
St Francis Medical Institute ClinEdge PPDS
Clearwater, Florida, 33765
Vermont Lung Center at the University of Vermont
Colchester, Vermont, 05446-3052
Medtrial, LLC
Columbia, South Carolina, 29204
Corsicana Medical Research
Corsicana, Texas, 75110-2471
Research Carolina Elite
Denver, North Carolina, 28037-7929
SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
Dothan, Alabama, 36305
Clinical Research Associates Of Central Pa , Llc
DuBois, Pennsylvania, 15801-2277
OK Clinical Research
Edmond, Oklahoma, 73034-3258
Western Washington Medical Group
Everett, Washington, 98208
Exordia Medical Research, Inc.
Fall River, Massachusetts, 02723-1511
Pulmonary Research Institute of Southeast Michigan
Farmington Hills, Michigan, 48336-2817
Flushing Road Internal Medicine and Pediatrics - F
Flint, Michigan, 48504-4730
Velocity Clinical Research - Gaffney - PPDS
Gaffney, South Carolina, 29340-4737
Clinical Research of Gastonia
Gastonia, North Carolina, 28054
Finlay Medical Research Corporation
Greenacres City, Florida, 33467-2979
Allergy Asthma and Sinus Center-Greenfield
Greenfield, Wisconsin, 53228
Pulmonix LLC
Greensboro, North Carolina, 27403-4443
ASHA Clinical Research - ClinEdge - PPDS
Hammond, Indiana, 46324-2213
Hannibal Regional Healthcare System HRMG Hannibal
Hannibal, Missouri, 63401-6890
Tennessee Comprehensive Lung & Sleep Center
Hendersonville, Tennessee, 37075-3085
Trio Clinical Trials
Houston, Texas, 77008-1772
Baylor College of Medicine
Houston, Texas, 77030-4202
Houston Pulmonary Medicine Associates, PA - Biopharma Informatic, LLC
Houston, Texas, 77089-6097
Jasper Summit Research LLC
Jasper, Alabama, 35501
The Machuca Foundation Inc
Las Vegas, Nevada, 89101-3485
Sierra Clinical Research - ClinEdge - PPDS
Las Vegas, Nevada, 89106-4159
Flourish Research - Leesburg - PPDS
Leesburg, Florida, 34748-5077
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida, 33470-9272
Metroplex Pulmonary and Sleep Medicine Center
McKinney, Texas, 75069
San Marcus Research Clinic Inc.
Miami, Florida, 33014
Finlay Medical Research Corporation
Miami, Florida, 33126-1941
Oceane7 Medical & Research Center, Inc.
Miami, Florida, 33144-2155
Research Institute of South Florida Inc
Miami, Florida, 33173
Diverse Clinical Research, LLC
Miami, Florida, 33175-3434
Pulmonary Associates of Mobile PC
Mobile, Alabama, 36608-3135
Best Clinical Trials
New Orleans, Louisiana, 70115-3628
AES - DRS - Synexus Clinical Research US, Inc. - New York
New York, New York, 10017-4008
Lowcountry Lung and Critical Care
North Charleston, South Carolina, 29406
Central Florida Pulmonary Group, PA
Orlando, Florida, 32803
Florida Institute for Clinical Research, LLC
Orlando, Florida, 32825-4454
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Pulmonary Associates Deer Valley Office
Phoenix, Arizona, 85027-5163
Allergy & Clinical Immun Assoc
Pittsburgh, Pennsylvania, 15241
The Oregon Clinic.
