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

April 10, 2024 updated by: Hoffmann-La Roche

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B7600FZN
        • Recruiting
        • Instituto de Investigaciones Clinicas-Mar del Plata
      • Buenos Aires, Argentina, C1121ABE
        • Recruiting
        • Fundacion Cidea
      • Buenos Aires, Argentina, C1426ABP
        • Recruiting
        • Centro Médico Dra de Salvo
      • Caba, Argentina, C1414AIF
        • Recruiting
        • CARE - Centro de Alergia y Enfermedades Respiratorias
      • Ciudad Autonoma Buenos Aires, Argentina, C1425AZB
        • Recruiting
        • Centro de Investigaciones Clínicas Belgrano
      • Lobos, Argentina, B7240AAN
        • Recruiting
        • Centro de Especialidades Medicas Lobos
      • Mar Del Plata, Argentina, B7600FYK
        • Recruiting
        • Centro de Investigaciones Medicas Mar Del Plata
      • Mar Del Plata, Argentina, B7602DCK
        • Recruiting
        • Instituto Ave Pulmo
      • Mendoza, Argentina, M5500AYB
        • Recruiting
        • Fundacion Scherbovsky
      • Mendoza, Mendoza City, Argentina, M5500CCG
        • Recruiting
        • INSARES
      • Quilmes, Argentina, B1878FNR
        • Recruiting
        • Centro Respiratorio Quilmes
      • Rosario, Argentina, S2013SBK
        • Recruiting
        • Centro Medico IPAM
      • Rosario, Argentina, 2002
        • Recruiting
        • Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
      • San Fernando, Argentina, B1646EBJ
        • Recruiting
        • Centro Medico Respire
      • San Miguel de Tucuman, Argentina, T4000IAJ
        • Recruiting
        • Instituto De Patologias Respiratorias
      • San Miguel de Tucumán, Argentina, T4000CHE
        • Recruiting
        • Centro Integral de Medicina Respiratoria (CIMER)
      • Villa Vatteone, Argentina, B1853AIK
        • Recruiting
        • Instituto De Enfermedades Respiratorias E Investigacion Medica
  • Australia
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Recruiting
        • Box Hill Hospital
    • Western Australia
      • Spearwood, Western Australia, Australia, 6163
        • Recruiting
        • TrialsWest Pty Ltd
  • Belgium
      • Edegem, Belgium, 2650
        • Recruiting
        • Antwerp University Hospital
      • Erpent, Belgium, 5101
        • Recruiting
        • Private Practice Dr Jean Benoit Martinot
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven
      • Mechelen, Belgium, 2800
        • Recruiting
        • Az Sint-Maarten
      • Roeselare, Belgium, 8800
        • Recruiting
        • AZ Delta
      • Thuin, Belgium, 6534
        • Recruiting
        • Office of Marc De Meulemeester
      • Yoir, Belgium, 5530
        • Recruiting
        • CHU UCL Namur asbl - Site Godinne
  • Bulgaria
      • Dupnitsa, Bulgaria, 2600
        • Recruiting
        • Medical Centre "Asklepii", OOD
      • Haskovo, Bulgaria, 6300
        • Recruiting
        • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD
      • Lovech, Bulgaria, 5500
        • Recruiting
        • Medical Center Leo Clinic EOOD, branch Lovech
      • Montana, Bulgaria, 3400
        • Recruiting
        • MEDICAL CENTER HERA EOOD; Office of Pulmonology and Phtisiatrics
      • Pernik, Bulgaria, 2300
        • Recruiting
        • Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD
      • Pleven, Bulgaria, 5800
        • Recruiting
        • Medical Center Medconsult Pleven Ood
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
      • Plovdiv, Bulgaria, 4023
        • Recruiting
        • Medical Center Unimed Eood
      • Stara Zagora, Bulgaria, 6000
        • Recruiting
        • Medical Center New rehabilitation center EOOD
  • Canada
    • Ontario
      • Burlington, Ontario, Canada, L7N 3V2
        • Recruiting
        • Burlington Lung Clinic
    • Quebec
      • Saint-Charles-Borromee, Quebec, Canada, J6E 2B4
        • Recruiting
        • Clinique de pneumologie et du sommeil de Lanaudiere
  • Chile
      • Providencia, Chile, 7500000
        • Recruiting
        • Sociedad Médica SyG SpA
      • Providencia, Chile, 7500587
        • Recruiting
        • Enroll SpA - PPDS
      • Recoleta, Chile, 8420000
        • Recruiting
        • Centro Internacional de Estudios Clinicos (CIEC)
      • Santiago, Chile, 7500692
        • Recruiting
        • Centro de Investigaciones Medicas Respiratorias CIMER
  • Czechia
      • Jind?ich?v Hradec, Czechia, 377 01
        • Recruiting
        • MediTrial s.r.o.
