A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
Launched by GENENTECH, INC. · Aug 31, 2021
Trial Information
Current as of April 28, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called astegolimab to see how well it works and how safe it is for people with Chronic Obstructive Pulmonary Disease (COPD). The focus is on individuals who are current or former smokers and have experienced frequent flare-ups or worsening of their COPD symptoms. The trial will look at how astegolimab works alongside the usual treatments that these patients are already receiving for their COPD.
To participate in the trial, patients need to have been diagnosed with COPD for at least a year and have had multiple flare-ups in the past two years. They should also have a specific level of lung function and a history of smoking. Participants can expect to continue their regular COPD treatments while also receiving the study medication. It’s important to note that this trial is currently active, but not recruiting new participants at this time. If you think you might qualify, it’s a good idea to talk to your doctor for more information.
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- • Documented physician diagnosis of COPD for at least 12 months
- • 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
- • Current documented diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines within 5 years prior to screening
- • 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
About Genentech, Inc.
Genentech, Inc. is a leading biotechnology company and a member of the Roche Group, dedicated to transforming the lives of patients with serious medical conditions through innovative therapies. Established in 1976, Genentech is recognized for its pioneering research in biologics and for developing groundbreaking treatments in areas such as oncology, immunology, and neuroscience. With a commitment to scientific excellence and patient-centered care, the company leverages cutting-edge technology and collaborative partnerships to advance drug discovery and development. Genentech's robust pipeline and focus on personalized medicine underscore its mission to address unmet medical needs and improve health outcomes globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Houston, Texas, United States
Westmead, New South Wales, Australia
Madrid, , Spain
Zaragoza, , Spain
Malaga, , Spain
Philadelphia, Pennsylvania, United States
Box Hill, Victoria, Australia
Chicago, Illinois, United States
Evansville, Indiana, United States
Charlottesville, Virginia, United States
Barcelona, , Spain
Rehovot, , Israel
Spartanburg, South Carolina, United States
Bedford Park, South Australia, Australia
Leuven, , Belgium
Odense, , Denmark
Charlottesville, Virginia, United States
Dundee, , United Kingdom
Breda, , Netherlands
Leicester, , United Kingdom
Zwolle, , Netherlands
Barcelona, , Spain
Santander, Cantabria, Spain
Granada, , Spain
Eindhoven, , Netherlands
Breda, , Netherlands
Hvidovre, , Denmark
Bradford, , United Kingdom
Granada, , Spain
Hong Kong, , Hong Kong
Durban, , South Africa
Denver, Colorado, United States
Hellerup, , Denmark
Edegem, , Belgium
Odense C, , Denmark
Buenos Aires, , Argentina
Strasbourg, , France
Torrance, California, United States
Seoul, , Korea, Republic Of
Merida, Badajoz, Spain
Hannibal, Missouri, United States
Madrid, , Spain
Caceres, , Spain
Auckland, , New Zealand
Philadelphia, Pennsylvania, United States
Jerusalem, , Israel
Dundee, , United Kingdom
Gießen, , Germany
