AzTrials
AzTrials

Chronic Obstructive Pulmonary DiseasePhase 3NCT05878769

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing Astegolimab in people with Chronic Obstructive Pulmonary Disease, run by Hoffmann-La Roche at 481 sites in 40 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332. Read more about this study

Who is it for?
Ages 40 to 90 years
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Astegolimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,000 participants
Where
481 sitesin 40 countries
Study dates
28 Jun 2023to 30 Jun 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Completion of the 52-week treatment period in either parent GB43311 or GB44332

Who cannot join

  • Withdrawal of consent and/or premature discontinuation from parent study
  • Any permanent discontinuation of study drug in parent study
  • Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator's judgment
  • Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study
  • Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study
  • Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study

Trial locations and contacts

481 sites in 40 countries.

481 sites in 40 countries

United States68 sites
  • Kern Allergy and Medical Research

    Bakersfield, California, 93301-4205

  • Paul A. Shapero, MD, PA

    Bangor, Maine, 04401-5691

  • UAB Lung Health Center

    Birmingham, Alabama, 35205-2610

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

    Boerne, Texas, 78006-1993

  • American Health Research Inc.

    Charlotte, North Carolina, 28277

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

  • ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • The Lung Research Center

    Chesterfield, Missouri, 63017-3625

  • Northwestern Center for Clinical Research

    Chicago, Illinois, 60611

  • St Francis Medical Institute ClinEdge PPDS

    Clearwater, Florida, 33765

  • Vermont Lung Center at the University of Vermont

    Colchester, Vermont, 05446-3052

  • Medtrial, LLC

    Columbia, South Carolina, 29204

  • Corsicana Medical Research

    Corsicana, Texas, 75110-2471

  • Research Carolina Elite

    Denver, North Carolina, 28037-7929

  • SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS

    Dothan, Alabama, 36305

  • Clinical Research Associates Of Central Pa , Llc

    DuBois, Pennsylvania, 15801-2277

  • OK Clinical Research

    Edmond, Oklahoma, 73034-3258

  • Western Washington Medical Group

    Everett, Washington, 98208

  • Exordia Medical Research, Inc.

    Fall River, Massachusetts, 02723-1511

  • Pulmonary Research Institute of Southeast Michigan

    Farmington Hills, Michigan, 48336-2817

  • Flushing Road Internal Medicine and Pediatrics - F

    Flint, Michigan, 48504-4730

  • Velocity Clinical Research - Gaffney - PPDS

    Gaffney, South Carolina, 29340-4737

  • Clinical Research of Gastonia

    Gastonia, North Carolina, 28054

  • Finlay Medical Research Corporation

    Greenacres City, Florida, 33467-2979

  • Allergy Asthma and Sinus Center-Greenfield

    Greenfield, Wisconsin, 53228

  • Pulmonix LLC

    Greensboro, North Carolina, 27403-4443

  • ASHA Clinical Research - ClinEdge - PPDS

    Hammond, Indiana, 46324-2213

  • Hannibal Regional Healthcare System HRMG Hannibal

    Hannibal, Missouri, 63401-6890

  • Tennessee Comprehensive Lung & Sleep Center

    Hendersonville, Tennessee, 37075-3085

  • Trio Clinical Trials

    Houston, Texas, 77008-1772

  • Baylor College of Medicine

    Houston, Texas, 77030-4202

  • Houston Pulmonary Medicine Associates, PA - Biopharma Informatic, LLC

    Houston, Texas, 77089-6097

  • Jasper Summit Research LLC

    Jasper, Alabama, 35501

  • The Machuca Foundation Inc

    Las Vegas, Nevada, 89101-3485

  • Sierra Clinical Research - ClinEdge - PPDS

    Las Vegas, Nevada, 89106-4159

  • Flourish Research - Leesburg - PPDS

    Leesburg, Florida, 34748-5077

  • Advanced Pulmonary Research Institute

    Loxahatchee Groves, Florida, 33470-9272

  • Metroplex Pulmonary and Sleep Medicine Center

    McKinney, Texas, 75069

  • San Marcus Research Clinic Inc.

    Miami, Florida, 33014

  • Finlay Medical Research Corporation

    Miami, Florida, 33126-1941

  • Oceane7 Medical & Research Center, Inc.

    Miami, Florida, 33144-2155

  • Research Institute of South Florida Inc

    Miami, Florida, 33173

  • Diverse Clinical Research, LLC

    Miami, Florida, 33175-3434

  • Pulmonary Associates of Mobile PC

    Mobile, Alabama, 36608-3135

  • Best Clinical Trials

    New Orleans, Louisiana, 70115-3628

  • AES - DRS - Synexus Clinical Research US, Inc. - New York

    New York, New York, 10017-4008

  • Lowcountry Lung and Critical Care

    North Charleston, South Carolina, 29406

  • Central Florida Pulmonary Group, PA

    Orlando, Florida, 32803

  • Florida Institute for Clinical Research, LLC

    Orlando, Florida, 32825-4454

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Pulmonary Associates Deer Valley Office

    Phoenix, Arizona, 85027-5163

  • Allergy & Clinical Immun Assoc

    Pittsburgh, Pennsylvania, 15241

  • The Oregon Clinic.

