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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Astegolimab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 1440
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: GB43311 https://forpatients.roche.com/; Phone Number: 888-662-6728; Email: global-roche-genentech-trials@gene.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, B7600FZN
    • Recruiting
    • Instituto de Investigaciones Clinicas-Mar del Plata
  • Buenos Aires, Argentina, C1121ABE
    • Recruiting
    • Fundacion Cidea
  • Buenos Aires, Argentina, C1426ABP
    • Recruiting
    • Centro Médico Dra de Salvo
  • Caba, Argentina, C1414AIF
    • Recruiting
    • CARE - Centro de Alergia y Enfermedades Respiratorias
  • Ciudad Autonoma Buenos Aires, Argentina, C1425AZB
    • Recruiting
    • Centro de Investigaciones Clínicas Belgrano
  • Córdoba, Argentina, X5003DCE
    • Recruiting
    • Instituto de Medicina Respiratoria, IMeR; Clinic/Outpatient Facility
  • Lobos, Argentina, B7240AAN
    • Recruiting
    • Centro de Especialidades Medicas Lobos
  • Mar Del Plata, Argentina, B7600FYK
    • Recruiting
    • Centro de Investigaciones Médicas Mar del Plata
  • Mar Del Plata, Argentina, B7602DCK
    • Recruiting
    • Instituto Ave Pulmo
  • Mendoza, Argentina, M5500AYB
    • Recruiting
    • Fundación Scherbovsky
  • Mendoza, Mendoza City, Argentina, M5500CCG
    • Recruiting
    • INSARES
  • Quilmes, Argentina, B1878FNR
    • Recruiting
    • Centro Respiratorio Quilmes
  • Rosario, Argentina, S2013SBK
    • Recruiting
    • Centro Medico IPAM
  • Rosario, Argentina, 2002
    • Recruiting
    • Instituto Medico Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion Medica
  • San Fernando, Argentina, B1646EBJ
    • Recruiting
    • Centro Médico Respire
  • San Miguel de Tucuman, Argentina, T4000IAR
    • Recruiting
    • Investigaciones en Patologías Respiratorias
  • San Miguel de Tucumán, Argentina, T4000CHE
    • Recruiting
    • Centro Integral de Medicina Respiratoria (CIMER)
  • Villa Vatteone, Argentina, B1853AIK
    • Recruiting
    • Instituto De Enfermedades Respiratorias E Investigacion Medica
• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Recruiting
      • Westmead Hospital
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Recruiting
      • Flinders Medical Centre
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Recruiting
      • Box Hill Hospital
  • Western Australia
    • Spearwood, Western Australia, Australia, 6163
      • Recruiting
      • TrialsWest Pty Ltd
• Austria
  • Linz, Austria, 4010
    • Withdrawn
    • Ordensklinikum Linz GmbH
  • Wien, Austria, 1090
    • Active, not recruiting
    • Medizinische Universitat Wien Medical University of Vienna
• Belgium
  • Edegem, Belgium, 2650
    • Recruiting
    • UZ Antwerpen
  • Erpent, Belgium, 5101
    • Recruiting
    • Private Practice Dr Jean Benoit Martinot
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven Gasthuisberg
  • Mechelen, Belgium, 2800
    • Recruiting
    • AZ Sint-Maarten
  • Roeselare, Belgium, 8800
    • Recruiting
    • AZ Delta
  • Thuin, Belgium, 6534
    • Recruiting
    • Office of Marc De Meulemeester
  • Yoir, Belgium, 5530
    • Recruiting
    • CHU UCL Namur asbl - Site Godinne
• Bulgaria
  • Dupnitsa, Bulgaria, 2600
    • Active, not recruiting
    • Medical Centre "Asklepii", OOD
  • Haskovo, Bulgaria, 6300
    • Active, not recruiting
    • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD
  • Lovech, Bulgaria, 5500
    • Active, not recruiting
    • Medical Center Leo Clinic EOOD, branch Lovech
  • Pazardzhik, Bulgaria, 4400
    • Active, not recruiting
    • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Dr.Nikola Penchev-Paza
