A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease | NCT05037929 | Trialant

A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease | NCT05037929 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS

Dothan, Alabama 36305, United States

Jasper Summit Research LLC

Jasper, Alabama 35501, United States

Pulmonary Associates of Mobile PC

Mobile, Alabama 36608-3135, United States

Cadena Care Institute, LLC

Poway, California 92064-2021, United States

Inst. of Healthcare Assessment, Inc.

San Diego, California 92120, United States

Allianz Research Institute Inc

Westminster, California 92683, United States

National Jewish Health

Denver, Colorado 80206, United States

Clinical Site Partners - Leesburg Suite 101 - HyperCore - PPDS

Leesburg, Florida 34748-5077, United States

Florida Institute for Clinical Research, LLC

Orlando, Florida 32825-4454, United States

Clinical Site Partners - Winter Park - HyperCore - PPDS

Winter Park, Florida 32789-4681, United States

Northwestern Center for Clinical Research

Chicago, Illinois 60611, United States

Medisphere Medical Research Center, Llc

Evansville, Indiana 47714, United States

Exordia Medical Research, Inc.

Fall River, Massachusetts 20723, United States

Northern Pines Health Center PC

Buckley, Michigan 49620, United States

Revive Research Institute

Lathrup Village, Michigan 48076, United States

Cardio-Pulmonary Associates

Chesterfield, Missouri 63017-3627, United States

Blessing Health Hannibal

Hannibal, Missouri 63401, United States

Midwest Chest Consultants

Saint Charles, Missouri 63301, United States

CARE Clinical Research

St Louis, Missouri 63141-6823, United States

Midwest Clinical Research LLC

St Louis, Missouri 63141, United States

Sierra Clinical Research - ClinEdge - PPDS

Las Vegas, Nevada 89106-4159, United States

American Health Research Inc.

Charlotte, North Carolina 28277, United States

Clinical Research of Gastonia

Gastonia, North Carolina 28054-7481, United States

Carolina Research Center

Shelby, North Carolina 28150-3803, United States

Southeastern Research Center

Winston-Salem, North Carolina 27103-4029, United States

Temple University Hospital

Philadelphia, Pennsylvania 19140, United States

Lowcountry Lung and Critical Care

North Charleston, South Carolina 29406, United States

Clinical Research of Rock Hill

Rock Hill, South Carolina 29732-1160, United States

Velocity Clinical Research Spartanburg PPDS

Spartanburg, South Carolina 29303-4225, United States

Spartanburg Medical Center

Spartanburg, South Carolina 29303, United States

South Texas Medical Research Institute, Inc., dba TTS Research ? ClinEdge ? PPDS

Boerne, Texas 78006-1993, United States

Baylor College of Medicine

Houston, Texas 77030, United States

Metroplex Pulmonology & Sleep Center

McKinney, Texas 75069, United States

Sherman Clinical Research - ClinEdge - PPDS

Sherman, Texas 75092, United States

Centro Medico IPAM

Rosario, Santa Fe Province S2001SBK, Argentina

Centro de Investigaciones Clínicas Belgrano

Buenos Aires, 7240, Argentina

Instituto de Investigaciones Clinicas-Mar del Plata

Buenos Aires, B7600FZN, Argentina

Fundacion Cidea

Buenos Aires, C1121ABE, Argentina

Centro Médico Dra de Salvo

Buenos Aires, C1426ABP, Argentina

CARE - Centro de Alergia y Enfermedades Respiratorias

CABA, C1414AIF, Argentina

Instituto de Medicina Respiratoria, IMeR

Córdoba, X5003DCE, Argentina

Centro de Especialidades Medicas Lobos

Lobos, B7240AAN, Argentina

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, 7600, Argentina

Instituto Ave Pulmo

Mar del Plata, B7602DCK, Argentina

INSARES

Mendoza, M5500CCG, Argentina

Centro Respiratorio Quilmes

Quilmes, B1878FNR, Argentina

Instituto Medico Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion Medica

Rosario, S2013OJN, Argentina

Centro Médico Respire

San Fernando, B1646EBJ, Argentina

Instituto De Enfermedades Respiratorias E Investigacion Medica

San Juan Bautista, CP 1888, Argentina

Investigaciones en Patologias Respiratorias

San Miguel de Tucumán, 4000, Argentina

Centro Integral de Medicina Respiratoria (CIMER)

San Miguel de Tucumán, T4000CBC, Argentina

Westmead Hospital

Westmead, New South Wales 2145, Australia

Flinders Medical Centre

Bedford Park, South Australia 5042, Australia

Box Hill Hospital

Box Hill, Victoria 3128, Australia

TrialsWest Pty Ltd

Spearwood, Western Australia 6163, Australia

AZ Sint-Maarten

Mechelen, Antwerpen 2800, Belgium

UZ Antwerpen

Edegem, 2650, Belgium

Private Practice Dr Jean Benoit Martinot

Erpent, 5101, Belgium

AZ Delta

Roeselare, 8800, Belgium

Office of Marc De Meulemeester

Thuin, 6534, Belgium

CHU UCl Namur asbl - Site Godinne

Yvoir, 5530, Belgium

Medical Centre "Asklepii", OOD

Dupnitsa, 2600, Bulgaria

Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD

Haskovo, 6300, Bulgaria

Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Dr.Nikola Penchev-Paza

Pazardzhik, 4400, Bulgaria

Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD

Pernik, 2300, Bulgaria

Medical center Medconsult Pleven OOD

Pleven, 5800, Bulgaria

University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

Plovdiv, 4001, Bulgaria

Medical center Unimed EOOD

Plovdiv, 4023, Bulgaria

Medical Centre Respiro OOD

Razgrad, 7200, Bulgaria

Medical Center Hera EOOD

Sofia, 1510, Bulgaria

University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD

Sofia, 1606, Bulgaria

Medical Center New rehabilitation center EOOD

Stara Zagora, 6003, Bulgaria

Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa

Vratsa, 3000, Bulgaria

Burlington Lung Clinic

Burlington, Ontario L7N 3V2, Canada

St. Joseph's Healthcare Hamilton- Charlton Campus

Hamilton, Ontario L8N 4A6, Canada

Bluewater Clinical Research Group

Sarnia, Ontario N7T 4X3, Canada

University of Saskatchewan, Royal University Hospital

Saskatoon, Saskatchewan S7N 0W8, Canada

Centro de Investigaciones Medicas Respiratorias

Providencia, Región-MetropolitanadeSantiago 7500000, Chile

Centro de Investigación Curico

Curicó, 3340000, Chile

MIRES/MYF estudios clinicos

Ñuñoa, 7750495, Chile

Sociedad Médica SyG SpA

Providencia, 7500000, Chile

Enroll SpA - PPDS

Providencia, 7500587, Chile

Meditek Ltda

Santiago, 8320000, Chile

Centro de Investigacion del Maule

Talca, Chile

Hospital Carlos Van Buren

Valparaíso, 2340000, Chile

MediTrial s.r.o.

Jind?ich?v Hradec, 377 01, Czechia

Plicni Ambulance Kralupy nad Vltavou

Kralupy nad Vltavou, 278 01, Czechia

MUDr. Ilona Pavlisova s.r.o.

Miroslav, 671 72, Czechia

Pneumologie Varnsdorf S.r.o.

Nový Bor, 473 01, Czechia

KASMED s.r.o.

Tábor, 390 02, Czechia

Aalborg Universitetshospital

Aalborg, 9000, Denmark

Gentofte Hospital

Hellerup, 2900, Denmark

Hvidovre Hospital

Hvidovre, DK-2650, Denmark

Odense Universitetshospital

Odense, 5000, Denmark

Sygehus Lillebælt, Vejle

Vejle, 7100, Denmark

Hôpital de La Croix Rousse

Lyon, 69004, France

CHU de Nice

Nice, 06001, France

Nouvel Hôpital Civil

Strasbourg, 67091, France

Zentrum fuer Pneumologie, Onkologie und Schlafmedizin am Diako

Augsburg, 86150, Germany

CIMS-Studienzentrum Bamberg,

Bamberg, Germany

KPPK Studienzentrum Kroker-Schmidt

Bendorf, 56170, Germany

MECS Research GmbH

Berlin, 12203, Germany

Praxis Dr. Med Evelin Liefring

Berlin, 13187, Germany

Gemeinscharftspraxis Dres Jung - Deggingen

Deggingen, 73326, Germany

Medizentrum Essen Borbeck

Essen, 45355, Germany

Praxis Dr med Claus Keller

Frankfurt am Main, 60389, Germany

Universitätsklinikum Gießen und Marburg GmbH

Giessen, 35392, Germany

Asklepios MVZ Bayern GmbH

Landsberg, 86899, Germany

Salvus-Klinische Studien GmbH

Leipzig, 04207, Germany

Zentrum fuer ambulante pneumologische Forschung Marburg GbR

Marburg, 35037, Germany

Studienzentrum Dr Med Schlenska

Peine, 31224, Germany

Tuen Mun Hospital

Hong Kong, Hong Kong

Assuta Ashdod Medical Center

Ashdod, 7747629, Israel

Barzilai Medical Center

Ashkelon, 7830604, Israel

Shamir Medical Center Assaf Harofeh

Beer Jacob, 0073100, Israel

Tel Aviv Sourasky Medical Center PPDS

Jerusalem, 90000, Israel

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Kaplan Medical Center

Rehovot, 76100, Israel

Sheba Medical Center - PPDS

Tel Litwinsky, 52621, Israel

Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

Guadalajara, Jalisco 44100, Mexico

Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.

