A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Launched by HOFFMANN-LA ROCHE · May 19, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
**Study Summary: Astegolimab for COPD**
This clinical trial is investigating the long-term safety and effectiveness of a medication called astegolimab in people with Chronic Obstructive Pulmonary Disease (COPD). The study is for individuals who have already participated in a previous 52-week trial and completed their treatment. The goal is to see how well astegolimab works over a longer period and to ensure it remains safe for patients.
To participate, you must have finished the earlier study (either GB43311 or GB44332) without any major issues, such as stopping the treatment early or having significant health problems. If you meet these criteria and are between the ages of 14 and 87, you may be eligible to join the trial. If you participate, you can expect regular check-ins to monitor your health and how you respond to the medication. This study is currently recruiting participants, and it aims to provide important information about managing COPD with astegolimab.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Completion of the 52-week treatment period in either parent GB43311 or GB44332
- Exclusion Criteria:
- • 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
About Hoffmann La Roche
Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Houston, Texas, United States
Valencia, , Spain
Madrid, , Spain
Malaga, , Spain
Philadelphia, Pennsylvania, United States
Box Hill, Victoria, Australia
Jerusalem, , Israel
Chicago, Illinois, United States
Evansville, Indiana, United States
Barcelona, , Spain
Rehovot, , Israel
Madrid, , Spain
Bedford Park, South Australia, Australia
Burlington, Vermont, United States
Vancouver, British Columbia, Canada
Charlottesville, Virginia, United States
Breda, , Netherlands
Leicester, , United Kingdom
Zwolle, , Netherlands
Alzira, Valencia, Spain
Santander, Cantabria, Spain
Granada, , Spain
Eindhoven, , Netherlands
Hvidovre, , Denmark
Brussels, , Belgium
Sevilla, , Spain
Haifa, , Israel
Leuven, , Belgium
Bradford, , United Kingdom
Granada, , Spain
Hong Kong, , Hong Kong
Leuven, , Belgium
Durban, , South Africa
Khon Kaen, , Thailand
Hellerup, , Denmark
Santiago De Compostela, La Coruña, Spain
Odense C, , Denmark
Buenos Aires, , Argentina
Taipei, , Taiwan
Seoul, , Korea, Republic Of
Merida, Badajoz, Spain
Hamilton, , New Zealand
Quezon City, , Philippines
Seoul, , Korea, Republic Of
Cambridge, , United Kingdom
Immenhausen, , Germany
Chattanooga, Tennessee, United States
Chengdu, , China
Caceres, , Spain
Taipei, , Taiwan
Auckland, , New Zealand
Hradec Kralove, , Czechia
Jerusalem, , Israel
Poznan, , Poland
Liège, , Belgium
Orlando, Florida, United States
Heidelberg, , Germany
Daugavpils, , Latvia
Taipei City, , Taiwan
Madrid, , Spain
Lyon, , France
Madrid, , Spain
Seoul, , Korea, Republic Of
Quezon City, , Philippines
Valparaiso, , Chile
Aalborg, , Denmark
Orlando, Florida, United States
Cottingham, , United Kingdom
Bloemfontein, , South Africa
Edegem, , Belgium
Santiago, , Chile
Kennewick, Washington, United States
Lipa City, , Philippines
Amiens, , France
Roeselare, , Belgium
Guangzhou, , China
Hangzhou, , China
Santiago De Compostela, La Coruna, Spain
Dunedin, , New Zealand
Amersfoort, , Netherlands
Seoul, , Korea, Republic Of
Ashkelon, , Israel
Malmö, , Sweden
Jasper, Alabama, United States
Rock Hill, South Carolina, United States
Saint Louis, Missouri, United States
Haifa, , Israel
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Strasbourg, , France
Daegu, , Korea, Republic Of
Linhai, , China
Xiamen, , China
Saint Louis, Missouri, United States
Buenos Aires, , Argentina
Auckland, , New Zealand
