Chronic Obstructive Pulmonary DiseasePhase 2NCT05037929
A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
A Phase 2 study testing Astegolimab in people with Chronic Obstructive Pulmonary Disease, run by Genentech, Inc. at 193 sites in 24 countries.
Trial summary
This study will evaluate the efficacy, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or current smokers and have a history of frequent exacerbations. 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?
- Yes, some participants may receive a placebo
- How many people
- 1,334 participants
- Where
- 193 sitesin 24 countries
- Study dates
- 5 Oct 2021to 7 Jul 2025
- Phase
- Phase 2
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
- Documented physician diagnosis of COPD for at least 12 months
- History of frequent exacerbations, defined as having had two or more moderate or severe exacerbations occurring within a 12-month period in the 24 months prior to screening
- Post-bronchodilator FEV1 >=20 and <80% of predicted normal value at screening
- Modified Medical Research Council (dyspnea scale) (mMRC) score >=2
- Current or former smoker with a minimum of 10 pack-year history
- History of one of the following combinations of optimized, stable, standard-of-care COPD maintenance therapy for at least 4 weeks prior to screening, with no anticipated changes in therapy prior to initiation of study drug and throughout the study: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA); Long-acting muscarinic antagonist (LAMA) plus LABA; ICS plus LAMA plus LABA
Who cannot join
- Current documented diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines within 5 years prior to screening
- History of clinically significant pulmonary disease other than COPD
- History of long-term treatment with oxygen at >4.0 liters/minute
- Lung volume reduction surgery or procedure within 12 months prior to screening
- Participation in or planned participation in a new pulmonary rehabilitation program. Patients who are in the maintenance phase of a rehabilitation program are eligible
- History of lung transplant
Show all 10Show fewer
- Occurrence of moderate or severe COPD exacerbation, COVID-19, upper or lower respiratory infection, pneumonia, or hospitalization of 24 hours duration within 4 weeks prior to initiation of study drug
- Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
- Initiation of a methylxanthine preparation, maintenance macrolide therapy, and/or PDE4 inhibitor within 4 weeks prior to screening
- Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening
Trial locations and contacts
193 sites in 24 countries.
193 sites in 24 countries
United States36 sites
South Texas Medical Research Institute, Inc., dba TTS Research ? ClinEdge ? PPDS
Boerne, Texas, 78006-1993
Northern Pines Health Center PC
Buckley, Michigan, 49620
American Health Research Inc.
Charlotte, North Carolina, 28277
University of Virginia Health System
Charlottesville, Virginia, 22903-2980
Cardio-Pulmonary Associates
Chesterfield, Missouri, 63017-3627
Northwestern Center for Clinical Research
Chicago, Illinois, 60611
St. Francis Sleep
Clearwater, Florida, 33765
SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
Dothan, Alabama, 36305
Medisphere Medical Research Center, Llc
Evansville, Indiana, 47714
Exordia Medical Research, Inc.
Fall River, Massachusetts, 20723
Clinical Research of Gastonia
Gastonia, North Carolina, 28054-7481
Blessing Health Hannibal
Hannibal, Missouri, 63401
Baylor College of Medicine
Houston, Texas, 77030
Jasper Summit Research LLC
Jasper, Alabama, 35501
Sierra Clinical Research - ClinEdge - PPDS
Las Vegas, Nevada, 89106-4159
Revive Research Institute
Lathrup Village, Michigan, 48076
Clinical Site Partners - Leesburg Suite 101 - HyperCore - PPDS
Leesburg, Florida, 34748-5077
Pulmonary Specialists of the Palm Beaches
Loxahatchee Groves, Florida, 33470-9206
Metroplex Pulmonology & Sleep Center
McKinney, Texas, 75069
Pulmonary Associates of Mobile PC
Mobile, Alabama, 36608-3135
Lowcountry Lung and Critical Care
North Charleston, South Carolina, 29406
Florida Institute for Clinical Research, LLC
Orlando, Florida, 32825-4454
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Cadena Care Institute, LLC
Poway, California, 92064-2021
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732-1160
Midwest Chest Consultants
Saint Charles, Missouri, 63301
Inst. of Healthcare Assessment, Inc.