Portland, Oregon, 97220
Cadena Care Institute, LLC
Poway, California, 92064-2419
Renown Regional Medical Center Hospital
Reno, Nevada, 89502-1576
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732
Midwest Chest Consultants
Saint Charles, Missouri, 63301
Apex Clinical Research
San Diego, California, 92120
Carolina Research Center
Shelby, North Carolina, 28150-3803
Sherman Clinical Research - ClinEdge - PPDS
Sherman, Texas, 75090
Revive Research Institute
Southfield, Michigan, 48075
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
Midwest Clinical Research LLC
St Louis, Missouri, 63141
Pivotal Research Solutions
Stonecrest, Georgia, 30038-2649
Oakland Medical Research Center
Troy, Michigan, 48085-5524
AES - DRS - Synexus Clinical Research US, Inc. - Tucson
Tucson, Arizona, 85741-3118
Southeastern Research Center
Winston-Salem, North Carolina, 27103-4029
Flourish Research - Orlando - PPDS
Winter Park, Florida, 32789-4681
Argentina40 sites
Consultorios Medicos Organizacion de Buen Ayre SRL
Buenos Aires, 1425
Centro de Investigaciones Clínicas Belgrano
Buenos Aires, 7240
Fundacion Cidea
Buenos Aires, C1121ABE
Fundacion Faicep
Buenos Aires, C1122AAK
Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias
Buenos Aires, C1425
AES - AS - Glenny Corp. S.A. Buenos Aires
Buenos Aires, C1430
CARE - Centro de Alergia y Enfermedades Respiratorias
CABA, C1414AIF
Nexo Salud Investigacion Clinica - Riobamba 429
Ciudad Autonoma Buenos Aires, C1025ABI
CINME S.A. ? Centro de Investigaciones Metabolicas - Rx Trials LLC
Ciudad Autonoma Buenos Aires, C1056ABI
Centro Médico Dra de Salvo
Ciudad Autonoma Buenos Aires, C1426ABP
Centro de Medicina Respiratoria
Concepción del Uruguay, 3260
Sanatorio de la Canada
Córdoba, X5000BSQ
Instituto de Medicina Respiratoria, IMeR
Córdoba, X5003DCE
Centro Privado de Medicina Respiratoria
Entre Ríos, E3100BBJ
Centro Medico Capital
La Plata, Buenos Aires, B1900
Framingham Centro Medico
La Plata, 1900
Centro Platense en Investigaciones Respiratorias
La Plata, B1900BNN
CEMLO - Centro de Especialidades Médicas Lobos - Patagones 94
Lobos, Buenos Aires, B7240KJB
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, B7600FYK
Instituto de Investigaciones Clinicas-Mar del Plata
Mar del Plata, B7600FZN
Instituto Ave Pulmo
Mar del Plata, B7602DCK
Centro Medico Dharma
Mendoza, 5500
Fundacion Scherbovsky
Mendoza, M5500AXR
INSARES
Mendoza, Mendoza City, M5500CCG
Centro Respiratorio Quilmes
Quilmes, B1878FNR
Sala de primeros auxilios Alberto Mignaburu
Ranelagh, Berazategui, 1886
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, S2000DEJ
Sanatorio Parque de Rosario
Rosario, S2000KZD
Instituto Medico Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion Medica
Rosario, S2002OJP
Servicio de Investigacion de Patologias Alergicas-Instituto ABC
Rosario, S2013JKR
Centro Medico IPAM
Rosario, S2013SBK
Centro Médico Respire
San Fernando, B1646EBJ
Instituto De Patologias Respiratorias
San Miguel de Tucumán, 4000
Centro Integral de Medicina Respiratoria (CIMER)
San Miguel de Tucumán, T4000CHE
Centro Modelo de Cardiologia
San Miguel de Tucumán, T4000IFL
Centro Medico San Nicolas Grupo Orono
San Nicolás de los Arroyos, B2900
CEPROSS- Centro Profesional San Salvador
San Salvador, E3218CHH
Instituto Del Buen Aire
Santa Fe, 3000
Centro de Diagnostico Y Rehabilitacion
Santa Fe, S3000
Instituto De Enfermedades Respiratorias E Investigacion Medica
Villa Vatteone, B1853AIK
Poland36 sites
Centrum Medycyny Oddechowej Mroz sp. j.
Bia?ystok, 15-044
Vitamed Galaj i Cichomski sp.j.
Bydgoszcz, 85-079
Medical Center Kermed
Bydgoszcz, 85-231
Centrum Medyczne Bydgoszcz- PRATIA - PPDS
Bydgoszcz, 85-796
Centrum Medyczne Lukamed Joanna Luka-Wendrowska
Chojnice, 89-600
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, 81-537
Centrum Medyczne CLW-med Aneta Cichomska , Joanna Luka -Wendrowska
Grudzadz, 86-300
Centrum Medyczne Katowice - PRATIA - PPDS
Katowice, 40-081
Indywidualna Specjalistyczna Praktyka Lekarska lek.
Kielce, 25-751
Centrum Medyczne ALL-MED
Krakow, 30-033
Diamond Clinic
Krakow, 31-559
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.
Krakow, 31-637
Praktyka Lekarska Adam Smialowski
Ksawerów, 95-054
AppleTreeClinics Network Sp. z o.o.