Kraków, , Poland
Kirikkale, , Turkey
Miami, Florida, United States
Buenos Aires, , Argentina
San Miguel De Tucuman, , Argentina
Smolyan, , Bulgaria
Veliko Tarnovo, , Bulgaria
Monterrey, , Mexico
Auckland, , New Zealand
Wroclaw, , Poland
Portland, Oregon, United States
Mendoza, Mendoza City, , Argentina
San Miguel De Tucumán, , Argentina
Santa Fe, , Argentina
München, , Germany
Guadalajara, , Mexico
Jerusalem, , Israel
Gastonia, North Carolina, United States
Rehovot, , Israel
Mechelen, , Belgium
Iloilo City, , Philippines
Xuzhou, , China
Pittsburgh, Pennsylvania, United States
Essen, , Germany
Vejle, , Denmark
Gdynia, , Poland
Lund, , Sweden
Dupnitsa, , Bulgaria
Pleven, , Bulgaria
Herakleion, , Greece
Palermo, Sicilia, Italy
Wonju Si, , Korea, Republic Of
Christchurch, , New Zealand
Cape Town, , South Africa
Pavia, Lombardia, Italy
Incheon, , Korea, Republic Of
Sofia, , Bulgaria
New Taipei, , Taiwan
Porto Alegre, Rio Grande Do Sul, Brazil
Madrid, , Spain
Changchun City, , China
Beer Sheva, , Israel
Torrejon De Ardoz, Madrid, Spain
Petach Tiqwa, , Israel
Plovdiv, , Bulgaria
Rosario, , Argentina
Everett, Washington, United States
Columbia, South Carolina, United States
Burlington, Ontario, Canada
Guangdong, , China
Chang Hua, , Taiwan
Tianjin, , China
Kfar Saba, , Israel
Troy, Michigan, United States
Darmstadt, , Germany
Hannover, , Germany
Saint Charles Borromee, Quebec, Canada
Madrid, , Spain
Aalborg, , Denmark
Bucheon Si,, , Korea, Republic Of
Centurion, , South Africa
Athens, , Greece
Magdeburg, , Germany
Sarnia, Ontario, Canada
Marseille, , France
Tabor, , Czechia
Gyeonggi Do, , Korea, Republic Of
Yvoir, , Belgium
Charlotte, North Carolina, United States
Erpent, , Belgium
Toronto, Ontario, Canada
Tabor, , Czechia
Krakow, , Poland
Cape Town, , South Africa
Guangzhou, , China
Nanjing, , China
Lodz, , Poland
Roskilde, , Denmark
Beijing City, , China
Ioannina, , Greece
Sofia, , Bulgaria
Beijing City, , China
Haifa, , Israel
Jeollabuk Do, , Korea, Republic Of
Windsor, Ontario, Canada
Wroclaw, , Poland
Pingxiang, , China
Palma De Mallorca, Islas Baleares, Spain
Mendoza, , Argentina
Siedlce, , Poland
Kraków, , Poland
Lublin, , Poland
Changsha, , China
Zunyi, Guizhou, China
Feldbach, , Austria
Suceava, , Romania
Xinxiang, , China
Mckinney, Texas, United States
Santiago, , Chile
Xuzhou, , China
Brugge, , Belgium
Ramat Gan, , Israel
Hefei, , China
Beijing, , China
Riga, , Latvia
Rio De Janeiro, , Brazil
Sofia, , Bulgaria
Saint Charles, Missouri, United States
Farmington Hills, Michigan, United States
Nagpur, Maharashtra, India
Montana, , Bulgaria
Kraaifontein, , South Africa
Shumen, , Bulgaria
Mar Del Plata, , Argentina
Pessac, , France
Edmond, Oklahoma, United States
Caba, , Argentina
Quilmes, , Argentina
Ostrowiec Swietokrzysk, , Poland
Sosnowiec, , Poland
Sofia, , Bulgaria
Westminster, California, United States
Sherman, Texas, United States
Córdoba, , Argentina
Haskovo, , Bulgaria
Pernik, , Bulgaria
Plovdiv, , Bulgaria
Stara Zagora, , Bulgaria
Nowa Sól, , Poland
Nanchang, , China
Stara Zagora, , Bulgaria
Ashdod, , Israel
Berlin, , Germany
Lübeck, , Germany
Plovdiv, , Bulgaria
Lianyungang, , China
San Diego, California, United States
Miami, Florida, United States
Chesterfield, Missouri, United States
North Charleston, South Carolina, United States
Córdoba, , Argentina
Marburg, , Germany
Napoli, Campania, Italy
Blagoevgrad, , Bulgaria
Bydgoszcz, , Poland
Warszawa, , Poland
Cardiff, , United Kingdom
Chorley, , United Kingdom
Mar Del Plata, , Argentina
Sao Bernardo Do Campo, , Brazil
Windsor, Ontario, Canada
Mobile, Alabama, United States
Banning, California, United States
Poway, California, United States
Loxahatchee Groves, Florida, 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
