A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
NCT ID: NCT05037929
Last Updated: 2025-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
1334 participants
INTERVENTIONAL
2021-10-05
2025-07-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
NCT05878769
A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
NCT05595642
The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01205269
A 4 Week Study to Investigate the Safety and Tolerability of AZD5069 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT01233232
Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT00758459
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Astegolimab Q2W
Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W).
Astegolimab
Participants will receive SC astegolimab Q2W or Q4W.
Astegolimab Q4W
Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving astegolimab every 4 weeks (Q4W).
Astegolimab
Participants will receive SC astegolimab Q2W or Q4W.
Placebo
Participants will receive SC placebo Q2W.
Placebo
Participants will receive SC placebo Q2W.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Astegolimab
Participants will receive SC astegolimab Q2W or Q4W.
Placebo
Participants will receive SC placebo Q2W.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* History of frequent exacerbations, defined as having had two or more moderate or severe exacerbations occurring within a 12-month period in the 24 months prior to screening
* Post-bronchodilator FEV1 \>=20 and \<80% of predicted normal value at screening
* Modified Medical Research Council (dyspnea scale) (mMRC) score \>=2
* Current or former smoker with a minimum of 10 pack-year history
* History of one of the following combinations of optimized, stable, standard-of-care COPD maintenance therapy for at least 4 weeks prior to screening, with no anticipated changes in therapy prior to initiation of study drug and throughout the study: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA); Long-acting muscarinic antagonist (LAMA) plus LABA; ICS plus LAMA plus LABA
Exclusion Criteria
* History of clinically significant pulmonary disease other than COPD
* History of long-term treatment with oxygen at \>4.0 liters/minute
* Lung volume reduction surgery or procedure within 12 months prior to screening
* Participation in or planned participation in a new pulmonary rehabilitation program. Patients who are in the maintenance phase of a rehabilitation program are eligible
* History of lung transplant
* Occurrence of moderate or severe COPD exacerbation, COVID-19, upper or lower respiratory infection, pneumonia, or hospitalization of 24 hours duration within 4 weeks prior to initiation of study drug
* Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
* Initiation of a methylxanthine preparation, maintenance macrolide therapy, and/or PDE4 inhibitor within 4 weeks 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
40 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Genentech, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
Dothan, Alabama, United States
Jasper Summit Research LLC
Jasper, Alabama, United States
Pulmonary Associates of Mobile PC
Mobile, Alabama, United States
Cadena Care Institute, LLC
Poway, California, United States
Inst. of Healthcare Assessment, Inc.
San Diego, California, United States
Allianz Research Institute Inc
Westminster, California, United States
National Jewish Health
Denver, Colorado, United States
Clinical Site Partners - Leesburg Suite 101 - HyperCore - PPDS
Leesburg, Florida, United States
Florida Institute for Clinical Research, LLC
Orlando, Florida, United States
Clinical Site Partners - Winter Park - HyperCore - PPDS
Winter Park, Florida, United States
Northwestern Center for Clinical Research
Chicago, Illinois, United States
Medisphere Medical Research Center, Llc
Evansville, Indiana, United States
Exordia Medical Research, Inc.
Fall River, Massachusetts, United States
Northern Pines Health Center PC
Buckley, Michigan, United States
Revive Research Institute
Lathrup Village, Michigan, United States
Cardio-Pulmonary Associates
Chesterfield, Missouri, United States
Blessing Health Hannibal
Hannibal, Missouri, United States
Midwest Chest Consultants
Saint Charles, Missouri, United States
CARE Clinical Research
St Louis, Missouri, United States
Midwest Clinical Research LLC
St Louis, Missouri, United States
Sierra Clinical Research - ClinEdge - PPDS
Las Vegas, Nevada, United States
American Health Research Inc.
