Recruiting

Phase 3

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

Sponsor:

Hoffmann-La Roche

Code:

NCT05878769

Conditions

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Astegolimab

Study Details

Brief summary:

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

Conditions

Chronic Obstructive Pulmonary Disease

Study ID

NCT05878769

Start date

Jun 28, 2023

Status verified date

Nov, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Completion of the 52-week treatment period in an astegolimab parent study

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 Design

Enrollment

2000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Astegolimab

Participants will receive SC astegolimab Q2W

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Reference Study ID Number: GB43374 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 global-roche-genentech-trials@gene.com

Locations

UAB Lung Health Center

Recruiting

Birmingham, Alabama, United States, 35205-2610

SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS

Recruiting

Dothan, Alabama, United States, 36305

Jasper Summit Research LLC

Recruiting

Jasper, Alabama, United States, 35501

Pulmonary Associates of Mobile PC

Recruiting

Mobile, Alabama, United States, 36608-3135

Pulmonary Associates Deer Valley Office

Recruiting

Phoenix, Arizona, United States, 85027-5163

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

Recruiting

Tucson, Arizona, United States, 85741-3118

Kern Allergy and Medical Research

Recruiting

Bakersfield, California, United States, 93301-4205

Cadena Care Institute, LLC

Recruiting

Poway, California, United States, 92064-2419

St Francis Medical Institute ClinEdge PPDS

Recruiting

Clearwater, Florida, United States, 33765

Finlay Medical Research Corporation

Recruiting

Greenacres City, Florida, United States, 33467-2979

Flourish Research - Leesburg - PPDS

Recruiting

Leesburg, Florida, United States, 34748-5077

Advanced Pulmonary Research Institute

Recruiting

Loxahatchee Groves, Florida, United States, 33470-9272

San Marcus Research Clinic Inc.

Recruiting

Miami, Florida, United States, 33014

Finlay Medical Research Corporation

Recruiting

Miami, Florida, United States, 33126-1941

Oceane7 Medical & Research Center, Inc.

Recruiting

Miami, Florida, United States, 33144-2155

Research Institute of South Florida Inc

Recruiting

Miami, Florida, United States, 33173

Diverse Clinical Research, LLC

Recruiting

Miami, Florida, United States, 33175-3434

Central Florida Pulmonary Group, PA

Recruiting

Orlando, Florida, United States, 32803

Florida Institute for Clinical Research, LLC

Recruiting

Orlando, Florida, United States, 32825-4454

Flourish Research - Orlando - PPDS

Recruiting

Winter Park, Florida, United States, 32789-4681

Pivotal Research Solutions

Recruiting

Stonecrest, Georgia, United States, 30038-2649

Northwestern Center for Clinical Research

Recruiting

Chicago, Illinois, United States, 60611

ASHA Clinical Research - ClinEdge - PPDS

Recruiting

Hammond, Indiana, United States, 46324-2213

Best Clinical Trials

Recruiting

New Orleans, Louisiana, United States, 70115-3628

Paul A. Shapero, MD, PA

Recruiting

Bangor, Maine, United States, 04401-5691

Exordia Medical Research, Inc.

Recruiting

Fall River, Massachusetts, United States, 02723-1511

Pulmonary Research Institute of Southeast Michigan

Recruiting

Farmington Hills, Michigan, United States, 48336-2817

Flushing Road Internal Medicine and Pediatrics - F

Recruiting

Flint, Michigan, United States, 48504-4730

Revive Research Institute

Recruiting

Southfield, Michigan, United States, 48075

Oakland Medical Research Center

Recruiting

Troy, Michigan, United States, 48085-5524

The Lung Research Center

Recruiting

Chesterfield, Missouri, United States, 63017-3625

Midwest Chest Consultants

Recruiting

Saint Charles, Missouri, United States, 63301

Washington University School of Medicine in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Midwest Clinical Research LLC

Recruiting

St Louis, Missouri, United States, 63141

The Machuca Foundation Inc

Recruiting

Las Vegas, Nevada, United States, 89101-3485

Sierra Clinical Research - ClinEdge - PPDS

Recruiting

Las Vegas, Nevada, United States, 89106-4159

Renown Regional Medical Center Hospital

Recruiting

Reno, Nevada, United States, 89502-1576

American Health Research Inc.