      • Kralupy nad Vltavou, Czechia, 278 01
        • Recruiting
        • Plicni Ambulance Kralupy nad Vltavou
      • Tabor, Czechia, 390 01
        • Recruiting
        • KASMED s.r.o.
  • Denmark
      • Aalborg, Denmark, 9100
        • Recruiting
        • Aalborg Universitetshospital
      • Hellerup, Denmark, 2900
        • Recruiting
        • Gentofte Hospital
      • Hvidovre, Denmark, DK-2650
        • Recruiting
        • Hvidovre Hospital
  • France
      • Lyon, France, 69004
        • Recruiting
        • Hôpital de La Croix Rousse
      • Marseille, France, 13008
        • Recruiting
        • Hopital Saint Joseph - Marseille
      • Nice, France, 06001
        • Recruiting
        • Hopital Pasteur II
  • Germany
      • Augsburg, Germany, 86150
        • Recruiting
        • Zentrum fuer Pneumologie, Onkologie und Schlafmedizin am Diako
      • Bamberg, Germany, 96049
        • Recruiting
        • Gemeinschaftspraxis fuer Herz und Lunge am Bruderw
      • Berlin, Germany, 12203
        • Recruiting
        • MECS Research GmbH
      • Berlin, Germany, 13187
        • Recruiting
        • Clinical Studies Pankow
      • Deggingen, Germany, 73326
        • Recruiting
        • MVZ Jung GbR - Deggingen
      • Essen, Germany, 45355
        • Recruiting
        • Medizentrum Essen Borbeck
      • Frankfurt am Main, Germany, 60389
        • Recruiting
        • Praxis Dr med Claus Keller
      • Koblenz, Germany, 56068
        • Recruiting
        • KPPK Studienzentrum Kroker-Schmidt
      • Landsberg, Germany, 86899
        • Recruiting
        • Asklepios MVZ Bayern GmbH
      • Leipzig, Germany, 04207
        • Recruiting
        • Salvus-Klinische Studien GmbH
      • Mainz, Germany, 55128
        • Recruiting
        • Ikf Pneumologie Mainz
      • Marburg, Germany, 35037
        • Recruiting
        • Praxis für Pneumologie Dr. Silke Mronga & Dr. Lukas Jerrentrup
      • Peine, Germany, 31224
        • Recruiting
        • Studienzentrum Dr Med Schlenska
  • Israel
      • Ashkelon, Israel, 7830604
        • Recruiting
        • Barzilai Medical Center
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center
      • Petach Tiqwa, Israel, 4941492
        • Recruiting
        • Rabin Medical Center
      • Rehovot, Israel, 7610001
        • Recruiting
        • Kaplan Medical Center
      • Tel Aviv-Yafo, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center PPDS
  • Korea, Republic of
      • Incheon, Korea, Republic of, 21431
        • Recruiting
        • Catholic Univ. of Incheon St.Mary's Hospital
      • Jeollabuk-do, Korea, Republic of, 54907
        • Recruiting
        • Chonbuk National University Hospital
      • Seoul, Korea, Republic of, 02841
        • Recruiting
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 05030
        • Recruiting
        • Konkuk University Medical Center
  • Mexico
    • Jalisco
      • Americana, Jalisco, Mexico, 44160
        • Recruiting
        • CICUM San Miguel
      • Santa Cecilia, Jalisco, Mexico, 44700
        • Recruiting
        • Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 64718
        • Recruiting
        • Unidad de Investigacion Clinica En Medicina (Udicem) S.C.
