A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
2,000
39 countries
479
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 chronic-obstructive-pulmonary-disease
Started Jun 2023
Longer than P75 for phase_3 chronic-obstructive-pulmonary-disease
479 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2023
CompletedFirst Posted
Study publicly available on registry
May 26, 2023
CompletedStudy Start
First participant enrolled
June 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
April 2, 2026
April 1, 2026
4 years
May 19, 2023
April 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of all adverse events (AEs)
Up to 12 weeks after last dose of study treatment
Study Arms (1)
Open-Label Extension
EXPERIMENTALEligible participants from parent studies GB43311 and GB44332 will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study
Interventions
Eligibility Criteria
You may qualify if:
- Completion of the 52-week treatment period in either parent GB43311 or GB44332
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (483)
UAB Lung Health Center
Birmingham, Alabama, 35205-2610, United States
SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
Dothan, Alabama, 36305, United States
Jasper Summit Research LLC
Jasper, Alabama, 35501, United States
Pulmonary Associates of Mobile PC
Mobile, Alabama, 36608-3135, United States
Pulmonary Associates Deer Valley Office
Phoenix, Arizona, 85027-5163, United States
AES - DRS - Synexus Clinical Research US, Inc. - Tucson
Tucson, Arizona, 85741-3118, United States
Kern Allergy and Medical Research
Bakersfield, California, 93301-4205, United States
Cadena Care Institute, LLC
Poway, California, 92064-2419, United States
Apex Clinical Research
San Diego, California, 92120, United States
St Francis Medical Institute ClinEdge PPDS
Clearwater, Florida, 33765, United States
Finlay Medical Research Corporation
Greenacres City, Florida, 33467-2979, United States
Flourish Research - Leesburg - PPDS
Leesburg, Florida, 34748-5077, United States
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida, 33470-9272, United States
San Marcus Research Clinic Inc.
Miami, Florida, 33014, United States
Finlay Medical Research Corporation
Miami, Florida, 33126-1941, United States
Oceane7 Medical & Research Center, Inc.
Miami, Florida, 33144-2155, United States
Research Institute of South Florida Inc
Miami, Florida, 33173, United States
Diverse Clinical Research, LLC
Miami, Florida, 33175-3434, United States
Central Florida Pulmonary Group, PA
Orlando, Florida, 32803, United States
Florida Institute for Clinical Research, LLC
Orlando, Florida, 32825-4454, United States
Flourish Research - Orlando - PPDS
Winter Park, Florida, 32789-4681, United States
Pivotal Research Solutions
Stonecrest, Georgia, 30038-2649, United States
Northwestern Center for Clinical Research
Chicago, Illinois, 60611, United States
ASHA Clinical Research - ClinEdge - PPDS
Hammond, Indiana, 46324-2213, United States
Best Clinical Trials
New Orleans, Louisiana, 70115-3628, United States
Paul A. Shapero, MD, PA
Bangor, Maine, 04401-5691, United States
Exordia Medical Research, Inc.
Fall River, Massachusetts, 02723-1511, United States
Pulmonary Research Institute of Southeast Michigan
Farmington Hills, Michigan, 48336, United States
Flushing Road Internal Medicine and Pediatrics - F
Flint, Michigan, 48504-4730, United States
Revive Research Institute
Southfield, Michigan, 48075, United States
Oakland Medical Research
Troy, Michigan, 48085, United States
The Lung Research Center
Chesterfield, Missouri, 63017-3625, United States
Hannibal Regional Healthcare System HRMG Hannibal
Hannibal, Missouri, 63401-6890, United States
Midwest Chest Consultants
Saint Charles, Missouri, 63301, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110, United States
Midwest Clinical Research LLC
St Louis, Missouri, 63141, United States
The Machuca Foundation Inc
Las Vegas, Nevada, 89101-3485, United States
Sierra Clinical Research - ClinEdge - PPDS
Las Vegas, Nevada, 89106-4159, United States
Renown Regional Medical Center Hospital
Reno, Nevada, 89502-1576, United States
AES - DRS - Synexus Clinical Research US, Inc. - New York
New York, New York, 10017-4008, United States
American Health Research Inc.
Charlotte, North Carolina, 28277, United States
Research Carolina Elite
Denver, North Carolina, 28037-7929, United States
Clinical Research of Gastonia
Gastonia, North Carolina, 28054, United States
Pulmonix LLC
Greensboro, North Carolina, 27403-4443, United States
Carolina Research Center
Shelby, North Carolina, 28150-3803, United States
Southeastern Research Center
Winston-Salem, North Carolina, 27103-4029, United States
OK Clinical Research
Edmond, Oklahoma, 73034-3258, United States
The Oregon Clinic.
