Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease
This study will evaluate the efficacy, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or current smokers and have a history of frequent exacerbations.
Status | Recruiting |
Enrollment | 1440 |
Est. completion date | March 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 90 Years |
Eligibility | 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 |
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 | Investigaciones en 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 |
Australia | Westmead Hospital | Westmead | New South Wales |
Austria | Ordensklinikum Linz GmbH | Linz | |
Austria | Medizinische Universitat Wien Medical University of Vienna | Wien | |
Belgium | UZ Antwerpen | Edegem | |
Belgium | Private Practice Dr Jean Benoit Martinot | Erpent | |
Belgium | UZ Leuven Gasthuisberg | 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 | 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 | Medical center Unimed EOOD | Plovdiv | |
Bulgaria | University Multiprofile Hospital for Active Treatment Sveti Georgi EAD | 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 | |
Canada | Burlington Lung Clinic | Burlington | Ontario |
Canada | St. Joseph's Healthcare Hamilton- Charlton Campus | Hamilton | Ontario |
Canada | Clinique de pneumologie et du sommeil de Lanaudiere | Saint-Charles-Borromee | Quebec |
Canada | Bluewater Clinical Research Group | Sarnia | Ontario |
Chile | Centro de Investigación Curico | Curico | |
Chile | MIRES/MYF estudios cli-nicos | Ñuñoa | |
Chile | Enroll SpA - PPDS | Providencia | |
Chile | Sociedad Médica SyG SpA | Providencia | |
Chile | Centro de Investigaciones Medicas Respiratorias | Santiago | |
Chile | Meditek Ltda | Santiago | |
Chile | Centro de Investigacion del Maule | Talca | |
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 | MUDr. Ilona Pavlisova s.r.o. | Miroslav | |
Czechia | Pneumologie Varnsdorf S.r.o. | Novy Bor | |
Czechia | Plicni stredisko | Strakonice | |
Czechia | KASMED s.r.o. | Tabor | |
Denmark | Aalborg Universitetshospital | Aalborg | |
Denmark | Gentofte Hospital | Hellerup | |
Denmark | Hvidovre Hospital | Hvidovre | |
Denmark | Odense Universitetshospital | Odense C | |
Denmark | Sygehus Lillebælt, Vejle | Vejle | |
France | Hôpital de La Croix Rousse | Lyon | |
France | Hopital Saint Joseph - Marseille | Marseille | |
France | CHU de Nice; Service Système Nerveux Périphérique | Nice Cedex 1 | |
France | Nouvel Hôpital Civil | Strasbourg | |
Germany | Zentrum fuer Pneumologie, Onkologie und Schlafmedizin am Diako | Augsburg | |
Germany | CIMS-Studienzentrum Bamberg, | Bamberg | |
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 | KPPK Studienzentrum Kroker-Schmidt | Koblenz | |
Germany | Praxis Dr. Steffen | Landsberg | |
Germany | Salvus-Klinische Studien GmbH | Leipzig | |
Germany | IKF Pneumologie Mainz | Mainz | |
Germany | Zentrum fuer ambulante pneumologische Forschung Marburg GbR | Marburg | |
Germany | Studienzentrum Dr Med Schlenska | Peine | |
Hong Kong | Tuen Mun Hospital; Clinical Onc | Hong Kong | |
Israel | Assuta Ashdod Medical Center | Ashdod | |
Israel | Barzilai Medical Center | Ashkelon | |
Israel | Shamir Medical Center Assaf Harofeh | Beer Jacob | |
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 | Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C. | Guadalajara | Jalisco |
Mexico | Unidad Medica de Occidente | Guadalajara | 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 | 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 | |
Netherlands | Isala Klinieken | Zwolle | |
New Zealand | Middlemore Hospital | Auckland | |
New Zealand | NZ Respiratory & Sleep Institute | Auckland | |
New Zealand | Canterbury Respiratory Research Group | Christchurch | |
New Zealand | P3 Research | Hastings | |
New Zealand | P3 Research ? Tauranga | Tauranga | |
Peru | Clinica Internacional | Lima | |
Peru | Clinica Providencia (Inverconsult Sociedad Anonima) | Lima | |
Peru | Medicentro Biociencias Peru S.R.L. | Lima | |
Peru | Clinica Ricardo Palma | San Isidro | |
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 Warszawa- PPDS | 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 | Spitalul Clinic de Pneumoftiziologie Constanta | Constanta | |
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 | St Augustines Hospital | Durban | |
South Africa | Dr A.C Wilhase practice-Reimed | Ekurhuleni | |
South Africa | Lakeview Hospital | Ekurhuleni | |
South Africa | Langeberg Clinical Trials | Kraaifontein | |
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
Spain | Hospital de San Pedro de Alcantara | Caceres | |
Spain | Hospital Universitario Virgen de Las Nieves | Granada | |
Spain | Hospital Arnau de Vilanova | Lerida | |
Spain | Hosp. 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 Quironsalud Madrid | Pozuelo de Alarcón | Madrid |
Spain | Hospital Universitario Marques de Valdecilla | Santander | Cantabria |
Spain | CHUS H Clinico U de Santiago | Santiago de Compostela | LA Coruña |
Spain | Hospital Universitario Miguel Servet | Zaragoza | |
Sweden | Öbackakliniken | Härnösand | |
Sweden | Fysikalisk Medicin i Stockholm AB | Lidingö | |
Sweden | ProbarE i Lund AB | Lund | |
Sweden | PharmaSite | Malmö | |
Sweden | ProbarE i Stockholm AB | Stockholm | |
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 | Queen Anne Street Medical Centre | London | |
United States | IMD Clinical Trials | Bakersfield | California |
United States | CARE Clinical Research | Banning | California |
United States | South Texas Medical Research Institute, Inc., dba TTS Research ? ClinEdge ? PPDS | Boerne | Texas |
United States | Northern Pines Health Center PC | Buckley | Michigan |
United States | American Health Research Inc. | Charlotte | North Carolina |
United States | University of Virginia Health System | Charlottesville | Virginia |
United States | Feinberg School of Medicine Northwestern University | Chicago | Illinois |
United States | Cincinnati Veterans Affairs Medical Center - NAVREF - PPDS | Cincinnati | Ohio |
United States | St. Francis Sleep; Allergy & Lung Institute | Clearwater | Florida |
United States | Carolina Medical Research, LLC | Clinton | South Carolina |
United States | Columbus Regional Research Institute at Talbotton - IACT - HyperCore - PPDS | Columbus | Georgia |
United States | National Jewish Health | Denver | Colorado |
United States | SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS | Dothan | Alabama |
United States | Medisphere Medical Research Center, Llc | Evansville | Indiana |
United States | Exordia Medical Research, Inc. | Fall River | Massachusetts |
United States | Piedmont Research Partners LLC - Clinedge - PPDS | Fort Mill | South Carolina |
United States | Clinical Research of Gastonia | Gastonia | North Carolina |
United States | Blessing Health Hannibal | Hannibal | Missouri |
United States | Baylor College of Medicine | Houston | Texas |
United States | Horizon Clinical Research Group: Houston Pulmonary Sleep & Allergy Associates -Clinedge ? PPDS | Houston | Texas |
United States | University of Florida College of Medicine Jacksonville | Jacksonville | Florida |
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 | Clinical Site Partners - Leesburg Suite 101 - HyperCore - PPDS | Leesburg | Florida |
United States | VA Loma Linda Healthcare System - NAVREF - PPDS | Loma Linda | California |
United States | Pulmonary Specialists of the Palm Beaches | Loxahatchee Groves | Florida |
United States | Metroplex Pulmonology & Sleep Center | McKinney | Texas |
United States | Suncoast Research Group LLC | Miami | 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 | Phoenix Medical Group PC | Peoria | Arizona |
United States | Temple University Hospital | Philadelphia | Pennsylvania |
United States | Cardio-Pulmonary Associates | Plantation | Florida |
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 | University of Texas Health Sciences Center in San Antonio | San Antonio | Texas |
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 | LSU Health Sciences Center - Shreveport | Shreveport | Louisiana |
United States | Spartanburg Medical Center | Spartanburg | South Carolina |
United States | Velocity Clinical Research Spartanburg PPDS | Spartanburg | South Carolina |
United States | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California |
United States | Oakland Medical Research | Troy | Michigan |
United States | Allianz Research Institute Inc | Westminster | California |
United States | Southeastern Research Center | Winston-Salem | North Carolina |
United States | Clinical Site Partners - Winter Park - HyperCore - PPDS | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
Genentech, Inc. |
United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, Czechia, Denmark, France, Germany, Hong Kong, Israel, Korea, Republic of, Mexico, Netherlands, New Zealand, Peru, Poland, Romania, South Africa, Spain, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Annualized Rate of Moderate and Severe COPD Exacerbations Over the 52-Week Treatment Period | Baseline up to Week 52 | ||
Secondary | Time to First Moderate or Severe COPD Exacerbation During the 52-Week Treatment Period | Baseline up to Week 52 | ||
Secondary | Absolute Change from Baseline in Health-Related Quality of Life (HRQoL) at Week 52 as Assessed Through the St. George's Respiratory Questionnaire-COPD (SGRQ-C) Total Score | Baseline to Week 52 | ||
Secondary | Proportion of SGRQ-C Responders at Week 52 | Baseline to Week 52 | ||
Secondary | Absolute Change from Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (liters) at Week 52 | Baseline to Week 52 | ||
Secondary | Absolute Change from Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Score at Week 52 | Baseline to Week 52 | ||
Secondary | Annualized Rate of Severe COPD Exacerbations Over the 52-Week Treatment Period | Baseline up to Week 52 | ||
Secondary | Absolute Change from Baseline in Five-Repetition Sit-to-Stand (5STS) time (seconds) at Week 52 | Baseline to Week 52 |
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