  • Pernik, Bulgaria, 2300
    • Active, not recruiting
    • Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD
  • Pleven, Bulgaria, 5800
    • Active, not recruiting
    • Medical center Medconsult Pleven OOD
  • Plovdiv, Bulgaria, 4002
    • Active, not recruiting
    • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
  • Plovdiv, Bulgaria, 4023
    • Active, not recruiting
    • Medical center Unimed EOOD
  • Razgrad, Bulgaria, 7200
    • Completed
    • Medical Centre Respiro OOD
  • Sofia, Bulgaria, 1606
    • Active, not recruiting
    • University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD
  • Sofia, Bulgaria, 1510
    • Active, not recruiting
    • Medical Center Hera EOOD
  • Stara Zagora, Bulgaria, 6000
    • Active, not recruiting
    • Medical Center New rehabilitation center EOOD
  • Vratsa, Bulgaria, 3000
    • Active, not recruiting
    • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa
• Canada
  • Saskatchewan, Canada, S7N 0W8
    • Recruiting
    • University of Saskatchewan, Royal University Hospital
  • Ontario
    • Burlington, Ontario, Canada, L7N 3V2
      • Recruiting
      • Burlington Lung Clinic
    • Hamilton, Ontario, Canada, L8N 4A6
      • Recruiting
      • St. Joseph's Healthcare Hamilton- Charlton Campus
    • Sarnia, Ontario, Canada, N7T 4X3
      • Recruiting
      • Bluewater Clinical Research Group
  • Quebec
    • Saint-Charles-Borromee, Quebec, Canada, J6E 2B4
      • Recruiting
      • Clinique de pneumologie et du sommeil de Lanaudiere
• Chile
  • Curico, Chile, 3340000
    • Recruiting
    • Centro de Investigación Curico
  • Providencia, Chile, 7500000
    • Recruiting
    • Sociedad Médica SyG SpA
  • Providencia, Chile, 7500587
    • Recruiting
    • Enroll SpA - PPDS
  • Santiago, Chile, 8320000
    • Recruiting
    • Meditek Ltda
  • Santiago, Chile, 7500692
    • Recruiting
    • Centro de Investigaciones Medicas Respiratorias
  • Talca, Chile
    • Completed
    • Centro de Investigación del Maule
  • Valparaiso, Chile, 2340000
    • Recruiting
    • Hospital Carlos Van Buren
  • Ñuñoa, Chile, 7750495
    • Recruiting
    • MIRES/MYF estudios cli-nicos
• Czechia
  • Jind?ich?v Hradec, Czechia, 377 01
    • Active, not recruiting
    • MediTrial s.r.o.
  • Kralupy nad Vltavou, Czechia, 278 01
    • Active, not recruiting
    • Plicni Ambulance Kralupy nad Vltavou
  • Miroslav, Czechia, 671 72
    • Active, not recruiting
    • MUDr. Ilona Pavlisova s.r.o.
  • Novy Bor, Czechia, 473 01
    • Withdrawn
    • Pneumologie Varnsdorf S.r.o.
  • Strakonice, Czechia, 386 01
    • Withdrawn
    • Plicni stredisko
  • Tabor, Czechia, 390 01
    • Active, not recruiting
    • KASMED s.r.o.
• Denmark
  • Aalborg, Denmark, 9100
    • Recruiting
    • Aalborg Universitetshospital
  • Hellerup, Denmark, 2900
    • Recruiting
    • Gentofte Hospital
  • Hvidovre, Denmark, DK-2650
    • Recruiting
    • Hvidovre Hospital
  • Odense C, Denmark, 5000
    • Recruiting
    • Odense Universitetshospital
  • Vejle, Denmark, 7100
    • Recruiting
    • Sygehus Lillebælt, Vejle
• France
  • Lyon, France, 69004
    • Recruiting
    • Hopital de la Croix Rousse
  • Marseille, France, 13008
    • Recruiting
    • Hopital Saint Joseph - Marseille
  • Nice Cedex 1, France, 06001
    • Recruiting
    • CHU de Nice; Service Système Nerveux Périphérique
  • Strasbourg, France, 67091
    • Recruiting
    • Nouvel Hopital Civil
• Germany
  • Augsburg, Germany, 86150
    • Recruiting
    • Zentrum fuer Pneumologie, Onkologie und Schlafmedizin am Diako
  • Bamberg, Germany
    • Recruiting
    • CIMS-Studienzentrum Bamberg,
  • Berlin, Germany, 12203
    • Recruiting
    • MECS Research GmbH