    Portland, Oregon, 97220

  • Cadena Care Institute, LLC

    Poway, California, 92064-2419

  • Renown Regional Medical Center Hospital

    Reno, Nevada, 89502-1576

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina, 29732

  • Midwest Chest Consultants

    Saint Charles, Missouri, 63301

  • Apex Clinical Research

    San Diego, California, 92120

  • Carolina Research Center

    Shelby, North Carolina, 28150-3803

  • Sherman Clinical Research - ClinEdge - PPDS

    Sherman, Texas, 75090

  • Revive Research Institute

    Southfield, Michigan, 48075

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110

  • Midwest Clinical Research LLC

    St Louis, Missouri, 63141

  • Pivotal Research Solutions

    Stonecrest, Georgia, 30038-2649

  • Oakland Medical Research Center

    Troy, Michigan, 48085-5524

  • AES - DRS - Synexus Clinical Research US, Inc. - Tucson

    Tucson, Arizona, 85741-3118

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103-4029

  • Flourish Research - Orlando - PPDS

    Winter Park, Florida, 32789-4681

Other trials in United States

Argentina40 sites
  • Consultorios Medicos Organizacion de Buen Ayre SRL

    Buenos Aires, 1425

  • Centro de Investigaciones Clínicas Belgrano

    Buenos Aires, 7240

  • Fundacion Cidea

    Buenos Aires, C1121ABE

  • Fundacion Faicep

    Buenos Aires, C1122AAK

  • Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias

    Buenos Aires, C1425

  • AES - AS - Glenny Corp. S.A. Buenos Aires

    Buenos Aires, C1430

  • CARE - Centro de Alergia y Enfermedades Respiratorias

    CABA, C1414AIF

  • Nexo Salud Investigacion Clinica - Riobamba 429

    Ciudad Autonoma Buenos Aires, C1025ABI

  • CINME S.A. ? Centro de Investigaciones Metabolicas - Rx Trials LLC

    Ciudad Autonoma Buenos Aires, C1056ABI

  • Centro Médico Dra de Salvo

    Ciudad Autonoma Buenos Aires, C1426ABP

  • Centro de Medicina Respiratoria

    Concepción del Uruguay, 3260

  • Sanatorio de la Canada

    Córdoba, X5000BSQ

  • Instituto de Medicina Respiratoria, IMeR

    Córdoba, X5003DCE

  • Centro Privado de Medicina Respiratoria

    Entre Ríos, E3100BBJ

  • Centro Medico Capital

    La Plata, Buenos Aires, B1900

  • Framingham Centro Medico

    La Plata, 1900

  • Centro Platense en Investigaciones Respiratorias

    La Plata, B1900BNN

  • CEMLO - Centro de Especialidades Médicas Lobos - Patagones 94

    Lobos, Buenos Aires, B7240KJB

  • Centro de Investigaciones Medicas Mar Del Plata

    Mar del Plata, B7600FYK

  • Instituto de Investigaciones Clinicas-Mar del Plata

    Mar del Plata, B7600FZN

  • Instituto Ave Pulmo

    Mar del Plata, B7602DCK

  • Centro Medico Dharma

    Mendoza, 5500

  • Fundacion Scherbovsky

    Mendoza, M5500AXR

  • INSARES

    Mendoza, Mendoza City, M5500CCG

  • Centro Respiratorio Quilmes

    Quilmes, B1878FNR

  • Sala de primeros auxilios Alberto Mignaburu

    Ranelagh, Berazategui, 1886

  • Instituto Medico de la Fundacion Estudios Clinicos

    Rosario, S2000DEJ

  • Sanatorio Parque de Rosario

    Rosario, S2000KZD

  • Instituto Medico Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion Medica

    Rosario, S2002OJP

  • Servicio de Investigacion de Patologias Alergicas-Instituto ABC

    Rosario, S2013JKR

  • Centro Medico IPAM

    Rosario, S2013SBK

  • Centro Médico Respire

    San Fernando, B1646EBJ

  • Instituto De Patologias Respiratorias

    San Miguel de Tucumán, 4000

  • Centro Integral de Medicina Respiratoria (CIMER)

    San Miguel de Tucumán, T4000CHE

  • Centro Modelo de Cardiologia

    San Miguel de Tucumán, T4000IFL

  • Centro Medico San Nicolas Grupo Orono

    San Nicolás de los Arroyos, B2900

  • CEPROSS- Centro Profesional San Salvador

    San Salvador, E3218CHH

  • Instituto Del Buen Aire

    Santa Fe, 3000

  • Centro de Diagnostico Y Rehabilitacion

    Santa Fe, S3000

  • Instituto De Enfermedades Respiratorias E Investigacion Medica

    Villa Vatteone, B1853AIK

Other trials in Argentina

Poland36 sites
  • Centrum Medycyny Oddechowej Mroz sp. j.

