Chronic Obstructive Pulmonary Disease Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 2000 |
| Est. completion date | June 30, 2027 |
| Est. primary completion date | June 30, 2027 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 90 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Centro Médico Dra de Salvo | Buenos Aires | |
| Argentina | Fundacion Cidea | Buenos Aires | |
| Argentina | Instituto de Investigaciones Clinicas-Mar del Plata | Buenos Aires | |
| Argentina | CARE - Centro de Alergia y Enfermedades Respiratorias | Caba | |
| Argentina | Centro de Investigaciones Clínicas Belgrano | Ciudad Autonoma Buenos Aires | |
| Argentina | Instituto de Medicina Respiratoria, IMeR; Clinic/Outpatient Facility | 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 | Fundacion Scherbovsky | Mendoza | |
| Argentina | INSARES | Mendoza, Mendoza City | |
| Argentina | Centro Respiratorio Quilmes | Quilmes | |
| Argentina | Centro Medico IPAM | Rosario | |
| Argentina | Instituto Medico Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion Medica | Rosario | |
| Argentina | Centro Médico Respire | San Fernando | |
| Argentina | Instituto De Patologias Respiratorias | San Miguel de Tucuman | |
| Argentina | Centro Integral de Medicina Respiratoria (CIMER) | San Miguel de Tucumán | |
| Argentina | Instituto De Enfermedades Respiratorias E Investigacion Medica | Villa Vatteone | |
| Australia | Flinders Medical Centre | Bedford Park | South Australia |
| Australia | Box Hill Hospital | Box Hill | Victoria |
| Australia | TrialsWest Pty Ltd | Spearwood | Western Australia |
| Belgium | Antwerp University Hospital | Edegem | |
| Belgium | Private Practice Dr Jean Benoit Martinot | Erpent | |
| Belgium | UZ Leuven | Leuven | |
| Belgium | AZ Sint-Maarten | Mechelen | |
| Belgium | AZ Delta | Roeselare | |
| Belgium | Office of Marc De Meulemeester | Thuin | |
| Belgium | CHU UCl Namur asbl - Site Godinne | Yoir | |
| Bulgaria | Medical Centre "Asklepii", OOD | Dupnitsa | |
| Bulgaria | Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD | Haskovo | |
| Bulgaria | Medical Center Leo Clinic EOOD, branch Lovech | Lovech | |
| Bulgaria | MEDICAL CENTER HERA EOOD; Office of Pulmonology and Phtisiatrics | Montana | |
| Bulgaria | Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD | Pernik | |
| Bulgaria | Medical center Medconsult Pleven OOD | Pleven | |
| Bulgaria | Medical center Unimed EOOD | Plovdiv | |
| Bulgaria | University Multiprofile Hospital for Active Treatment Sveti Georgi EAD | Plovdiv | |
| 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 | |
| Canada | Burlington Lung Clinic | Burlington | Ontario |
| Canada | Clinique de pneumologie et du sommeil de Lanaudiere | Saint-Charles-Borromee | Quebec |
| Canada | Dr Anil Dhar Professional Medicine Corporation | Windsor | Ontario |
| Chile | Enroll SpA - PPDS | Providencia | |
| Chile | Sociedad Médica SyG SpA | Providencia | |
| Chile | Centro Internacional de Estudios Clínicos (CIEC) | Recoleta | |
| Chile | Centro de Estudios Clinicos | Santiago | |
| Chile | Centro de Investigaciones Medicas Respiratorias CIMER | Santiago | |
| Chile | Hospital Carlos Van Buren | Valparaiso | |
| Czechia | MediTrial s.r.o. | Jind?ich?v Hradec | |
| Czechia | Plicni Ambulance Kralupy nad Vltavou | Kralupy nad Vltavou | |
| Czechia | KASMED s.r.o. | Tabor | |
| Denmark | Aalborg Universitetshospital | Aalborg | |
| Denmark | Gentofte Hospital | Hellerup | |
| Denmark | Hvidovre Hospital | Hvidovre | |