  • Berlin, Germany, 13187
    • Recruiting
    • Praxis Dr. Med Evelin Liefring
  • Deggingen, Germany, 73326
    • Recruiting
    • Gemeinscharftspraxis Dres Jung - Deggingen
  • Essen, Germany, 45355
    • Recruiting
    • Medizentrum Essen Borbeck
  • Frankfurt am Main, Germany, 60389
    • Recruiting
    • Praxis Dr med Claus Keller
  • Gießen, Germany, 35392
    • Recruiting
    • Universitätsklinikum Gießen und Marburg GmbH
  • Koblenz, Germany, 56068
    • Recruiting
    • KPPK Studienzentrum Kroker-Schmidt
  • Landsberg, Germany, 86899
    • Recruiting
    • Asklepios MVZ Bayern GmbH
  • Leipzig, Germany, 04207
    • Recruiting
    • Salvus-Klinische Studien GmbH
  • Mainz, Germany, 55128
    • Recruiting
    • IKF Pneumologie Mainz
  • Marburg, Germany, 35037
    • Recruiting
    • Zentrum fuer ambulante pneumologische Forschung Marburg GbR
  • Peine, Germany, 31224
    • Recruiting
    • Studienzentrum Dr Med Schlenska
• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Tuen Mun Hospital; Clinical Onc
• Israel
  • Ashdod, Israel, 7747629
    • Recruiting
    • Assuta Ashdod Medical Center
  • Ashkelon, Israel, 7830604
    • Recruiting
    • Barzilai Medical Center
  • Beer Jacob, Israel, 0073100
    • Recruiting
    • Shamir Medical Center Assaf Harofeh
  • Jerusalem, Israel, 9103102
    • Recruiting
    • Shaare Zedek Medical Center
  • Petach Tiqwa, Israel, 4941492
    • Recruiting
    • Rabin Medical Center
  • Ramat Gan, Israel, 5266202
    • Recruiting
    • Sheba Medical Center - PPDS
  • Rehovot, Israel, 7610001
    • Recruiting
    • Kaplan Medical Center
  • Tel Aviv-Yafo, Israel, 6423906
    • Recruiting
    • Tel Aviv Sourasky Medical Center PPDS
• Korea, Republic of
  • Incheon, Korea, Republic of, 21431
    • Recruiting
    • Catholic Univ. of Incheon St.Mary's Hospital
  • Jeollabuk-do, Korea, Republic of, 54907
    • Active, not recruiting
    • Chonbuk National University Hospital
  • Seoul, Korea, Republic of, 05030
    • Active, not recruiting
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of, 02841
    • Active, not recruiting
    • Korea University Anam Hospital
• Mexico
  • Durango
    • Victoria de Durango, Durango, Mexico, 34080
      • Recruiting
      • Centro de Investigacion y Atencion Integral Durango CIAID
  • Jalisco
    • Americana, Jalisco, Mexico, 44160
      • Recruiting
      • CICUM San Miguel
    • Guadalajara, Jalisco, Mexico, 44130
      • Recruiting
      • Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
    • Guadalajara, Jalisco, Mexico, 44220
      • Recruiting
      • Unidad Medica de Occidente
    • Santa Cecilia, Jalisco, Mexico, 44700
      • Recruiting
      • Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
  • Nuevo LEON
    • Monterrey, Nuevo LEON, Mexico, 64718
      • Recruiting
      • Unidad de Investigacion Clinica En Medicina (Udicem) S.C.
• Netherlands
  • Breda, Netherlands, 4818 CK
    • Recruiting
    • Amphia Ziekenhuis
  • Eindhoven, Netherlands, 5623 EJ
    • Recruiting
    • Catharina Hospital; Apotheek
  • Hoorn, Netherlands, 1624 NP
    • Recruiting
    • Dijklander Ziekenhuis - loc Hoorn
  • Zwolle, Netherlands, 8011 JW
    • Recruiting
    • ISALA Klinieken
• New Zealand
  • Auckland, New Zealand, 1051
    • Recruiting
    • NZ Respiratory & Sleep Institute
  • Auckland, New Zealand, 1640
    • Recruiting
    • Middlemore Hospital
  • Christchurch, New Zealand, 8011
    • Recruiting
    • Canterbury Respiratory Research Group
  • Hastings, New Zealand, 4122
    • Recruiting
    • P3 Research
  • Tauranga, New Zealand, 3110
    • Withdrawn
    • P3 Research ? Tauranga
• Peru
  • Lima, Peru, 15084
    • Active, not recruiting
    • Medicentro Biociencias Peru S.R.L.