Portland, Oregon, 97220, United States
Clinical Research Associates Of Central Pa , Llc
DuBois, Pennsylvania, 15801-2277, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Allergy & Clinical Immun Assoc
Pittsburgh, Pennsylvania, 15241, United States
Medtrial, LLC
Columbia, South Carolina, 29204, United States
Velocity Clinical Research - Gaffney - PPDS
Gaffney, South Carolina, 29340-4737, United States
Lowcountry Lung and Critical Care
North Charleston, South Carolina, 29406, United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732, United States
ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
Tennessee Comprehensive Lung & Sleep Center
Hendersonville, Tennessee, 37075-3085, United States
South Texas Medical Research Institute, Inc., dba TTS Research ? ClinEdge ? PPDS
Boerne, Texas, 78006-1993, United States
Corsicana Medical Research
Corsicana, Texas, 75110-2471, United States
Trio Clinical Trials
Houston, Texas, 77008-1772, United States
Baylor College of Medicine
Houston, Texas, 77030-4202, United States
Houston Pulmonary Medicine Associates, PA - Biopharma Informatic, LLC
Houston, Texas, 77089-6097, United States
Metroplex Pulmonary and Sleep Medicine Center
McKinney, Texas, 75069, United States
Sherman Clinical Research - ClinEdge - PPDS
Sherman, Texas, 75090, United States
Vermont Lung Center at the University of Vermont
Colchester, Vermont, 05446-3052, United States
University of Virginia Health System
Charlottesville, Virginia, 22903, United States
Western Washington Medical Group
Everett, Washington, 98208, United States
Allergy Asthma and Sinus Center-Greenfield
Greenfield, Wisconsin, 53228, United States
Centro Medico Capital
La Plata, Buenos Aires, B1900, Argentina
CEMLO - Centro de Especialidades Médicas Lobos - Patagones 94
Lobos, Buenos Aires, B7240KJB, Argentina
Consultorios Medicos Organizacion de Buen Ayre SRL
Buenos Aires, 1425, Argentina
Centro de Investigaciones Clínicas Belgrano
Buenos Aires, 7240, Argentina
Fundacion Cidea
Buenos Aires, C1121ABE, Argentina
Fundacion Faicep
Buenos Aires, C1122AAK, Argentina
Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias
Buenos Aires, C1425, Argentina
AES - AS - Glenny Corp. S.A. Buenos Aires
Buenos Aires, C1430, Argentina
CARE - Centro de Alergia y Enfermedades Respiratorias
CABA, C1414AIF, Argentina
Nexo Salud Investigacion Clinica - Riobamba 429
Ciudad Autonoma Buenos Aires, C1025ABI, Argentina
CINME S.A. ? Centro de Investigaciones Metabolicas - Rx Trials LLC
Ciudad Autonoma Buenos Aires, C1056ABI, Argentina
Centro Médico Dra de Salvo
Ciudad Autonoma Buenos Aires, C1426ABP, Argentina
Centro de Medicina Respiratoria
Concepción del Uruguay, 3260, Argentina
Sanatorio de la Canada
Córdoba, X5000BSQ, Argentina
Instituto de Medicina Respiratoria, IMeR
Córdoba, X5003DCE, Argentina
Centro Privado de Medicina Respiratoria
Entre Ríos, E3100BBJ, Argentina
Framingham Centro Medico
La Plata, 1900, Argentina
Centro Platense en Investigaciones Respiratorias
La Plata, B1900BNN, Argentina
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, B7600FYK, Argentina
Instituto de Investigaciones Clinicas-Mar del Plata
Mar del Plata, B7600FZN, Argentina
Instituto Ave Pulmo
Mar del Plata, B7602DCK, Argentina
Centro Medico Dharma
Mendoza, 5500, Argentina
Fundacion Scherbovsky
Mendoza, M5500AXR, Argentina
INSARES
Mendoza, Mendoza City, M5500CCG, Argentina
Centro Respiratorio Quilmes
Quilmes, B1878FNR, Argentina
Sala de primeros auxilios Alberto Mignaburu
Ranelagh, Berazategui, 1886, Argentina
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, S2000DEJ, Argentina
Sanatorio Parque de Rosario
Rosario, S2000KZD, Argentina
Instituto Medico Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion Medica
Rosario, S2002OJP, Argentina
Servicio de Investigacion de Patologias Alergicas-Instituto ABC
Rosario, S2013JKR, Argentina
Centro Medico IPAM