Charlotte, North Carolina, United States
Clinical Research of Gastonia
Gastonia, North Carolina, United States
Carolina Research Center
Shelby, North Carolina, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Lowcountry Lung and Critical Care
North Charleston, South Carolina, United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, United States
Velocity Clinical Research Spartanburg PPDS
Spartanburg, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
South Texas Medical Research Institute, Inc., dba TTS Research ? ClinEdge ? PPDS
Boerne, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Metroplex Pulmonology & Sleep Center
McKinney, Texas, United States
Sherman Clinical Research - ClinEdge - PPDS
Sherman, Texas, United States
Centro Medico IPAM
Rosario, Santa Fe Province, Argentina
Centro de Investigaciones Clínicas Belgrano
Buenos Aires, , Argentina
Instituto de Investigaciones Clinicas-Mar del Plata
Buenos Aires, , Argentina
Fundacion Cidea
Buenos Aires, , Argentina
Centro Médico Dra de Salvo
Buenos Aires, , Argentina
CARE - Centro de Alergia y Enfermedades Respiratorias
CABA, , Argentina
Instituto de Medicina Respiratoria, IMeR
Córdoba, , Argentina
Centro de Especialidades Medicas Lobos
Lobos, , Argentina
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, , Argentina
Instituto Ave Pulmo
Mar del Plata, , Argentina
INSARES
Mendoza, , Argentina
Centro Respiratorio Quilmes
Quilmes, , Argentina
Instituto Medico Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion Medica
Rosario, , Argentina
Centro Médico Respire
San Fernando, , Argentina
Instituto De Enfermedades Respiratorias E Investigacion Medica
San Juan Bautista, , Argentina
Investigaciones en Patologias Respiratorias
San Miguel de Tucumán, , Argentina
Centro Integral de Medicina Respiratoria (CIMER)
San Miguel de Tucumán, , Argentina
Westmead Hospital
Westmead, New South Wales, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
TrialsWest Pty Ltd
Spearwood, Western Australia, Australia
AZ Sint-Maarten
Mechelen, Antwerpen, Belgium
UZ Antwerpen
Edegem, , Belgium
Private Practice Dr Jean Benoit Martinot
Erpent, , Belgium
AZ Delta
Roeselare, , Belgium
Office of Marc De Meulemeester
Thuin, , Belgium
CHU UCl Namur asbl - Site Godinne
Yvoir, , Belgium
Medical Centre "Asklepii", OOD
Dupnitsa, , Bulgaria
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD
Haskovo, , Bulgaria
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Dr.Nikola Penchev-Paza
Pazardzhik, , Bulgaria
Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD
Pernik, , Bulgaria
Medical center Medconsult Pleven OOD
Pleven, , Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv, , Bulgaria
Medical center Unimed EOOD
Plovdiv, , Bulgaria
Medical Centre Respiro OOD
Razgrad, , Bulgaria
Medical Center Hera EOOD
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD
Sofia, , Bulgaria
Medical Center New rehabilitation center EOOD
Stara Zagora, , Bulgaria
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa
Vratsa, , Bulgaria
Burlington Lung Clinic
Burlington, Ontario, Canada
St. Joseph's Healthcare Hamilton- Charlton Campus
Hamilton, Ontario, Canada
Bluewater Clinical Research Group
Sarnia, Ontario, Canada
University of Saskatchewan, Royal University Hospital
Saskatoon, Saskatchewan, Canada
Centro de Investigaciones Medicas Respiratorias
Providencia, Región-MetropolitanadeSantiago, Chile
Centro de Investigación Curico
Curicó, , Chile
MIRES/MYF estudios clinicos
Ñuñoa, , Chile
Sociedad Médica SyG SpA
Providencia, , Chile
Enroll SpA - PPDS
Providencia, , Chile
Meditek Ltda
Santiago, , Chile
Centro de Investigacion del Maule
Talca, , Chile
Hospital Carlos Van Buren
Valparaíso, , Chile
MediTrial s.r.o.
Jind?ich?v Hradec, , Czechia
Plicni Ambulance Kralupy nad Vltavou
Kralupy nad Vltavou, , Czechia
MUDr. Ilona Pavlisova s.r.o.
Miroslav, , Czechia
Pneumologie Varnsdorf S.r.o.
Nový Bor, , Czechia
KASMED s.r.o.