San Diego, California, 92120
Carolina Research Center
Shelby, North Carolina, 28150-3803
Sherman Clinical Research - ClinEdge - PPDS
Sherman, Texas, 75092
Velocity Clinical Research Spartanburg PPDS
Spartanburg, South Carolina, 29303-4225
CARE Clinical Research
St Louis, Missouri, 63141-6823
Midwest Clinical Research LLC
St Louis, Missouri, 63141
Oakland Medical Research
Troy, Michigan, 48085
Allianz Research Institute Inc
Westminster, California, 92683
Southeastern Research Center
Winston-Salem, North Carolina, 27103-4029
Clinical Site Partners - Winter Park - HyperCore - PPDS
Winter Park, Florida, 32789-4681
Argentina18 sites
Centro de Investigaciones Clínicas Belgrano
Buenos Aires, 7240
Instituto de Investigaciones Clinicas-Mar del Plata
Buenos Aires, B7600FZN
Fundacion Cidea
Buenos Aires, C1121ABE
Centro Médico Dra de Salvo
Buenos Aires, C1426ABP
CARE - Centro de Alergia y Enfermedades Respiratorias
CABA, C1414AIF
Instituto de Medicina Respiratoria, IMeR
Córdoba, X5003DCE
Centro de Especialidades Medicas Lobos
Lobos, B7240AAN
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, 7600
Instituto Ave Pulmo
Mar del Plata, B7602DCK
Fundacion Scherbovsky
Mendoza, 5500
INSARES
Mendoza, M5500CCG
Centro Respiratorio Quilmes
Quilmes, B1878FNR
Centro Medico IPAM
Rosario, Santa Fe Province, S2001SBK
Instituto Medico Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion Medica
Rosario, S2013OJN
Centro Médico Respire
San Fernando, B1646EBJ
Instituto De Enfermedades Respiratorias E Investigacion Medica
San Juan Bautista, CP 1888
Investigaciones en Patologias Respiratorias
San Miguel de Tucumán, 4000
Centro Integral de Medicina Respiratoria (CIMER)
San Miguel de Tucumán, T4000CBC
Poland15 sites
Centrum Medyczne Bydgoszcz- PRATIA - PPDS
Bydgoszcz, 85 001
Centrum Medyczne Bydgoszcz- PRATIA - PPDS
Bydgoszcz, 85-796
Indywidualna Specjalistyczna Praktyka Lekarska lek.
Kielce, 25-751
Specjalistyczny Osrodek Alergologiczno-Internistyczny ALL-MED
Krakow, Lesser Poland Voivodeship, 31-023
Diamond Clinic
Krakow, 31-559
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.
Krakow, 31-637
ETG Lodz
Lódz, Lódzkie, 90-302
ETG Lublin
Lublin, 20-412
Twoja Przychodnia Centrum Medyczne Nowa Sol
Nowa Sól, 67-100
Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik
Ostrowiec Swietokrzysk, 27-400
Centrum Alergologii Teresa Hofman
Poznan, 60-214
EMED Centrum Uslug Medycznych Ewa Smialek
Rzeszów, 35-205
PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna
Sosnowiec, 41-208
ETG Warszawa- PPDS
Warsaw, 02-793
Ewa Pisarczyk-Bogacka Specjalistyczna Praktyka Lekarska
Wroclaw, Lower Silesian Voivodeship, 53-301
Germany14 sites
Zentrum fuer Pneumologie, Onkologie und Schlafmedizin am Diako
Augsburg, 86150
CIMS-Studienzentrum Bamberg,
Bamberg
KPPK Studienzentrum Kroker-Schmidt
Bendorf, 56170
MECS Research GmbH
Berlin, 12203
Praxis Dr. Med Evelin Liefring
Berlin, 13187
Gemeinscharftspraxis Dres Jung - Deggingen
Deggingen, 73326
Medizentrum Essen Borbeck
Essen, 45355
Praxis Dr med Claus Keller
Frankfurt am Main, 60389
Universitätsklinikum Gießen und Marburg GmbH
Giessen, 35392
Asklepios MVZ Bayern GmbH
Landsberg, 86899
Salvus-Klinische Studien GmbH
Leipzig, 04207
IKF Pneumologie Mainz
Mainz, 55128
Zentrum fuer ambulante pneumologische Forschung Marburg GbR
Marburg, 35037
Studienzentrum Dr Med Schlenska
Peine, 31224
Bulgaria13 sites
Medical Centre "Asklepii", OOD
Dupnitsa, 2600
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD
Haskovo, 6300
Medical center Vip Clinic OOD
Lovech, 5500
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, 4001
Medical center Unimed EOOD
Plovdiv, 4023
Medical Centre Respiro OOD
Razgrad, 7200
Medical Center Hera EOOD
Sofia, 1510
University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD
Sofia, 1606
Medical Center New rehabilitation center EOOD
Stara Zagora, 6003
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa
Vratsa, 3000
Spain9 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 000000
Hospital de San Pedro de Alcantara
Cáceres, 10003
Hospital Universitario Virgen de Las Nieves
Granada, 18012
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Hospital Universitario Fundacion Jimenez Diaz.
