Clinical trial NCT05037929: A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
COPD
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-08
Enrollment: 1334
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Annualized Rate of Moderate and Severe COPD Exacerbations Over the 52-Week Treatment Period
timeFrame: Baseline up to Week 52
Secondary outcomes:
measure: Time to First Moderate or Severe COPD Exacerbation During the 52-Week Treatment Period
timeFrame: Baseline up to Week 52
measure: 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
timeFrame: Baseline to Week 52
measure: Proportion of SGRQ-C Responders at Week 52
timeFrame: Baseline to Week 52
measure: Absolute Change from Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (liters) at Week 52
timeFrame: Baseline to Week 52
measure: Absolute Change from Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Score at Week 52
timeFrame: Baseline to Week 52
measure: Annualized Rate of Severe COPD Exacerbations Over the 52-Week Treatment Period
timeFrame: Baseline up to Week 52
measure: Absolute Change from Baseline in Five-Repetition Sit-to-Stand (5STS) time (seconds) at Week 52
timeFrame: Baseline to Week 52
Other outcomes:
Locations:
city: Dothan
country: United States
facility: SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
state: Alabama
city: Jasper
country: United States
facility: Jasper Summit Research LLC
state: Alabama
city: Mobile
country: United States
facility: Pulmonary Associates of Mobile PC
state: Alabama
city: Poway
country: United States
facility: Cadena Care Institute, LLC
state: California
city: San Diego
country: United States
facility: Inst. of Healthcare Assessment, Inc.
state: California
city: Westminster
country: United States
facility: Allianz Research Institute Inc
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Leesburg
country: United States
facility: Clinical Site Partners - Leesburg Suite 101 - HyperCore - PPDS
state: Florida
city: Orlando
country: United States
facility: Florida Institute for Clinical Research, LLC
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners - Winter Park - HyperCore - PPDS
state: Florida
city: Chicago
country: United States
facility: Northwestern Center for Clinical Research
state: Illinois
city: Evansville
country: United States
facility: Medisphere Medical Research Center, Llc
state: Indiana
city: Fall River
country: United States
facility: Exordia Medical Research, Inc.
state: Massachusetts
city: Buckley
country: United States
facility: Northern Pines Health Center PC
state: Michigan
city: Lathrup Village
country: United States
facility: Revive Research Institute
state: Michigan
city: Chesterfield
country: United States
facility: Cardio-Pulmonary Associates
state: Missouri
city: Hannibal
country: United States
facility: Blessing Health Hannibal
state: Missouri
city: Saint Charles
country: United States
facility: Midwest Chest Consultants
state: Missouri
city: Saint Louis
country: United States
facility: CARE Clinical Research
state: Missouri
city: Saint Louis
country: United States
facility: Midwest Clinical Research LLC
state: Missouri
city: Las Vegas
country: United States
facility: Sierra Clinical Research - ClinEdge - PPDS
state: Nevada
city: Charlotte
country: United States
facility: American Health Research Inc.
state: North Carolina
city: Gastonia
country: United States
facility: Clinical Research of Gastonia
state: North Carolina
city: Shelby
country: United States
facility: Carolina Research Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: North Charleston
country: United States
facility: Lowcountry Lung and Critical Care
state: South Carolina
city: Rock Hill
country: United States
facility: Clinical Research of Rock Hill
state: South Carolina
city: Spartanburg
country: United States
facility: Velocity Clinical Research Spartanburg PPDS
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Center
state: South Carolina
city: Boerne
country: United States
facility: South Texas Medical Research Institute, Inc., dba TTS Research ? ClinEdge ? PPDS
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonology & Sleep Center
state: Texas
city: Sherman
country: United States
facility: Sherman Clinical Research - ClinEdge - PPDS
state: Texas
city: Rosario
country: Argentina
facility: Centro Medico IPAM
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Instituto de Investigaciones Clinicas-Mar del Plata
city: Buenos Aires
country: Argentina
facility: Fundacion Cidea
city: Caba
country: Argentina
facility: CARE - Centro de Alergia y Enfermedades Respiratorias
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro Médico Dra de Salvo
city: Ciudad Autónoma De Buenos Aires
country: Argentina
facility: Centro de Investigaciones Clínicas Belgrano
city: Córdoba
country: Argentina
facility: Instituto de Medicina Respiratoria, IMeR
city: Florencio Varela
country: Argentina
facility: Instituto De Enfermedades Respiratorias E Investigacion Medica
city: Lobos
country: Argentina
facility: Centro de Especialidades Medicas Lobos
city: Mar Del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar Del Plata
city: Mar Del Plata
country: Argentina
facility: Instituto Ave Pulmo
city: Mendoza
country: Argentina
facility: INSARES
city: Quilmes
country: Argentina
facility: Centro Respiratorio Quilmes
city: Rosario
country: Argentina
