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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Astegolimab Q2W | Experimental | Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W). |
|
| Astegolimab Q4W | Experimental | Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving astegolimab every 4 weeks (Q4W). |
|
| Placebo | Placebo Comparator | Participants will receive SC placebo Q2W. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Astegolimab | Drug | Participants will receive SC astegolimab Q2W or Q4W. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Rate of Moderate and Severe COPD Exacerbations Over the 52-Week Treatment Period | Baseline up to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS | Dothan | Alabama | 36305 | United States | ||
| Jasper Summit Research LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42150581 | Derived | 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. | |
| 42148875 |
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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
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| Placebo | Drug | Participants will receive SC placebo Q2W. |
|
| 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 |
| Annualized Rate of Severe COPD Exacerbations Over the 52-Week Treatment Period | Baseline up to Week 52 |
| Absolute Change from Baseline in Five-Repetition Sit-to-Stand (5STS) time (seconds) at Week 52 | Baseline to Week 52 |
| Jasper |
| Alabama |
| 35501 |
| United States |
| Pulmonary Associates of Mobile PC | Mobile | Alabama | 36608-3135 | United States |
| Cadena Care Institute, LLC | Poway | California | 92064-2021 | United States |
| Inst. of Healthcare Assessment, Inc. | San Diego | California | 92120 | United States |
| Allianz Research Institute Inc | Westminster | California | 92683 | United States |
| National Jewish Health | Denver | Colorado | 80206 | United States |
| Clinical Site Partners - Leesburg Suite 101 - HyperCore - PPDS | Leesburg | Florida | 34748-5077 | United States |
| Florida Institute for Clinical Research, LLC | Orlando | Florida | 32825-4454 | United States |
| Clinical Site Partners - Winter Park - HyperCore - PPDS | Winter Park | Florida | 32789-4681 | United States |
| Northwestern Center for Clinical Research | Chicago | Illinois | 60611 | United States |
| Medisphere Medical Research Center, Llc | Evansville | Indiana | 47714 | United States |
| Exordia Medical Research, Inc. | Fall River | Massachusetts | 20723 | United States |
| Northern Pines Health Center PC | Buckley | Michigan | 49620 | United States |
| Revive Research Institute | Lathrup Village | Michigan | 48076 | United States |
| Cardio-Pulmonary Associates | Chesterfield | Missouri | 63017-3627 | United States |
| Blessing Health Hannibal | Hannibal | Missouri | 63401 | United States |
| Midwest Chest Consultants | Saint Charles | Missouri | 63301 | United States |
| CARE Clinical Research | St Louis | Missouri | 63141-6823 | United States |
| Midwest Clinical Research LLC | St Louis | Missouri | 63141 | United States |
| Sierra Clinical Research - ClinEdge - PPDS | Las Vegas | Nevada | 89106-4159 | United States |
| American Health Research Inc. | Charlotte | North Carolina | 28277 | United States |
| Clinical Research of Gastonia | Gastonia | North Carolina | 28054-7481 | United States |
| Carolina Research Center | Shelby | North Carolina | 28150-3803 | United States |
| Southeastern Research Center | Winston-Salem | North Carolina | 27103-4029 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Lowcountry Lung and Critical Care | North Charleston | South Carolina | 29406 | United States |