| France | Hôpital de La Croix Rousse | Lyon | |
| France | Hopital Saint Joseph - Marseille | Marseille | |
| France | Hopital Pasteur II | Nice | |
| Germany | Zentrum fuer Pneumologie, Onkologie und Schlafmedizin am Diako | Augsburg | |
| Germany | Gemeinschaftspraxis fuer Herz und Lunge am Bruderw | Bamberg | |
| Germany | Clinical Studies Pankow | Berlin | |
| Germany | MECS Research GmbH | Berlin | |
| Germany | MVZ Jung GbR - Deggingen | Deggingen | |
| Germany | Medizentrum Essen Borbeck | Essen | |
| Germany | Praxis Dr med Claus Keller | Frankfurt am Main | |
| Germany | KPPK Studienzentrum Kroker-Schmidt | Koblenz | |
| Germany | Asklepios MVZ Bayern GmbH | Landsberg | |
| Germany | Salvus-Klinische Studien GmbH | Leipzig | |
| Germany | IKF Pneumologie Mainz | Mainz | |
| Germany | Praxis für Pneumologie Dr. Silke Mronga & Dr. Lukas Jerrentrup | Marburg | |
| Germany | Studienzentrum Dr Med Schlenska | Peine | |
| Israel | Barzilai Medical Center | Ashkelon | |
| Israel | Shaare Zedek Medical Center | Jerusalem | |
| Israel | Rabin Medical Center | Petach Tiqwa | |
| Israel | Sheba Medical Center - PPDS | Ramat Gan | |
| Israel | Kaplan Medical Center | Rehovot | |
| Israel | Tel Aviv Sourasky Medical Center PPDS | Tel Aviv-Yafo | |
| Korea, Republic of | Catholic Univ. of Incheon St.Mary's Hospital | Incheon | |
| Korea, Republic of | Chonbuk National University Hospital | Jeollabuk-do | |
| Korea, Republic of | Konkuk University Medical Center | Seoul | |
| Korea, Republic of | Korea University Anam Hospital | Seoul | |
| Mexico | CICUM San Miguel | Americana | Jalisco |
| Mexico | Unidad de Investigacion Clinica En Medicina (Udicem) S.C. | Monterrey | Nuevo LEON |
| Mexico | Instituto Jalisciense de Investigacion Clinica S.A. de C.V. | Santa Cecilia | Jalisco |
| Mexico | Unidad Medica de Occidente | Santa Elena Alcalde | Jalisco |
| Mexico | Centro de Investigacion y Atencion Integral Durango CIAID | Victoria de Durango | Durango |
| Netherlands | Amphia Ziekenhuis | Breda | |
| Netherlands | Catharina Hospital; Apotheek | Eindhoven | |
| Netherlands | Dijklander Ziekenhuis - loc Hoorn | Hoorn | |
| New Zealand | Aotearoa Clinical Trials Trust | Auckland | |
| New Zealand | NZ Respiratory & Sleep Institute | Auckland | |
| New Zealand | Canterbury Respiratory Research Group | Christchurch | |
| Poland | Centrum Medyczne Bydgoszcz- PRATIA - PPDS | Bydgoszcz | |
| Poland | Indywidualna Specjalistyczna Praktyka Lekarska lek. | Kielce | |
| Poland | Centrum Medyczne ALL-MED | Krakow | |
| Poland | Diamond Clinic | Kraków | |
| Poland | Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k. | Kraków | |
| 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; Krzysztof 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 Neuroscience Sp. z o.o. | Warszawa | |
| Poland | Dobrostan Gabinety Lekarskie | Wroclaw | |
| Romania | 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 | Sf. Ioan cel Nou Emergency County Hospital | Suceava | |
| South Africa | University of Cape Town Lung Institute; Lung Clinical Research | Cape Town | |
| South Africa | Clinical Trial Systems | City Of Tshwane | |
| South Africa | Dr A.C Wilhase practice-Reimed | Ekurhuleni | |
| South Africa | Lakeview Hospital | Ekurhuleni | |
| South Africa | Langeberg Clinical Trials | Kraaifontein | |
| Spain | Hospital de San Pedro de Alcantara | Caceres | |
| Spain | Hospital Clinico San Carlos | Madrid | |
| Spain | Hospital General Universitario Gregorio Maranon | Madrid | |
| Spain | Hospital Universitario Fundacion Jimenez Diaz. | Madrid | |
| Spain | Hospital Universitario Virgen de la Victoria | Malaga | |
| Spain | Hospital de Merida | Merida | Badajoz |
| Spain | Hospital Universitario Marques de Valdecilla | Santander | Cantabria |
| Spain | CHUS H Clinico U de Santiago | Santiago de Compostela | LA Coruña |
| Sweden | Fysikalisk Medicin i Stockholm AB | Lidingö | |
| Sweden | PharmaSite | Malmö | |
| Sweden | ProbarE i Stockholm AB | Stockholm | |
| United Kingdom | Bradford Royal Infirmary | Bradford | |
| United Kingdom | Glenfield Hospital | Leicester | |
| United States | South Texas Medical Research Institute, Inc., dba TTS Research ? ClinEdge ? PPDS | Boerne | Texas |
| United States | American Health Research Inc. | Charlotte | North Carolina |
| United States | St Francis Medical Institute ClinEdge PPDS | Clearwater | Florida |
| United States | Corsicana Medical Research | Corsicana | Texas |
| United States | SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS | Dothan | Alabama |
| United States | OK Clinical Research | Edmond | Oklahoma |
| United States | Flushing Road Internal Medicine and Pediatrics - F | Flint | Michigan |
| United States | Clinical Research of Gastonia | Gastonia | North Carolina |
| United States | Finlay Medical Research Corporation | Greenacres City | Florida |
| United States | Hannibal Regional Healthcare System HRMG Hannibal | Hannibal | Missouri |
| United States | Baylor College of Medicine | Houston | Texas |
| United States | Jasper Summit Research LLC | Jasper | Alabama |
| United States | Sierra Clinical Research - ClinEdge - PPDS | Las Vegas | Nevada |
| United States | Revive Research Institute | Lathrup Village | Michigan |
| United States | Flourish Research - Leesburg - PPDS | Leesburg | Florida |
| United States | Pulmonary Specialists of the Palm Beaches | Loxahatchee Groves | Florida |
| United States | Pulmonary Associates of Mobile PC | Mobile | Alabama |
| United States | Lowcountry Lung and Critical Care | North Charleston | South Carolina |
| United States | Florida Institute for Clinical Research, LLC | Orlando | Florida |
| United States | Temple University Hospital | Philadelphia | Pennsylvania |
| United States | Cadena Care Institute, LLC | Poway | California |
| United States | Clinical Research of Rock Hill | Rock Hill | South Carolina |
| United States | Midwest Chest Consultants | Saint Charles | Missouri |
| United States | Midwest Clinical Research LLC | Saint Louis | Missouri |
| United States | Inst. of Healthcare Assessment, Inc. | San Diego | California |
| United States | Carolina Research Center | Shelby | North Carolina |
| United States | Sherman Clinical Research - ClinEdge - PPDS | Sherman | Texas |
| United States | Velocity Clinical Research Spartanburg PPDS | Spartanburg | South Carolina |
| United States | Exordia Medical Research, Inc. | Stow | Massachusetts |
| United States | Oakland Medical Research | Troy | Michigan |
| United States | Allianz Research Institute Inc | Westminster | California |
| United States | Southeastern Research Center | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
United States, Argentina, Australia, Belgium, Bulgaria, Canada, Chile, Czechia, Denmark, France, Germany, Israel, Korea, Republic of, Mexico, Netherlands, New Zealand, Poland, Romania, South Africa, Spain, Sweden, United Kingdom,
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