AzTrials
AzTrials

Chronic Obstructive Pulmonary Disease (COPD)Phase 3ARNASANCT05595642

A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

A Phase 3 study testing Astegolimab in people with Chronic Obstructive Pulmonary Disease (COPD), run by Hoffmann-La Roche at 348 sites in 36 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations. Read more about this study

Who is it for?
Ages 40 to 80 years
What is being tested?
Astegolimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,380 participants
Where
348 sitesin 36 countries
Study dates
29 Dec 2022to 19 Aug 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented COPD diagnosis for ≥ 12 months
  • History of frequent exacerbations, defined as having had 2 or more moderate or severe COPD exacerbations within 12 months prior to screening
  • Post-bronchodilator FEV1 ≥ 20% and < 80% of predicted at screening
  • Post-bronchodilator FEV1/FVC < 0.70 at screening
  • Modified Medical Research Council (dyspnea scale) (mMRC) score ≥ 2
  • Current tobacco smoker or former smoker with a history of smoking ≥ 10 pack-years
  • On optimized COPD maintenance therapy as defined below for ≥ 12 months prior to screening, and stable on current therapy for at least 4 weeks prior to screening: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA), Long-acting muscarinic antagonist (LAMA) plus LABA, ICS plus LAMA plus LABA
  • Chest X-ray or computed tomography (CT) scan within 6 months prior to screening or chest X-ray during the screening period that confirms the absence of clinically significant lung disease besides COPD

Who cannot join

  • Current documented diagnosis of asthma
  • History of clinically significant pulmonary disease other than COPD
  • Diagnosis of 1-antitrypsin deficiency
  • History of long-term treatment with oxygen at > 4.0 liters/minute
  • Lung volume reduction surgery or procedure within 12 months prior to screening
  • Individuals participating in, or scheduled for, an intensive COPD rehabilitation program (participants who are in the maintenance phase of a rehabilitation program are eligible)
Show all 12Show fewer
  • History of lung transplant
  • Any infection that resulted in hospital admission for ≥ 24 hours and/or treatment with oral, IV, or IM antibiotics within 4 weeks prior to or during screening
  • Upper or lower respiratory tract infection within 4 weeks prior to or during screening
  • Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
  • Initiation of or change in non-biologic immunomodulatory or immunosuppressive therapy within 3 months 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

Trial locations and contacts

348 sites in 36 countries.

348 sites in 36 countries

United States53 sites

  • Clinical Research Associates Of Central Pa , Llc

    Altoona, Pennsylvania, 16602

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

    Atlanta, Georgia, 30328

  • Kern Research

    Bakersfield, California, 93301

  • Paul A. Shapero, MD, PA

    Bangor, Maine, 04401-5691

  • Nebraska Medical Research Institute, Inc. - CRN

    Bellevue, Nebraska, 68123-4318

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • TTS Research

    Boerne, Texas, 78006

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • Medtrial, LLC

    Columbia, South Carolina, 29204

  • Allergy Center at Brookstone Research - Centricity Research - HyperCore - PPD

    Columbus, Georgia, 31904-2954

  • 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

  • OK Clinical Research

    Edmond, Oklahoma, 73034-3258

  • Western Washington Medical Group

    Everett, Washington, 98208

  • Pulmonary Research Institute of Southeast Michigan

    Farmington Hills, Michigan, 48336-2817

  • Flushing Road Internal Medicine and Pediatrics - F

    Flint, Michigan, 48504-4730

  • Clinical Trials Center of Middle Tennessee

    Franklin, Tennessee, 37067-5603

  • Velocity Clinical Research - Gaffney - PPDS

    Gaffney, South Carolina, 29340-4737

  • Pulmonary Associates PA

    Glendale, Arizona, 85306-4669

  • Finlay Medical Research Corporation

    Greenacres City, Florida, 33467-2979

  • Allergy Asthma and Sinus Center-Greenfield

    Greenfield, Wisconsin, 53228-3467

  • Pulmonix LLC

    Greensboro, North Carolina, 27403

  • ASHA Clinical Research - ClinEdge - PPDS

    Hammond, Indiana, 46324-2213

  • Tennessee Comprehensive Lung & Sleep Center

    Hendersonville, Tennessee, 37075-3085

  • Trio Clinical Trials

    Houston, Texas, 77008

  • Baylor College of Medicine Medical Center

    Houston, Texas, 77030

  • Biopharma Informatic - Park Row - PPDS

    Houston, Texas, 77084

  • Advanced Respiratory and Sleep Medicine, PLLC

    Huntersville, North Carolina, 28078

  • R & H Clinical Research

    Katy, Texas, 77494-2031

  • Machuca Family Medicine

    Las Vegas, Nevada, 89104-3953

  • Revive Research Institute

    Lathrup Village, Michigan, 48076

  • The Research Group of Lexington, LLC

    Lexington, Kentucky, 40504

  • Hassman Research Institute - HRI - Berlin - CenExel - PPDS

    Marlton, New Jersey, 08053

  • San Marcus Research Clinic Inc.