Madrid, 28040
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Hospital de Merida
Mérida, Badajoz, 06800
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
CHUS H Clinico U de Santiago
Santiago de Compostela, LA Coruna, 15706
Chile8 sites
Centro de Investigación Curico
Curicó, 3340000
MIRES/MYF estudios clinicos
Ñuñoa, 7750495
Centro de Investigaciones Medicas Respiratorias
Providencia, Región-MetropolitanadeSantiago, 7500000
Sociedad Médica SyG SpA
Providencia, 7500000
Enroll SpA - PPDS
Providencia, 7500587
Meditek Ltda
Santiago, 8320000
Centro de Investigacion del Maule
Talca
Hospital Carlos Van Buren
Valparaíso, 2340000
Israel8 sites
Assuta Ashdod Medical Center
Ashdod, 7747629
Barzilai Medical Center
Ashkelon, 7830604
Shamir Medical Center Assaf Harofeh
Beer Jacob, 0073100
Tel Aviv Sourasky Medical Center PPDS
Jerusalem, 90000
Shaare Zedek Medical Center
Jerusalem, 9103102
Rabin Medical Center
Petach Tiqwa, 49100
Kaplan Medical Center
Rehovot, 76100
Sheba Medical Center - PPDS
Tel Litwinsky, 52621
Belgium7 sites
UZ Antwerpen
Edegem, 2650
Private Practice Dr Jean Benoit Martinot
Erpent, 5101
UZ Leuven Gasthuisberg
Leuven, 3000
AZ Sint-Maarten
Mechelen, Antwerpen, 2800
AZ Delta
Roeselare, 8800
Office of Marc De Meulemeester
Thuin, 6534
CHU UCl Namur asbl - Site Godinne
Yvoir, 5530
Mexico6 sites
Centro de Investigacion y Atencion Integral Durango CIAID
Durango, 34080
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
Guadalajara, Jalisco, 44100
Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
Guadalajara, Jalisco, 44130
Unidad Medica de Occidente
Guadalajara, Jalisco, 44220
CICUM San Miguel
Guadalajara Centro, Jalisco, 44100
Unidad de Investigacion Clinica En Medicina (Udicem) S.C.
Monterrey, Nuevo León, 64718
South Africa6 sites
University of Cape Town Lung Institute
Cape Town, 7700
Clinical Trial Systems
City of Tshwane, 0186
St Augustines Hospital
Durban, 4001
Dr A.C Wilhase practice-Reimed
Ekurhuleni, 1459
Lakeview Hospital
Ekurhuleni, 1501
Langeberg Clinical Trials
Kraaifontein, 7570
Canada5 sites
Burlington Lung Clinic
Burlington, Ontario, L7N 3V2
St. Joseph's Healthcare Hamilton- Charlton Campus
Hamilton, Ontario, L8N 4A6
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, Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Czechia5 sites
MediTrial s.r.o.
