Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2025-12-25 @ 8:44 PM
Study NCT ID:
NCT05878769
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2023-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711667', 'term': 'astegolimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2023-05-19', 'studyFirstSubmitQcDate': '2023-05-19', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of all adverse events (AEs)', 'timeFrame': 'Up to 12 weeks after last dose of study treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic obstructive pulmonary disease, COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Completion of the 52-week treatment period in either parent GB43311 or GB44332\n\nExclusion Criteria:\n\n* Withdrawal of consent and/or premature discontinuation from parent study\n* Any permanent discontinuation of study drug in parent study\n* Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator's judgment\n* Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study\n* 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\n* Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study"}, 'identificationModule': {'nctId': 'NCT05878769', 'briefTitle': 'A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'GB43374'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open-Label Extension', 'description': 'Eligible participants from parent studies GB43311 and GB44332 will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study', 'interventionNames': ['Drug: Astegolimab']}], 'interventions': [{'name': 'Astegolimab', 'type': 'DRUG', 'description': 'Participants will receive SC astegolimab Q2W', 'armGroupLabels': ['Open-Label Extension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205-2610', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UAB Lung Health Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36305', 'city': 'Dothan', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '35501', 'city': 'Jasper', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Jasper Summit Research LLC', 'geoPoint': {'lat': 33.83122, 'lon': -87.27751}}, {'zip': '36608-3135', 'city': 'Mobile', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Pulmonary Associates of Mobile PC', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85027-5163', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Pulmonary Associates Deer Valley Office', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85741-3118', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'AES - DRS - Synexus Clinical Research US, Inc. - Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '93301-4205', 'city': 'Bakersfield', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Kern Allergy and Medical Research', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '92064-2419', 'city': 'Poway', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cadena Care Institute, LLC', 'geoPoint': {'lat': 32.96282, 'lon': -117.03586}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Apex Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'St Francis Medical Institute ClinEdge PPDS', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33467-2979', 'city': 'Greenacres City', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Finlay Medical Research Corporation', 'geoPoint': {'lat': 26.62368, 'lon': -80.12532}}, {'zip': '34748-5077', 'city': 'Leesburg', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Flourish Research - Leesburg - PPDS', 'geoPoint': {'lat': 28.81082, 'lon': -81.87786}}, {'zip': '33470-9272', 'city': 'Loxahatchee Groves', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Advanced Pulmonary Research Institute', 'geoPoint': {'lat': 26.68368, 'lon': -80.27977}}, {'zip': '33014', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'San Marcus Research Clinic Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33126-1941', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Finlay Medical Research Corporation', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33144-2155', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Oceane7 Medical & Research Center, Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Institute of South Florida Inc', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33175-3434', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Diverse Clinical Research, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Central Florida Pulmonary Group, PA', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32825-4454', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Florida Institute for Clinical Research, LLC', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32789-4681', 'city': 'Winter Park', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Flourish Research - 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Shapero, MD, PA', 'geoPoint': {'lat': 44.79884, 'lon': -68.77265}}, {'zip': '02723-1511', 'city': 'Fall River', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Exordia Medical Research, Inc.', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '48336', 'city': 'Farmington Hills', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Pulmonary Research Institute of Southeast Michigan', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '48504-4730', 'city': 'Flint', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Flushing Road Internal Medicine and Pediatrics - F', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '48075', 'city': 'Southfield', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Revive Research Institute', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'zip': '48085', 'city': 'Troy', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Oakland Medical Research', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '63017-3625', 'city': 'Chesterfield', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Lung Research Center', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '63401-6890', 'city': 'Hannibal', 'state': 'Missouri', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Hannibal Regional Healthcare System HRMG Hannibal', 'geoPoint': {'lat': 39.70838, 'lon': -91.35848}}, {'zip': '63301', 'city': 'Saint Charles', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Midwest Chest Consultants', 'geoPoint': {'lat': 38.78394, 'lon': -90.48123}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Washington University School of Medicine in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Midwest Clinical Research LLC', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89101-3485', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Machuca Foundation Inc', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89106-4159', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sierra Clinical Research - ClinEdge - PPDS', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89502-1576', 'city': 'Reno', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Renown Regional Medical Center Hospital', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '10017-4008', 'city': 'New York', 'state': 'New York', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'AES - DRS - Synexus Clinical Research US, Inc. - New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28277', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'American Health Research Inc.', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28037-7929', 'city': 'Denver', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Carolina Elite', 'geoPoint': {'lat': 35.53125, 'lon': -81.0298}}, {'zip': '28054', 'city': 'Gastonia', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Research of Gastonia', 'geoPoint': {'lat': 35.26208, 'lon': -81.1873}}, {'zip': '27403-4443', 'city': 'Greensboro', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Pulmonix LLC', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '28150-3803', 'city': 'Shelby', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Carolina Research Center', 'geoPoint': {'lat': 35.29235, 'lon': -81.53565}}, {'zip': '27103-4029', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Southeastern Research Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '73034-3258', 'city': 'Edmond', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'OK Clinical Research', 'geoPoint': {'lat': 35.65283, 'lon': -97.4781}}, {'zip': '97220', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Oregon Clinic.', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15801-2277', 'city': 'DuBois', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Research Associates Of Central Pa , Llc', 'geoPoint': {'lat': 41.11923, 'lon': -78.76003}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Temple University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15241', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Allergy & Clinical Immun Assoc', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29204', 'city': 'Columbia', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Medtrial, LLC', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '29340-4737', 'city': 'Gaffney', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Velocity Clinical Research - 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ClinEdge ? PPDS', 'geoPoint': {'lat': 29.79466, 'lon': -98.73197}}, {'zip': '75110-2471', 'city': 'Corsicana', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Corsicana Medical Research', 'geoPoint': {'lat': 32.09543, 'lon': -96.46887}}, {'zip': '77008-1772', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Trio Clinical Trials', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030-4202', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77089-6097', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Houston Pulmonary Medicine Associates, PA - Biopharma Informatic, LLC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75069', 'city': 'McKinney', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Metroplex Pulmonary and Sleep Medicine Center', 'geoPoint': {'lat': 33.19762, 'lon': -96.61527}}, {'zip': '75090', 'city': 'Sherman', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sherman Clinical Research - ClinEdge - PPDS', 'geoPoint': {'lat': 33.63566, 'lon': -96.60888}}, {'zip': '05446-3052', 'city': 'Colchester', 'state': 'Vermont', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Vermont Lung Center at the University of Vermont', 'geoPoint': {'lat': 44.54394, 'lon': -73.14791}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Virginia Health System', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '98208', 'city': 'Everett', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Western Washington Medical Group', 'geoPoint': {'lat': 47.97898, 'lon': -122.20208}}, {'zip': '53228', 'city': 'Greenfield', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Allergy Asthma and Sinus Center-Greenfield', 'geoPoint': {'lat': 42.9614, 'lon': -88.01259}}, {'zip': 'B1900', 'city': 'La Plata', 'state': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Centro Medico Capital', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'zip': '1425', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Consultorios Medicos Organizacion de Buen Ayre SRL', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '7240', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Centro de Investigaciones Clínicas Belgrano', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1121ABE', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Fundacion Cidea', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1122AAK', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Fundacion Faicep', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1425', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1430', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'AES - AS - Glenny Corp. 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