    Miami, Florida, 33014

  • Oceane7 Medical & Research Center, Inc.

    Miami, Florida, 33144-2155

  • Avantis Clinical Research, LLC

    Miami, Florida, 33155-3265

  • Research Institute of South Florida Inc

    Miami, Florida, 33173

  • Diverse Clinical Research, LLC

    Miami, Florida, 33175-3434

  • Best Clinical Trials

    New Orleans, Louisiana, 70115

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

    New York, New York, 10017-4008

  • Central Florida Pulmonary Group, PA

    Orlando, Florida, 32803

  • Allergy & Clinical Immun Assoc

    Pittsburgh, Pennsylvania, 15241

  • The Oregon Clinic

    Portland, Oregon, 97213

  • Renown Regional Medical Center Hospital

    Reno, Nevada, 89502-1576

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110

  • Pivotal Research Solutions

    Stonecrest, Georgia, 30038-2649

  • AES - DRS - Synexus Clinical Research US, Inc. - The Villages

    The Villages, Florida, 32162-7116

  • Oakland Medical Research Center

    Troy, Michigan, 48085-5524

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

    Tucson, Arizona, 85741-3118

  • Allergy & Asthma Medical Group of the Bay Area

    Walnut Creek, California, 94598

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103-4029

Other trials in United States

China38 sites

  • Beijing Chaoyang Hospital Capital Medical University

    Beijing, 100020

  • China-Japan Friendship Hospital

    Beijing, 100029

  • Beijing Jingmei Group General Hospital

    Beijing, 100042

  • Beijing Hospital

    Beijing, 100730

  • Peking University Shougang Hospital

    Beijing

  • The First Hospital of Jilin University

    Changchun, 130021

  • The First Hospital of Changsha

    Changsha, 410005

  • The Third Hospital of Changsha

    Changsha

  • 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

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510150

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510160

  • Guangzhou First People's Hospital

    Guangzhou, 510180

  • Hangzhou First People's Hospital

    Hangzhou, 310006

  • Anhui Chest Hospital

    Hefei, 230022

  • Huizhou Central People's Hospital

    Huizhou, 516001

  • The First People's Hospital of Lian Yun Gang

    Lianyungang, Jiangsu, 222061

  • Taizhou Hospital of Zhejiang Province

    Linhai, 317000

  • Jiangxi Provincial People's Hospital

    Nanchang, 330006

  • Zhongda Hospital Southeast University

    Nanjing, 210009

  • Jiangxi Pingxiang People's Hospital

    Pingxiang, 337055

  • Huadong Hospital Affiliated to Fudan University

    Shanghai, 200000

  • Shengjing Hospital of China Medical University

    Shenyang, 110004

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • Central Hospital of Wuhan

    Wuhan

  • 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

  • Yangzhou First People?s Hospital

    Yangzhou, 225001

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong, 524001

  • The Fifth Affiliated Hospital Sun Yat-Sen University

    Zhuhai, 519001

  • Zigong First People's Hospital

    Zigong, 643036

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563000