  • Lima, Peru, 32
    • Active, not recruiting
    • Clinica Providencia (Inverconsult Sociedad Anonima)
  • Lima, Peru, Lima 1
    • Active, not recruiting
    • Clinica Internacional
  • San Isidro, Peru, Lima 27
    • Active, not recruiting
    • Clinica Ricardo Palma
• Poland
  • Bydgoszcz, Poland, 85-796
    • Completed
    • Centrum Medyczne Bydgoszcz- PRATIA - PPDS
  • Kielce, Poland, 25-751
    • Active, not recruiting
    • Indywidualna Specjalistyczna Praktyka Lekarska lek.
  • Krakow, Poland, 30-033
    • Active, not recruiting
    • Centrum Medyczne All-Med
  • Kraków, Poland, 31-209
    • Active, not recruiting
    • Diamond Clinic
  • Kraków, Poland, 31-637
    • Active, not recruiting
    • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.
  • Lublin, Poland, 20-412
    • Active, not recruiting
    • ETG Lublin
  • Lódz, Poland, 90-302
    • Active, not recruiting
    • ETG Lodz
  • Nowa Sól, Poland, 67-100
    • Active, not recruiting
    • Twoja Przychodnia Centrum Medyczne Nowa Sol
  • Ostrowiec Swietokrzysk, Poland, 27-400
    • Active, not recruiting
    • Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik; Krzysztof Cudzik
  • Poznan, Poland, 60-214
    • Active, not recruiting
    • Centrum Alergologii Teresa Hofman
  • Rzeszów, Poland, 35-205
    • Active, not recruiting
    • EMED Centrum Uslug Medycznych Ewa Smialek
  • Siedlce, Poland, 08-110
    • Active, not recruiting
    • ETG Siedlce
  • Sosnowiec, Poland, 41-200
    • Active, not recruiting
    • PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna
  • Warszawa, Poland, 02-793
    • Active, not recruiting
    • ETG Warszawa- PPDS
  • Wroclaw, Poland, 53-301
    • Active, not recruiting
    • Dobrostan Gabinety Lekarskie
• Romania
  • Brasov, Romania, 500283
    • Active, not recruiting
    • Neomed Out-Patient Treatment and Diagnosis Medical Center SRL
  • Bucharest, Romania, 030301
    • Active, not recruiting
    • Dr. Victor Babes Foundation
  • Cluj-Napoca, Romania, 400371
    • Active, not recruiting
    • Leon Daniello Pneumophthisiology Clinical Hospital
  • Constanta, Romania, 900002
    • Active, not recruiting
    • Spitalul Clinic de Pneumoftiziologie Constanta
  • Suceava, Romania, 720224
    • Active, not recruiting
    • Sf. Ioan cel Nou Emergency County Hospital
• South Africa
  • Cape Town, South Africa, 7700
    • Recruiting
    • University of Cape Town Lung Institute; Lung Clinical Research
  • City Of Tshwane, South Africa, 0186
    • Recruiting
    • Clinical Trial Systems
  • Durban, South Africa, 4001
    • Recruiting
    • St Augustines Hospital
  • Ekurhuleni, South Africa, 1459
    • Recruiting
    • Dr A.C Wilhase practice-Reimed
  • Ekurhuleni, South Africa, 1501
    • Recruiting
    • Lakeview Hospital
  • Kraaifontein, South Africa, 7570
    • Recruiting
    • Langeberg Clinical Trials
• Spain
  • Barcelona, Spain, 8041
    • Recruiting
    • Hospital de la Santa Creu I Sant Pau
  • Caceres, Spain, 10003
    • Recruiting
    • Hospital de San Pedro de Alcantara
  • Granada, Spain, 18012
    • Recruiting
    • Hospital Universitario Virgen de las Nieves
  • Lerida, Spain, 25198
    • Recruiting
    • Hospital Arnau de Vilanova
  • Madrid, Spain, 28040
    • Recruiting
    • Hosp. Clinico San Carlos
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Universitario Fundacion Jimenez Diaz.