Rosario, S2013SBK, Argentina
Centro Médico Respire
San Fernando, B1646EBJ, Argentina
Instituto De Patologias Respiratorias
San Miguel de Tucumán, 4000, Argentina
Centro Integral de Medicina Respiratoria (CIMER)
San Miguel de Tucumán, T4000CHE, Argentina
Centro Modelo de Cardiologia
San Miguel de Tucumán, T4000IFL, Argentina
Centro Medico San Nicolas Grupo Orono
San Nicolás de los Arroyos, B2900, Argentina
CEPROSS- Centro Profesional San Salvador
San Salvador, E3218CHH, Argentina
Instituto Del Buen Aire
Santa Fe, 3000, Argentina
Centro de Diagnostico Y Rehabilitacion
Santa Fe, S3000, Argentina
Instituto De Enfermedades Respiratorias E Investigacion Medica
Villa Vatteone, B1853AIK, Argentina
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Institute for Respiratory Health Inc
Midland, Western Australia, 6056, Australia
TrialsWest Pty Ltd
Spearwood, Western Australia, 6163, Australia
Ordination Dr. Robert Voves
Feldbach, 8330, Austria
Ordination fur Lungenkrankheiten
Linz, 4020, Austria
AZ Sint-Jan Brugge-Oostende
Bruges, 8000, Belgium
Universitair Ziekenhuis Brussel
Brussels, 1090, Belgium
Antwerp University Hospital
Edegem, 2650, Belgium
Private Practice Dr Jean Benoit Martinot
Erpent, 5101, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHU de Liège
Liège, 4000, Belgium
AZ Sint-Maarten
Mechelen, 2800, Belgium
AZ Delta
Roeselare, 8800, Belgium
Office of Marc De Meulemeester
Thuin, 6534, Belgium
CHU UCl Namur asbl - Site Godinne
Yvoir, 5530, Belgium
LMK Servicos Medicos SS
Porto Alegre, Rio Grande do Sul, 90480-000, Brazil
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Faculdade de Medicina do ABC - FMABC
Santo André, São Paulo, 09060-650, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, São Paulo, 09715-090, Brazil
IBPCLIN Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, 20241-180, Brazil
MHAT Knyaginya Klementina Sofia EAD
Sofia, Sofia-Grad, 1233, Bulgaria
Diagnostic-Consultative Center Aleksandrovska EOOD
Sofia, Sofia-Grad, 1431, Bulgaria
Multiprofile Hospital for Active Treatment Puls AD PPDS
Blagoevgrad, 2700, Bulgaria
Multiprofile Hospital For Active Treatment Sveta Ekaterina - Dimitrovgrad EOOD
Dimitrovgrad, 6400, Bulgaria
Medical Centre "Asklepii", OOD
Dupnitsa, 2600, Bulgaria
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD
Haskovo, 6300, Bulgaria
Medical Centre Pratia EOOD branch Lovech
Lovech, 5500, Bulgaria
Medical Center Hera EOOD
Montana, 3400, Bulgaria
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Dr.Nikola Penchev-Paza
Pazardzhik, 4400, Bulgaria
Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD
Pernik, 2300, Bulgaria
Medical center Medconsult Pleven OOD
Pleven, 5800, Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv, 4002, Bulgaria
Multiprofile Hospital for Active Treatment Plovdiv
Plovdiv, 4003, Bulgaria
Medical center Unimed EOOD
Plovdiv, 4023, Bulgaria
Multiprofile Hospital for Active Treatment Shumen
Shumen, 9700, Bulgaria
Multiprofile Hospital for Active Treatment - Silistra AD
Silistra, 7500, Bulgaria
Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
Smolyan, 4700, Bulgaria
Medical Center Hera Eood
Sofia, 1510, Bulgaria
University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD
Sofia, 1606, Bulgaria
Diagnostic- Consultative Center Convex EOOD
Sofia, 1680, Bulgaria
AES DRS Medical Center Synexus Sofia EOOD
Sofia, 1784, Bulgaria
Medical Center New rehabilitation center EOOD
Stara Zagora, 6003, Bulgaria
Medical Center Researchexpert OOD
Varna, 9000, Bulgaria
Medical Center Tara OOD
Veliko Tarnovo, 5000, Bulgaria
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa
Vratsa, 3000, Bulgaria
Edmonton Respiratory Consultants
Edmonton, Alberta, T5J 3S9, Canada
Synergy Respiratory & Cardiac Care - Synergy Wellness Centre Location
Sherwood Park, Alberta, T8H 0N2, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1L8, Canada
Dynamic Drug Advancement Ltd.
Ajax, Ontario, L1S 2J5, Canada
Burlington Lung Clinic
Burlington, Ontario, L7N 3V2, Canada
Bluewater Clinical Research Group
Sarnia, Ontario, N7T 4X3, Canada
Inspiration Research
Toronto, Ontario, M5T 3A9, Canada
Dr. Syed Anees Medicine Profession Corporation
Windsor, Ontario, N8X 1T3, Canada
Dr Anil Dhar Professional Medicine Corporation
Windsor, Ontario, N8X 5A6, Canada
Clinique de pneumologie et du sommeil de Lanaudiere
Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 5A2, Canada
Centre Hospitalier de l'Universite Laval
Québec, G1V 4G5, Canada
Centro de Estudios Clinicos
Ñuñoa, 7750495, Chile
Centro Respiratorio Integral LTDA. (CENRESIN)
Pavie Gallegos, 2340000, Chile
Centro de Investigaciones Medicas Respiratorias CIMER
Providencia, 7500000, Chile
Sociedad Médica SyG SpA
Providencia, 7500000, Chile
Enroll SpA - PPDS
Providencia, 7500587, Chile
Centro Internacional de Estudios Clínicos (CIEC)
Santiago, 8420383, Chile
Centro de Investigacion del Maule
Talca, Chile
Hospital Carlos Van Buren
Valparaíso, 2340000, Chile
Centro de Investigacion de Enfermedades Respiratorias e Inmunologicas
Viña del Mar, 2531172, Chile
Fundacion Medica San Cristobal
Vitacura, 7630000, Chile
Anhui Chest Hospital
Hefei, Anhui, 230022, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100144, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000, China
The Central Hospital of Wuhan
Wuhan, Hubei, 430014, China
The First Hospital of Changsha
Changsha, Hunan, 410005, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221002, China
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055, China
Huadong Hospital Affiliated of Fudan University
Shanghai, Shanghai Municipality, 200040, China
Beijing Hospital
Beijing, 100006, China
Beijing Chaoyang Hospital Capital Medical University
Beijing, 100020, China
China-Japan Friendship Hospital
Beijing, 100029, China
Beijing Jingmei Group General Hospital
Beijing, 100042, China
The First Hospital of Jilin University
Changchun, 130021, China
The Third Hospital of Changsha
Changsha, China
West China Hospital, Sichuan University
Chengdu, 610041, China
Chengdu Fifth People's Hospital
Chengdu, 611130, China
The Southwest Hospital of Army Medical University
Chongqing, 400038, China
Army Medical Center of PLA(Daping Hospital)
Chongqing, 400042, China
Affiliated Hospital of Guangdong Medical University
Guangdong, 524023, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120, China
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510150, China
Guangzhou First People's Hospital
Guangzhou, 510180, China
Hangzhou First People's Hospital
Hangzhou, 310006, China
Huizhou Central People's Hospital
Huizhou, 516001, China
The First People's Hospital of Lian Yun Gang
Lianyungang, 222023, China
Taizhou Hospital of Zhejiang Province
Linhai, 317000, China
Jiangxi Provincial People's Hospital
Nanchang, 330006, China
Zhongda Hospital Affiliated to Southeast University
Nanjing, 210009, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
Wuxi People's Hospital
Wuxi, 214023, China
Jiangyin People's Hospital
Wuxi, 214400, China
Xi'an International Medical Center Hospital
Xi'an, 710100, China
Zhongshan Hospital Xiamen University
Xiamen, 361004, China
Xinxiang First People's Hospital
Xinxiang, 453000, China
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai, 519001, China
Zigong First People's Hospital
Zigong, 643036, China
Plicní ambulance MUDr. I. Cierná Peterová s.r.o.
Brandýs nad Labem-Stará Boleslav, 250 01, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
MediTrial s.r.o.
Jind?ich?v Hradec, 377 01, Czechia
Plicni Ambulance Kralupy nad Vltavou
Kralupy nad Vltavou, 278 01, Czechia
Odborna plicni ambulance Opava s.r.o
Opava, 746 01, Czechia
Ordinace chorob plicních s.r.o.
Prague, 110 00, Czechia
AES - DRS - Synexus Czech s.r.o.
Prague, 120 00, Czechia
KASMED s.r.o.
Tábor, 390 02, Czechia
Nemocnice Tabor, a.s.
Tábor, 390 03, Czechia
Plicni stredisko Teplice s.r.o.