Other trials in China

Japan31 sites

  • Fukuwa Clinic

    Chūōku, 104-0031

  • Nishi Fukuoka Hospital

    Fukuoka-Shi Nishi-Ku, 819-0055

  • University of the Ryukyus Hospital

    Ginowan-shi, Okinawa, 901-2725

  • Terada Respiratory and Internal Clinic

    Himeji, 670-0849

  • Kagoshima University Hospital

    Kagoshima, 890-8520

  • Kiryu Kosei General Hospital

    Kiryū, 376-0024

  • Kishiwada City Hospital

    Kishiwada, 596-0822

  • Hospital of the University of Occupational and Environmental Health,Japan

    Kitakyushu-shi, 807-8556

  • Juntendo Tokyo Koto Geriatric Medical Center

    Kōtō City, 136-0075

  • National Hospital Organization Kyoto Medical Center

    Kyoto, 612-8555

  • Matsusaka City Hospital

    Matsusaka-Shi, Mie-ken, 515-8544

  • Miura Medical Clinic

    Miura-shi, Kanagawa, 238-0111

  • Fukushima Medical University Hospital

    Miyagi, 960-1295

  • Kojunkai Social Medical Corporation Daido Clinic

    Nagoya-shi Minami-ku, 457-8511

  • National Hospital Organization Ibarakihigashi National Hospital

    Naka-gun, 319-1113

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192

  • Okayama Rosai Hospital

    Okayama-Shi Minami-ku, 702-8055

  • Omuta National Hospital

    Omuta, 837-0911

  • Kitasato University Hospital

    Sagamihara-shi, Kanagawa, 252-0375

  • Sakaide City Hospital

    Sakaidechō, 762-0043

  • NHO Kinki-Chuo Chest Medical Center

    Sakaishi, 591-8555

  • Japan Community Health Care Organization Hokkaido Hospital

    Sapporo, 062-8618

  • Idaimae Minami 4-Jo Internal Medicine

    Sapporo-shi Chuo-ku, 064-0804

  • Shizuoka City Shizuoka Hospital

    Shizuoka, 424-0911

  • Kamei Internal Medicine and Respiratory Clinic

    Takamatsu, 761-8073

  • Tokyo-Eki Center-building Clinic

    Tokyo, 103-0027

  • Japanese Red Cross Medical Center

    Tokyo

  • Yamaguchi University Hospital

    Ube-shi, Yamaguchi, 755-8505

  • Yamagata University Hospital

    Yamagata, 990-9585

  • National Hospital Organization - Yokohama Medical Center

    Yokohama-Shi Totsuka-Ku, 245-8575

  • Sanyudo Hospital

    Yonezawa, 992-0033

Other trials in Japan

Poland25 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 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

  • Prywatny Gabinet Pulmonologiczny Joanna Nowacka-Apiyo

    Grudziądz, 86-300

  • Centrum Medyczne Katowice - PRATIA - PPDS

    Katowice, 40-081

  • Prywatna Praktyka Lekarska Adam Smialowski

    Ksawerów, 95-054

  • AppleTreeClinics Network Sp. z o.o.

    Lodz, Lódzkie, 90-349

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

    Lodz, 90-127

  • Clinical Best Solutions - Lublin

    Lublin, 20-078

  • NZOZ Przychodnia Alergologiczno-pulmonologiczna

    Lublin, 20-089

  • ABC-Pulmo NZOZ Agnieszka Dobielska, Jaroslaw Dobie

    Radom, 26-600

  • NZOZ Poradnia Chorob Pluc i Alergologii

    Słupsk, 76-200

  • Centrum Medyczne KARDIOTEL

    Sopot, 81-741

  • Kiepury Clinic

    Sosnowiec, 41-200

  • Gabinet Pulmonologii i Diagnostyki Chorob Alergicznych Dorota Malosek

    Szczecin, 70-111

  • CenterMed Sp. z o.o.