Poznan, , Poland
Plantation, Florida, United States
Orlando, Florida, United States
San Isidro, , Peru
Cambridge, , United Kingdom
Lyon, , France
Seoul, , Korea, Republic Of
Mendoza, , Argentina
Wien, , Austria
Valparaiso, , Chile
Aalborg, , Denmark
Saskatoon, Saskatchewan, Canada
Durango, , Mexico
Roeselare, , Belgium
Lima, , Peru
Ashkelon, , Israel
Auckland, , New Zealand
Malmö, , Sweden
Jasper, Alabama, United States
Rock Hill, South Carolina, United States
Miami, Florida, United States
Clearwater, Florida, United States
Saint Louis, Missouri, United States
Mckinney, Texas, United States
Buenos Aires, , Argentina
San Miguel De Tucuman, , Argentina
Santiago, , Chile
Guadalajara, , Mexico
Auckland, , New Zealand
Tauranga, , New Zealand
Kraków, , Poland
Buenos Aires, , Argentina
Guadalajara, , Mexico
Monterrey, , Mexico
Lima, , Peru
Wroclaw, , Poland
Mendoza, Mendoza City, , Argentina
San Miguel De Tucumán, , Argentina
Guadalajara, , Mexico
Gastonia, North Carolina, United States
Rehovot, , Israel
Mechelen, , Belgium
Essen, , Germany
Nice Cedex 1, , France
Vejle, , Denmark
Lund, , Sweden
Dupnitsa, , Bulgaria
Pleven, , Bulgaria
Christchurch, , New Zealand
Cape Town, , South Africa
Mar Del Plata, , Argentina
Lerida, , Spain
Incheon, , Korea, Republic Of
Winston Salem, North Carolina, United States
Sofia, , Bulgaria
Madrid, , Spain
Petach Tiqwa, , Israel
Petach Tiqwa, , Israel
Plovdiv, , Bulgaria
Burlington, Ontario, Canada
Troy, Michigan, United States
Linz, , Austria
Saint Charles Borromee, Quebec, Canada
Pozuelo De Alarcón, Madrid, Spain
Madrid, , Spain
Aalborg, , Denmark
Sarnia, Ontario, Canada
Yvoir, , Belgium
Charlotte, North Carolina, United States
Erpent, , Belgium
Jindřichův Hradec, , Czechia
Tabor, , Czechia
Krakow, , Poland
Cape Town, , South Africa
Sofia, , Bulgaria
Jeollabuk Do, , Korea, Republic Of
Wellington, , New Zealand
San Antonio, Texas, United States
Mendoza, , Argentina
Siedlce, , Poland
Tauranga, , New Zealand
Kraków, , Poland
Lublin, , Poland
Warszawa, , Poland
Haskovo, , Bulgaria
Suceava, , Romania
Mendoza, , Argentina
Plovdiv, , Bulgaria
Saint Charles, Missouri, United States
San Miguel De Tucuman, , Argentina
Kraaifontein, , South Africa
Mar Del Plata, , Argentina
Caba, , Argentina
Quilmes, , Argentina
Lima, , Peru
Ostrowiec Swietokrzysk, , Poland
Sosnowiec, , Poland
Talca, , Chile
Hong Kong, , Hong Kong
Westminster, California, United States
Sherman, Texas, United States
Córdoba, , Argentina
Haskovo, , Bulgaria
Pernik, , Bulgaria
Plovdiv, , Bulgaria
Stara Zagora, , Bulgaria
Nowa Sól, , Poland
Stara Zagora, , Bulgaria
Stockholm, , Sweden
Ashdod, , Israel
Berlin, , Germany
Ramat Gan, , Israel
San Diego, California, United States
North Charleston, South Carolina, United States
Córdoba, , Argentina
Santiago De Compostela, La Coruña, Spain
Mar Del Plata, , Argentina
Santiago, , Chile
Beer Jacob, , Israel
Mar Del Plata, Buenos Aires, Argentina
ñuñoa, Región Metropolitanadesantiago, Chile
Andalusia, Alabama, United States
Mobile, Alabama, United States
Peoria, Arizona, United States
Bakersfield, California, United States
Banning, California, United States
Poway, California, United States
Leesburg, Florida, United States
Loxahatchee Groves, Florida, United States
Winter Park, Florida, United States
Columbus, Georgia, United States
Fall River, Massachusetts, United States
Buckley, Michigan, United States
Lathrup Village, Michigan, United States
Las Vegas, Nevada, United States
Shelby, North Carolina, United States