Recruiting

Charlotte, North Carolina, United States, 28277

Research Carolina Elite

Recruiting

Denver, North Carolina, United States, 28037-7929

Clinical Research of Gastonia

Recruiting

Gastonia, North Carolina, United States, 28054

Pulmonix LLC

Recruiting

Greensboro, North Carolina, United States, 27403-4443

Carolina Research Center

Recruiting

Shelby, North Carolina, United States, 28150-3803

Southeastern Research Center

Recruiting

Winston-Salem, North Carolina, United States, 27103-4029

OK Clinical Research

Recruiting

Edmond, Oklahoma, United States, 73034-3258

The Oregon Clinic.

Recruiting

Portland, Oregon, United States, 97220

Clinical Research Associates Of Central Pa , Llc

Recruiting

DuBois, Pennsylvania, United States, 15801-2277

Allergy & Clinical Immun Assoc

Recruiting

Pittsburgh, Pennsylvania, United States, 15241

Medtrial, LLC

Recruiting

Columbia, South Carolina, United States, 29204

Velocity Clinical Research - Gaffney - PPDS

Recruiting

Gaffney, South Carolina, United States, 29340-4737

Lowcountry Lung and Critical Care

Recruiting

North Charleston, South Carolina, United States, 29406

Clinical Research of Rock Hill

Recruiting

Rock Hill, South Carolina, United States, 29732

ClinSearch, LLC - M3 WR - 6035 Shallowford Rd

Recruiting

Chattanooga, Tennessee, United States, 37421-1605

Tennessee Comprehensive Lung & Sleep Center

Recruiting

Hendersonville, Tennessee, United States, 37075-3085

Corsicana Medical Research

Recruiting

Corsicana, Texas, United States, 75110-2471

Trio Clinical Trials

Recruiting

Houston, Texas, United States, 77008-1772

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030-4202

Houston Pulmonary Medicine Associates, PA - Biopharma Informatic, LLC

Recruiting

Houston, Texas, United States, 77089-6097

Metroplex Pulmonary and Sleep Medicine Center

Recruiting

McKinney, Texas, United States, 75069

Sherman Clinical Research - ClinEdge - PPDS

Recruiting

Sherman, Texas, United States, 75090

Vermont Lung Center at the University of Vermont

Recruiting

Colchester, Vermont, United States, 05446-3052

University of Virginia Health System

Recruiting

Charlottesville, Virginia, United States, 22903

Western Washington Medical Group

Recruiting

Everett, Washington, United States, 98208

Allergy Asthma and Sinus Center-Greenfield

Recruiting

Greenfield, Wisconsin, United States, 53228

Edmonton Respiratory Consultants

Recruiting

Edmonton, Alberta, Canada, T5J 3S9

Synergy Respiratory & Cardiac Care - Synergy Wellness Centre Location

Recruiting

Sherwood Park, Alberta, Canada, T8H 0N2

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1L8

Dynamic Drug Advancement Ltd.

Recruiting

Ajax, Ontario, Canada, L1S 2J5

Burlington Lung Clinic

Recruiting

Burlington, Ontario, Canada, L7N 3V2

Bluewater Clinical Research Group

Recruiting

Sarnia, Ontario, Canada, N7T 4X3

Inspiration Research

Recruiting

Toronto, Ontario, Canada, M5T 3A9

Dr. Syed Anees Medicine Profession Corporation

Recruiting

Windsor, Ontario, Canada, N8X 1T3

Dr Anil Dhar Professional Medicine Corporation

Recruiting

Windsor, Ontario, Canada, N8X 5A6

Clinique de pneumologie et du sommeil de Lanaudiere

Recruiting

Saint-Charles-Borromée, Quebec, Canada, J6E 2B4

University of Saskatchewan

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 5A2

Centre Hospitalier de l'Universite Laval

Recruiting

Québec, Canada, G1V 4G5

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Keywords

chronic obstructive pulmonary disease, COPD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.