Tábor, , Czechia
Aalborg Universitetshospital
Aalborg, , Denmark
Gentofte Hospital
Hellerup, , Denmark
Hvidovre Hospital
Hvidovre, , Denmark
Odense Universitetshospital
Odense, , Denmark
Sygehus Lillebælt, Vejle
Vejle, , Denmark
Hôpital de La Croix Rousse
Lyon, , France
CHU de Nice
Nice, , France
Nouvel Hôpital Civil
Strasbourg, , France
Zentrum fuer Pneumologie, Onkologie und Schlafmedizin am Diako
Augsburg, , Germany
CIMS-Studienzentrum Bamberg,
Bamberg, , Germany
KPPK Studienzentrum Kroker-Schmidt
Bendorf, , Germany
MECS Research GmbH
Berlin, , Germany
Praxis Dr. Med Evelin Liefring
Berlin, , Germany
Gemeinscharftspraxis Dres Jung - Deggingen
Deggingen, , Germany
Medizentrum Essen Borbeck
Essen, , Germany
Praxis Dr med Claus Keller
Frankfurt am Main, , Germany
Universitätsklinikum Gießen und Marburg GmbH
Giessen, , Germany
Asklepios MVZ Bayern GmbH
Landsberg, , Germany
Salvus-Klinische Studien GmbH
Leipzig, , Germany
Zentrum fuer ambulante pneumologische Forschung Marburg GbR
Marburg, , Germany
Studienzentrum Dr Med Schlenska
Peine, , Germany
Tuen Mun Hospital
Hong Kong, , Hong Kong
Assuta Ashdod Medical Center
Ashdod, , Israel
Barzilai Medical Center
Ashkelon, , Israel
Shamir Medical Center Assaf Harofeh
Beer Jacob, , Israel
Tel Aviv Sourasky Medical Center PPDS
Jerusalem, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Kaplan Medical Center
Rehovot, , Israel
Sheba Medical Center - PPDS
Tel Litwinsky, , Israel
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
Guadalajara, Jalisco, Mexico
Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
Guadalajara, Jalisco, Mexico
Unidad Medica de Occidente
Guadalajara, Jalisco, Mexico
CICUM San Miguel
Guadalajara Centro, Jalisco, Mexico
Unidad de Investigacion Clinica En Medicina (Udicem) S.C.
Monterrey, Nuevo León, Mexico
Centro de Investigacion y Atencion Integral Durango CIAID
Durango, , Mexico
Amphia Ziekenhuis
Breda, , Netherlands
Isala Klinieken
Zwolle, , Netherlands
Aotearoa Clinical Trials Trust
Auckland, , New Zealand
Canterbury Respiratory Research Group
Christchurch, , New Zealand
Clinica Providencia (Inverconsult Sociedad Anonima)
Lima, , Peru
Clinica Internacional
Lima, , Peru
Clinica Ricardo Palma
Lima, , Peru
Alfredo Berrocal Kasay Reuma Sociedad de Responsabilidad Limitada
Lima Cercado, , Peru
Centrum Medyczne Bydgoszcz- PRATIA - PPDS
Bydgoszcz, , Poland
Indywidualna Specjalistyczna Praktyka Lekarska lek.
Kielce, , Poland
Centrum Medyczne ALL-MED
Krakow, , Poland
Diamond Clinic
Krakow, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.
Krakow, , Poland
ETG Lodz
Lódz, , Poland
ETG Lublin
Lublin, , Poland
Twoja Przychodnia Centrum Medyczne Nowa Sol
Nowa Sól, , Poland
Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik
Ostrowiec Swietokrzysk, , Poland
Centrum Alergologii Teresa Hofman
Poznan, , Poland
EMED Centrum Uslug Medycznych Ewa Smialek
Rzeszów, , Poland
ETG Siedlce
Siedlce, , Poland
PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna
Sosnowiec, , Poland
ETG Warszawa- PPDS
Warsaw, , Poland
Dobrostan Gabinety Lekarskie
Wroclaw, , Poland
Neomed Out-Patient Treatment and Diagnosis Medical Center SRL
Brasov, , Romania
Dr. Victor Babes Foundation
Bucharest, , Romania
Leon Daniello Pneumophthisiology Clinical Hospital
Cluj-Napoca, , Romania
Spitalul Clinic de Pneumoftiziologie Constanta
Constanța, , Romania
Sf. Ioan cel Nou Emergency County Hospital
Suceava, , Romania
University of Cape Town Lung Institute
Cape Town, , South Africa
Clinical Trial Systems
City of Tshwane, , South Africa
St Augustines Hospital
Durban, , South Africa
Dr A.C Wilhase practice-Reimed
Ekurhuleni, , South Africa
Lakeview Hospital
Ekurhuleni, , South Africa
Langeberg Clinical Trials
Kraaifontein, , South Africa
Catholic Univ. of Incheon St.Mary's Hospital
Incheon, , South Korea
Chonbuk National University Hospital
Jeonju, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Hospital de Merida
Mérida, Badajoz, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
CHUS H Clinico U de Santiago
Santiago de Compostela, LA Coruna, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital de San Pedro de Alcantara
Cáceres, , Spain
Hospital Universitario Virgen de Las Nieves
Granada, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz.
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Fysikalisk Medicin i Stockholm AB
Lidingö, , Sweden
ProbarE i Lund AB
Lund, , Sweden
PharmaSite
Malmo, , Sweden
ProbarE i Stockholm AB
Stockholm, , Sweden
Queen Anne Street Medical Centre
London, London, City of, United Kingdom
Bradford Royal Infirmary
Bradford, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
Ninewells Hospital
Dundee, , United Kingdom
Glenfield Hospital
Leicester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GB43311
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.