Teplice, 415 01, Czechia
Aalborg Universitetshospital
Aalborg, 9000, Denmark
Gentofte Hospital
Hellerup, 2900, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
Odense Universitetshospital
Odense C, 5000, Denmark
Sjaellands Universitetshospital, Roskilde
Roskilde, 4000, Denmark
Sygehus Lillebælt, Vejle
Vejle, 7100, Denmark
Clinique de l'Europe
Amiens, 80090, France
Hôpital de La Croix Rousse
Lyon, 69004, France
Hopital Saint Joseph - Marseille
Marseille, 13285, France
Hopital Pasteur II
Nice, 06000, France
Hopital Haut Leveque
Pessac, 33600, France
Nouvel Hopital Civil - CHU Strasbourg
Strasbourg, 67091, France
Zentrum fuer Pneumologie, Onkologie und Schlafmedizin am Diako
Augsburg, 86150, Germany
Gemeinschaftspraxis fuer Herz und Lunge am Bruderw
Bamberg, 96049, Germany
KPPK Studienzentrum Kroker-Schmidt
Bendorf, 56170, Germany
Studienpraxis Berlin-Brandenburg, Berlin
Berlin, 10119, Germany
Praxis fur Kardiologie und Pneumologie Dr. med. Karin Forster
Berlin, 10367, Germany
MECS Research GmbH
Berlin, 12203, Germany
AES - DRS - Synexus Berlin Research Centre
Berlin, 12627, Germany
Clinical Studies Pankow
Berlin, 13187, Germany
Lungenzentrum Darmstadt
Darmstadt, 64283, Germany
MVZ Jung GbR - Deggingen
Deggingen, 73326, Germany
Medizentrum Essen Borbeck
Essen, 45355, Germany
Universitaetsklinikum Frankfurt
Frankfurt, 60596, Germany
Praxis Dr med Claus Keller
Frankfurt am Main, 60389, Germany
ME Clinical Respiratory Research Hamburg GmbH
Hamburg, 22299, Germany
Pneumologicum
Hanover, 30173, Germany
University Clinic Heidelberg
Heidelberg, 69120, Germany
Lungenfachklinik Immenhausen
Immenhausen, 34376, Germany
Asklepios MVZ Bayern GmbH
Landsberg, 86899, Germany
Salvus-Klinische Studien GmbH
Leipzig, 04207, Germany
BAG Prof. Dr. G. Hoheisel Dr. A. Bonitz
Leipzig, 04299, Germany
KLB Gesundheitsforschung Lubeck GmbH
Lübeck, 23552, Germany
SMO.MD GmbH
Magdeburg, 39120, Germany
IKF Pneumologie Mainz
Mainz, 55128, Germany
Praxis für Pneumologie Dr. Silke Mronga & Dr. Lukas Jerrentrup
Marburg, 35037, Germany
Praxis Dr. med. Jan Feimer
München, 80539, Germany
Institut fur klinische Forschung GmbH
Neu-Isenburg, 63263, Germany
Studienzentrum Dr Med Schlenska
Peine, 31224, Germany
framol-med GmbH
Rheine, 48431, Germany
RoMed Klinikum Rosenheim-Pettenkoferstr. 10
Rosenheim, 83022, Germany
Evangelismos General Hospital of Athens
Athens, 106 76, Greece
Navy Hospital of Athens
Athens, 115 21, Greece
Iatriko Palaiou Falirou
Athens, 175 62, Greece
University General Hospital of Heraklion
Heraklion, 711 10, Greece
University General Hospital of Ioannina
Ioannina, 455 00, Greece
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloniki, 570 10, Greece
Tuen Mun Hospital
Hong Kong, Hong Kong
Obudai Egeszsegugyi Centrum Kft.-Budapest
Budapest, 1036, Hungary
Paarthiv Lung Care Center
Hyderabad, Andhra Pradesh, 500018, India
Yashoda Hospitals Hitec City
Hyderabad, Andhra Pradesh, 500084, India
GMERS Medical College and Hospital, Sola
Ahmedabad, Gujarat, 380059, India
ESIC Medical College and Hospital - Faridabad
Faridabad, Haryana, 121012, India
Karnataka Institute of Medical Sciences (KIMS), Hubbali
Hubli, Karnataka, 580021, India
Shree Hospital And Critical Care Centre
Nagpur, Maharashtra, 440009, India
Kothrud Hospital
Pune, Maharashtra, 411038, India
Jawaharlal Nehru Medical College (JNMC)
Ajmer, Rajasthan, 305001, India
Sawai Man Singh Hospital and Medical College
Jaipur, Rajasthan, 302004, India
Maharaja Agrasen Super Speciality Hospital
Jaipur, Rajasthan, 302039, India
Jawaharlal Nehru Medical College (JNMC)
Aligarh, Uttar Pradesh, 202002, India
Apollo Spectra Hospital
Kanpur, Uttar Pradesh, 208001, India
MV Hospital and Research Centre
Lucknow, Uttar Pradesh, 226018, India
Assuta Ashdod Medical Center
Ashdod, 7747629, Israel
Barzilai Medical Center
Ashkelon, 7830604, Israel
Soroka University Medical Centre
Beersheba, 8410101, Israel
Shamir Medical Center Assaf Harofeh
Be’er Ya‘aqov, 7033001, Israel
Rambam Medical Center - PPDS
Haifa, 3109601, Israel
Lady Davis Carmel Medical Center
Haifa, 3436212, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Hadassah Medical Center
Jerusalem, 9112001, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Rabin Medical Center