Winston Salem, North Carolina, United States
Anderson, South Carolina, United States
Clinton, South Carolina, United States
Fort Mill, South Carolina, United States
Boerne, Texas, United States
Houston, Texas, United States
Ciudad Autónoma De Buenos Aires, , Argentina
Lobos, , Argentina
Rosario, , Argentina
Rosario, , Argentina
Villa Vatteone, , Argentina
Spearwood, Western Australia, Australia
Thuin, , Belgium
Yoir, , Belgium
Razgrad, , Bulgaria
Curico, , Chile
Providencia, , Chile
Providencia, , Chile
Talca, , Chile
ñuñoa, , Chile
Kralupy Nad Vltavou, , Czechia
Miroslav, , Czechia
Novy Bor, , Czechia
Strakonice, , Czechia
Marseille, , France
Augsburg, , Germany
Bamberg, , Germany
Berlin, , Germany
Deggingen, , Germany
Frankfurt Am Main, , Germany
Koblenz, , Germany
Landsberg, , Germany
Leipzig, , Germany
Marburg, , Germany
Peine, , Germany
Americana, Jalisco, Mexico
Eindhoven, , Netherlands
Hoorn, , Netherlands
Bydgoszcz, , Poland
Kielce, , Poland
Kraków, , Poland
Lódz, , Poland
Rzeszów, , Poland
Brasov, , Romania
Bucuresti, , Romania
Cluj Napoca, , Romania
Constanta, , Romania
City Of Tshwane, , South Africa
Ekurhuleni, , South Africa
Ekurhuleni, , South Africa
Härnösand, , Sweden
Stockholm, , Sweden
London, , United Kingdom
Florencio Varela, Buenos Aires, Argentina
Curico, Maule, Chile
Santiago, Región Metropolitanadesantiago, Chile
Mendoza, , Argentina
San Fernando, , Argentina
Lovech, , Bulgaria
Pazardzhik, , Bulgaria
Vratsa, , Bulgaria
Mainz, , Germany
Lidingö, , Sweden
Jacksonville, Florida, United States
Tel Aviv Yafo, , Israel
Chicago, Illinois, United States
Boerne, Texas, United States
Houston, Texas, United States
Jind?Ich?V Hradec, , Czechia
Tauranga, , New Zealand
Santiago De Compostela, La Coruña, Spain
Dothan, Alabama, United States
Cincinnati, Ohio, United States
Hamilton, Ontario, Canada
Guadalajara, Jalisco, Mexico
Victoria De Durango, Durango, Mexico
Guadalajara, Jalisco, Mexico
Guadalajara, Jalisco, Mexico
Monterrey, Nuevo Leon, Mexico
Loma Linda, California, United States
Hannibal, Missouri, United States
Lima, , Peru
Warszawa, , Poland
Sosnowiec, , Poland
Santiago De Compostela, La Coruña, Spain
Warszawa, , Poland
Warszawa, , Poland
Bucharest, , Romania
Spartanburg, South Carolina, United States
Ciudad Autonoma Buenos Aires, , Argentina
Rosario, , Argentina
Landsberg, , Germany
London, , United Kingdom
Hastings, , New Zealand
Tel Hashomer, , Israel
Nice Cedex 1, , France
Auckland, , New Zealand
Shreveport, Louisiana, United States
Santa Cecilia, Jalisco, Mexico
Ramat Gan, , Israel
New Brunswick, New Jersey, United States
Saskatchewan, , Canada
Santa Elena Alcalde, Jalisco, Mexico
Be'er Ya'akov, , Israel
Mar Del Plata, , Argentina
Jerusalem, , Israel
Santiago De Compostela, La Coruna, Spain
Orlando, Florida, United States
Tábor, , Czechia
Ostrowiec Swietokrzysk, , Poland
Clearwater, Florida, United States
Chesterfield, Missouri, United States
Saint Louis, Missouri, United States
Ciudad Autonoma De Buenos Aires, , Argentina
Rosario, , Argentina
San Miguel De Tucuman, , Argentina
ñuñoa, , Chile
Bendorf, , Germany
Jeonju Si, , Korea, Republic Of
Lima, , Peru
Suceava, , Romania
London, , United Kingdom
Providencia, Región Metropolitanadesantiago, Chile
Guadalajara Centro, Jalisco, Mexico
Lidingö, , Sweden
London, London, City Of, United Kingdom
Patients applied
Trial Officials
Clinical Trials
Study Director
Hoffmann-La Roche
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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