Lodz, Lódzkie, 90-349
Prywatny Gabinet Lekarski Ginekologia i Poloznictwo Ultrasonografia Prof. Jacek Suzin
Lodz, Lódzkie, 90-602
AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi
Lodz, 90-127
ETG Lodz
Lodz, 90-302
Clinical Best Solutions - Lublin
Lublin, 20-078
NZOZ Przychodnia Alergologiczno-pulmonologiczna
Lublin, 20-089
ETG Lublin
Lublin, 20-412
Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o
Nowa Sól, 67-100
Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik
Ostrowiec Swietokrzysk, 27-400
Centrum Alergologii Teresa Hofman
Poznan, 60-214
ABC-Pulmo NZOZ Agnieszka Dobielska, Jaroslaw Dobie
Radom, 26-600
EMED Centrum Uslug Medycznych Ewa Smialek
Rzeszów, 35-205
ETG Siedlce
Siedlce, 08-110
Centrum Medyczne KARDIOTEL
Sopot, 81-741
Kiepury Clinic
Sosnowiec, 41-200
PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna
Sosnowiec, 41-208
Gabinet Pulmonologii i Diagnostyki Chorob Alergicznych Dorota Malosek
Szczecin, 70-111
CenterMed Bandrowskiego
Tarnów, 33-100
Viltis Medica Sp. Z o.o.
Trzebnica, Lower Silesian Voivodeship, 55-100
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, 01-192
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
Wroc?aw, 51-162
Dobrostan Gabinety Lekarskie
Wroc?aw, 53-301
Lekarze Specjalisci J. Malolepszy i Partnerzy
Wroclaw, Lower Silesian Voivodeship, 54-239
China34 sites
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100144
Beijing Hospital
Beijing, 100006
Beijing Chaoyang Hospital Capital Medical University
Beijing, 100020
China-Japan Friendship Hospital
Beijing, 100029
Beijing Jingmei Group General Hospital
Beijing, 100042
The First Hospital of Jilin University
Changchun, 130021
West China Hospital, Sichuan University
Chengdu, 610041
Chengdu Fifth People's Hospital
Chengdu, 611130
The Southwest Hospital of Army Medical University
Chongqing, 400038
Army Medical Center of PLA(Daping Hospital)
Chongqing, 400042
Affiliated Hospital of Guangdong Medical University
Guangdong, 524023
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510150
Guangzhou First People's Hospital
Guangzhou, 510180
Hangzhou First People's Hospital
Hangzhou, 310006
Anhui Chest Hospital
Hefei, Anhui, 230022
Huizhou Central People's Hospital
Huizhou, 516001
The First People's Hospital of Lian Yun Gang
Lianyungang, 222023
Taizhou Hospital of Zhejiang Province
Linhai, 317000
Jiangxi Provincial People's Hospital
Nanchang, 330006
Zhongda Hospital Affiliated to Southeast University
Nanjing, 210009
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055
Huadong Hospital Affiliated of Fudan University
Shanghai, Shanghai Municipality, 200040
Tianjin Medical University General Hospital
Tianjin, 300052
The Central Hospital of Wuhan
Wuhan, Hubei, 430014
Wuxi People's Hospital
Wuxi, 214023
Jiangyin People's Hospital
Wuxi, 214400
Xi'an International Medical Center Hospital
Xi'an, 710100
Zhongshan Hospital Xiamen University
Xiamen, 361004
Xinxiang First People's Hospital
Xinxiang, 453000
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221002
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai, 519001
Zigong First People's Hospital - East Campus
Zigong, Sichuan, 643000
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000
Japan33 sites
Asahikawa Medical Center
Asahikawa-shi, 070-8644
Fukuoka University Chikushi Hospital
Chikushino-shi, 818-8502
Fukuwa Clinic
Chūō, 104-0031
Fukuoka University Hospital
Fukuoka, 814-0180
Nishi Fukuoka Hospital
Fukuoka-Shi Nishi-Ku, 819-8555
Fukushima Medical University Hospital
Fukushima, 960-1295
National Hospital Organization Kyoto Medical Center
Fushimi-ku, Kyoto, 612-8555
Terada Respiratory and Internal Clinic