    Bia?ystok, 15-044

  • Vitamed Galaj i Cichomski sp.j.

    Bydgoszcz, 85-079

  • Medical Center Kermed

    Bydgoszcz, 85-231

  • Centrum Medyczne Bydgoszcz- PRATIA - PPDS

    Bydgoszcz, 85-796

  • Centrum Medyczne Lukamed Joanna Luka-Wendrowska

    Chojnice, 89-600

  • Synexus Polska Sp. z o.o. Oddzial w Gdyni

    Gdynia, 81-537

  • Centrum Medyczne CLW-med Aneta Cichomska , Joanna Luka -Wendrowska

    Grudzadz, 86-300

  • Centrum Medyczne Katowice - PRATIA - PPDS

    Katowice, 40-081

  • Indywidualna Specjalistyczna Praktyka Lekarska lek.

    Kielce, 25-751

  • Centrum Medyczne ALL-MED

    Krakow, 30-033

  • Diamond Clinic

    Krakow, 31-559

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

    Krakow, 31-637

  • Praktyka Lekarska Adam Smialowski

    Ksawerów, 95-054

  • AppleTreeClinics Network Sp. z o.o.

    Lodz, Lódzkie, 90-349

  • Prywatny Gabinet Lekarski Ginekologia i Poloznictwo Ultrasonografia Prof. Jacek Suzin

    Lodz, Lódzkie, 90-602

  • AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi

    Lodz, 90-127

  • ETG Lodz

    Lodz, 90-302

  • Clinical Best Solutions - Lublin

    Lublin, 20-078

  • NZOZ Przychodnia Alergologiczno-pulmonologiczna

    Lublin, 20-089

  • ETG Lublin

    Lublin, 20-412

  • Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o

    Nowa Sól, 67-100

  • Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik

    Ostrowiec Swietokrzysk, 27-400

  • Centrum Alergologii Teresa Hofman

    Poznan, 60-214

  • ABC-Pulmo NZOZ Agnieszka Dobielska, Jaroslaw Dobie

    Radom, 26-600

  • EMED Centrum Uslug Medycznych Ewa Smialek

    Rzeszów, 35-205

  • ETG Siedlce

    Siedlce, 08-110

  • Centrum Medyczne KARDIOTEL

    Sopot, 81-741

  • Kiepury Clinic

    Sosnowiec, 41-200

  • PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna

    Sosnowiec, 41-208

  • Gabinet Pulmonologii i Diagnostyki Chorob Alergicznych Dorota Malosek

    Szczecin, 70-111

  • CenterMed Bandrowskiego

    Tarnów, 33-100

  • Viltis Medica Sp. Z o.o.

    Trzebnica, Lower Silesian Voivodeship, 55-100

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie

    Warsaw, 01-192

  • Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

    Wroc?aw, 51-162

  • Dobrostan Gabinety Lekarskie

    Wroc?aw, 53-301

  • Lekarze Specjalisci J. Malolepszy i Partnerzy

    Wroclaw, Lower Silesian Voivodeship, 54-239

Other trials in Poland

China34 sites
  • Peking University Shougang Hospital

    Beijing, Beijing Municipality, 100144

  • Beijing Hospital

    Beijing, 100006

  • Beijing Chaoyang Hospital Capital Medical University

    Beijing, 100020

  • China-Japan Friendship Hospital

    Beijing, 100029

  • Beijing Jingmei Group General Hospital

    Beijing, 100042

  • The First Hospital of Jilin University

    Changchun, 130021

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • Chengdu Fifth People's Hospital

    Chengdu, 611130

  • The Southwest Hospital of Army Medical University

    Chongqing, 400038

  • Army Medical Center of PLA(Daping Hospital)

    Chongqing, 400042

  • Affiliated Hospital of Guangdong Medical University

    Guangdong, 524023

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510150

  • Guangzhou First People's Hospital

    Guangzhou, 510180

  • Hangzhou First People's Hospital

    Hangzhou, 310006

  • Anhui Chest Hospital

    Hefei, Anhui, 230022

  • Huizhou Central People's Hospital

    Huizhou, 516001

  • The First People's Hospital of Lian Yun Gang

    Lianyungang, 222023

  • Taizhou Hospital of Zhejiang Province

    Linhai, 317000

  • Jiangxi Provincial People's Hospital

    Nanchang, 330006

  • Zhongda Hospital Affiliated to Southeast University

    Nanjing, 210009

  • Jiangxi Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337055

  • Huadong Hospital Affiliated of Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • The Central Hospital of Wuhan