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital General Universitario Gregorio Maranon
  • Malaga, Spain, 29010
    • Recruiting
    • Hospital Universitario Virgen de la Victoria
  • Zaragoza, Spain, 50009
    • Withdrawn
    • Hospital Universitario Miguel Servet
  • Badajoz
    • Merida, Badajoz, Spain, 06800
      • Recruiting
      • Hospital de Mérida
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Recruiting
      • Hospital Universitario Marques de Valdecilla
  • LA Coruña
    • Santiago de Compostela, LA Coruña, Spain, 15706
      • Recruiting
      • CHUS H Clinico U de Santiago
  • Madrid
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Active, not recruiting
      • Hospital Universitario Quironsalud Madrid
• Sweden
  • Härnösand, Sweden, 871 31
    • Withdrawn
    • Öbackakliniken
  • Lidingö, Sweden, 181 61
    • Recruiting
    • Fysikalisk Medicin i Stockholm AB
  • Lund, Sweden, 222 22
    • Recruiting
    • ProbarE i Lund AB
  • Malmö, Sweden, 211 52
    • Recruiting
    • Pharmasite
  • Stockholm, Sweden, SE-17145
    • Recruiting
    • ProbarE i Stockholm AB
• United Kingdom
  • Bradford, United Kingdom, BD9 6RJ
    • Recruiting
    • Bradford Royal Infirmary
  • Cambridge, United Kingdom, CB2 0QQ
    • Recruiting
    • Cambridge University Hospitals NHS Foundation Trust
  • Dundee, United Kingdom, DD12 9SY
    • Recruiting
    • Ninewells Hospital
  • Leicester, United Kingdom, LE3 9QP
    • Recruiting
    • Glenfield Hospital
  • London, United Kingdom, W1T 6AH
    • Recruiting
    • Queen Anne Street Medical Centre
• United States
  • Alabama
    • Dothan, Alabama, United States, 36305
      • Recruiting
      • SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
    • Jasper, Alabama, United States, 35501
      • Recruiting
      • Jasper Summit Research LLC
    • Mobile, Alabama, United States, 36608-3135
      • Recruiting
      • Pulmonary Associates of Mobile PC
  • Arizona
    • Peoria, Arizona, United States, 85381-4872
      • Recruiting
      • Phoenix Medical Group PC
  • California
    • Bakersfield, California, United States, 93309-0609
      • Withdrawn
      • IMD Clinical Trials
    • Banning, California, United States, 92220
      • Recruiting
      • CARE Clinical Research
    • Loma Linda, California, United States, 92357-1000
      • Recruiting
      • VA Loma Linda Healthcare System - NAVREF - PPDS
    • Poway, California, United States, 92064-2021
      • Active, not recruiting
      • Cadena Care Institute, LLC
    • San Diego, California, United States, 92120
      • Recruiting
      • Inst. of Healthcare Assessment, Inc.
    • Torrance, California, United States, 90502
      • Recruiting
      • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
    • Westminster, California, United States, 92683
      • Active, not recruiting
      • Allianz Research Institute Inc
  • Colorado
    • Denver, Colorado, United States, 80206
      • Recruiting
      • National Jewish Health
  • Florida
    • Clearwater, Florida, United States, 33765
      • Recruiting
      • St. Francis Sleep; Allergy & Lung Institute
    • Jacksonville, Florida, United States, 32209-6511
      • Recruiting
      • University of Florida College of Medicine Jacksonville
    • Leesburg, Florida, United States, 34748-5077
      • Recruiting
      • Clinical Site Partners - Leesburg Suite 101 - HyperCore - PPDS
    • Loxahatchee Groves, Florida, United States, 33470-9206
      • Recruiting
      • Pulmonary Specialists of the Palm Beaches
    • Miami, Florida, United States, 33135
      • Withdrawn
      • Suncoast Research Group LLC
    • Orlando, Florida, United States, 32822
      • Recruiting
      • Florida Institute for Clinical Research, LLC
    • Plantation, Florida, United States, 33317
      • Recruiting
      • Cardio-Pulmonary Associates
    • Winter Park, Florida, United States, 32789-4681
      • Recruiting
      • Clinical Site Partners - Winter Park - HyperCore - PPDS
  • Georgia
    • Columbus, Georgia, United States, 31904-8946
      • Withdrawn
      • Columbus Regional Research Institute at Talbotton - IACT - HyperCore - PPDS
  • Illinois
    • Chicago, Illinois, United States, 60611-2909
      • Recruiting
      • Feinberg School of Medicine Northwestern University
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Recruiting
      • MediSphere Medical Research Center, LLC
  • Louisiana
    • Shreveport, Louisiana, United States, 71101-4460
      • Recruiting
      • LSU Health Sciences Center - Shreveport
  • Massachusetts
    • Fall River, Massachusetts, United States, 20723
      • Recruiting
      • Exordia Medical Research, Inc.
