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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05037929
Other study ID # GB43311
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 5, 2021
Est. completion date March 1, 2025

Study information

Verified date March 2024
Source Genentech, Inc.
Contact Reference Study ID Number: GB43311 https://forpatients.roche.com
Phone 888-662-6728
Email global-roche-genentech-trials@gene.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Astegolimab
Participants will receive SC astegolimab Q2W or Q4W.
Placebo
Participants will receive SC placebo Q2W.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

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, 

Outcome

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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