Himeji, 670-0849
Hiroshima Prefectural Hospital
Hiroshima, 734-8530
National Hospital Organization Minami Kyoto Hospital
Jōyō, 610-0113
Kagoshima Kouseiren Hospital
Kagoshima, 890-0062
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, 236-0051
Sagamihara National Hospital
Kanagawa, 252-0392
Osaka-Minami Medical Center
Kawachinagano-Shi, 586-8521
Kishiwada City Hospital
Kishiwada-Shi, 596-8501
Juntendo Tokyo Koto Geriatric Medical Center
Kōtō City, 136-0075
Saiseikai Kumamoto Hospital
Kumamoto, 861-4193
Matsusaka City Hospital
Matsusaka-Shi, Mie-ken, 515-8544
Social Medical Corporation Daido Clinic
Nagoya, Aichi-ken, 457-8511
National Hospital Organization Okayama Medical Center
Okayama, 701-1192
Okayama Rosai Hospital
Okayama-Shi Minami-ku, 702-8055
Omuta National Hospital
Omuta, 837-0911
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai-shi Kita-ku, Osaka, 591-8555
Sakaide City Hospital
Sakaide-Shi, 762-8550
Idaimae Minami 4-Jo Internal Medicine
Sapporo-shi Chuo-ku, 064-0804
Japanese Red Cross Medical Center
Shibuya-ku, 150-8935
Shizuoka City Shizuoka Hospital
Shizuoka-Shi Aoi-Ku, Shizuoka, 420-8630
Kamei Internal Medicine and Respiratory Clinic
Takamatsu, 761-8073
Japan Community Health Care Organization Hokkaido Hospital
Toyohira-ku, Sapporo City, Hokkaido, 062-8618
Nagata Hospital
Yanagawa, 832-0059
Yokohama City University Medical Center
Yokohama, 232-0024
Showa University Fujigaoka Hospital
Yokohama-shi Aoba-ku, 227-8501
National Hospital Organization - Yokohama Medical Center
Yokohama-Shi Totsuka-Ku, 245-8575
Germany28 sites
Zentrum fuer Pneumologie, Onkologie und Schlafmedizin am Diako
Augsburg, 86150
Gemeinschaftspraxis fuer Herz und Lunge am Bruderw
Bamberg, 96049
KPPK Studienzentrum Kroker-Schmidt
Bendorf, 56170
Studienpraxis Berlin-Brandenburg, Berlin
Berlin, 10119
Praxis fur Kardiologie und Pneumologie Dr. med. Karin Forster
Berlin, 10367
MECS Research GmbH
Berlin, 12203
Clinical Studies Pankow
Berlin, 13187
Lungenzentrum Darmstadt
Darmstadt, 64283
MVZ Jung GbR - Deggingen
Deggingen, 73326
Medizentrum Essen Borbeck
Essen, 45355
Universitaetsklinikum Frankfurt
Frankfurt, 60596
Praxis Dr med Claus Keller
Frankfurt am Main, 60389
ME Clinical Respiratory Research Hamburg GmbH
Hamburg, 22299
Pneumologicum
Hanover, 30173
University Clinic Heidelberg
Heidelberg, 69120
Lungenfachklinik Immenhausen
Immenhausen, 34376
Asklepios MVZ Bayern GmbH
Landsberg, 86899
Salvus-Klinische Studien GmbH
Leipzig, 04207
BAG Prof. Dr. G. Hoheisel Dr. A. Bonitz
Leipzig, 04299
KLB Gesundheitsforschung Lubeck GmbH
Lübeck, 23552
SMO.MD GmbH
Magdeburg, 39120
IKF Pneumologie Mainz
Mainz, 55128
Praxis für Pneumologie Dr. Silke Mronga & Dr. Lukas Jerrentrup
Marburg, 35037
Praxis Dr. med. Jan Feimer
München, 80539
Institut fur klinische Forschung GmbH
Neu-Isenburg, 63263
Praxis Dr. med. Christian Schlenska
Peine, 31224
framol-med GmbH
Rheine, 48431
RoMed Klinikum Rosenheim-Pettenkoferstr. 10
Rosenheim, 83022
Bulgaria25 sites
Multiprofile Hospital for Active Treatment Puls AD PPDS
Blagoevgrad, 2700
Multiprofile Hospital For Active Treatment Sveta Ekaterina - Dimitrovgrad EOOD
Dimitrovgrad, 6400
Medical Centre "Asklepii", OOD
Dupnitsa, 2600
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD
Haskovo, 6300
Medical Centre Pratia EOOD branch Lovech
Lovech, 5500
Medical Center Hera EOOD
Montana, 3400
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Dr.Nikola Penchev-Paza
Pazardzhik, 4400
Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD
Pernik, 2300
Medical center Medconsult Pleven OOD
Pleven, 5800
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv, 4002