    Wuhan, Hubei, 430014

  • Wuxi People's Hospital

    Wuxi, 214023

  • Jiangyin People's Hospital

    Wuxi, 214400

  • Xi'an International Medical Center Hospital

    Xi'an, 710100

  • Zhongshan Hospital Xiamen University

    Xiamen, 361004

  • Xinxiang First People's Hospital

    Xinxiang, 453000

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221002

  • The Fifth Affiliated Hospital Sun Yat-Sen University

    Zhuhai, 519001

  • Zigong First People's Hospital - East Campus

    Zigong, Sichuan, 643000

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563000

Other trials in China

Japan33 sites
  • Asahikawa Medical Center

    Asahikawa-shi, 070-8644

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, 818-8502

  • Fukuwa Clinic

    Chūō, 104-0031

  • Fukuoka University Hospital

    Fukuoka, 814-0180

  • Nishi Fukuoka Hospital

    Fukuoka-Shi Nishi-Ku, 819-8555

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

  • National Hospital Organization Kyoto Medical Center

    Fushimi-ku, Kyoto, 612-8555

  • Terada Respiratory and Internal Clinic

    Himeji, 670-0849

  • Hiroshima Prefectural Hospital

    Hiroshima, 734-8530

  • National Hospital Organization Minami Kyoto Hospital

    Jōyō, 610-0113

  • Kagoshima Kouseiren Hospital

    Kagoshima, 890-0062

  • Kanagawa Cardiovascular and Respiratory Center

    Kanagawa, 236-0051

  • Sagamihara National Hospital

    Kanagawa, 252-0392

  • Osaka-Minami Medical Center

    Kawachinagano-Shi, 586-8521

  • Kishiwada City Hospital

    Kishiwada-Shi, 596-8501

  • Juntendo Tokyo Koto Geriatric Medical Center

    Kōtō City, 136-0075

  • Saiseikai Kumamoto Hospital

    Kumamoto, 861-4193

  • Matsusaka City Hospital

    Matsusaka-Shi, Mie-ken, 515-8544

  • Social Medical Corporation Daido Clinic

    Nagoya, Aichi-ken, 457-8511

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192

  • Okayama Rosai Hospital

    Okayama-Shi Minami-ku, 702-8055

  • Omuta National Hospital

    Omuta, 837-0911

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Sakai-shi Kita-ku, Osaka, 591-8555

  • Sakaide City Hospital

    Sakaide-Shi, 762-8550

  • Idaimae Minami 4-Jo Internal Medicine

    Sapporo-shi Chuo-ku, 064-0804

  • Japanese Red Cross Medical Center

    Shibuya-ku, 150-8935

  • Shizuoka City Shizuoka Hospital

    Shizuoka-Shi Aoi-Ku, Shizuoka, 420-8630

  • Kamei Internal Medicine and Respiratory Clinic

    Takamatsu, 761-8073

  • Japan Community Health Care Organization Hokkaido Hospital

    Toyohira-ku, Sapporo City, Hokkaido, 062-8618

  • Nagata Hospital

    Yanagawa, 832-0059

  • Yokohama City University Medical Center

    Yokohama, 232-0024

  • Showa University Fujigaoka Hospital

    Yokohama-shi Aoba-ku, 227-8501

  • National Hospital Organization - Yokohama Medical Center

    Yokohama-Shi Totsuka-Ku, 245-8575

Other trials in Japan

Germany28 sites
  • Zentrum fuer Pneumologie, Onkologie und Schlafmedizin am Diako

