Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-03-12 @ 6:13 AM
Study NCT ID:
NCT03926793
Status:
COMPLETED
Last Update Posted:
2021-09-01
First Post:
2019-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Clinical site investigators, study personnel, and study subjects will be blinded to treatment assignment; however, the Sponsor will be unblinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-30', 'studyFirstSubmitDate': '2019-04-22', 'studyFirstSubmitQcDate': '2019-04-22', 'lastUpdatePostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Treatment-Related Adverse Events GB002 (Main study)', 'timeFrame': 'Up to 45 days', 'description': 'To evaluate the safety and tolerability of GB002'}, {'measure': 'Number of participants with Treatment-Related Adverse Events GB002 (OLE study)', 'timeFrame': 'Up to 200 days', 'description': 'To evaluate the long-term safety and tolerability and efficacy of GB002'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of GB002 (Main study)', 'timeFrame': '14 days'}, {'measure': 'Pharmacokinetics: Maximum Concentration (Cmax) of GB002 (Main study)', 'timeFrame': '14 days'}, {'measure': 'Pharmacokinetics: Area Under the Concentration Curve (AUC) of GB002 (Main study)', 'timeFrame': '14 days'}, {'measure': 'Changes from baseline in 6-Minute Walk Test (6MWT) (OLE study)', 'timeFrame': '169 days'}, {'measure': 'Changes from baseline in WHO Functional Class (OLE study)', 'timeFrame': '197 days'}, {'measure': 'Changes from baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP) (OLE study)', 'timeFrame': '169 days'}, {'measure': 'Changes from baseline in Pulmonary Arterial Hypertension - Symptoms and Impact (PAH-SYMPACT) Quality of Life questionnaire (OLE study)', 'timeFrame': '197 days'}, {'measure': 'Changes from baseline in Right Ventricular function by imaging (OLE study)', 'timeFrame': '169 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pulmonary Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1B, randomized, participant- and investigator-blinded, placebo-controlled, multi-center clinical trial to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and biomarkers of inhaled GB002 in adults with World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH).', 'detailedDescription': 'The primary objective for this trial is to evaluate the safety and tolerability of GB002. The secondary objective for this trial is to evaluate the PK parameters of GB002. Exploratory objectives are to evaluate the PD readouts, change in WHO Group I functional class, and change in quality of life associated with GB002 treatment.\n\nIn this Phase 1B study, two dose levels of GB002 will be tested in adult participants with PAH. Four participants in cohort 1 will be randomized to receive up to two daily doses of either active drug or placebo, with 3 subjects receiving GB002 and 1 subject receiving placebo. An additional 4 participants (3 active and 1 placebo) may be added to cohort 1 at the discretion of the Data Review Committee (DRC). The dose and dosing interval (i.e., once daily or twice daily) for the second cohort will be determined by review of the safety, tolerability, and drug levels in the blood from cohort 1. Cohort 2 participants will also be randomized such that 6 subjects receive GB002 and 2 subjects receive placebo.\n\nEligible subjects who have completed the 2 week treatment period have the option to participate in a 24 week open label extension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult (males and females) aged 18 to 75 years (inclusive) with pulmonary arterial hypertension (PAH) (Main study)\n2. A current diagnosis of symptomatic PAH classified by one of the following (Main and OLE study):\n\n 1. Idiopathic (IPAH) or heritable pulmonary arterial hypertension (HPAH)\n 2. PAH associated with one of the following connective tissue diseases (CTDs):\n\n systemic sclerosis, rheumatoid arthritis, mixed CTD or overlap syndrome, or systemic lupus erythematosus\n 3. PAH associated with anorexigen or methamphetamine use\n3. World Health Organization (WHO)/New York Heart Association (NYHA) functional class II-IV symptomatology (Main study)\n\nExclusion Criteria:\n\n1. Clinically significant systemic hypertension or hypotension (Main and OLE study)\n2. History of left-sided heart disease and/or clinically significant cardiac disease (Main and OLE study)\n3. History of decompensated right heart failure within 30 days of screening (e.g., hospitalization for PAH or the need to add an additional PAH medication) (Main study)\n\nNOTE: Additional inclusion/exclusion criteria may apply, per protocol.'}, 'identificationModule': {'nctId': 'NCT03926793', 'acronym': 'PAH', 'briefTitle': 'Clinical Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gossamer Bio Inc.'}, 'officialTitle': 'A Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension (PAH)', 'orgStudyIdInfo': {'id': 'GB002-1101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Patients will be randomized to receive inhaled GB002 or Placebo daily for 14 days', 'interventionNames': ['Drug: GB002', 'Drug: Placebo', 'Device: Generic Dry Powder Inhaler']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Patients will be randomized to receive inhaled GB002 or Placebo daily for 14 days', 'interventionNames': ['Drug: GB002', 'Drug: Placebo', 'Device: Generic Dry Powder Inhaler']}, {'type': 'EXPERIMENTAL', 'label': 'Open Label Extension', 'description': 'Eligible subjects may participate in the Open Label Extension (OLE) study for a period of 24 weeks.', 'interventionNames': ['Drug: GB002', 'Device: Generic Dry Powder Inhaler']}], 'interventions': [{'name': 'GB002', 'type': 'DRUG', 'description': 'GB002 low dose or high dose for inhalation', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Open Label Extension']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for inhalation', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}, {'name': 'Generic Dry Powder Inhaler', 'type': 'DEVICE', 'description': 'Generic dry powder inhaler for GB002 or Placebo delivery', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Open Label Extension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Medical Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Pulmonary Specialists', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Early Phase Research', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center Montefiore University Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'VitaLink Research - Anderson', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': 'G814DY', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Golden Jubilee National Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'W12 0HS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Hammersmith Hospital, Imperial Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}