Jind?ich?v Hradec, 377 01
Plicni Ambulance Kralupy nad Vltavou
Kralupy nad Vltavou, 278 01
MUDr. Ilona Pavlisova s.r.o.
Miroslav, 671 72
Pneumologie Varnsdorf S.r.o.
Nový Bor, 473 01
KASMED s.r.o.
Tábor, 390 02
Denmark5 sites
Aalborg Universitetshospital
Aalborg, 9000
Gentofte Hospital
Hellerup, 2900
Hvidovre Hospital
Hvidovre, DK-2650
Odense Universitetshospital
Odense, 5000
Sygehus Lillebælt, Vejle
Vejle, 7100
Romania5 sites
Neomed Out-Patient Treatment and Diagnosis Medical Center SRL
Brasov, 500283
Dr. Victor Babes Foundation
Bucharest, 030303
Leon Daniello Pneumophthisiology Clinical Hospital
Cluj-Napoca, 400371
Spitalul Clinic de Pneumoftiziologie Constanta
Constanța, 900002
Sf. Ioan cel Nou Emergency County Hospital
Suceava, 720237
United Kingdom5 sites
Bradford Royal Infirmary
Bradford, BD9 6RJ
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Ninewells Hospital
Dundee, DD1 9SY
Glenfield Hospital
Leicester, LE3 9QP
Queen Anne Street Medical Centre
London, London, City of, W1T6AH
Australia4 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
Box Hill Hospital
Box Hill, Victoria, 3128
TrialsWest Pty Ltd
Spearwood, Western Australia, 6163
Westmead Hospital
Westmead, New South Wales, 2145
France4 sites
Hôpital de La Croix Rousse
Lyon, 69004
Hopital Saint Joseph - Marseille
Marseille, 13008
CHU de Nice
Nice, 06001
Nouvel Hôpital Civil
Strasbourg, 67091
Netherlands4 sites
Amphia Ziekenhuis
Breda, 4819 EV
Catharina Hospital
Eindhoven, 5623 EJ
Dijklander Ziekenhuis - loc Hoorn
Hoorn, 1624 NP
Isala Klinieken
Zwolle, 8011 JW
Peru4 sites
Clinica Providencia (Inverconsult Sociedad Anonima)
Lima, 32
Clinica Internacional
Lima, Lima 01
Clinica Ricardo Palma
Lima, Lima 27
Alfredo Berrocal Kasay Reuma Sociedad de Responsabilidad Limitada
Lima Cercado, 000000
South Korea4 sites
Catholic Univ. of Incheon St.Mary's Hospital
Incheon, 21431
Jeonbuk National University Hospital
Jeonju, 54907
Korea University Anam Hospital
Seoul, 02841
Konkuk University Medical Center
Seoul, 05030
Sweden4 sites
Fysikalisk Medicin i Stockholm AB
Lidingö, 181 29
ProbarE i Lund AB
Lund, 222 22
PharmaSite
Malmö, 211 52
ProbarE i Stockholm AB
Stockholm, 113 29
New Zealand3 sites
NZ Respiratory & Sleep Institute
Auckland, 1051
Aotearoa Clinical Trials Trust
Auckland, 2025
Canterbury Respiratory Research Group
Christchurch, 8011
About this study
Official title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease
This study will evaluate the efficacy, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or current smokers and have a history of frequent exacerbations.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Astegolimab, Placebo
- 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 or Q4W.
PlaceboDrug
Participants will receive SC placebo Q2W.
| Study group | Role | What they receive |
|---|---|---|
| Astegolimab Q2W | Experimental | Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W). Receives: Drug: Astegolimab |
| Astegolimab Q4W | Experimental | Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving astegolimab every 4 weeks (Q4W). Receives: Drug: Astegolimab |
| Placebo | Placebo comparator | Participants 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.
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 annual exacerbation rate (AER) was estimated as the total number of moderate and severe COPD exacerbations over the treatment period divided by the total patient-years at risk. The time at risk (in years) was the number of days from the date of first administration of study drug to the date of study completion or discontinuation in the 52-week treatment period, divided by 365.25 days. The adjusted AER was estimated using a negative binomial regression model. Adjusted rate values have been reported.