Petach Tiqwa, 4941492, Israel
Sheba Medical Center - PPDS
Ramat Gan, 52621, Israel
Kaplan Medical Center
Rehovot, 76100, Israel
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, 6423906, Israel
Azienda Ospedaliera Dei Colli
Naples, Campania, 80131, Italy
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna
Cona, Ferrara, Emilia-Romagna, 44124, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Lombardy, 27100, Italy
Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco
Catania, Sicily, 95123, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Sicily, 90127, Italy
Japan Community Health Care Organization Hokkaido Hospital
Toyohira-ku, Sapporo City, Hokkaido, 062-8618, Japan
Matsusaka City Hospital
Matsusaka-Shi, Mie-ken, 515-8544, Japan
Shizuoka City Shizuoka Hospital
Shizuoka-Shi Aoi-Ku, Shizuoka, 420-8630, Japan
Asahikawa Medical Center
Asahikawa-shi, 070-8644, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, 818-8502, Japan
Fukuwa Clinic
Chūō, 104-0031, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Nishi Fukuoka Hospital
Fukuoka-Shi Nishi-Ku, 819-8555, Japan
Fukushima Medical University Hospital
Fukushima, 960-1295, Japan
National Hospital Organization Kyoto Medical Center
Fushimi-ku, Kyoto, 612-8555, Japan
Terada Respiratory and Internal Clinic
Himeji, 670-0849, Japan
Hiroshima Prefectural Hospital
Hiroshima, 734-8530, Japan
National Hospital Organization Minami Kyoto Hospital
Jōyō, 610-0113, Japan
Kagoshima Kouseiren Hospital
Kagoshima, 890-0062, Japan
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, 236-0051, Japan
Sagamihara National Hospital
Kanagawa, 252-0392, Japan
Osaka-Minami Medical Center
Kawachinagano-Shi, 586-8521, Japan
Kishiwada City Hospital
Kishiwada-Shi, 596-8501, Japan
Juntendo Tokyo Koto Geriatric Medical Center
Kōtō City, 136-0075, Japan
Saiseikai Kumamoto Hospital
Kumamoto, 861-4193, Japan
National Hospital Organization Okayama Medical Center
Okayama, 701-1192, Japan
Okayama Rosai Hospital
Okayama-Shi Minami-ku, 702-8055, Japan
Omuta National Hospital
Omuta, 837-0911, Japan
Idaimae Minami 4-Jo Internal Medicine
Sapporo-shi Chuo-ku, 064-0804, Japan
Japanese Red Cross Medical Center
Shibuya-ku, 150-8935, Japan
Kamei Internal Medicine and Respiratory Clinic
Takamatsu, 761-8073, Japan
Nagata Hospital
Yanagawa, 832-0059, Japan
Yokohama City University Medical Center
Yokohama, 232-0024, Japan
Showa University Fujigaoka Hospital
Yokohama-shi Aoba-ku, 227-8501, Japan
National Hospital Organization - Yokohama Medical Center
Yokohama-Shi Totsuka-Ku, 245-8575, Japan
KEMRI-MTWAPA Clinical Trial Site
Kilifi, 80108, Kenya
Clinical Research Health Network (CREA-N)
Machakos, 90100, Kenya
KEMRI CRDR Clinical Research Clinic Nairobi
Nairobi, 00100, Kenya
University of Nairobi Clinical Research Centre
Nairobi, 202, Kenya
Center for Research In Tropical Medicine and community development
Thika, 01000, Kenya
Daugavpils Regional Hospital
Daugavpils, LV-5417, Latvia
Pauls Stradins Clinical University Hospital
R?ga, LV-1002, Latvia
Riga 1st Hospital
Riga, LV-1001, Latvia
ConsiliumMedicum
Riga, LV-1010, Latvia
CICUM San Miguel
Guadalajara, Jalisco, 44200, Mexico
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
Santa Cecilia, Jalisco, 44700, Mexico
Unidad Medica de Occidente
Guadalajara, 44220, Mexico
Unidad de Investigacion Clinica En Medicina (Udicem) S.C.
Monterrey, 64718, Mexico
Meander Medisch Centrum
Amersfoort, 3813 TZ, Netherlands
Amphia Ziekenhuis
Breda, 4818 CK, Netherlands
Catharina Hospital
Eindhoven, 5623 EJ, Netherlands
Dijklander Ziekenhuis - loc Hoorn
Hoorn, 1624 NP, Netherlands
Isala Klinieken
Zwolle, 8011 JW, Netherlands
P3 Research - Kapiti - PPDS
Waikanae, Wellington Region, 5036, New Zealand
Greenlane Clinical Centre
Auckland, 1051, New Zealand
NZ Respiratory & Sleep Institute
Auckland, 1051, New Zealand
Aotearoa Clinical Trials Trust
Auckland, 2025, New Zealand
Canterbury Respiratory Research Group
Christchurch, 8011, New Zealand
Dunedin Hospital
Dunedin, 9054, New Zealand
Waikato Hospital
Hamilton, 3240, New Zealand
Clinica Providencia (Inverconsult Sociedad Anonima) - PPDS
San Miguel, Lima region, 15088, Peru
Clinica Internacional - PPDS
Lima, 15001, Peru
Medicentro Biociencias Peru S.R.L.