| Clinical Research of Rock Hill | Rock Hill | South Carolina | 29732-1160 | United States |
| Velocity Clinical Research Spartanburg PPDS | Spartanburg | South Carolina | 29303-4225 | United States |
| Spartanburg Medical Center | Spartanburg | South Carolina | 29303 | United States |
| South Texas Medical Research Institute, Inc., dba TTS Research ? ClinEdge ? PPDS | Boerne | Texas | 78006-1993 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Metroplex Pulmonology & Sleep Center | McKinney | Texas | 75069 | United States |
| Sherman Clinical Research - ClinEdge - PPDS | Sherman | Texas | 75092 | United States |
| Centro Medico IPAM | Rosario | Santa Fe Province | S2001SBK | Argentina |
| Centro de Investigaciones Clínicas Belgrano | Buenos Aires | 7240 | Argentina |
| Instituto de Investigaciones Clinicas-Mar del Plata | Buenos Aires | B7600FZN | Argentina |
| Fundacion Cidea | Buenos Aires | C1121ABE | Argentina |
| Centro Médico Dra de Salvo | Buenos Aires | C1426ABP | Argentina |
| CARE - Centro de Alergia y Enfermedades Respiratorias | CABA | C1414AIF | Argentina |
| Instituto de Medicina Respiratoria, IMeR | Córdoba | X5003DCE | Argentina |
| Centro de Especialidades Medicas Lobos | Lobos | B7240AAN | Argentina |
| Centro de Investigaciones Medicas Mar Del Plata | Mar del Plata | 7600 | Argentina |
| Instituto Ave Pulmo | Mar del Plata | B7602DCK | Argentina |
| INSARES | Mendoza | M5500CCG | Argentina |
| Centro Respiratorio Quilmes | Quilmes | B1878FNR | Argentina |
| Instituto Medico Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion Medica | Rosario | S2013OJN | Argentina |
| Centro Médico Respire | San Fernando | B1646EBJ | Argentina |
| Instituto De Enfermedades Respiratorias E Investigacion Medica | San Juan Bautista | CP 1888 | Argentina |
| Investigaciones en Patologias Respiratorias | San Miguel de Tucumán | 4000 | Argentina |
| Centro Integral de Medicina Respiratoria (CIMER) | San Miguel de Tucumán | T4000CBC | Argentina |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| TrialsWest Pty Ltd | Spearwood | Western Australia | 6163 | Australia |
| AZ Sint-Maarten | Mechelen | Antwerpen | 2800 | Belgium |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| Private Practice Dr Jean Benoit Martinot | Erpent | 5101 | Belgium |
| AZ Delta | Roeselare | 8800 | Belgium |
| Office of Marc De Meulemeester | Thuin | 6534 | Belgium |
| CHU UCl Namur asbl - Site Godinne | Yvoir | 5530 | Belgium |
| Medical Centre "Asklepii", OOD | Dupnitsa | 2600 | Bulgaria |
| Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD | Haskovo | 6300 | Bulgaria |
| Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Dr.Nikola Penchev-Paza | Pazardzhik | 4400 | Bulgaria |
| Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD | Pernik | 2300 | Bulgaria |
| Medical center Medconsult Pleven OOD | Pleven | 5800 | Bulgaria |
| University Multiprofile Hospital for Active Treatment Sveti Georgi EAD | Plovdiv | 4001 | Bulgaria |
| Medical center Unimed EOOD | Plovdiv | 4023 | Bulgaria |
| Medical Centre Respiro OOD | Razgrad | 7200 | Bulgaria |
| Medical Center Hera EOOD | Sofia | 1510 | Bulgaria |
| University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD | Sofia | 1606 | Bulgaria |
| Medical Center New rehabilitation center EOOD | Stara Zagora | 6003 | Bulgaria |
| Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa | Vratsa | 3000 | Bulgaria |
| Burlington Lung Clinic | Burlington | Ontario | L7N 3V2 | Canada |
| St. Joseph's Healthcare Hamilton- Charlton Campus | Hamilton | Ontario | L8N 4A6 | Canada |