Measured: Baseline up to Week 52
Secondary outcomes (12)
Annualized Rate of Moderate and Severe COPD Exacerbations Over the 52-Week Treatment Period in Participants With Low Baseline Blood Eosinophil Level (< 300 Cells/uL)
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 led to hospitalization (duration > 24 hours) or death. Unadjusted AER was estimated as the total number of moderate and severe COPD exacerbations over the treatment period divided by the total patient-years at risk. The time at risk (in years) was the number of days from the date of first administration of study drug to the date of study completion or discontinuation in the 52-week treatment period, divided by 365.25 days. The adjusted AER was estimated using a negative binomial regression model. Adjusted rate values are reported. Number analyzed is the number of participants with data available for analysis.
Measured: Baseline to Week 52
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 is 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 is defined as new or increased COPD symptoms that lead to hospitalization (duration > 24 hours) or lead to death. Kaplan-Meier (K-M) method was used to estimate the median time.
Measured: 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
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. This analysis used a Mixed Model for Repeated Measurements (MMRM) model. Adjusted mean of change from baseline (CFB) is reported here.
Measured: At Week 52
Percentage of Participants With Improvement in HRQoL at Week 52, as Assessed Through SGRQ-C Total Score
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
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. This analysis used a MMRM model. Adjusted mean of CFB is reported here.
Measured: At Week 52
Absolute Change From Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Score at Week 52
EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) is a 14-item participant-reported instrument used to assess frequency, severity, \& 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. This analysis used a MMRM model. Adjusted mean of CFB has been reported here.
Measured: At Week 52
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 lead to death. The unadjusted annual exacerbation rate (AER) was estimated as the total number of moderate and severe COPD exacerbations over the treatment period divided by the total patient-years at risk. The time at risk (in years) was the number of days from the date of first administration of study drug to the date of study completion or discontinuation in the 52-week treatment period, divided by 365.25 days. The adjusted AER was estimated using a negative binomial regression model. Adjusted rate values have been reported.
Measured: Baseline up to Week 52
Absolute Change From Baseline in Five-repetition Sit-to-stand (5STS) Time (Seconds) at Week 52
The 5STS was used to assess the time taken to stand up from a seated position five times, in as rapid succession as possible. The functional test related strongly to lower limb function and frailty in participants with COPD; an inability to perform a single sit-to-stand or to complete five repeat sit-to-stands within 60 seconds denoted an inability to perform the test. This analysis used a MMRM model. Adjusted mean values have been reported.
Measured: At Week 52
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Up to 98.1 weeks
Main Study: Serum Concentrations of Astegolimab at Specified Timepoints
PK samples in the main study were collected during the 52-week double-blinded treatment period (Period 1), additional blinded treatment period (Period 2), and SFU period.
Measured: Period 1: Pre-dose on Day 1 of Week 1 and at Weeks 4, 12, 24, 36, 52 and 62 (SFU); Period 2: Pre-dose at Weeks 52, 64, 76, 88, and 98 (SFU)
Intensive PK Sampling Substudy: Serum Concentrations of Astegolimab at Specified Timepoints
PK samples in the intensive PK sampling substudy were collected during the 52-week double-blinded treatment period (Period 1), additional blinded treatment period (Period 2), and SFU period.
Measured: Period 1: Pre-dose on Day 1 of Week 1 and at Weeks 4, 12, 24, 36, 48, 52, and 62 (SFU), Post-dose on Days 3, 7, and 10 of Week 1, Day 7 of Week 48, Day 28 post-dose from Week 52; Period 2: Pre-dose at Weeks 52, 64, 76, 88, and 98 (SFU)
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). Participants with a positive post-baseline sample have been reported here.
Measured: Up to 98.1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start5 Oct 2021
- Primary completion24 Feb 2025
- Study completion7 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037929
- Sponsor's protocol ID
- GB43311
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2021
- Last updated
- 16 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 42150581Wedzicha 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