Lima, 15084, Peru
Clinica Ricardo Palma - PPDS
San Isidro, 15036, Peru
Manila Central University-Filemon D Tanchoco Medical Foundation
Caloocan, 1442, Philippines
CARE CT Group Inc.
Dasmariñas, 4114, Philippines
Healthlink Medicalsurgicaldental Clinic and Diagnostic Center
Iloilo City, 5000, Philippines
West Visayas State University Medical Center
Iloilo City, 5000, Philippines
Mary Mediatrix Medical Center
Lipa City, 4217, Philippines
Philippine Heart Center
Quezon City, 1100, Philippines
Quirino Memorial Medical Center
Quezon City, 1109, Philippines
Viltis Medica Sp. Z o.o.
Trzebnica, Lower Silesian Voivodeship, 55-100, Poland
Lekarze Specjalisci J. Malolepszy i Partnerzy
Wroclaw, Lower Silesian Voivodeship, 54-239, Poland
AppleTreeClinics Network Sp. z o.o.
Lodz, Lódzkie, 90-349, Poland
Prywatny Gabinet Lekarski Ginekologia i Poloznictwo Ultrasonografia Prof. Jacek Suzin
Lodz, Lódzkie, 90-602, Poland
Centrum Medycyny Oddechowej Mroz sp. j.
Bia?ystok, 15-044, Poland
Vitamed Galaj i Cichomski sp.j.
Bydgoszcz, 85-079, Poland
Medical Center Kermed
Bydgoszcz, 85-231, Poland
Centrum Medyczne Bydgoszcz- PRATIA - PPDS
Bydgoszcz, 85-796, Poland
Centrum Medyczne Lukamed Joanna Luka-Wendrowska
Chojnice, 89-600, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, 81-537, Poland
Centrum Medyczne CLW-med Aneta Cichomska , Joanna Luka -Wendrowska
Grudzadz, 86-300, Poland
Centrum Medyczne Katowice - PRATIA - PPDS
Katowice, 40-081, Poland
Indywidualna Specjalistyczna Praktyka Lekarska lek.
Kielce, 25-751, Poland
Centrum Medyczne ALL-MED
Krakow, 30-033, Poland
Diamond Clinic
Krakow, 31-559, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.
Krakow, 31-637, Poland
Praktyka Lekarska Adam Smialowski
Ksawerów, 95-054, Poland
AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi
Lodz, 90-127, Poland
ETG Lodz
Lodz, 90-302, Poland
Clinical Best Solutions - Lublin
Lublin, 20-078, Poland
NZOZ Przychodnia Alergologiczno-pulmonologiczna
Lublin, 20-089, Poland
ETG Lublin
Lublin, 20-412, Poland
Twoja Przychodnia Centrum Medyczne Nowa Sol
Nowa Sól, 67-100, Poland
Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik
Ostrowiec Swietokrzysk, 27-400, Poland
Centrum Alergologii Teresa Hofman
Poznan, 60-214, Poland
ABC-Pulmo NZOZ Agnieszka Dobielska, Jaroslaw Dobie
Radom, 26-600, Poland
EMED Centrum Uslug Medycznych Ewa Smialek
Rzeszów, 35-205, Poland
ETG Siedlce
Siedlce, 08-110, Poland
Centrum Medyczne KARDIOTEL
Sopot, 81-741, Poland
Kiepury Clinic
Sosnowiec, 41-200, Poland
PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna
Sosnowiec, 41-208, Poland
Gabinet Pulmonologii i Diagnostyki Chorob Alergicznych Dorota Malosek
Szczecin, 70-111, Poland
CenterMed Bandrowskiego
Tarnów, 33-100, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, 01-192, Poland
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
Wroc?aw, 51-162, Poland
Dobrostan Gabinety Lekarskie
Wroc?aw, 53-301, Poland
Allianze Pulmonary Research LLC
Guaynabo, 00968, Puerto Rico
Neomed Out-Patient Treatment and Diagnosis Medical Center SRL
Brasov, 500283, Romania
Dr. Victor Babes Foundation
Bucharest, 030301, Romania
Leon Daniello Pneumophthisiology Clinical Hospital
Cluj-Napoca, 400371, Romania
Sf. Ioan cel Nou Emergency County Hospital
Suceava, 720224, Romania
Johese Clinical Research
City of Tshwane, Gauteng, 0157, South Africa
Iatros International
Bloemfontein, 9301, South Africa
University of Cape Town Lung Institute
Cape Town, 7700, South Africa
Dr. Ismail Abdullah Private Practice
City of Cape Town, 7764, South Africa
Newtown Clinical Research Centre
City of Johannesburg, 2001, South Africa
Clinical Trial Systems
City of Tshwane, 0186, South Africa
St Augustines Hospital
Durban, 4001, South Africa
Lakeview Hospital
Ekurhuleni, 1500, South Africa
Dr A.C Wilhase practice-Reimed
Ekurhuleni, 1501, South Africa
CLINRESCO, ARWYP Medical Suites
Ekurhuleni, 1619, South Africa
Langeberg Clinical Trials
Kraaifontein, 7570, South Africa