    Augsburg, 86150

  • Gemeinschaftspraxis fuer Herz und Lunge am Bruderw

    Bamberg, 96049

  • KPPK Studienzentrum Kroker-Schmidt

    Bendorf, 56170

  • Studienpraxis Berlin-Brandenburg, Berlin

    Berlin, 10119

  • Praxis fur Kardiologie und Pneumologie Dr. med. Karin Forster

    Berlin, 10367

  • MECS Research GmbH

    Berlin, 12203

  • Clinical Studies Pankow

    Berlin, 13187

  • Lungenzentrum Darmstadt

    Darmstadt, 64283

  • MVZ Jung GbR - Deggingen

    Deggingen, 73326

  • Medizentrum Essen Borbeck

    Essen, 45355

  • Universitaetsklinikum Frankfurt

    Frankfurt, 60596

  • Praxis Dr med Claus Keller

    Frankfurt am Main, 60389

  • ME Clinical Respiratory Research Hamburg GmbH

    Hamburg, 22299

  • Pneumologicum

    Hanover, 30173

  • University Clinic Heidelberg

    Heidelberg, 69120

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376

  • Asklepios MVZ Bayern GmbH

    Landsberg, 86899

  • Salvus-Klinische Studien GmbH

    Leipzig, 04207

  • BAG Prof. Dr. G. Hoheisel Dr. A. Bonitz

    Leipzig, 04299

  • KLB Gesundheitsforschung Lubeck GmbH

    Lübeck, 23552

  • SMO.MD GmbH

    Magdeburg, 39120

  • IKF Pneumologie Mainz

    Mainz, 55128

  • Praxis für Pneumologie Dr. Silke Mronga & Dr. Lukas Jerrentrup

    Marburg, 35037

  • Praxis Dr. med. Jan Feimer

    München, 80539

  • Institut fur klinische Forschung GmbH

    Neu-Isenburg, 63263

  • Praxis Dr. med. Christian Schlenska

    Peine, 31224

  • framol-med GmbH

    Rheine, 48431

  • RoMed Klinikum Rosenheim-Pettenkoferstr. 10

    Rosenheim, 83022

Other trials in Germany

Bulgaria25 sites
  • Multiprofile Hospital for Active Treatment Puls AD PPDS

    Blagoevgrad, 2700

  • Multiprofile Hospital For Active Treatment Sveta Ekaterina - Dimitrovgrad EOOD

    Dimitrovgrad, 6400

  • Medical Centre "Asklepii", OOD

    Dupnitsa, 2600

  • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD

    Haskovo, 6300

  • Medical Centre Pratia EOOD branch Lovech

    Lovech, 5500

  • Medical Center Hera EOOD

    Montana, 3400

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

    Pazardzhik, 4400

  • Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD

    Pernik, 2300

  • Medical center Medconsult Pleven OOD

    Pleven, 5800

  • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

    Plovdiv, 4002

  • Multiprofile Hospital for Active Treatment Plovdiv

    Plovdiv, 4003

  • Medical center Unimed EOOD

    Plovdiv, 4023

  • Multiprofile Hospital for Active Treatment Shumen

    Shumen, 9700

  • Multiprofile Hospital for Active Treatment - Silistra AD

    Silistra, 7500

  • Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD

    Smolyan, 4700

  • MHAT Knyaginya Klementina Sofia EAD

    Sofia, Sofia-Grad, 1233

  • Diagnostic-Consultative Center Aleksandrovska EOOD

    Sofia, Sofia-Grad, 1431

  • Medical Center Hera Eood

    Sofia, 1510

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

    Sofia, 1606

  • Diagnostic- Consultative Center Convex EOOD

    Sofia, 1680

  • AES DRS Medical Center Synexus Sofia EOOD

    Sofia, 1784

  • Medical Center New rehabilitation center EOOD

    Stara Zagora, 6003

  • Medical Center Researchexpert OOD

    Varna, 9000

  • Medical Center Tara OOD

    Veliko Tarnovo, 5000

  • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa

    Vratsa, 3000

Other trials in Bulgaria

Spain15 sites
  • Hospital de La Ribera

    Alzira, Valencia, 46600

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Vithas Xanit International Hospital

    Benalmádena Costa, Malaga, 29630

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18012

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Universitario Fundacion Jimenez Diaz.

    Madrid, 28040

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital de Merida

    Mérida, Badajoz, 06800

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07120

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, LA Coruna, 15706

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitario de Torrejon

    Torrejón de Ardoz, Madrid, 28850

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

South Africa14 sites
  • Iatros International

    Bloemfontein, 9301

  • University of Cape Town Lung Institute

    Cape Town, 7700

  • Dr. Ismail Abdullah Private Practice

    City of Cape Town, 7764

  • Newtown Clinical Research Centre

    City of Johannesburg, 2001

  • Johese Clinical Research

    City of Tshwane, Gauteng, 0157

  • Clinical Trial Systems

    City of Tshwane, 0186

  • St Augustines Hospital

    Durban, 4001

  • Lakeview Hospital

    Ekurhuleni, 1500

  • Dr A.C Wilhase practice-Reimed

    Ekurhuleni, 1501

  • CLINRESCO, ARWYP Medical Suites

    Ekurhuleni, 1619

  • Langeberg Clinical Trials

    Kraaifontein, 7570

  • Medicross Pretoria West, Jongaie Research

    Pretoria, 0183

  • AES - DRS - Synexus - Helderberg Clinical Research Centre

    Somerset West, 7130

  • Dr Yacoob AK Private Practice

    Welkom, 9459

Other trials in South Africa

United Kingdom14 sites
  • AES - DRS - Synexus Scotland Clinical Research Centre

    Bellshill, ML4 3NJ

  • Bradford Royal Infirmary

    Bradford, BD9 6RJ

  • Addenbrooke's Hospital

    Cambridge, Cambridgeshire, CB2 0QQ

  • AES - DRS - Synexus Wales Clinical Research Centre

    Cardiff, CF15 9SS

  • Royal Primary Care - Ashgate Manor

    Chesterfield, S40 4AA

  • AES - DRS - NW Consortium Lancashire

    Chorley, PR7 7NA

  • Castle Hill Hospital

    Cottingham, HU16 5JQ

  • AES - DRS - Synexus Midlands Clinical Research Centre

    Edgbaston, B15 2SQ

  • AES - DRS - Synexus Hexham Clinical Research Centre

    Hexham, NE46 1QJ

  • Glenfield Hospital

    Leicester, LE3 9QP

  • AES - DRS - NW Consortium Merseyside

    Liverpool, L32 2AN

  • Guys Hospital

    London, Middlesex, SE1 9RT

  • Velocity Clinical Research North London - Percy Road - PPDS

    London, N12 8BU

  • Queen Anne Street Medical Centre

    London, W1G 8HU

Other trials in United Kingdom

India13 sites
  • GMERS Medical College and Hospital, Sola

    Ahmedabad, Gujarat, 380059

  • Jawaharlal Nehru Medical College (JNMC)

    Ajmer, Rajasthan, 305001

  • Jawaharlal Nehru Medical College (JNMC)

    Aligarh, Uttar Pradesh, 202002

  • ESIC Medical College and Hospital - Faridabad

    Faridabad, Haryana, 121012

  • Karnataka Institute of Medical Sciences (KIMS), Hubbali

    Hubli, Karnataka, 580021

  • Paarthiv Lung Care Center

    Hyderabad, Andhra Pradesh, 500018

  • Yashoda Hospitals Hitec City

    Hyderabad, Andhra Pradesh, 500084

  • Sawai Man Singh Hospital and Medical College

    Jaipur, Rajasthan, 302004

  • Maharaja Agrasen Super Speciality Hospital

    Jaipur, Rajasthan, 302039

  • Apollo Spectra Hospital

    Kanpur, Uttar Pradesh, 208001

  • MV Hospital and Research Centre

    Lucknow, Uttar Pradesh, 226018

  • Shree Hospital And Critical Care Centre

    Nagpur, Maharashtra, 440009

  • Kothrud Hospital

    Pune, Maharashtra, 411038

Other trials in India

Israel13 sites
  • Assuta Ashdod Medical Center

    Ashdod, 7747629

  • Barzilai Medical Center

    Ashkelon, 7830604

  • Shamir Medical Center Assaf Harofeh

    Be’er Ya‘aqov, 7033001

  • Soroka University Medical Centre

    Beersheba, 8410101

  • Rambam Medical Center - PPDS

    Haifa, 3109601

  • Lady Davis Carmel Medical Center

    Haifa, 3436212

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Hadassah Medical Center

    Jerusalem, 9112001

  • Meir Medical Center

    Kfar Saba, 4428164

  • Rabin Medical Center

    Petach Tiqwa, 4941492

  • Sheba Medical Center - PPDS

    Ramat Gan, 52621

  • Kaplan Medical Center

    Rehovot, 76100

  • Tel Aviv Sourasky Medical Center PPDS

    Tel Aviv, 6423906

Other trials in Israel

South Korea13 sites
  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si, 420-767

  • Yeungnam University Hospital

    Daegu, 42415

  • CHA Bundang Medical Center

    Gyeonggi-do, 13496

  • Catholic Univ. of Incheon St.Mary's Hospital

    Incheon, 21431

  • Chonbuk National University Hospital

    Jeollabuk-do, 54907

  • Korea University Anam Hospital

    Seoul, 02841

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Konkuk University Medical Center

    Seoul, 05030

  • Asan Medical Center - PPDS

    Seoul, 05505

  • Samsung Medical Center - PPDS

    Seoul, 06351

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591

  • Chung-Ang University Hospital

    Seoul, 06973

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, 220-701

Other trials in South Korea

Canada12 sites
  • Dynamic Drug Advancement Ltd.

    Ajax, Ontario, L1S 2J5

  • Burlington Lung Clinic

    Burlington, Ontario, L7N 3V2

  • Edmonton Respiratory Consultants

    Edmonton, Alberta, T5J 3S9

  • Centre Hospitalier de l'Universite Laval

    Québec, G1V 4G5

  • Clinique de pneumologie et du sommeil de Lanaudiere

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • Bluewater Clinical Research Group

    Sarnia, Ontario, N7T 4X3

  • University of Saskatchewan

    Saskatoon, Saskatchewan, S7N 5A2

  • Synergy Respiratory & Cardiac Care - Synergy Wellness Centre Location

    Sherwood Park, Alberta, T8H 0N2

  • Inspiration Research

    Toronto, Ontario, M5T 3A9

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1L8

  • Dr. Syed Anees Medicine Profession Corporation

    Windsor, Ontario, N8X 1T3

  • Dr Anil Dhar Professional Medicine Corporation

    Windsor, Ontario, N8X 5A6

Other trials in Canada

Belgium10 sites
  • AZ Sint-Jan Brugge-Oostende

    Bruges, 8000

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • UZ Antwerpen - PIN

    Edegem, 2650

  • Private Practice Dr Jean Benoit Martinot

    Erpent, 5101

  • Cabinet Médical De Meulemeester

    Gozée, 6534

  • UZ Leuven

    Leuven, 3000

  • CHU de Liège

    Liège, 4000

  • AZ Sint-Maarten

    Mechelen, 2800

  • AZ Delta

    Roeselare, 8800

  • CHU UCl Namur asbl - Site Godinne

    Yvoir, 5530

Other trials in Belgium

Chile10 sites
  • Centro de Investigaciones Medicas Respiratorias CIMER

    Ñuñoa, 7750000

  • Centro de Estudios Clinicos

    Ñuñoa, 7750495

  • Centro Respiratorio Integral LTDA. (CENRESIN)

    Pavie Gallegos, 2340000

  • Sociedad Médica SyG SpA

    Providencia, 7500000

  • Enroll SpA - PPDS

    Providencia, 7500587

  • Centro Internacional de Estudios Clínicos (CIEC)

    Santiago, 8420383

  • Centro de Investigacion del Maule

    Talca

  • Hospital Carlos Van Buren

    Valparaíso, 2340000

  • Centro de Investigacion de Enfermedades Respiratorias e Inmunologicas

    Viña del Mar, 2531172

  • Fundacion Medica San Cristobal

    Vitacura, 7630000

Other trials in Chile

Czechia10 sites
  • Plicní ambulance MUDr. I. Cierná Peterová s.r.o.