facility: Instituto Medico Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion Medica
city: San Fernando
country: Argentina
facility: Centro Médico Respire
city: San Miguel de Tucuman
country: Argentina
facility: Investigaciones en Patologias Respiratorias
city: San Miguel De Tucuman
country: Argentina
facility: Centro Integral de Medicina Respiratoria (CIMER)
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Spearwood
country: Australia
facility: TrialsWest Pty Ltd
state: Western Australia
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Erpent
country: Belgium
facility: Private Practice Dr Jean Benoit Martinot
city: Mechelen
country: Belgium
facility: AZ Sint-Maarten
city: Roeselare
country: Belgium
facility: AZ Delta
city: Thuin
country: Belgium
facility: Office of Marc De Meulemeester
city: Yvoir
country: Belgium
facility: CHU UCl Namur asbl - Site Godinne
city: Dupnitsa
country: Bulgaria
facility: Medical Centre "Asklepii", OOD
city: Haskovo
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD
city: Pazardzhik
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Dr.Nikola Penchev-Paza
city: Pernik
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD
city: Pleven
country: Bulgaria
facility: Medical center Medconsult Pleven OOD
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
city: Plovdiv
country: Bulgaria
facility: Medical center Unimed EOOD
city: Razgrad
country: Bulgaria
facility: Medical Centre Respiro OOD
city: Sofia
country: Bulgaria
facility: Medical Center Hera EOOD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD
city: Stara Zagora
country: Bulgaria
facility: Medical Center New rehabilitation center EOOD
city: Vratsa
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa
city: Burlington
country: Canada
facility: Burlington Lung Clinic
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton- Charlton Campus
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clinical Research Group
state: Ontario
city: Saskatoon
country: Canada
facility: University of Saskatchewan, Royal University Hospital
state: Saskatchewan
city: Providencia
country: Chile
facility: Centro de Investigaciones Medicas Respiratorias
state: Región-MetropolitanadeSantiago
city: Curico
country: Chile
facility: Centro de Investigación Curico
city: Providencia
country: Chile
facility: Sociedad Médica SyG SpA
city: Providencia
country: Chile
facility: Enroll SpA - PPDS
city: Santiago
country: Chile
facility: Meditek Ltda
city: Talca
country: Chile
facility: Centro de Investigacion del Maule
city: Valparaiso
country: Chile
facility: Hospital Carlos Van Buren
city: Ñuñoa
country: Chile
facility: MIRES/MYF estudios clinicos
city: Jind?ich?v Hradec
country: Czechia
facility: MediTrial s.r.o.
city: Kralupy nad Vltavou
country: Czechia
facility: Plicni Ambulance Kralupy nad Vltavou
city: Miroslav
country: Czechia
facility: MUDr. Ilona Pavlisova s.r.o.
city: Novy Bor
country: Czechia
facility: Pneumologie Varnsdorf S.r.o.
city: Tábor
country: Czechia
facility: KASMED s.r.o.
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Vejle
country: Denmark
facility: Sygehus Lillebælt, Vejle
city: Lyon
country: France
facility: Hôpital de La Croix Rousse
city: Nice Cedex 1
country: France
facility: CHU de Nice
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil
city: Augsburg
country: Germany
facility: Zentrum fuer Pneumologie, Onkologie und Schlafmedizin am Diako
city: Bamberg
country: Germany
facility: CIMS-Studienzentrum Bamberg,
city: Bendorf
country: Germany
facility: KPPK Studienzentrum Kroker-Schmidt
city: Berlin
country: Germany
facility: MECS Research GmbH
city: Berlin
country: Germany
facility: Praxis Dr. Med Evelin Liefring
city: Deggingen
country: Germany
facility: Gemeinscharftspraxis Dres Jung - Deggingen
city: Essen
country: Germany
facility: Medizentrum Essen Borbeck
city: Frankfurt am Main
country: Germany
facility: Praxis Dr med Claus Keller
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH
city: Landsberg
country: Germany
facility: Asklepios MVZ Bayern GmbH
city: Leipzig
country: Germany
facility: Salvus-Klinische Studien GmbH
city: Marburg
country: Germany
facility: Zentrum fuer ambulante pneumologische Forschung Marburg GbR
city: Peine
country: Germany
facility: Studienzentrum Dr Med Schlenska
city: Hong Kong
country: Hong Kong
facility: Tuen Mun Hospital
city: Ashdod
country: Israel
facility: Assuta Ashdod Medical Center
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Beer Jacob
country: Israel
facility: Shamir Medical Center Assaf Harofeh
city: Jerusalem
country: Israel
facility: Tel Aviv Sourasky Medical Center PPDS
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center - PPDS
city: Incheon
country: Korea, Republic of
facility: Catholic Univ. of Incheon St.Mary's Hospital
city: Jeonju-si
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Guadalajara Centro
country: Mexico
facility: CICUM San Miguel
state: Jalisco
city: Guadalajara
country: Mexico
facility: Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
state: Jalisco
city: Guadalajara
country: Mexico
facility: Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
state: Jalisco
city: Guadalajara
country: Mexico
facility: Unidad Medica de Occidente
state: Jalisco
city: Monterrey
country: Mexico
facility: Unidad de Investigacion Clinica En Medicina (Udicem) S.C.