Multiprofile Hospital for Active Treatment Plovdiv
Plovdiv, 4003
Medical center Unimed EOOD
Plovdiv, 4023
Multiprofile Hospital for Active Treatment Shumen
Shumen, 9700
Multiprofile Hospital for Active Treatment - Silistra AD
Silistra, 7500
Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
Smolyan, 4700
MHAT Knyaginya Klementina Sofia EAD
Sofia, Sofia-Grad, 1233
Diagnostic-Consultative Center Aleksandrovska EOOD
Sofia, Sofia-Grad, 1431
Medical Center Hera Eood
Sofia, 1510
University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD
Sofia, 1606
Diagnostic- Consultative Center Convex EOOD
Sofia, 1680
AES DRS Medical Center Synexus Sofia EOOD
Sofia, 1784
Medical Center New rehabilitation center EOOD
Stara Zagora, 6003
Medical Center Researchexpert OOD
Varna, 9000
Medical Center Tara OOD
Veliko Tarnovo, 5000
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa
Vratsa, 3000
Spain15 sites
Hospital de La Ribera
Alzira, Valencia, 46600
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Vithas Xanit International Hospital
Benalmádena Costa, Malaga, 29630
Hospital Universitario Virgen de Las Nieves
Granada, 18012
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Hospital Universitario Fundacion Jimenez Diaz.
Madrid, 28040
Hospital Universitario La Paz - PPDS
Madrid, 28046
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Hospital de Merida
Mérida, Badajoz, 06800
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07120
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
Hospital Clinico Universitario de Santiago
Santiago de Compostela, LA Coruna, 15706
Hospital Universitario Virgen del Rocio
Seville, 41013
Hospital Universitario de Torrejon
Torrejón de Ardoz, Madrid, 28850
Hospital Clinico Universitario de Valencia
Valencia, 46010
South Africa14 sites
Iatros International
Bloemfontein, 9301
University of Cape Town Lung Institute
Cape Town, 7700
Dr. Ismail Abdullah Private Practice
City of Cape Town, 7764
Newtown Clinical Research Centre
City of Johannesburg, 2001
Johese Clinical Research
City of Tshwane, Gauteng, 0157
Clinical Trial Systems
City of Tshwane, 0186
St Augustines Hospital
Durban, 4001
Lakeview Hospital
Ekurhuleni, 1500
Dr A.C Wilhase practice-Reimed
Ekurhuleni, 1501
CLINRESCO, ARWYP Medical Suites
Ekurhuleni, 1619
Langeberg Clinical Trials
Kraaifontein, 7570
Medicross Pretoria West, Jongaie Research
Pretoria, 0183
AES - DRS - Synexus - Helderberg Clinical Research Centre
Somerset West, 7130
Dr Yacoob AK Private Practice
Welkom, 9459
United Kingdom14 sites
AES - DRS - Synexus Scotland Clinical Research Centre
Bellshill, ML4 3NJ
Bradford Royal Infirmary
Bradford, BD9 6RJ
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ
AES - DRS - Synexus Wales Clinical Research Centre
Cardiff, CF15 9SS
Royal Primary Care - Ashgate Manor
Chesterfield, S40 4AA
AES - DRS - NW Consortium Lancashire
Chorley, PR7 7NA
Castle Hill Hospital
Cottingham, HU16 5JQ
AES - DRS - Synexus Midlands Clinical Research Centre
Edgbaston, B15 2SQ
AES - DRS - Synexus Hexham Clinical Research Centre
Hexham, NE46 1QJ
Glenfield Hospital
Leicester, LE3 9QP
AES - DRS - NW Consortium Merseyside
Liverpool, L32 2AN
Guys Hospital
London, Middlesex, SE1 9RT
Velocity Clinical Research North London - Percy Road - PPDS
London, N12 8BU
Queen Anne Street Medical Centre
London, W1G 8HU
India13 sites
GMERS Medical College and Hospital, Sola
Ahmedabad, Gujarat, 380059
Jawaharlal Nehru Medical College (JNMC)
Ajmer, Rajasthan, 305001
Jawaharlal Nehru Medical College (JNMC)
Aligarh, Uttar Pradesh, 202002
ESIC Medical College and Hospital - Faridabad
Faridabad, Haryana, 121012
Karnataka Institute of Medical Sciences (KIMS), Hubbali