Guadalajara, Jalisco 44130, Mexico

Unidad Medica de Occidente

Guadalajara, Jalisco 44220, Mexico

CICUM San Miguel

Guadalajara Centro, Jalisco 44100, Mexico

Unidad de Investigacion Clinica En Medicina (Udicem) S.C.

Monterrey, Nuevo León 64718, Mexico

Centro de Investigacion y Atencion Integral Durango CIAID

Durango, 34080, Mexico

Amphia Ziekenhuis

Breda, 4819 EV, Netherlands

Isala Klinieken

Zwolle, 8011 JW, Netherlands

Aotearoa Clinical Trials Trust

Auckland, 2025, New Zealand

Canterbury Respiratory Research Group

Christchurch, 8011, New Zealand

Clinica Providencia (Inverconsult Sociedad Anonima)

Lima, 32, Peru

Clinica Internacional

Lima, Lima 01, Peru

Clinica Ricardo Palma

Lima, Lima 27, Peru

Alfredo Berrocal Kasay Reuma Sociedad de Responsabilidad Limitada

Lima Cercado, 000000, Peru

Centrum Medyczne Bydgoszcz- PRATIA - PPDS

Bydgoszcz, 85-796, Poland

Indywidualna Specjalistyczna Praktyka Lekarska lek.

Kielce, 25-751, Poland

Centrum Medyczne ALL-MED

Krakow, 30-033, Poland

Diamond Clinic

Krakow, 31-559, Poland

Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.

Krakow, 31-637, Poland

ETG Lodz

Lódz, 90-302, Poland

ETG Lublin

Lublin, 20-412, Poland

Twoja Przychodnia Centrum Medyczne Nowa Sol

Nowa Sól, 67-100, Poland

Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik

Ostrowiec Swietokrzysk, 27-400, Poland

Centrum Alergologii Teresa Hofman

Poznan, 60-214, Poland

EMED Centrum Uslug Medycznych Ewa Smialek

Rzeszów, 35-205, Poland

ETG Siedlce

Siedlce, 08-110, Poland

PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna

Sosnowiec, 41-208, Poland

ETG Warszawa- PPDS

Warsaw, 02-793, Poland

Dobrostan Gabinety Lekarskie

Wroclaw, 53-301, Poland

Neomed Out-Patient Treatment and Diagnosis Medical Center SRL

Brasov, 500283, Romania

Dr. Victor Babes Foundation

Bucharest, 030303, Romania

Leon Daniello Pneumophthisiology Clinical Hospital

Cluj-Napoca, 400371, Romania

Spitalul Clinic de Pneumoftiziologie Constanta

Constanța, 900002, Romania

Sf. Ioan cel Nou Emergency County Hospital

Suceava, 720237, Romania

University of Cape Town Lung Institute

Cape Town, 7700, South Africa

Clinical Trial Systems

City of Tshwane, 0186, South Africa

St Augustines Hospital

Durban, 4001, South Africa

Dr A.C Wilhase practice-Reimed

Ekurhuleni, 1459, South Africa

Lakeview Hospital

Ekurhuleni, 1501, South Africa

Langeberg Clinical Trials

Kraaifontein, 7570, South Africa

Catholic Univ. of Incheon St.Mary's Hospital

Incheon, 21431, South Korea

Chonbuk National University Hospital

Jeonju, 54907, South Korea

Korea University Anam Hospital

Seoul, 02841, South Korea

Konkuk University Medical Center

Seoul, 05030, South Korea

Hospital de Merida

Mérida, Badajoz 06800, Spain

Hospital Universitario Marques de Valdecilla

Santander, Cantabria 39008, Spain

CHUS H Clinico U de Santiago

Santiago de Compostela, LA Coruna 15706, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, 000000, Spain

Hospital de San Pedro de Alcantara

Cáceres, 10003, Spain

Hospital Universitario Virgen de Las Nieves

Granada, 18012, Spain

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Hospital Universitario Fundacion Jimenez Diaz.

Madrid, 28040, Spain

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Fysikalisk Medicin i Stockholm AB

Lidingö, 181 29, Sweden

ProbarE i Lund AB

Lund, 222 22, Sweden

PharmaSite

Malmö, 211 52, Sweden

ProbarE i Stockholm AB

Stockholm, 113 29, Sweden

Queen Anne Street Medical Centre

London, London, City of W1T6AH, United Kingdom

Bradford Royal Infirmary

Bradford, BD9 6RJ, United Kingdom

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Ninewells Hospital

Dundee, DD1 9SY, United Kingdom

Glenfield Hospital

Leicester, LE3 9QP, United Kingdom