| Bluewater Clinical Research Group | Sarnia | Ontario | N7T 4X3 | Canada |
| University of Saskatchewan, Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Centro de Investigaciones Medicas Respiratorias | Providencia | Región-MetropolitanadeSantiago | 7500000 | Chile |
| Centro de Investigación Curico | Curicó | 3340000 | Chile |
| MIRES/MYF estudios clinicos | Ñuñoa | 7750495 | Chile |
| Sociedad Médica SyG SpA | Providencia | 7500000 | Chile |
| Enroll SpA - PPDS | Providencia | 7500587 | Chile |
| Meditek Ltda | Santiago | 8320000 | Chile |
| Centro de Investigacion del Maule | Talca | Chile |
| Hospital Carlos Van Buren | Valparaíso | 2340000 | Chile |
| MediTrial s.r.o. | Jind?ich?v Hradec | 377 01 | Czechia |
| Plicni Ambulance Kralupy nad Vltavou | Kralupy nad Vltavou | 278 01 | Czechia |
| MUDr. Ilona Pavlisova s.r.o. | Miroslav | 671 72 | Czechia |
| Pneumologie Varnsdorf S.r.o. | Nový Bor | 473 01 | Czechia |
| KASMED s.r.o. | Tábor | 390 02 | Czechia |
| Aalborg Universitetshospital | Aalborg | 9000 | Denmark |
| Gentofte Hospital | Hellerup | 2900 | Denmark |
| Hvidovre Hospital | Hvidovre | DK-2650 | Denmark |
| Odense Universitetshospital | Odense | 5000 | Denmark |
| Sygehus Lillebælt, Vejle | Vejle | 7100 | Denmark |
| Hôpital de La Croix Rousse | Lyon | 69004 | France |
| CHU de Nice | Nice | 06001 | France |
| Nouvel Hôpital Civil | Strasbourg | 67091 | France |
| Zentrum fuer Pneumologie, Onkologie und Schlafmedizin am Diako | Augsburg | 86150 | Germany |
| CIMS-Studienzentrum Bamberg, | Bamberg | Germany |
| KPPK Studienzentrum Kroker-Schmidt | Bendorf | 56170 | Germany |
| MECS Research GmbH | Berlin | 12203 | Germany |
| Praxis Dr. Med Evelin Liefring | Berlin | 13187 | Germany |
| Gemeinscharftspraxis Dres Jung - Deggingen | Deggingen | 73326 | Germany |
| Medizentrum Essen Borbeck | Essen | 45355 | Germany |
| Praxis Dr med Claus Keller | Frankfurt am Main | 60389 | Germany |
| Universitätsklinikum Gießen und Marburg GmbH | Giessen | 35392 | Germany |
| Asklepios MVZ Bayern GmbH | Landsberg | 86899 | Germany |
| Salvus-Klinische Studien GmbH | Leipzig | 04207 | Germany |
| Zentrum fuer ambulante pneumologische Forschung Marburg GbR | Marburg | 35037 | Germany |
| Studienzentrum Dr Med Schlenska | Peine | 31224 | Germany |
| Tuen Mun Hospital | Hong Kong | Hong Kong |
| Assuta Ashdod Medical Center | Ashdod | 7747629 | Israel |
| Barzilai Medical Center | Ashkelon | 7830604 | Israel |
| Shamir Medical Center Assaf Harofeh | Beer Jacob | 0073100 | Israel |
| Tel Aviv Sourasky Medical Center PPDS | Jerusalem | 90000 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| Kaplan Medical Center | Rehovot | 76100 | Israel |
| Sheba Medical Center - PPDS | Tel Litwinsky | 52621 | Israel |
| Instituto Jalisciense de Investigacion Clinica S.A. de C.V. | Guadalajara | Jalisco | 44100 | Mexico |
| Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C. | Guadalajara | Jalisco | 44130 | Mexico |
| Unidad Medica de Occidente | Guadalajara | Jalisco | 44220 | Mexico |
| CICUM San Miguel | Guadalajara Centro | Jalisco | 44100 | Mexico |
| Unidad de Investigacion Clinica En Medicina (Udicem) S.C. | Monterrey | Nuevo León | 64718 | Mexico |
| Centro de Investigacion y Atencion Integral Durango CIAID | Durango | 34080 | Mexico |
| Amphia Ziekenhuis | Breda | 4819 EV | Netherlands |
| Isala Klinieken | Zwolle | 8011 JW | Netherlands |
| Aotearoa Clinical Trials Trust | Auckland | 2025 | New Zealand |
| Canterbury Respiratory Research Group | Christchurch | 8011 | New Zealand |