Ciudad Autónoma De Buenos Aires, , Argentina
Lobos, , Argentina
Rosario, , Argentina
Villa Vatteone, , Argentina
Spearwood, Western Australia, Australia
Thuin, , Belgium
Yoir, , Belgium
Providencia, , Chile
Providencia, , Chile
Talca, , Chile
Kralupy Nad Vltavou, , Czechia
Marseille, , France
Augsburg, , Germany
Frankfurt Am Main, , Germany
Koblenz, , Germany
Leipzig, , Germany
Peine, , Germany
Americana, Jalisco, Mexico
Eindhoven, , Netherlands
Hoorn, , Netherlands
Bydgoszcz, , Poland
Kielce, , Poland
Kraków, , Poland
Lódz, , Poland
Rzeszów, , Poland
Brasov, , Romania
Cluj Napoca, , Romania
City Of Tshwane, , South Africa
Ekurhuleni, , South Africa
Ekurhuleni, , South Africa
Stockholm, , Sweden
London, , United Kingdom
Sosnowiec, , Poland
Athina, , Greece
San Fernando, , Argentina
Lovech, , Bulgaria
Pazardzhik, , Bulgaria
Vratsa, , Bulgaria
Mainz, , Germany
Lidingö, , Sweden
New York, New York, United States
Montana, , Bulgaria
Ajax, Ontario, Canada
Nairobi, , Kenya
Denver, North Carolina, United States
Tel Aviv Yafo, , Israel
Lublin, , Poland
Muang, , Thailand
Changsha, , China
Guangzhou, , China
R?Ga, , Latvia
Bia?Ystok, , Poland
Boerne, Texas, United States
Jind?Ich?V Hradec, , Czechia
Adana, , Turkey
Greenacres City, Florida, United States
Kanpur, Uttar Pradesh, India
Flint, Michigan, United States
Gaffney, South Carolina, United States
Dothan, Alabama, United States
Bangor, Maine, United States
Hammond, Indiana, United States
Reno, Nevada, United States
Corsicana, Texas, United States
Victoria De Durango, Durango, Mexico
Monterrey, Nuevo Leon, Mexico
Porto Alegre, Rio Grande Do Sul, Brazil
Chongqing City, , China
Tucson, Arizona, United States
Stonecrest, Georgia, United States
Miami, Florida, United States
Hendersonville, Tennessee, United States
Houston, Texas, United States
Trzebnica, , Poland
City Of Johannesburg, , South Africa
Kempton Park, , South Africa
Pretoria, , South Africa
Lima, , Peru
Leesburg, Florida, United States
Houston, Texas, United States
Dimitrovgrad, , Bulgaria
Hamburg, , Germany
Paraparaumu, , New Zealand
Bydgoszcz, , Poland
Katowice, , Poland
Benalmadena Costa, Malaga, Spain
Hannibal, Missouri, United States
Clearwater, Florida, United States
Dubois, Pennsylvania, United States
Sosnowiec, , Poland
Johannesburg, , South Africa
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Mendoza, , Argentina
San Nicolas De Los Arroyos, , Argentina
Opava, , Czechia
Berlin, , Germany
Neu Isenburg, , Germany
Rheine, , Germany
Thessaloniki, , Greece
Chojnice, , Poland
Grudzadz, , Poland
Lodz, , Poland
Lublin, , Poland
Radom, , Poland
Sopot, , Poland
Szczecin, , Poland
Zurich, , Switzerland
Santiago De Compostela, La Coruña, Spain
Buenos Aires, , Argentina
Ciudad Autonoma Buenos Aires, , Argentina
Ciudad Autonoma De Buenos Aires, , Argentina
Concepcion Del Uruguay, , Argentina
Ranelagh, Berazategui, , Argentina
Rosario, , Argentina
San Salvador, , Argentina
Santa Fe, , Argentina
Linz, , Austria
Pavie Gallegos, , Chile
Vina Del Mar, , Chile
Vitacura, , Chile
Leipzig, , Germany
Athens, , Greece
Pretoria, , South Africa
Somerset West, , South Africa
Stockholm, , Sweden
Dubois, Pennsylvania, United States
Bucharest, , Romania
Las Vegas, Nevada, United States
Cordoba, , Argentina
Entre Rios, , Argentina
La Plata, , Argentina
Sofia, , Bulgaria
Varna, , Bulgaria
Edmonton, Alberta, Canada
Teplice, , Czechia
Berlin, , Germany
Linkoping, , Sweden
Berlin, , Germany
Bellshill, , United Kingdom
Spartanburg, South Carolina, United States
Ciudad Autonoma Buenos Aires, , Argentina
Rosario, , Argentina
Stow, Massachusetts, United States
Nice, , France
Landsberg, , Germany
Ciudad Autonoma De Buenos Aires, , Argentina
Silistra, , Bulgaria