Hubli, Karnataka, 580021
Paarthiv Lung Care Center
Hyderabad, Andhra Pradesh, 500018
Yashoda Hospitals Hitec City
Hyderabad, Andhra Pradesh, 500084
Sawai Man Singh Hospital and Medical College
Jaipur, Rajasthan, 302004
Maharaja Agrasen Super Speciality Hospital
Jaipur, Rajasthan, 302039
Apollo Spectra Hospital
Kanpur, Uttar Pradesh, 208001
MV Hospital and Research Centre
Lucknow, Uttar Pradesh, 226018
Shree Hospital And Critical Care Centre
Nagpur, Maharashtra, 440009
Kothrud Hospital
Pune, Maharashtra, 411038
Israel13 sites
Assuta Ashdod Medical Center
Ashdod, 7747629
Barzilai Medical Center
Ashkelon, 7830604
Shamir Medical Center Assaf Harofeh
Be’er Ya‘aqov, 7033001
Soroka University Medical Centre
Beersheba, 8410101
Rambam Medical Center - PPDS
Haifa, 3109601
Lady Davis Carmel Medical Center
Haifa, 3436212
Shaare Zedek Medical Center
Jerusalem, 91031
Hadassah Medical Center
Jerusalem, 9112001
Meir Medical Center
Kfar Saba, 4428164
Rabin Medical Center
Petach Tiqwa, 4941492
Sheba Medical Center - PPDS
Ramat Gan, 52621
Kaplan Medical Center
Rehovot, 76100
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, 6423906
South Korea13 sites
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, 420-767
Yeungnam University Hospital
Daegu, 42415
CHA Bundang Medical Center
Gyeonggi-do, 13496
Catholic Univ. of Incheon St.Mary's Hospital
Incheon, 21431
Chonbuk National University Hospital
Jeollabuk-do, 54907
Korea University Anam Hospital
Seoul, 02841
Kangbuk Samsung Hospital
Seoul, 03181
Konkuk University Medical Center
Seoul, 05030
Asan Medical Center - PPDS
Seoul, 05505
Samsung Medical Center - PPDS
Seoul, 06351
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Chung-Ang University Hospital
Seoul, 06973
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 220-701
Canada12 sites
Dynamic Drug Advancement Ltd.
Ajax, Ontario, L1S 2J5
Burlington Lung Clinic
Burlington, Ontario, L7N 3V2
Edmonton Respiratory Consultants
Edmonton, Alberta, T5J 3S9
Centre Hospitalier de l'Universite Laval
Québec, G1V 4G5
Clinique de pneumologie et du sommeil de Lanaudiere
Saint-Charles-Borromée, Quebec, J6E 2B4
Bluewater Clinical Research Group
Sarnia, Ontario, N7T 4X3
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 5A2
Synergy Respiratory & Cardiac Care - Synergy Wellness Centre Location
Sherwood Park, Alberta, T8H 0N2
Inspiration Research
Toronto, Ontario, M5T 3A9
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1L8
Dr. Syed Anees Medicine Profession Corporation
Windsor, Ontario, N8X 1T3
Dr Anil Dhar Professional Medicine Corporation
Windsor, Ontario, N8X 5A6
Belgium10 sites
AZ Sint-Jan Brugge-Oostende
Bruges, 8000
Universitair Ziekenhuis Brussel
Brussels, 1090
UZ Antwerpen - PIN
Edegem, 2650
Private Practice Dr Jean Benoit Martinot
Erpent, 5101
Cabinet Médical De Meulemeester
Gozée, 6534
UZ Leuven
Leuven, 3000
CHU de Liège
Liège, 4000
AZ Sint-Maarten
Mechelen, 2800
AZ Delta
Roeselare, 8800
CHU UCl Namur asbl - Site Godinne
Yvoir, 5530
Chile10 sites
Centro de Investigaciones Medicas Respiratorias CIMER
Ñuñoa, 7750000
Centro de Estudios Clinicos
Ñuñoa, 7750495
Centro Respiratorio Integral LTDA. (CENRESIN)
Pavie Gallegos, 2340000
Sociedad Médica SyG SpA
Providencia, 7500000
Enroll SpA - PPDS
Providencia, 7500587
Centro Internacional de Estudios Clínicos (CIEC)
Santiago, 8420383
Centro de Investigacion del Maule
Talca
Hospital Carlos Van Buren
Valparaíso, 2340000
Centro de Investigacion de Enfermedades Respiratorias e Inmunologicas
Viña del Mar, 2531172
Fundacion Medica San Cristobal
Vitacura, 7630000
Czechia10 sites
Plicní ambulance MUDr. I. Cierná Peterová s.r.o.
Brandýs nad Labem-Stará Boleslav, 250 01
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
MediTrial s.r.o.
Jind?ich?v Hradec, 377 01
Plicni Ambulance Kralupy nad Vltavou
Kralupy nad Vltavou, 278 01
Odborna plicni ambulance Opava s.r.o
Opava, 746 01
Ordinace chorob plicních s.r.o.
Prague, 110 00
AES - DRS - Synexus Czech s.r.o.
Prague, 120 00
KASMED s.r.o.
Tábor, 390 02
Nemocnice Tabor, a.s.
Tábor, 390 03
Plicni stredisko Teplice s.r.o.
Teplice, 415 01
New Zealand7 sites
Greenlane Clinical Centre
Auckland, 1051
NZ Respiratory & Sleep Institute
Auckland, 1051
Aotearoa Clinical Trials Trust
Auckland, 2025
Canterbury Respiratory Research Group
Christchurch, 8011
Dunedin Hospital
Dunedin, 9054
Waikato Hospital
Hamilton, 3240
P3 Research - Kapiti - PPDS
Waikanae, Wellington Region, 5036
Philippines7 sites
Manila Central University-Filemon D Tanchoco Medical Foundation
Caloocan, 1442
CARE CT Group Inc.
Dasmariñas, 4114
Healthlink Medicalsurgicaldental Clinic and Diagnostic Center
Iloilo City, 5000
West Visayas State University Medical Center
Iloilo City, 5000
Mary Mediatrix Medical Center
Lipa City, 4217
Philippine Heart Center
Quezon City, 1100
Quirino Memorial Medical Center
Quezon City, 1109
Denmark6 sites
Aalborg Universitetshospital
Aalborg, 9000
Gentofte Hospital
Hellerup, 2900
Hvidovre Hospital
Hvidovre, 2650
Odense Universitetshospital
Odense C, 5000
Sjaellands Universitetshospital, Roskilde
Roskilde, 4000
Sygehus Lillebælt, Vejle
Vejle, 7100
France6 sites
Clinique de l'Europe
Amiens, 80090
Hôpital de La Croix Rousse
Lyon, 69004
Hopital Saint Joseph - Marseille
Marseille, 13285
Hopital Pasteur II
Nice, 06000
Hopital Haut Leveque
Pessac, 33600
Nouvel Hopital Civil - CHU Strasbourg
Strasbourg, 67091
Greece6 sites
Evangelismos General Hospital of Athens
Athens, 106 76
Navy Hospital of Athens
Athens, 115 21
Iatriko Palaiou Falirou
Athens, 175 62
PAGNI-University General Hospital of Heraklion
Heraklion, Irakleio, 715 00
University General Hospital of Ioannina
Ioannina, 455 00
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloniki, 570 10
Taiwan6 sites
Changhua Christian Hospital
Chang-hua, 500
Kaohsiung Medical University Hospital
Kaoshiung City, 807
Far East Memorial Hospital
New Taipei City, 220
Taipei Medical University Hospital
Taipei, 110
Taipei Veterans General Hospital
Taipei, 112
Tri-Service General Hospital
Taipei, 11490
Brazil5 sites
LMK Servicos Medicos SS
Porto Alegre, Rio Grande do Sul, 90480-000
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre, Rio Grande do Sul, 90610-000
IBPCLIN Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, 20241-180
Faculdade de Medicina do ABC - FMABC
Santo André, São Paulo, 09060-650
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, São Paulo, 09715-090
Italy5 sites
Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco
Catania, Sicily, 95123
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna
Cona, Ferrara, Emilia-Romagna, 44124
Azienda Ospedaliera Dei Colli
Naples, Campania, 80131
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Sicily, 90127
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Lombardy, 27100
Kenya5 sites
KEMRI-MTWAPA Clinical Trial Site
Kilifi, 80108
Clinical Research Health Network (CREA-N)
Machakos, 90100
KEMRI CRDR Clinical Research Clinic Nairobi
Nairobi, 00100
University of Nairobi Clinical Research Centre
Nairobi, 202
Center for Research In Tropical Medicine and community development
Thika, 01000
Netherlands5 sites
Meander Medisch Centrum
Amersfoort, 3813 TZ
Amphia Ziekenhuis
Breda, 4818 CK
Catharina Hospital
Eindhoven, 5623 EJ
Dijklander Ziekenhuis - loc Hoorn
Hoorn, 1624 NP
Isala Klinieken
Zwolle, 8011 JW
Australia4 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
Box Hill Hospital
Box Hill, Victoria, 3128
Institute for Respiratory Health Inc
Midland, Western Australia, 6056
TrialsWest Pty Ltd
Spearwood, Western Australia, 6163
Latvia4 sites
Daugavpils Regional Hospital
Daugavpils, LV-5417
Pauls Stradins Clinical University Hospital
R?ga, LV-1002
Riga 1st Hospital
Riga, LV-1001
ConsiliumMedicum
Riga, LV-1010
Mexico4 sites
CICUM San Miguel
Guadalajara, Jalisco, 44200
Unidad Medica de Occidente
Guadalajara, 44220
Unidad de Investigacion Clinica En Medicina (Udicem) S.C.
Monterrey, 64718
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
Santa Cecilia, Jalisco, 44700
Peru4 sites
Clinica Internacional - PPDS
Lima, 15001
Medicentro Biociencias Peru S.R.L.
Lima, 15084
Clinica Ricardo Palma - PPDS
San Isidro, 15036
Clinica Providencia (Inverconsult Sociedad Anonima) - PPDS
San Miguel, Lima region, 15088
Romania4 sites
Neomed Out-Patient Treatment and Diagnosis Medical Center SRL
Brasov, 500283
Dr. Victor Babes Foundation
Bucharest, 030301
Leon Daniello Pneumophthisiology Clinical Hospital
Cluj-Napoca, 400371
Sf. Ioan cel Nou Emergency County Hospital
Suceava, 720224
Sweden4 sites
Fysikalisk Medicin i Stockholm AB
Lidingö, 181 61
Clinical Trial Consultants - Linkoping
Linköping, 582 13
ProbarE i Stockholm AB
Stockholm, 114 37
Akardo AB
Stockholm, 117 27
Turkey (Türkiye)3 sites
Cukurova University Medical Faculty Balcali Hospital
Adana, 1330
Kirikkale Universitesi Tip Fakultesi Hastanesi
Kirikkale, 71100
Rize Recep Tayyip Erdogan University Training and Research Hospital
Rize Merkez, 53020
Austria2 sites
Ordination Dr. Robert Voves
Feldbach, 8330
Ordination fur Lungenkrankheiten
Linz, 4020
Thailand2 sites
Srinagarind Hospital, Khon Kaen University
Khon Kaen, 40002
Central Chest Institute of Thailand
Muang, 11000
About this study
Official title: A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease
The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Astegolimab
- Keywords
- chronic obstructive pulmonary disease, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AstegolimabDrug
Participants will receive SC astegolimab Q2W
| Study group | Role | What they receive |
|---|---|---|
| Open-Label Extension | Experimental | Eligible participants from parent studies GB43311 and GB44332 will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study Receives: Drug: Astegolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all adverse events (AEs)
Measured: Up to 12 weeks after last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start28 Jun 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878769
- Sponsor's protocol ID
- GB43374
- Status last verified
- Aug 2026
- First submitted
- 19 May 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05878769
- Acronym / sponsor ID
- GB43374
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive pulmonary disease, COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label Extension | Experimental | Drug: AstegolimabEligible participants from parent studies GB43311 and GB44332 will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Completion of the 52-week treatment period in either parent GB43311 or GB44332
Key exclusion criteria (6 listed)
- Withdrawal of consent and/or premature discontinuation from parent study
- Any permanent discontinuation of study drug in parent study
- Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator's judgment
- Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study
- Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AstegolimabParticipants will receive SC astegolimab Q2W | Drug | Open-Label Extension |
Primary outcome
Incidence of all adverse events (AEs)
Time frame: Up to 12 weeks after last dose of study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
481 sites in 40 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Astegolimab in people with Chronic Obstructive Pulmonary Disease, run by Hoffmann-La Roche at 481 sites in 40 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 481 sites in United States, Argentina, Poland, China, Japan and 35 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of all adverse events (AEs) (time frame: Up to 12 weeks after last dose of study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.