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

NCT05037929 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: GB43311
• Study Type: interventional
• Target: 1,334
• Locations: 24 countries
• Sites: 181

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; COPD

Outcome Measures

Primary Outcomes (1)

• Annualized Rate of Moderate and Severe COPD Exacerbations Over the 52-Week Treatment Period

  Baseline up to Week 52

Secondary Outcomes (7)

• 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

Study Arms (3)

Astegolimab Q2W

EXPERIMENTAL

Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W).

Drug: Astegolimab

Astegolimab Q4W

EXPERIMENTAL

Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving astegolimab every 4 weeks (Q4W).

Drug: Astegolimab

Placebo

PLACEBO COMPARATOR

Participants will receive SC placebo Q2W.

Drug: Placebo

Interventions

Astegolimab DRUG

Participants will receive SC astegolimab Q2W or Q4W.

Astegolimab Q2W; Astegolimab Q4W

Placebo DRUG

Participants will receive SC placebo Q2W.

Placebo

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (181)

SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS

Dothan, Alabama, 36305, United States

Location

Jasper Summit Research LLC

Jasper, Alabama, 35501, United States

Location

Pulmonary Associates of Mobile PC

Mobile, Alabama, 36608-3135, United States

Location

Cadena Care Institute, LLC

Poway, California, 92064-2021, United States

Location

Inst. of Healthcare Assessment, Inc.

San Diego, California, 92120, United States

Location

Allianz Research Institute Inc

Westminster, California, 92683, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Clinical Site Partners - Leesburg Suite 101 - HyperCore - PPDS

Leesburg, Florida, 34748-5077, United States

Location

Florida Institute for Clinical Research, LLC

Orlando, Florida, 32825-4454, United States

Location

Clinical Site Partners - Winter Park - HyperCore - PPDS

Winter Park, Florida, 32789-4681, United States

Location

Northwestern Center for Clinical Research

Chicago, Illinois, 60611, United States

Location

Medisphere Medical Research Center, Llc

Evansville, Indiana, 47714, United States

Location

Exordia Medical Research, Inc.

Fall River, Massachusetts, 20723, United States

Location

Northern Pines Health Center PC

Buckley, Michigan, 49620, United States

Location

Revive Research Institute

Lathrup Village, Michigan, 48076, United States

Location

Cardio-Pulmonary Associates

Chesterfield, Missouri, 63017-3627, United States

Location

Blessing Health Hannibal

Hannibal, Missouri, 63401, United States

Location

Midwest Chest Consultants

Saint Charles, Missouri, 63301, United States

Location

CARE Clinical Research

St Louis, Missouri, 63141-6823, United States

Location

Midwest Clinical Research LLC

St Louis, Missouri, 63141, United States

Location

Sierra Clinical Research - ClinEdge - PPDS

Las Vegas, Nevada, 89106-4159, United States

Location

American Health Research Inc.

Charlotte, North Carolina, 28277, United States

Location

Clinical Research of Gastonia

Gastonia, North Carolina, 28054-7481, United States

Location

Carolina Research Center

Shelby, North Carolina, 28150-3803, United States

Location

Southeastern Research Center

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

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Lowcountry Lung and Critical Care

North Charleston, South Carolina, 29406, United States

Location

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732-1160, United States

Location

Velocity Clinical Research Spartanburg PPDS

Spartanburg, South Carolina, 29303-4225, United States

Location

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

Location

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

Boerne, Texas, 78006-1993, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Metroplex Pulmonology & Sleep Center

McKinney, Texas, 75069, United States

Location

Sherman Clinical Research - ClinEdge - PPDS

Sherman, Texas, 75092, United States

Location

Centro Medico IPAM

Rosario, Santa Fe Province, S2001SBK, Argentina

Location

Centro de Investigaciones Clínicas Belgrano

Buenos Aires, 7240, Argentina

Location

Instituto de Investigaciones Clinicas-Mar del Plata

Buenos Aires, B7600FZN, Argentina

Location

Fundacion Cidea

Buenos Aires, C1121ABE, Argentina

Location

Centro Médico Dra de Salvo

Buenos Aires, C1426ABP, Argentina

Location

CARE - Centro de Alergia y Enfermedades Respiratorias

CABA, C1414AIF, Argentina

Location

Instituto de Medicina Respiratoria, IMeR

Córdoba, X5003DCE, Argentina

Location

Centro de Especialidades Medicas Lobos

Lobos, B7240AAN, Argentina

Location

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, 7600, Argentina

Location

Instituto Ave Pulmo

Mar del Plata, B7602DCK, Argentina

Location

INSARES

Mendoza, M5500CCG, Argentina

Location

Centro Respiratorio Quilmes

Quilmes, B1878FNR, Argentina

Location

Instituto Medico Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion Medica

Rosario, S2013OJN, Argentina

Location

Centro Médico Respire

San Fernando, B1646EBJ, Argentina

Location

Instituto De Enfermedades Respiratorias E Investigacion Medica

San Juan Bautista, CP 1888, Argentina

Location

Investigaciones en Patologias Respiratorias

San Miguel de Tucumán, 4000, Argentina

Location

Centro Integral de Medicina Respiratoria (CIMER)

San Miguel de Tucumán, T4000CBC, Argentina

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

TrialsWest Pty Ltd

Spearwood, Western Australia, 6163, Australia

Location

AZ Sint-Maarten

Mechelen, Antwerpen, 2800, Belgium

Location

UZ Antwerpen

Edegem, 2650, Belgium

Location

Private Practice Dr Jean Benoit Martinot

Erpent, 5101, Belgium

Location

AZ Delta

Roeselare, 8800, Belgium

Location

Office of Marc De Meulemeester

Thuin, 6534, Belgium

Location

CHU UCl Namur asbl - Site Godinne

Yvoir, 5530, Belgium

Location

Medical Centre "Asklepii", OOD

Dupnitsa, 2600, Bulgaria

Location

Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD

Haskovo, 6300, Bulgaria

Location

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

Pazardzhik, 4400, Bulgaria

Location

Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD

Pernik, 2300, Bulgaria

Location

Medical center Medconsult Pleven OOD

Pleven, 5800, Bulgaria

Location

University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

Plovdiv, 4001, Bulgaria

Location

Medical center Unimed EOOD

Plovdiv, 4023, Bulgaria

Location

Medical Centre Respiro OOD

Razgrad, 7200, Bulgaria

Location

Medical Center Hera EOOD

Sofia, 1510, Bulgaria

Location

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

Sofia, 1606, Bulgaria

Location

Medical Center New rehabilitation center EOOD

Stara Zagora, 6003, Bulgaria

Location

Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa

Vratsa, 3000, Bulgaria

Location

Burlington Lung Clinic

Burlington, Ontario, L7N 3V2, Canada

Location

St. Joseph's Healthcare Hamilton- Charlton Campus

Hamilton, Ontario, L8N 4A6, Canada

Location

Bluewater Clinical Research Group

Sarnia, Ontario, N7T 4X3, Canada

Location

University of Saskatchewan, Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Centro de Investigaciones Medicas Respiratorias

Providencia, Región-MetropolitanadeSantiago, 7500000, Chile

Location

Centro de Investigación Curico

Curicó, 3340000, Chile

Location

MIRES/MYF estudios clinicos

Ñuñoa, 7750495, Chile

Location

Sociedad Médica SyG SpA

Providencia, 7500000, Chile

Location

Enroll SpA - PPDS

Providencia, 7500587, Chile

Location

Meditek Ltda

Santiago, 8320000, Chile

Location

Centro de Investigacion del Maule

Talca, Chile

Location

Hospital Carlos Van Buren

Valparaíso, 2340000, Chile

Location

MediTrial s.r.o.

Jind?ich?v Hradec, 377 01, Czechia

Location

Plicni Ambulance Kralupy nad Vltavou

Kralupy nad Vltavou, 278 01, Czechia

Location

MUDr. Ilona Pavlisova s.r.o.

Miroslav, 671 72, Czechia

Location

Pneumologie Varnsdorf S.r.o.

Nový Bor, 473 01, Czechia

Location

KASMED s.r.o.

Tábor, 390 02, Czechia

Location

Aalborg Universitetshospital

Aalborg, 9000, Denmark

Location

Gentofte Hospital

Hellerup, 2900, Denmark

Location

Hvidovre Hospital

Hvidovre, DK-2650, Denmark

Location

Odense Universitetshospital

Odense, 5000, Denmark

Location

Sygehus Lillebælt, Vejle

Vejle, 7100, Denmark

Location

Hôpital de La Croix Rousse

Lyon, 69004, France

Location

CHU de Nice

Nice, 06001, France

Location

Nouvel Hôpital Civil

Strasbourg, 67091, France

Location

Zentrum fuer Pneumologie, Onkologie und Schlafmedizin am Diako

Augsburg, 86150, Germany

Location

CIMS-Studienzentrum Bamberg,

Bamberg, Germany

Location

KPPK Studienzentrum Kroker-Schmidt

Bendorf, 56170, Germany

Location

MECS Research GmbH

Berlin, 12203, Germany

Location

Praxis Dr. Med Evelin Liefring

Berlin, 13187, Germany

Location

Gemeinscharftspraxis Dres Jung - Deggingen

Deggingen, 73326, Germany

Location

Medizentrum Essen Borbeck

Essen, 45355, Germany

Location

Praxis Dr med Claus Keller

Frankfurt am Main, 60389, Germany

Location

Universitätsklinikum Gießen und Marburg GmbH

Giessen, 35392, Germany

Location

Asklepios MVZ Bayern GmbH

Landsberg, 86899, Germany

Location

Salvus-Klinische Studien GmbH

Leipzig, 04207, Germany

Location

Zentrum fuer ambulante pneumologische Forschung Marburg GbR

Marburg, 35037, Germany

Location

Studienzentrum Dr Med Schlenska

Peine, 31224, Germany

Location

Tuen Mun Hospital

Hong Kong, Hong Kong

Location

Assuta Ashdod Medical Center

Ashdod, 7747629, Israel

Location

Barzilai Medical Center

Ashkelon, 7830604, Israel

Location

Shamir Medical Center Assaf Harofeh

Beer Jacob, 0073100, Israel

Location

Tel Aviv Sourasky Medical Center PPDS

Jerusalem, 90000, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Kaplan Medical Center

Rehovot, 76100, Israel

Location

Sheba Medical Center - PPDS

Tel Litwinsky, 52621, Israel

Location

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

Guadalajara, Jalisco, 44100, Mexico

Location

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

Guadalajara, Jalisco, 44130, Mexico

Location

Unidad Medica de Occidente

Guadalajara, Jalisco, 44220, Mexico

Location

CICUM San Miguel

Guadalajara Centro, Jalisco, 44100, Mexico

Location

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

Monterrey, Nuevo León, 64718, Mexico

Location

Centro de Investigacion y Atencion Integral Durango CIAID

Durango, 34080, Mexico

Location

Amphia Ziekenhuis

Breda, 4819 EV, Netherlands

Location

Isala Klinieken

Zwolle, 8011 JW, Netherlands

Location

Aotearoa Clinical Trials Trust

Auckland, 2025, New Zealand

Location

Canterbury Respiratory Research Group

Christchurch, 8011, New Zealand

Location

Clinica Providencia (Inverconsult Sociedad Anonima)

Lima, 32, Peru

Location

Clinica Internacional

Lima, Lima 01, Peru

Location

Clinica Ricardo Palma

Lima, Lima 27, Peru

Location

Alfredo Berrocal Kasay Reuma Sociedad de Responsabilidad Limitada

Lima Cercado, 000000, Peru

Location

Centrum Medyczne Bydgoszcz- PRATIA - PPDS

Bydgoszcz, 85-796, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska lek.

Kielce, 25-751, Poland

Location

Centrum Medyczne ALL-MED

Krakow, 30-033, Poland

Location

Diamond Clinic

Krakow, 31-559, Poland

Location

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

Krakow, 31-637, Poland

Location

ETG Lodz

Lódz, 90-302, Poland

Location

ETG Lublin

Lublin, 20-412, Poland

Location

Twoja Przychodnia Centrum Medyczne Nowa Sol

Nowa Sól, 67-100, Poland

Location

Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik

Ostrowiec Swietokrzysk, 27-400, Poland

Location

Centrum Alergologii Teresa Hofman

Poznan, 60-214, Poland

Location

EMED Centrum Uslug Medycznych Ewa Smialek

Rzeszów, 35-205, Poland

Location

ETG Siedlce

Siedlce, 08-110, Poland

Location

PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna

Sosnowiec, 41-208, Poland

Location

ETG Warszawa- PPDS

Warsaw, 02-793, Poland

Location

Dobrostan Gabinety Lekarskie

Wroclaw, 53-301, Poland

Location

Neomed Out-Patient Treatment and Diagnosis Medical Center SRL

Brasov, 500283, Romania

Location

Dr. Victor Babes Foundation

Bucharest, 030303, Romania

Location

Leon Daniello Pneumophthisiology Clinical Hospital

Cluj-Napoca, 400371, Romania

Location

Spitalul Clinic de Pneumoftiziologie Constanta

Constanța, 900002, Romania

Location

Sf. Ioan cel Nou Emergency County Hospital

Suceava, 720237, Romania

Location

University of Cape Town Lung Institute

Cape Town, 7700, South Africa

Location

Clinical Trial Systems

City of Tshwane, 0186, South Africa

Location

St Augustines Hospital

Durban, 4001, South Africa

Location

Dr A.C Wilhase practice-Reimed

Ekurhuleni, 1459, South Africa

Location

Lakeview Hospital

Ekurhuleni, 1501, South Africa

Location

Langeberg Clinical Trials

Kraaifontein, 7570, South Africa

Location

Catholic Univ. of Incheon St.Mary's Hospital

Incheon, 21431, South Korea

Location

Chonbuk National University Hospital

Jeonju, 54907, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Hospital de Merida

Mérida, Badajoz, 06800, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

CHUS H Clinico U de Santiago

Santiago de Compostela, LA Coruna, 15706, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 000000, Spain

Location

Hospital de San Pedro de Alcantara

Cáceres, 10003, Spain

Location

Hospital Universitario Virgen de Las Nieves

Granada, 18012, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz.

Madrid, 28040, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Fysikalisk Medicin i Stockholm AB

Lidingö, 181 29, Sweden

Location

ProbarE i Lund AB

Lund, 222 22, Sweden

Location

PharmaSite

Malmo, 211 52, Sweden

Location

ProbarE i Stockholm AB

Stockholm, 113 29, Sweden

Location

Queen Anne Street Medical Centre

London, London, City of, W1T6AH, United Kingdom

Location

Bradford Royal Infirmary

Bradford, BD9 6RJ, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

Ninewells Hospital

Dundee, DD1 9SY, United Kingdom

Location

Glenfield Hospital

Leicester, LE3 9QP, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

astegolimab

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 8, 2021
• Study Start: October 5, 2021
• Primary Completion: February 24, 2025
• Study Completion: July 7, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

SE (4); ME (6); AU (4); DK (5); CL (8); DE (13); ES (9); PE (4); BU (12); GB (5); RO (5); CZ (5); HK (1); CA (4); NL (2); US (34); BE (6); IL (7); PL (15); ZA (6); NZ (2); KR (4); FR (3); AR (17)