    Tarnów, Lesser Poland Voivodeship, 33-100

  • Viltis Medica Specjalistyczna Praktyka Lekarska Lek. Med. Agata Kot

    Trzebnica, 55-100

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

    Warsaw, 01-192

  • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

    Wroc?aw, 50-381

  • Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

    Wroc?aw, 51-162

  • Lekarze Specjalisci J. Malolepszy i Partnerzy

    Wroc?aw, 54-239

  • Medical Center Clinhouse

    Zabrze, 41-807

Other trials in Poland

Argentina22 sites

  • Consultorios Medicos Organizacion de Buen Ayre SRL

    Buenos Aires, 12345

  • Nexo Salud Investigacion Clinica - Riobamba 429

    Buenos Aires, C1025

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

    Buenos Aires, C1027AAP

  • 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

  • Centro de Medicina Respiratoria

    Concepción del Uruguay, 3260

  • Sanatorio de la Canada

    Córdoba, X5000BSQ

  • Framingham Centro Medico

    La Plata, 1900

  • Centro Medico Capital

    La Plata, 1904

  • Centro Platense en Investigaciones Respiratorias

    La Plata, B1900BNN

  • Centro Medico Dharma

    Mendoza, M5500AYB

  • Centro Privado de Medicina Respiratoria

    Paraná, 3100

  • Sala de primeros auxilios Alberto Mignaburu

    Ranelagh, Berazategui, 1886

  • Instituto Medico de la Fundacion Estudios Clinicos

    Rosario, S2000DEJ

  • Servicio de Investigacion de Patologias Alergicas-Instituto ABC

    Rosario, S2013JKR

  • Sanatorio Parque de Rosario

    Rosario, S2013KZD

  • Centro Modelo de Cardiologia

    San Miguel de Tucumán, 4000

  • 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, S3000ASF

  • Centro de Diagnostico Y Rehabilitacion

    Santa Fe, S3000

Other trials in Argentina

Germany16 sites

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

    Berlin, 10367

  • Studienpraxis Berlin-Brandenburg, Berlin

    Berlin, 12157

  • AES - DRS - Synexus Berlin Research Centre

    Berlin, 12627

  • Lungenzentrum Darmstadt

    Darmstadt, 64283

  • Universitaetsklinikum Frankfurt

    Frankfurt, 60596

  • Praxisgem. Dres. Schmoller und Ehlers

    Hamburg, 22299

  • Pneumologicum

    Hanover, 30173

  • University Clinic Heidelberg

    Heidelberg, 69120

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376

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

    Leipzig, 04299

  • Velocity Clinical Research Leipzig GmbH

    Lübeck, Schleswig-Holstein, 23552

  • SMO.MD GmbH

    Magdeburg, 39120

  • Praxis Dr. med. Jan Feimer

    München, 80539

  • Institut fur klinische Forschung GmbH

    Neu-Isenburg, 63263

  • framol-med GmbH

    Rheine, 48431

  • Klinikum Rosenheim

    Rosenheim, 83022

Other trials in Germany

Bulgaria15 sites

  • Multiprofile Hospital for Active Treatment Puls AD PPDS

    Blagoevgrad, 2700

  • Multiprofile Hospital For Active Treatment Sveta Ekaterina - Dimitrovgrad EOOD

    Dimitrovgrad, 6400

  • Multiprofile Hospital For Active Treatment Dr. Tota Venkova JSC

    Gabrovo, 5300

  • Medical Center Hera EOOD

    Montana, 3400

  • Multiprofile Hospital for Active Treatment Plovdiv

    Plovdiv, 4003

  • Multiprofile Hospital for Active Treatment Sv. Ivan Rilski- Razgrad AD

    Razgrad, 7200

  • 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

  • Fifth Multiprofile Hospital for Active Treatment - Sofia EAD

    Sofia, 1233

  • Diagnostic-Consultative Center Aleksandrovska EOOD

    Sofia, 1431

  • Diagnostic- Consultative Center Convex EOOD

    Sofia, 1680

  • AES DRS Medical Center Synexus Sofia EOOD

    Sofia, 1784

  • Diagnostic Consultative Centre Mladost?M OOD

    Varna, Varna, 9020

  • Medical Center Tara OOD

    Veliko Tarnovo, 5000

Other trials in Bulgaria

United Kingdom13 sites

  • AES - DRS - Synexus Scotland Clinical Research Centre

    Bellshill, ML4 3NJ

  • AES - DRS - Synexus Midlands Clinical Research Centre

    Birmingham, B15 2SQ

  • 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, Yorkshire, HU16 5JQ

  • Royal Infirmary of Edinburgh

    Edinburgh, EH16 4SA

  • AES - DRS - Synexus Hexham Clinical Research Centre

    Hexham, NE46 1QJ

  • Royal Lancaster Infirmary

    Lancaster, LA1 4RP

  • St James University Hospital

    Leeds, LS9 7TF

  • AES - DRS - NW Consortium Merseyside

    Liverpool, L32 2AN

  • Velocity Clinical Research North London - Percy Road - PPDS

    London, N12 8BU

  • St Thomas' Hospital

    London, SE1 7EH

Other trials in United Kingdom

India12 sites

  • GMERS Medical College and Hospital, Sola

    Ahmedabad, Gujarat, 380059

  • Jawaharlal Nehru Medical College (JNMC)

    Aligarh, Uttar Pradesh, 202002

  • ESIC Medical College and Hospital - Faridabad

    Faridabad, Haryana, 121012

  • Karnataka Medical College and Research Institute, Hubballi;Department of Medicine

    Hubballi, 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, 226003

  • Shree Hospital And Critical Care Centre

    Nagpur, Maharashtra, 044009

  • Kothrud Hospital

    Pune, Maharashtra, 411038

Other trials in India

Canada10 sites

  • Dynamic Drug Advancement Ltd.