Medicross Pretoria West, Jongaie Research
Pretoria, 0183, South Africa
AES - DRS - Synexus Watermeyer Clinical Research Centre
Pretoria, 0184, South Africa
AES - DRS - Synexus - Helderberg Clinical Research Centre
Somerset West, 7130, South Africa
Dr Yacoob AK Private Practice
Welkom, 9459, South Africa
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, 420-767, South Korea
Yeungnam University Hospital
Daegu, 42415, South Korea
CHA Bundang Medical Center
Gyeonggi-do, 13496, South Korea
Catholic Univ. of Incheon St.Mary's Hospital
Incheon, 21431, South Korea
Chonbuk National University Hospital
Jeollabuk-do, 54907, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Asan Medical Center - PPDS
Seoul, 05505, South Korea
Samsung Medical Center - PPDS
Seoul, 06351, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 220-701, South Korea
Hospital de Merida
Mérida, Badajoz, 06800, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07120, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, LA Coruna, 15706, Spain
Hospital Universitario de Torrejon
Torrejón de Ardoz, Madrid, 28850, Spain
Vithas Xanit International Hospital
Benalmádena Costa, Malaga, 29630, Spain
Hospital de La Ribera
Alzira, Valencia, 46600, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hospital Universitario Virgen de Las Nieves
Granada, 18012, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Hospital Universitario Fundacion Jimenez Diaz.
Madrid, 28040, Spain
Hospital Universitario La Paz - PPDS
Madrid, 28046, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Fysikalisk Medicin i Stockholm AB
Lidingö, 181 61, Sweden
Clinical Trial Consultants - Linkoping
Linköping, 582 13, Sweden
PharmaSite
Malmo, 211 52, Sweden
ProbarE i Stockholm AB
Stockholm, 114 37, Sweden
Akardo AB
Stockholm, 117 27, Sweden
Zurcher Reha Zentren Wald
Zurich, Switzerland
Changhua Christian Hospital
Chang-hua, 500, Taiwan
Kaohsiung Medical University Hospital
Kaoshiung City, 807, Taiwan
Far East Memorial Hospital
New Taipei City, 220, Taiwan
Taipei Medical University Hospital
Taipei, 110, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Tri-Service General Hospital
Taipei, 11490, Taiwan
Srinagarind Hospital, Khon Kaen University
Khon Kaen, 40002, Thailand
Central Chest Institute of Thailand
Muang, 11000, Thailand
Cukurova University Medical Faculty Balcali Hospital
Adana, 1330, Turkey (Türkiye)
Kirikkale Universitesi Tip Fakultesi Hastanesi
Kırıkkale, 71100, Turkey (Türkiye)
Rize Recep Tayyip Erdogan University Training and Research Hospital
Rize Merkez, 53020, Turkey (Türkiye)
Guys Hospital
London, Middlesex, SE1 9RT, United Kingdom
AES - DRS - Synexus Scotland Clinical Research Centre
Bellshill, ML4 3NJ, United Kingdom
Bradford Royal Infirmary
Bradford, BD9 6RJ, United Kingdom
Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
AES - DRS - Synexus Wales Clinical Research Centre
Cardiff, CF15 9SS, United Kingdom
Royal Primary Care - Ashgate Manor
Chesterfield, S40 4AA, United Kingdom
AES - DRS - NW Consortium Lancashire
Chorley, PR7 7NA, United Kingdom
Castle Hill Hospital
Cottingham, HU16 5JQ, United Kingdom
AES - DRS - Synexus Midlands Clinical Research Centre
Edgbaston, B15 2SQ, United Kingdom
AES - DRS - Synexus Hexham Clinical Research Centre
Hexham, NE46 1QJ, United Kingdom
Glenfield Hospital
Leicester, LE3 9QP, United Kingdom
AES - DRS - NW Consortium Merseyside
Liverpool, L32 2AN, United Kingdom
Velocity Clinical Research North London - Percy Road - PPDS
London, N12 8BU, United Kingdom
Queen Anne Street Medical Centre
London, W1G 8HU, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Central Study Contacts
Reference Study ID Number: GB43374 https://forpatients.roche.com/
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2023
First Posted
May 26, 2023
Study Start
June 28, 2023
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
April 2, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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