    Brandýs nad Labem-Stará Boleslav, 250 01

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • MediTrial s.r.o.

    Jind?ich?v Hradec, 377 01

  • Plicni Ambulance Kralupy nad Vltavou

    Kralupy nad Vltavou, 278 01

  • Odborna plicni ambulance Opava s.r.o

    Opava, 746 01

  • Ordinace chorob plicních s.r.o.

    Prague, 110 00

  • AES - DRS - Synexus Czech s.r.o.

    Prague, 120 00

  • KASMED s.r.o.

    Tábor, 390 02

  • Nemocnice Tabor, a.s.

    Tábor, 390 03

  • Plicni stredisko Teplice s.r.o.

    Teplice, 415 01

Other trials in Czechia

New Zealand7 sites
  • Greenlane Clinical Centre

    Auckland, 1051

  • NZ Respiratory & Sleep Institute

    Auckland, 1051

  • Aotearoa Clinical Trials Trust

    Auckland, 2025

  • Canterbury Respiratory Research Group

    Christchurch, 8011

  • Dunedin Hospital

    Dunedin, 9054

  • Waikato Hospital

    Hamilton, 3240

  • P3 Research - Kapiti - PPDS

    Waikanae, Wellington Region, 5036

Other trials in New Zealand

Philippines7 sites
  • Manila Central University-Filemon D Tanchoco Medical Foundation

    Caloocan, 1442

  • CARE CT Group Inc.

    Dasmariñas, 4114

  • Healthlink Medicalsurgicaldental Clinic and Diagnostic Center

    Iloilo City, 5000

  • West Visayas State University Medical Center

    Iloilo City, 5000

  • Mary Mediatrix Medical Center

    Lipa City, 4217

  • Philippine Heart Center

    Quezon City, 1100

  • Quirino Memorial Medical Center

    Quezon City, 1109

Other trials in Philippines

Denmark6 sites
  • Aalborg Universitetshospital

    Aalborg, 9000

  • Gentofte Hospital

    Hellerup, 2900

  • Hvidovre Hospital

    Hvidovre, 2650

  • Odense Universitetshospital

    Odense C, 5000

  • Sjaellands Universitetshospital, Roskilde

    Roskilde, 4000

  • Sygehus Lillebælt, Vejle

    Vejle, 7100

Other trials in Denmark

France6 sites
  • Clinique de l'Europe

    Amiens, 80090

  • Hôpital de La Croix Rousse

    Lyon, 69004

  • Hopital Saint Joseph - Marseille

    Marseille, 13285

  • Hopital Pasteur II

    Nice, 06000

  • Hopital Haut Leveque

    Pessac, 33600

  • Nouvel Hopital Civil - CHU Strasbourg

    Strasbourg, 67091

Other trials in France

Greece6 sites
  • Evangelismos General Hospital of Athens

    Athens, 106 76

  • Navy Hospital of Athens

    Athens, 115 21

  • Iatriko Palaiou Falirou

    Athens, 175 62

  • PAGNI-University General Hospital of Heraklion

    Heraklion, Irakleio, 715 00

  • University General Hospital of Ioannina

    Ioannina, 455 00

  • Georgios Papanikolaou General Hospital of Thessaloniki

    Thessaloniki, 570 10

Other trials in Greece

Taiwan6 sites
  • Changhua Christian Hospital

    Chang-hua, 500

  • Kaohsiung Medical University Hospital

    Kaoshiung City, 807

  • Far East Memorial Hospital

    New Taipei City, 220

  • Taipei Medical University Hospital

    Taipei, 110

  • Taipei Veterans General Hospital

    Taipei, 112

  • Tri-Service General Hospital

    Taipei, 11490

Other trials in Taiwan

Brazil5 sites
  • LMK Servicos Medicos SS

    Porto Alegre, Rio Grande do Sul, 90480-000

  • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

    Porto Alegre, Rio Grande do Sul, 90610-000

  • IBPCLIN Instituto Brasil de Pesquisa Clinica

    Rio de Janeiro, 20241-180

  • Faculdade de Medicina do ABC - FMABC

    Santo André, São Paulo, 09060-650

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos

    São Bernardo do Campo, São Paulo, 09715-090

Other trials in Brazil

Italy5 sites
  • Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco

    Catania, Sicily, 95123

  • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna

    Cona, Ferrara, Emilia-Romagna, 44124

  • Azienda Ospedaliera Dei Colli

    Naples, Campania, 80131

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, Sicily, 90127

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    Pavia, Lombardy, 27100

Other trials in Italy

Kenya5 sites
  • KEMRI-MTWAPA Clinical Trial Site

    Kilifi, 80108

  • Clinical Research Health Network (CREA-N)