Brandys Nad Labem Stara Boleslav, , Czechia
Frankfurt, , Germany
Machakos, , Kenya
Lodz, , Poland
Chesterfield, , United Kingdom
Hexham, , United Kingdom
Miami, Florida, United States
San Miguel De Tucuman, , Argentina
Miami, Florida, United States
Farmington Hills, Michigan, United States
La Plata, , Argentina
La Plata, , Argentina
Sherwood Park, Alberta, Canada
Quebec, , Canada
Huizhou, , China
Praha 1, , Czechia
Praha, , Czechia
Ajmer, Rajasthan, India
Jaipur, Rajasthan, India
Lucknow, Uttar Pradesh, India
Edgbaston, , United Kingdom
Liverpool, , United Kingdom
Warszawa, , Poland
Santa Fe, , Argentina
Beijing, , China
Wuxi, , China
Zigong, , China
Iloilo City, , Philippines
Hyderabad, Andhra Pradesh, India
Auckland, , New Zealand
Chengdu, , China
Takamatsu, , Japan
Dasmarinas, , Philippines
Tarnow, , Poland
Welkom, , South Africa
London, , United Kingdom
Guaynabo, , Puerto Rico
Santa Cecilia, Jalisco, Mexico
Jaipur, Rajasthan, India
Bamberg, , Germany
Berlin, , Germany
Deggingen, , Germany
Xian, , China
Wuhan, , China
Pune City, Maharashtra, India
Kilifi, , Kenya
Nairobi, , Kenya
Thika, , Kenya
Caloocan City, , Philippines
Rize Merkez, , Turkey
Ramat Gan, , Israel
Recoleta, , Chile
Pittsburgh, Pennsylvania, United States
Zhuhai City, , China
Budapest, , Hungary
City Of Cape Town, , South Africa
Santa Elena Alcalde, Jalisco, Mexico
Santiago, , Chile
Las Vegas, Nevada, United States
Beijing City, , China
San Diego, California, United States
Mendoza, , Argentina
New Orleans, Louisiana, United States
Lodz, Lódzkie, Poland
Be'er Ya'akov, , Israel
Hefei, , China
Ciudad Autonoma Buenos Aires, , Argentina
Mar Del Plata, , Argentina
Phoenix, Arizona, United States
Portland, Oregon, United States
Charlottesville, Virginia, United States
Lovech, , Bulgaria
Ciudad Autonoma Buenos Aires, , Argentina
Rosario, , Argentina
San Miguel De Tucuman, , Argentina
Chicago, Illinois, United States
Southfield, Michigan, United States
Santo Andre, São Paulo, Brazil
Sao Bernardo Do Campo, São Paulo, Brazil
Hyderabad, Andhra Pradesh, India
Aligarh, Uttar Pradesh, India
Riga, , Latvia
Kaoshiung City, , Taiwan
Greensboro, North Carolina, United States
San Miguel De Tucuman, , Argentina
Phoenix, Arizona, United States
Poway, California, United States
Miami, Florida, United States
Orlando, Florida, United States
Wellington, Florida, United States
New Orleans, Louisiana, United States
Fall River, Massachusetts, United States
Edmond, Oklahoma, United States
Greenfield, Wisconsin, United States
Ciudad Autonoma Buenos Aires, , Argentina
Mar Del Plata, , Argentina
Rosario, , Argentina
Midland, Western Australia, Australia
Providencia, , Chile
ñuñoa, , Chile
Tábor, , Czechia
Nice, , France
Catania, Sicilia, Italy
Ksawerow, , Poland
Ostrowiec Swietokrzysk, , Poland
Wroc?Aw, , Poland
Ekurhuleni, , South Africa
Ekurhuleni, , South Africa
Ethekwini, , South Africa
Bendorf, , Germany
Houston, Texas, United States
La Plata, Buenos Aires, Argentina
Sofia, Sofia Grad, Bulgaria
Sofia, Sofia Grad, Bulgaria
Hefei, , China
San Isidro, , Peru
San Miguel, , Peru
Birmingham, Alabama, United States
Winter Park, Florida, United States
Changsha, , China
Wuhan, , China
Bakersfield, California, United States
Wuxi City, , China
Rosenheim, , Germany
Cona, Ferrara, Emilia Romagna, Italy
Lima, , Peru
Lodz, Lódzkie, Poland
City Of Tshwane, Gauteng, South Africa
Colchester, Vermont, United States
Vina Del Mar, , Chile
Shanghai, Shanghai, China
Hubli, Karnataka, India
San Miguel, Lima, Peru
Wroclaw, Dolnoslaskie, Poland
London, Middlesex, United Kingdom
Santo Andre, , Brazil
Lodz, , Poland
Patients applied
Trial Officials
Clinical Trials
Study Director
Hoffmann-La Roche
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported