Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-31 @ 7:04 AM
Study NCT ID:
NCT04816604
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-28
First Post:
2021-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2021-03-23', 'studyFirstSubmitQcDate': '2021-03-23', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events', 'timeFrame': 'From first dose of study drug up to 80 months or availability of commercial product'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline Over Time on the Six-Minute Walk Test (6MWT)', 'timeFrame': 'Baseline, up to 80 months or availability of commercial product', 'description': 'Change in the distance achieved on the 6MWT (Δ6MWT)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['seralutinib'], 'conditions': ['Pulmonary Arterial Hypertension']}, 'referencesModule': {'references': [{'pmid': '40788460', 'type': 'DERIVED', 'citation': 'Sitbon O, Sahay S, Escribano Subias P, Zolty RL, Kingrey JF, Ryan JJ, Sobol I, Sood N, Benza RL, Channick RN, Chin KM, Frantz RP, Ghofrani HA, Hemnes AR, McLaughlin VV, Vachiery JL, Zamanian RT, Ter Veer A, Roscigno RF, Mottola D, Parsley E, Aranda R, Zisman LS, Howard LS; TORREY Study Investigators. Seralutinib for the Treatment of Pulmonary Arterial Hypertension in Adults: TORREY Open-Label Extension Study. Adv Ther. 2025 Oct;42(10):5104-5123. doi: 10.1007/s12325-025-03297-2. Epub 2025 Aug 11.'}]}, 'descriptionModule': {'briefSummary': 'This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nType of Subject and Disease Characteristics\n\n1. Subjects must have completed a prior GB002 PAH study and, in the opinion of the Investigator and Sponsor, have been compliant with study procedures and have completed treatment with IP through parent study end-of-treatment (EOT) visit.\n2. Treatment with standard of care PAH disease-specific background therapies (stable dose).\n\n Informed Consent\n3. Review and signature of an IRB-approved informed consent form.\n\nExclusion Criteria:\n\nMedical Conditions\n\n1. Persistent and clinically significant systemic hypertension or hypotension.\n2. Interval history of newly developed left-sided heart disease.\n3. Potentially life-threatening cardiac arrhythmia with an ongoing risk.\n4. Uncontrolled bacterial, viral, or fungal infections which require systemic therapy.\n5. Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or GB002 administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.\n6. History of portopulmonary hypertension or portal hypertension due to cirrhosis classified as Child-Pugh Class A or higher.\n7. Subjects with a history of severe milk protein allergy. In addition, subjects with known intolerance or hypersensitivity to lactose who, in the opinion of the investigator, may experience severe symptoms following the ingestion of lactose.\n8. Current use of inhaled tobacco and/or inhaled marijuana. Ingestible or topical marijuana is allowed, per local restrictions and regulations.\n9. Current alcohol use disorder as defined by DSM-5, and/or history of current utilization of drugs of abuse (amphetamines, methamphetamines, cocaine, phencyclidine \\[PCP\\]).\n10. Have any other condition or reason that, in the opinion of the Investigator and/or the Sponsor's Medical Monitor (or designee), would prohibit the subject from participating in the study.\n\n Diagnostic Assessments\n11. Chronic renal insufficiency\n12. Hemoglobin (Hgb) concentration \\<8.5 g/dL.\n13. Absolute neutrophil count (ANC) \\< 1x 10\\^9/L.\n14. Platelet count \\<50 x 10\\^9/L.\n\n Prior Therapy\n15. Use of inhaled prostanoids.\n16. Chronic use of oral anticoagulants (ie, vitamin K antagonist such as warfarin or novel oral anticoagulant \\[NOAC\\]/direct oral anticoagulant \\[DOAC\\]).\n17. Chronic use of any prohibited medication.\n\nNOTE: Additional inclusion/exclusion criteria may apply, per protocol."}, 'identificationModule': {'nctId': 'NCT04816604', 'briefTitle': 'Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gossamer Bio Inc.'}, 'officialTitle': 'An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)', 'orgStudyIdInfo': {'id': 'GB002-2102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GB002 (seralutinib)', 'description': 'GB002 (seralutinib) inhaled orally twice per day (BID)', 'interventionNames': ['Drug: GB002 (seralutinib)', 'Device: Generic Dry Powder Inhaler']}], 'interventions': [{'name': 'GB002 (seralutinib)', 'type': 'DRUG', 'description': 'Capsule containing GB002 (seralutinib)', 'armGroupLabels': ['GB002 (seralutinib)']}, {'name': 'Generic Dry Powder Inhaler', 'type': 'DEVICE', 'description': 'Generic dry powder inhaler for GB002 (seralutinib) delivery', 'armGroupLabels': ['GB002 (seralutinib)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Medical Corporation', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Cleveland Clinic Florida', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Pulmonary Specialists', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian Hospital - Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'INTEGRIS Baptist Medical Center, Inc.', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Health', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '7000', 'city': 'Hobart', 'state': 'Tasmania', 'country': 'Australia', 'facility': 'Royal Hobart Hospital', 'geoPoint': {'lat': -42.87936, 'lon': 147.32941}}, {'zip': '3065', 'city': 'Fitzroy', 'state': 'Victoria', 'country': 'Australia', 'facility': "St. Vincent's Hospital Melbourne", 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '128 08', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Všeobecná fakultní nemocnice v Praze', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'AP-HP Hôpital de Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'DRK Kliniken Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Giessen', 'country': 'Germany', 'facility': 'Universitaetsklinikum Giessen und Marburg GmbH - Medizinische Klinik IV und V', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Klinik für Pneumologie, Klinisches Studienzentrum Medizinische Hochschule', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '69126', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Thoraxklinik-Heidelberg gGmbH', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Klinik und Poliklinik f. Innere Medizin II Universitätsklinikum Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '39008', 'city': 'Santander', 'country': 'Spain', 'facility': 'Hospital Universitario Marqués de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': 'CB2 OAY', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Royal Papworth Hospital NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College Healthcare NHS Trust - Hammersmith Medicines Research Limited', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Richard Aranda', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gossamer Bio Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}