    Machakos, 90100

  • KEMRI CRDR Clinical Research Clinic Nairobi

    Nairobi, 00100

  • University of Nairobi Clinical Research Centre

    Nairobi, 202

  • Center for Research In Tropical Medicine and community development

    Thika, 01000

Other trials in Kenya

Netherlands5 sites
  • Meander Medisch Centrum

    Amersfoort, 3813 TZ

  • Amphia Ziekenhuis

    Breda, 4818 CK

  • Catharina Hospital

    Eindhoven, 5623 EJ

  • Dijklander Ziekenhuis - loc Hoorn

    Hoorn, 1624 NP

  • Isala Klinieken

    Zwolle, 8011 JW

Other trials in Netherlands

Australia4 sites
  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Institute for Respiratory Health Inc

    Midland, Western Australia, 6056

  • TrialsWest Pty Ltd

    Spearwood, Western Australia, 6163

Other trials in Australia

Latvia4 sites
  • Daugavpils Regional Hospital

    Daugavpils, LV-5417

  • Pauls Stradins Clinical University Hospital

    R?ga, LV-1002

  • Riga 1st Hospital

    Riga, LV-1001

  • ConsiliumMedicum

    Riga, LV-1010

Other trials in Latvia

Mexico4 sites
  • CICUM San Miguel

    Guadalajara, Jalisco, 44200

  • Unidad Medica de Occidente

    Guadalajara, 44220

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

    Monterrey, 64718

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

    Santa Cecilia, Jalisco, 44700

Other trials in Mexico

Peru4 sites
  • Clinica Internacional - PPDS

    Lima, 15001

  • Medicentro Biociencias Peru S.R.L.

    Lima, 15084

  • Clinica Ricardo Palma - PPDS

    San Isidro, 15036

  • Clinica Providencia (Inverconsult Sociedad Anonima) - PPDS

    San Miguel, Lima region, 15088

Other trials in Peru

Romania4 sites
  • Neomed Out-Patient Treatment and Diagnosis Medical Center SRL

    Brasov, 500283

  • Dr. Victor Babes Foundation

    Bucharest, 030301

  • Leon Daniello Pneumophthisiology Clinical Hospital

    Cluj-Napoca, 400371

  • Sf. Ioan cel Nou Emergency County Hospital

    Suceava, 720224

Other trials in Romania

Sweden4 sites
  • Fysikalisk Medicin i Stockholm AB

    Lidingö, 181 61

  • Clinical Trial Consultants - Linkoping

    Linköping, 582 13

  • ProbarE i Stockholm AB

    Stockholm, 114 37

  • Akardo AB

    Stockholm, 117 27

Other trials in Sweden

Turkey (Türkiye)3 sites
  • Cukurova University Medical Faculty Balcali Hospital

    Adana, 1330

  • Kirikkale Universitesi Tip Fakultesi Hastanesi

    Kirikkale, 71100

  • Rize Recep Tayyip Erdogan University Training and Research Hospital

    Rize Merkez, 53020

Other trials in Turkey (Türkiye)

Austria2 sites
  • Ordination Dr. Robert Voves

    Feldbach, 8330

  • Ordination fur Lungenkrankheiten

    Linz, 4020

Other trials in Austria

Thailand2 sites
  • Srinagarind Hospital, Khon Kaen University

    Khon Kaen, 40002

  • Central Chest Institute of Thailand

    Muang, 11000

Other trials in Thailand

Hong Kong1 site
  • Tuen Mun Hospital

    Hong Kong

Other trials in Hong Kong

Hungary1 site
  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, Pest County, 1036

Other trials in Hungary

Puerto Rico1 site
  • Allianze Pulmonary Research LLC

    Guaynabo, 00968

Other trials in Puerto Rico

Switzerland1 site
  • Zurcher Reha Zentren Wald

    Zurich

Other trials in Switzerland

About this study

Official title: A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease

The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332.

Being tested
Astegolimab
Keywords
chronic obstructive pulmonary disease, COPD
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AstegolimabDrug

    Participants will receive SC astegolimab Q2W

Study groups in NCT05878769
Study groupRoleWhat they receive
Open-Label ExtensionExperimentalEligible participants from parent studies GB43311 and GB44332 will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study
Receives: Drug: Astegolimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of all adverse events (AEs)

    Measured: Up to 12 weeks after last dose of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2023
  2. Study start28 Jun 2023
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05878769
Sponsor's protocol ID
GB43374
Status last verified
Aug 2026
First submitted
19 May 2023
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Astegolimab in people with Chronic Obstructive Pulmonary Disease, run by Hoffmann-La Roche at 481 sites in 40 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 481 sites in United States, Argentina, Poland, China, Japan and 35 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of all adverse events (AEs) (time frame: Up to 12 weeks after last dose of study treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.

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