    Ajax, Ontario, L1S 2J5

  • Edmonton Respiratory Consultants

    Edmonton, Alberta, T5J 3S9

  • Recherche GCP Research

    Montreal, Quebec, H1Y 3H5

  • Centre Hospitalier de l'Universite Laval

    Québec, Quebec, G1V 4G5

  • Clinique de pneumologie et du sommeil de Lanaudiere

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • 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 1M9

  • Dr. Syed Anees Medicine Profession Corporation

    Windsor, Ontario, N8X 1T3

  • Dr Anil Dhar Professional Medicine Corporation

    Windsor, Ontario, N8X 5A6

Other trials in Canada

South Africa9 sites

  • Iatros International

    Bloemfontein, Free State, 9301

  • Johese Clinical Research

    Centurion, 1692

  • Dr. Ismail Abdullah Private Practice

    City of Cape Town, 7764

  • Newtown Clinical Research Centre

    City of Johannesburg, Gauteng, Hillbrow 2001

  • CLINRESCO, ARWYP Medical Suites

    Kempton Park, 1619

  • AES - DRS - Synexus Watermeyer Clinical Research Centre

    Pretoria, 0184

  • Medicross Pretoria West, Jongaie Research

    Pretoria, 183

  • AES - DRS - Synexus - Helderberg Clinical Research Centre

    Somerset West, 7130

  • Dr Yacoob AK Private Practice

    Welkom, 9459

Other trials in South Africa

South Korea9 sites

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si, 420-767

  • Yeungnam University Hospital

    Daegu, 42415

  • CHA Bundang Medical Center

    Gyeonggi-do, 13496

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Asan Medical Center - PPDS

    Seoul, 05505

  • Samsung Medical Center - PPDS

    Seoul, 06351

  • Chung-Ang University Hospital

    Seoul, 06973

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

    Seoul, 137-701

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, 220-701

Other trials in South Korea

Spain8 sites

  • Hospital Universitario La Paz - PPDS

    Barcelona, BARCELONA, 8041

  • Vithas Xanit International Hospital

    Benalmádena Costa, MALAGA, 29630

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07010

  • Hospital El Bierzo

    Ponferrada, LEON, 24411

  • Hospital Universitario Virgen del Rocio

    Seville, SEVILLA, 41013

  • Hospital Universitario de Torrejon

    Torrejón de Ardoz, Madrid, 28850

  • Hospital Clinico Universitario de Valencia

    Valencia, Valencia, 46010

  • Hospital de La Ribera

    Valencia, Valencia, 46600

Other trials in Spain

Brazil7 sites

  • L2IP ?Instituto de Pesquisas Clínicas Ltda.

    Brasília, Federal District, 70200-730

  • 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, 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

  • Instituto do Coracao - HCFMUSP

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Czechia7 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

  • 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

  • Nemocnice Tabor, a.s.

    Tábor, 390 03

  • Plicni stredisko Teplice s.r.o.

    Teplice, 415 01

Other trials in Czechia

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

Greece6 sites

  • Evangelismos General Hospital of Athens

    Athens, 106 76

  • Navy Hospital of Athens

    Athens, 115 21

  • University General Hospital of Heraklion

    Heraklio, 711 10

  • University General Hospital of Ioannina

    Ioannina, 455 00

  • Iatriko Palaiou Falirou

    Palaió Fáliro, 175 62

  • Georgios Papanikolaou General Hospital of Thessaloniki

    Thessaloniki, 570 10

Other trials in Greece

Italy6 sites

  • Presidio Ospedaliero Santa Maria della Speranza

    Battipaglia, Campania, 84091

  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

    Catania, Sicily, 95123

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

    Ferrara, Emilia-Romagna, 44121

  • 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

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, 11031

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Tri-Service General Hospital

    Taipei, 11490

Other trials in Taiwan

Israel5 sites

  • Soroka University Medical Centre

    Beersheba, 8410101

  • Rambam Medical Center - PPDS

    Haifa, 3109601

  • Lady Davis Carmel Medical Center

    Haifa, 3436212

  • Hadassah Medical Center

    Jerusalem, 9112001

  • Meir Medical Center

    Kfar Saba, 4428164

Other trials in Israel

Kenya5 sites

  • KEMRI-MTWAPA Clinical Trial Site

    Kilifi, Coast, 80108

  • Clinical Research Health Network (CREA-N)