  • Netherlands
      • Breda, Netherlands, 4818 CK
        • Recruiting
        • Amphia Ziekenhuis
      • Eindhoven, Netherlands, 5623 EJ
        • Recruiting
        • Catharina Hospital; Apotheek
      • Hoorn, Netherlands, 1624 NP
        • Recruiting
        • Dijklander Ziekenhuis - loc Hoorn
  • New Zealand
      • Auckland, New Zealand, 1051
        • Recruiting
        • NZ Respiratory & Sleep Institute
      • Auckland, New Zealand, 2025
        • Recruiting
        • Aotearoa Clinical Trials Trust
      • Christchurch, New Zealand, 8011
        • Recruiting
        • Canterbury Respiratory Research Group
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Recruiting
        • Centrum Medyczne Bydgoszcz- PRATIA - PPDS
      • Kielce, Poland, 25-751
        • Recruiting
        • Indywidualna Specjalistyczna Praktyka Lekarska lek.
      • Krakow, Poland, 30-033
        • Recruiting
        • Centrum Medyczne All-Med
      • Kraków, Poland, 31-209
        • Recruiting
        • Diamond Clinic
      • Kraków, Poland, 31-637
        • Recruiting
        • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.
      • Lublin, Poland, 20-412
        • Recruiting
        • Etg Lublin
      • Lódz, Poland, 90-302
        • Recruiting
        • ETG LODZ
      • Nowa Sól, Poland, 67-100
        • Recruiting
        • Twoja Przychodnia Centrum Medyczne Nowa Sol
      • Ostrowiec Swietokrzysk, Poland, 27-400
        • Active, not recruiting
        • Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik; Krzysztof Cudzik
      • Poznan, Poland, 60-214
        • Recruiting
        • Centrum Alergologii Teresa Hofman
      • Rzeszów, Poland, 35-205
        • Recruiting
        • EMED Centrum Uslug Medycznych Ewa Smialek
      • Siedlce, Poland, 08-110
        • Recruiting
        • ETG Siedlce
      • Sosnowiec, Poland, 41-200
        • Recruiting
        • PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna
      • Warszawa, Poland, 02-677
        • Withdrawn
        • ETG Neuroscience Sp. z o.o.
      • Wroclaw, Poland, 53-301
        • Recruiting
        • Dobrostan Gabinety Lekarskie
  • Romania
      • Brasov, Romania, 500283
        • Recruiting
        • Neomed Out-Patient Treatment and Diagnosis Medical Center SRL
      • Bucharest, Romania, 030301
        • Recruiting
        • Dr. Victor Babes Foundation
      • Cluj-Napoca, Romania, 400371
        • Recruiting
        • Leon Daniello Pneumophthisiology Clinical Hospital
      • Suceava, Romania, 720224
        • Recruiting
        • Sf. Ioan cel Nou Emergency County Hospital
  • South Africa
      • Cape Town, South Africa, 7700
        • Recruiting
        • University of Cape Town Lung Institute; Lung Clinical Research
      • City Of Tshwane, South Africa, 0186
        • Recruiting
        • Clinical Trial Systems
      • Ekurhuleni, South Africa, 1459
        • Recruiting
        • Dr A.C Wilhase practice-Reimed
      • Ekurhuleni, South Africa, 1501
        • Recruiting
        • Lakeview Hospital
      • Kraaifontein, South Africa, 7570
        • Recruiting
        • Langeberg Clinical Trials
  • Spain
      • Caceres, Spain, 10003
        • Withdrawn
        • Hospital de San Pedro de Alcantara
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain, 28040
        • Withdrawn
        • Hospital Clinico San Carlos
      • Malaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
    • Badajoz
      • Merida, Badajoz, Spain, 06800
        • Recruiting
        • Hospital de Mérida
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
    • LA Coruña
      • Santiago de Compostela, LA Coruña, Spain, 15706
        • Recruiting
        • CHUS H Clinico U de Santiago
  • Sweden
      • Lidingö, Sweden, 181 61
        • Recruiting
        • Fysikalisk Medicin i Stockholm AB
      • Malmö, Sweden, 211 52
        • Recruiting
        • PharmaSite
      • Stockholm, Sweden, SE-17145
        • Recruiting
        • ProbarE i Stockholm AB
  • United Kingdom
      • Leicester, United Kingdom, LE3 9QP
        • Recruiting
        • Glenfield Hospital
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Recruiting
        • SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
      • Jasper, Alabama, United States, 35501
        • Recruiting
        • Jasper Summit Research LLC
      • Mobile, Alabama, United States, 36608-3135
        • Recruiting
        • Pulmonary Associates of Mobile PC
    • California
      • Poway, California, United States, 92064-2021
        • Recruiting
        • Cadena Care Institute, LLC
      • San Diego, California, United States, 92120
        • Recruiting
        • Inst. of Healthcare Assessment, Inc.