  • Michigan
    • Buckley, Michigan, United States, 49620
      • Recruiting
      • Northern Pines Health Center PC
    • Lathrup Village, Michigan, United States, 48076
      • Recruiting
      • Revive Research Institute
    • Troy, Michigan, United States, 48085
      • Recruiting
      • Oakland Medical Research
  • Missouri
    • Hannibal, Missouri, United States, 63401
      • Recruiting
      • Blessing Health Hannibal
    • Saint Charles, Missouri, United States, 63301
      • Recruiting
      • Midwest Chest Consultants
    • Saint Louis, Missouri, United States, 63141
      • Recruiting
      • Midwest Clinical Research LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89106-4159
      • Recruiting
      • Sierra Clinical Research - ClinEdge - PPDS
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901-1962
      • Recruiting
      • Rutgers, The State University of New Jersey
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Recruiting
      • American Health Research Inc.
    • Gastonia, North Carolina, United States, 28054
      • Recruiting
      • Clinical Research of Gastonia
    • Shelby, North Carolina, United States, 28150-3803
      • Recruiting
      • Carolina Research Center
    • Winston-Salem, North Carolina, United States, 27103-4029
      • Recruiting
      • Southeastern Research Center
  • Ohio
    • Cincinnati, Ohio, United States, 45220-2213
      • Recruiting
      • Cincinnati Veterans Affairs Medical Center - NAVREF - PPDS
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Recruiting
      • Temple University Hospital
  • South Carolina
    • Clinton, South Carolina, United States, 29325-7556
      • Withdrawn
      • Carolina Medical Research, LLC
    • Fort Mill, South Carolina, United States, 29707-4526
      • Recruiting
      • Piedmont Research Partners LLC - Clinedge - PPDS
    • North Charleston, South Carolina, United States, 29406
      • Recruiting
      • Lowcountry Lung and Critical Care
    • Rock Hill, South Carolina, United States, 29732
      • Recruiting
      • Clinical Research of Rock Hill
    • Spartanburg, South Carolina, United States, 29303
      • Recruiting
      • Spartanburg Medical Center
    • Spartanburg, South Carolina, United States, 29303-4225
      • Recruiting
      • Velocity Clinical Research Spartanburg PPDS
  • Texas
    • Boerne, Texas, United States, 78006-1993
      • Recruiting
      • South Texas Medical Research Institute, Inc., dba TTS Research ? ClinEdge ? PPDS
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
    • Houston, Texas, United States, 77070
      • Recruiting
      • Horizon Clinical Research Group: Houston Pulmonary Sleep & Allergy Associates -Clinedge ? PPDS
    • McKinney, Texas, United States, 75069
      • Recruiting
      • Metroplex Pulmonology & Sleep Center
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • University of Texas Health Sciences Center in San Antonio
    • Sherman, Texas, United States, 75092
      • Recruiting
      • Sherman Clinical Research - ClinEdge - PPDS
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Astegolimab Q2W; Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W).	Drug: Astegolimab; Participants will receive SC astegolimab Q2W or Q4W.
Experimental: Astegolimab Q4W; Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving astegolimab every 4 weeks (Q4W).	Drug: Astegolimab; Participants will receive SC astegolimab Q2W or Q4W.
Placebo Comparator: Placebo; Participants will receive SC placebo Q2W.	Drug: Placebo; Participants will receive SC placebo Q2W.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Annualized Rate of Moderate and Severe COPD Exacerbations Over the 52-Week Treatment Period	Baseline up to Week 52

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to First Moderate or Severe COPD Exacerbation During the 52-Week Treatment Period	Baseline up to Week 52
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
Proportion of SGRQ-C Responders at Week 52	Baseline to Week 52
Absolute Change from Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (liters) at Week 52	Baseline to Week 52
Absolute Change from Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Score at Week 52	Baseline to Week 52
Annualized Rate of Severe COPD Exacerbations Over the 52-Week Treatment Period	Baseline up to Week 52
Absolute Change from Baseline in Five-Repetition Sit-to-Stand (5STS) time (seconds) at Week 52	Baseline to Week 52

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2021
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: COPD; Chronic Obstructive Pulmonary Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Anti-Infective Agents; Antiviral Agents; Anti-Inflammatory Agents; Tumor Necrosis Factor Inhibitors; Astegolimab
• Other Study ID Numbers: GB43311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No