    Machakos, 90100

  • KEMRI CRDR Clinical Research Clinic Nairobi

    Nairobi, 00100

  • University of Nairobi Clinical Research Centre

    Nairobi

  • Center for Research In Tropical Medicine and community development

    Thika, 01000

Other trials in Kenya

Latvia5 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

  • Postgraduate Medical Training Institute University of Latvia

    Riga, LV-1011

Other trials in Latvia

Belgium4 sites

  • AZ Sint-Jan Brugge-Oostende

    Bruges, 8000

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • CHU de Liège

    Liège, 4000

Other trials in Belgium

New Zealand4 sites

  • Greenlane Clinical Centre

    Auckland, 1051

  • Dunedin Hospital

    Dunedin, 9016

  • Waikato Hospital

    Hamilton, 3248

  • P3 Research - Kapiti - PPDS

    Waikanae Beach, 05036

Other trials in New Zealand

Chile3 sites

  • Centro Respiratorio Integral LTDA. (CENRESIN)

    Pavie Gallegos, 2340000

  • Oncocentro APYS

    Viña del Mar, 2520598

  • Fundacion Medica San Cristobal

    Vitacura, 7630000

Other trials in Chile

France3 sites

  • Sas Clinique De L Europe - Amiens

    Amiens, 80090

  • Hopital Calmette

    Lille, 59000

  • Hopital Haut Leveque

    Pessac, 33604

Other trials in France

Netherlands3 sites

  • Meander Medisch Centrum

    Amersfoort, 3813 TZ

  • Martini Ziekenhuis

    Groningen, 9728 MG

  • Zuyderland Medisch Centrum - Heerlen

    Heerlen, 6419PC

Other trials in Netherlands

Sweden3 sites

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45

  • Akardo AB

    Stockholm, 117 27

  • Clinical Trial Consultants - Linkoping

    Uppsala, Uppsala County, 752 37

Other trials in Sweden

Turkey (Türkiye)3 sites

  • Kirikkale Universitesi Tip Fakultesi Hastanesi

    Kirikkale, 71100

  • Rize Recep Tayyip Erdogan University Training and Research Hospital

    Rize Merkez, 53020

  • Cukurova Universitesi Tip Fakultesi Balcali Hastanesi

    Sarıçam, 01250

Other trials in Turkey (Türkiye)

Austria2 sites

  • Ordination Dr. Robert Voves

    Feldbach, 8330

  • Ordination fur Lungenkrankheiten

    Linz, 4020

Other trials in Austria

Denmark2 sites

  • Naestved Sygehus

    Næstved, 4700

  • Sjaellands Universitetshospital, Roskilde

    Roskilde, 4000

Other trials in Denmark

Hungary2 sites

  • Benyovszky Medical Center

    Budapest, Budapest, 1089

  • Omnimodus Elixír Kft.

    Csorna, 9300

Other trials in Hungary

Australia1 site

  • Institute for Respiratory Health - Midland

    Midland, South Australia, 6056

Other trials in Australia

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

Thailand1 site

  • Central Chest Institute of Thailand

    Muang, 11000

Other trials in Thailand

About this study

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease

This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations.

Being tested
Astegolimab, Placebo
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 or Q4W

  • PlaceboDrug

    Participants will receive SC placebo Q2W

Study groups in NCT05595642
Study groupRoleWhat they receive
Astegolimab SC Q2WExperimentalParticipants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W)
Receives: Drug: Astegolimab
Astegolimab SC Q4WExperimentalParticipants will receive alternating SC astegolimab and placebo Q2W, thus receiving SC astegolimab Q4W.
Receives: Drug: Astegolimab
Placebo SC Q2WPlacebo comparatorParticipants will receive SC placebo Q2W
Receives: Drug: Placebo

What is being measured

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

  1. Annualized Rate of Moderate and Severe COPD Exacerbations Over the 52-week Treatment Period

    A moderate COPD exacerbation was defined as new or increased COPD symptoms (e.g., dyspnea, sputum volume, and sputum purulence) that lead to treatment (duration ≥ 3 days) with systemic corticosteroids (oral, intravenous [IV], or intramuscular [IM]) at a dose of > 10 milligrams per day (mg/day) prednisolone equivalent and/or antibiotics. A severe COPD exacerbation was defined as new or increased COPD symptoms that lead to hospitalization (duration > 24 hours) or death. The unadjusted AER was estimated as the total number of exacerbations observed over the treatment period divided by the total participant-years at risk (participant-years = date of first study drug administration to completion or discontinuation during the double-blind treatment period divided by 365.25 days). The adjusted AER was estimated using negative binomial regression. Adjusted rate values have been reported. A method of dispersion was not specified in the SAP.

    Measured: Up to 52 weeks

Secondary outcomes (11)

  1. Annualized Rate of Moderate and Severe COPD Exacerbations Over the 52-week Treatment Period in Participants With Low Baseline Blood Eosinophil Level (<300 Cells Per Microliter [Cells/µL])

    A moderate COPD exacerbation was defined as new or increased COPD symptoms (e.g., dyspnea, sputum volume, and sputum purulence) that lead to treatment (duration ≥ 3 days) with systemic corticosteroids (oral, intravenous [IV], or intramuscular [IM]) at a dose of > 10 milligrams per day (mg/day) prednisolone equivalent and/or antibiotics. A severe COPD exacerbation was defined as new or increased COPD symptoms that lead to hospitalization (duration > 24 hours) or death. The unadjusted AER was estimated as the total number of exacerbations observed over the treatment period divided by the total participant-years at risk (participant-years = date of first study drug administration to completion or discontinuation during the double-blind treatment period divided by 365.25 days). The adjusted AER was estimated using negative binomial regression. Adjusted rate values have been reported A method of dispersion was not specified in the SAP.

    Measured: Up to 52 weeks

  2. Time to First Moderate or Severe COPD Exacerbation During the 52-week Treatment Period

    Time to first moderate or severe COPD exacerbation was defined as the time from the first administration of study drug to the first incidence of moderate or severe COPD exacerbation event during the 52-week treatment period. A moderate COPD exacerbation was defined as new or increased COPD symptoms (e.g., dyspnea, sputum volume, and sputum purulence) that lead to treatment (duration ≥3 days) with systemic corticosteroids (oral, IV, or IM) at a dose of >10 mg/day prednisolone equivalent and/or antibiotics. A severe COPD exacerbation was defined as new or increased COPD symptoms that lead to hospitalization (duration > 24 hours) or death. Kaplan-Meier (K-M) method was used to estimate the median time.

    Measured: Up to 52 weeks

  3. Absolute Change From Baseline in Health-related Quality-of-life (HRQoL) at Week 52, as Assessed Through the Saint George's Respiratory Questionnaire-COPD (SGRQ-C) Total Score

    SGRQ-C is a disease-specific, self-administered instrument designed to assess the impact of COPD on participants' health status and well-being based on their perception of COPD-related experiences. The questionnaire consists of 40 items across three sub-domains: symptoms (respiratory symptoms and severity- 7 items), activity (activities causing or limited by breathlessness-13 items) and impacts (social functioning and psychological disturbances due to airway disease- 20 items). Each response is assigned a unique empirically derived weight. Total score is calculated by summing the weights to all the positive responses across each domain, with scores ranging from 0 (no impairment) to 100 (maximum impairment), with lower scores indicating better HRQoL. Adjusted mean of change from baseline (CFB) is reported here.

    Measured: At Week 52

  4. Absolute Change From Baseline in Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (Liters) at Week 52

    Post-bronchodilator FEV1 was defined as the FEV1 value measured with spirometry 20-30 minutes after bronchodilator use. Maximal bronchodilation was achieved via administration of either albuterol (90 micrograms [µg] metered dose) or salbutamol (100 µg metered dose), with or without a spacer device, up to a maximum of 4 inhalations. Adjusted mean of CFB is reported here.

    Measured: At Week 52

  5. Absolute Change From Baseline in Evaluating Respiratory Symptoms in COPD (E-RS: COPD) Total Score at Week 52

    The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) is a 14-item participant-reported instrument used to assess the frequency, severity, and duration of COPD exacerbations using a daily electronic diary (eDiary). It includes four domains: breathlessness (5 items), cough and sputum (3 items), chest symptoms (3 items), and additional attributes (tired or weak, sleep disturbance, and scared or worried; 3 items). The E-RS:COPD is an 11-item subset of the EXACT designed to assess the severity of cardinal respiratory symptoms of COPD, including breathlessness, cough, sputum, chest congestion, and chest tightness. It consists of three subscales: RS-Breathlessness, RS-Cough \& Sputum, and RS-Chest Symptoms. Items are scored on 5- or 6-point Likert scales, and the total score is calculated by summing the item scores, ranging from 0 (no impact) to 40 (high impact), with higher scores indicating greater symptom severity. Adjusted mean of CFB is reported here.

    Measured: At Week 52

  6. Percentage of Participants With Improvement in HRQoL at Week 52, as Assessed by SGRQ-C

    Percentage of participants with SGRQ-C improvement was defined as the percentage of participants with an absolute decrease from baseline of ≥4 points in SGRQ-C total score. SGRQ-C is a disease-specific, self-administered instrument designed to assess the impact of COPD on participants' health status and well-being based on their perception of COPD-related experiences. The questionnaire consists of 40 items across three sub-domains: symptoms (respiratory symptoms and severity- 7 items), activity (activities causing or limited by breathlessness-13 items) and impacts (social functioning and psychological disturbances due to airway disease- 20 items). Each response is assigned a unique empirically derived weight. Total score is calculated by summing the weights to all the positive responses across each domain, with scores ranging from 0 (no impairment) to 100 (maximum impairment), with lower scores indicating better HRQoL.

    Measured: At Week 52

  7. Annualized Rate of Severe COPD Exacerbations Over the 52-week Treatment Period

    A severe COPD exacerbation was defined as new or increased COPD symptoms that lead to hospitalization (duration > 24 hours) or death. The unadjusted AER was estimated as the total number of exacerbations observed over the treatment period divided by the total participant-years at risk (participant-years = date of first study drug administration to completion or discontinuation during the double-blind treatment period divided by 365.25 days). The adjusted AER was estimated using negative binomial regression. Adjusted rate values have been reported. A method of dispersion was not specified in the SAP.

    Measured: Up to 52 weeks

  8. Number of Participants With Treatment-emergent Adverse Events (TEAEs), Including Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)

    An AE was defined as any untoward medical occurrence in a clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability or incapacity; is a congenital anomaly or birth defect; is medically significant. An AESI was defined as any of the following: cases of potential drug-induced liver injury; suspected transmission of an infectious agent by a study treatment; major adverse cardiovascular events (MACE); anaphylaxis, anaphylactoid, and hypersensitivity reactions.

    Measured: Up to a maximum of 62 weeks

  9. Number of Participants Who Died or Discontinued Study Due to TEAEs

    An AE was defined as any untoward medical occurrence in a clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Participants who died or discontinued the study due to TEAEs will be reported here.

    Measured: Up to a maximum of 62 weeks

  10. Serum Concentration of Astegolimab

    Measured: Up to a maximum of 62 weeks

  11. Number of Participants With Anti-drug Antibodies (ADAs) to Astegolimab

    Participants were considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following astegolimab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 0.60 titer unit (t.u.) greater than the baseline titer result (treatment-enhanced ADA response).

    Measured: Up to a maximum of 62 weeks

Timeline

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

  1. First posted27 Oct 2022
  2. Study start29 Dec 2022
  3. Primary completion24 Jun 2025
  4. Study completion19 Aug 2026

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,380 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05595642
Sponsor's protocol ID
GB44332
Other IDs
2022-502234-70-00
Acronym
ARNASA
Status last verified
Oct 2026
First submitted
24 Oct 2022
Last updated
28 Oct 2026
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

Publications

  • Papi A, Greening NJ, Bhatt SP, Roche N, Celli B, Wedzicha JA, Agusti A, Tal-Singer R, Han MK, Janssens W, Hanania NA, Nair P, Bremner P, Porpodis K, Shibata Y, Korn S, Yang T, Gordon O, Saenz R, Ng J, Cheung DS, Devine J, Grimbaldeston MA, Zhang W, Yang X, Mohan D, Vogelmeier CF, Brightling CE; ALIENTO and ARNASA investigators. Safety and efficacy of astegolimab for COPD with frequent exacerbations regardless of baseline blood eosinophil counts (ALIENTO and ARNASA): randomised, double-blind, placebo-controlled, phase 2b and 3 trials. Lancet. 2026 May 23;407(10543):2027-2039. doi: 10.1016/S0140-6736(26)00637-9. Epub 2026 May 18.

    PubMed 42150581

  • Wedzicha JA, Agusti A, Brightling CE, Calverley P, Chalmers JD, Greening NJ, Han MK, Mohan D, Ng J, Papi A, Roche N, Saenz R, Samara K, Tal-Singer R, Vogelmeier CF, Yang X, Celli BR. Astegolimab for COPD With Frequent Exacerbations: Pooled Analysis of the ALIENTO and ARNASA Trials. Am J Respir Crit Care Med. 2026 May 18:aamag226. doi: 10.1093/ajrccm/aamag226. Online ahead of print.

    PubMed 42148875

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Astegolimab in people with Chronic Obstructive Pulmonary Disease (COPD), run by Hoffmann-La Roche at 348 sites in 36 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 8 inclusion and 12 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: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 348 sites in United States, China, Japan, Poland, Argentina and 31 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 28 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Annualized Rate of Moderate and Severe COPD Exacerbations Over the 52-week Treatment Period (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05595642, which also lists 2 linked publications.

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 28 Oct 2026.

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