      • Westminster, California, United States, 92683
        • Withdrawn
        • Allianz Research Institute Inc
    • Florida
      • Clearwater, Florida, United States, 33765
        • Recruiting
        • St Francis Medical Institute ClinEdge PPDS
      • Greenacres City, Florida, United States, 33467-2979
        • Recruiting
        • Finlay Medical Research Corporation
      • Leesburg, Florida, United States, 34748-5077
        • Recruiting
        • Flourish Research - Leesburg - PPDS
      • Loxahatchee Groves, Florida, United States, 33470-9206
        • Recruiting
        • Pulmonary Specialists of the Palm Beaches
      • Orlando, Florida, United States, 32822
        • Recruiting
        • Florida Institute for Clinical Research, LLC
    • Massachusetts
      • Stow, Massachusetts, United States, 01775-1205
        • Recruiting
        • Exordia Medical Research, Inc.
    • Michigan
      • Lathrup Village, Michigan, United States, 48076
        • Recruiting
        • Revive Research Institute
      • Troy, Michigan, United States, 48085
        • Recruiting
        • Oakland Medical Research
    • Missouri
      • Hannibal, Missouri, United States, 63401-6890
        • Active, not recruiting
        • Hannibal Regional Healthcare System HRMG Hannibal
      • Saint Charles, Missouri, United States, 63301
        • Recruiting
        • Midwest Chest Consultants
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Midwest Clinical Research LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89106-4159
        • Recruiting
        • Sierra Clinical Research - ClinEdge - PPDS
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Recruiting
        • American Health Research Inc.
      • Gastonia, North Carolina, United States, 28054
        • Recruiting
        • Clinical Research of Gastonia
      • Shelby, North Carolina, United States, 28150-3803
        • Recruiting
        • Carolina Research Center
      • Winston-Salem, North Carolina, United States, 27103-4029
        • Recruiting
        • Southeastern Research Center
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Recruiting
        • OK Clinical Research
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University Hospital
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Recruiting
        • Lowcountry Lung and Critical Care
      • Rock Hill, South Carolina, United States, 29732
        • Recruiting
        • Clinical Research of Rock Hill
      • Spartanburg, South Carolina, United States, 29303-4225
        • Withdrawn
        • Velocity Clinical Research Spartanburg PPDS
    • Texas
      • Boerne, Texas, United States, 78006-1993
        • Recruiting
        • South Texas Medical Research Institute, Inc., dba TTS Research ? ClinEdge ? PPDS
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
      • Sherman, Texas, United States, 75092
        • Recruiting
        • Sherman Clinical Research - ClinEdge - PPDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open-Label Extension
Eligible participants from parent studies GB43311 and GB44332 will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study
Drug: Astegolimab
Participants will receive SC astegolimab Q2W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of all adverse events (AEs)
Time Frame: Up to 12 weeks after last dose of study treatment
Up to 12 weeks after last dose of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

May 19, 2023

First Submitted That Met QC Criteria

May 19, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GB43374

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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