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

Purpose

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.

Condition

  • Chronic Obstructive Pulmonary Disease

Eligibility

Eligible Ages
Between 40 Years and 90 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

UAB Lung Health Center
Birmingham, Alabama 35205-2610

SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
Dothan, Alabama 36305

Jasper Summit Research LLC
Jasper, Alabama 35501

Pulmonary Associates of Mobile PC
Mobile, Alabama 36608-3135

Pulmonary Associates Deer Valley Office
Phoenix, Arizona 85027-5163

AES - DRS - Synexus Clinical Research US, Inc. - Tucson
Tucson, Arizona 85741-3118

Kern Allergy and Medical Research
Bakersfield, California 93301-4205

Cadena Care Institute, LLC
Poway, California 92064-2419

St Francis Medical Institute ClinEdge PPDS
Clearwater, Florida 33765

Finlay Medical Research Corporation
Greenacres City, Florida 33467-2979

Flourish Research - Leesburg - PPDS
Leesburg, Florida 34748-5077

Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida 33470-9272

San Marcus Research Clinic Inc.
Miami, Florida 33014

Finlay Medical Research Corporation
Miami, Florida 33126-1941

Oceane7 Medical & Research Center, Inc.
Miami, Florida 33144-2155

Research Institute of South Florida Inc
Miami, Florida 33173

Diverse Clinical Research, LLC
Miami, Florida 33175-3434

Central Florida Pulmonary Group, PA
Orlando, Florida 32803

Florida Institute for Clinical Research, LLC
Orlando, Florida 32825-4454

Flourish Research - Orlando - PPDS
Winter Park, Florida 32789-4681

Pivotal Research Solutions
Stonecrest, Georgia 30038-2649

Northwestern Center for Clinical Research
Chicago, Illinois 60611

ASHA Clinical Research - ClinEdge - PPDS
Hammond, Indiana 46324-2213

Best Clinical Trials
New Orleans, Louisiana 70115-3628

Paul A. Shapero, MD, PA
Bangor, Maine 04401-5691

Exordia Medical Research, Inc.
Fall River, Massachusetts 02723-1511

Pulmonary Research Institute of Southeast Michigan
Farmington Hills, Michigan 48336-2817

Flushing Road Internal Medicine and Pediatrics - F
Flint, Michigan 48504-4730

Revive Research Institute
Southfield, Michigan 48075

Oakland Medical Research Center
Troy, Michigan 48085-5524

The Lung Research Center
Chesterfield, Missouri 63017-3625

Midwest Chest Consultants
Saint Charles, Missouri 63301

Washington University School of Medicine in St. Louis
St Louis, Missouri 63110

Midwest Clinical Research LLC
St Louis, Missouri 63141

The Machuca Foundation Inc
Las Vegas, Nevada 89101-3485

Sierra Clinical Research - ClinEdge - PPDS
Las Vegas, Nevada 89106-4159

Renown Regional Medical Center Hospital
Reno, Nevada 89502-1576

American Health Research Inc.
Charlotte, North Carolina 28277

Research Carolina Elite
Denver, North Carolina 28037-7929

Clinical Research of Gastonia
Gastonia, North Carolina 28054

Pulmonix LLC
Greensboro, North Carolina 27403-4443

Carolina Research Center
Shelby, North Carolina 28150-3803

Southeastern Research Center
Winston-Salem, North Carolina 27103-4029

OK Clinical Research
Edmond, Oklahoma 73034-3258

The Oregon Clinic.
Portland, Oregon 97220

Clinical Research Associates Of Central Pa , Llc
DuBois, Pennsylvania 15801-2277

Allergy & Clinical Immun Assoc
Pittsburgh, Pennsylvania 15241

Medtrial, LLC
Columbia, South Carolina 29204

Velocity Clinical Research - Gaffney - PPDS
Gaffney, South Carolina 29340-4737

Lowcountry Lung and Critical Care
North Charleston, South Carolina 29406

Clinical Research of Rock Hill
Rock Hill, South Carolina 29732

ClinSearch, LLC
Chattanooga, Tennessee 37421

Tennessee Comprehensive Lung & Sleep Center
Hendersonville, Tennessee 37075-3085

Corsicana Medical Research
Corsicana, Texas 75110-2471

Trio Clinical Trials
Houston, Texas 77008-1772

Baylor College of Medicine
Houston, Texas 77030-4202

Houston Pulmonary Medicine Associates, PA - Biopharma Informatic, LLC
Houston, Texas 77089-6097

Metroplex Pulmonary and Sleep Medicine Center
McKinney, Texas 75069

Sherman Clinical Research - ClinEdge - PPDS
Sherman, Texas 75090

Vermont Lung Center at the University of Vermont
Colchester, Vermont 05446-3052

University of Virginia Health System
Charlottesville, Virginia 22903

Western Washington Medical Group
Everett, Washington 98208

Allergy Asthma and Sinus Center-Greenfield
Greenfield, Wisconsin 53228

Allianze Pulmonary Research LLC
Guaynabo, Puerto Rico 00968

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: GB43374 https://forpatients.roche.com/ No attachments to email below.
888-662-6728
global-roche-genentech-trials@gene.com