| Clinica Providencia (Inverconsult Sociedad Anonima) | Lima | 32 | Peru |
| Clinica Internacional | Lima | Lima 01 | Peru |
| Clinica Ricardo Palma | Lima | Lima 27 | Peru |
| Alfredo Berrocal Kasay Reuma Sociedad de Responsabilidad Limitada | Lima Cercado | 000000 | Peru |
| Centrum Medyczne Bydgoszcz- PRATIA - PPDS | Bydgoszcz | 85-796 | Poland |
| Indywidualna Specjalistyczna Praktyka Lekarska lek. | Kielce | 25-751 | Poland |
| Centrum Medyczne ALL-MED | Krakow | 30-033 | Poland |
| Diamond Clinic | Krakow | 31-559 | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k. | Krakow | 31-637 | Poland |
| ETG Lodz | Lódz | 90-302 | Poland |
| ETG Lublin | Lublin | 20-412 | Poland |
| Twoja Przychodnia Centrum Medyczne Nowa Sol | Nowa Sól | 67-100 | Poland |
| Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik | Ostrowiec Swietokrzysk | 27-400 | Poland |
| Centrum Alergologii Teresa Hofman | Poznan | 60-214 | Poland |
| EMED Centrum Uslug Medycznych Ewa Smialek | Rzeszów | 35-205 | Poland |
| ETG Siedlce | Siedlce | 08-110 | Poland |
| PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna | Sosnowiec | 41-208 | Poland |
| ETG Warszawa- PPDS | Warsaw | 02-793 | Poland |
| Dobrostan Gabinety Lekarskie | Wroclaw | 53-301 | Poland |
| Neomed Out-Patient Treatment and Diagnosis Medical Center SRL | Brasov | 500283 | Romania |
| Dr. Victor Babes Foundation | Bucharest | 030303 | Romania |
| Leon Daniello Pneumophthisiology Clinical Hospital | Cluj-Napoca | 400371 | Romania |
| Spitalul Clinic de Pneumoftiziologie Constanta | Constanța | 900002 | Romania |
| Sf. Ioan cel Nou Emergency County Hospital | Suceava | 720237 | Romania |
| University of Cape Town Lung Institute | Cape Town | 7700 | South Africa |
| Clinical Trial Systems | City of Tshwane | 0186 | South Africa |
| St Augustines Hospital | Durban | 4001 | South Africa |
| Dr A.C Wilhase practice-Reimed | Ekurhuleni | 1459 | South Africa |
| Lakeview Hospital | Ekurhuleni | 1501 | South Africa |
| Langeberg Clinical Trials | Kraaifontein | 7570 | South Africa |
| Catholic Univ. of Incheon St.Mary's Hospital | Incheon | 21431 | South Korea |
| Chonbuk National University Hospital | Jeonju | 54907 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Konkuk University Medical Center | Seoul | 05030 | South Korea |
| Hospital de Merida | Mérida | Badajoz | 06800 | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | Cantabria | 39008 | Spain |
| CHUS H Clinico U de Santiago | Santiago de Compostela | LA Coruna | 15706 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 000000 | Spain |
| Hospital de San Pedro de Alcantara | Cáceres | 10003 | Spain |
| Hospital Universitario Virgen de Las Nieves | Granada | 18012 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz. | Madrid | 28040 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Fysikalisk Medicin i Stockholm AB | Lidingö | 181 29 | Sweden |
| ProbarE i Lund AB | Lund | 222 22 | Sweden |
| PharmaSite | Malmö | 211 52 | Sweden |
| ProbarE i Stockholm AB | Stockholm | 113 29 | Sweden |
| Queen Anne Street Medical Centre | London | London, City of | W1T6AH | United Kingdom |
| Bradford Royal Infirmary | Bradford | BD9 6RJ | United Kingdom |
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | CB2 0QQ | United Kingdom |
| Ninewells Hospital | Dundee | DD1 9SY | United Kingdom |
| Glenfield Hospital | Leicester | LE3 9QP | United Kingdom |
| Derived |
| 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 7, 2026 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000711667 | astegolimab |
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