state: Nuevo LEON
city: Durango
country: Mexico
facility: Centro de Investigacion y Atencion Integral Durango CIAID
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Auckland
country: New Zealand
facility: Aotearoa Clinical Trials Trust
city: Christchurch
country: New Zealand
facility: Canterbury Respiratory Research Group
city: Cercado De Lima
country: Peru
facility: Alfredo Berrocal Kasay Reuma Sociedad de Responsabilidad Limitada
city: Lima
country: Peru
facility: Clinica Providencia (Inverconsult Sociedad Anonima)
city: Lima
country: Peru
facility: Clinica Internacional
city: Lima
country: Peru
facility: Clinica Ricardo Palma
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Bydgoszcz- PRATIA - PPDS
city: Kielce
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska lek.
city: Krakow
country: Poland
facility: Centrum Medyczne ALL-MED
city: Kraków
country: Poland
facility: Diamond Clinic
city: Kraków
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.
city: Lublin
country: Poland
facility: ETG Lublin
city: Lódz
country: Poland
facility: ETG Lodz
city: Nowa Sól
country: Poland
facility: Twoja Przychodnia Centrum Medyczne Nowa Sol
city: Ostrowiec Swietokrzysk
country: Poland
facility: Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik
city: Poznan
country: Poland
facility: Centrum Alergologii Teresa Hofman
city: Rzeszów
country: Poland
facility: EMED Centrum Uslug Medycznych Ewa Smialek
city: Siedlce
country: Poland
facility: ETG Siedlce
city: Sosnowiec
country: Poland
facility: PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna
city: Warszawa
country: Poland
facility: ETG Warszawa- PPDS
city: Wroclaw
country: Poland
facility: Dobrostan Gabinety Lekarskie
city: Brasov
country: Romania
facility: Neomed Out-Patient Treatment and Diagnosis Medical Center SRL
city: Bucuresti
country: Romania
facility: Dr. Victor Babes Foundation
city: Cluj-Napoca
country: Romania
facility: Leon Daniello Pneumophthisiology Clinical Hospital
city: Constanta
country: Romania
facility: Spitalul Clinic de Pneumoftiziologie Constanta
city: Suceava
country: Romania
facility: Sf. Ioan cel Nou Emergency County Hospital
city: Cape Town
country: South Africa
facility: University of Cape Town Lung Institute
city: City Of Tshwane
country: South Africa
facility: Clinical Trial Systems
city: Durban
country: South Africa
facility: St Augustines Hospital
city: Ekurhuleni
country: South Africa
facility: Dr A.C Wilhase practice-Reimed
city: Ekurhuleni
country: South Africa
facility: Lakeview Hospital
city: Kraaifontein
country: South Africa
facility: Langeberg Clinical Trials
city: Merida
country: Spain
facility: Hospital de Merida
state: Badajoz
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Santiago de Compostela
country: Spain
facility: CHUS H Clinico U de Santiago
state: LA Coruna
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Caceres
country: Spain
facility: Hospital de San Pedro de Alcantara
city: Granada
country: Spain
facility: Hospital Universitario Virgen de Las Nieves
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz.
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Lidingö
country: Sweden
facility: Fysikalisk Medicin i Stockholm AB
city: Lund
country: Sweden
facility: ProbarE i Lund AB
city: Malmö
country: Sweden
facility: PharmaSite
city: Stockholm
country: Sweden
facility: ProbarE i Stockholm AB
city: London
country: United Kingdom
facility: Queen Anne Street Medical Centre
state: London, City Of
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: