Viewing Study NCT06097260

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Ignite Creation Date: 2025-12-25 @ 2:14 AM
Ignite Modification Date: 2025-12-27 @ 6:56 AM
Study NCT ID: NCT06097260
Status: TERMINATED
Last Update Posted: 2025-08-01
First Post: 2023-10-18
Is Gene Therapy: True
Has Adverse Events: False
Brief Title: Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria']}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'whyStopped': 'DSMB recommendation', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2023-10-18', 'studyFirstSubmitQcDate': '2023-10-18', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To characterize the effect of bexotegrast versus placebo on the change in forced vital capacity (FVC) in participants with idiopathic pulmonary fibrosis (IPF)', 'timeFrame': '52 weeks', 'description': 'Change from baseline in absolute FVC (mL) at Week 52'}], 'secondaryOutcomes': [{'measure': 'To characterize the effect of bexotegrast versus placebo over 52 weeks of treatment on disease progression', 'timeFrame': 'Up to 52 weeks', 'description': '• Time to disease progression, defined as time to first occurrence of ≥10% absolute decline from baseline in forced vital capacity percent predicted (FVCpp), adjudicated respiratory-related hospitalization, adjudicated acute IPF exacerbation or all-cause mortality through Week 52'}, {'measure': 'Time to disease progression defined as', 'timeFrame': 'Up to 52 weeks', 'description': 'Time to first occurrence of adjudicated respiratory-related hospitalization, adjudicated acute IPF exacerbation or all-cause mortality through Week 52'}, {'measure': 'Proportion of participants with disease progression defined as', 'timeFrame': 'Up to 52 weeks', 'description': 'Proportion of participants with a ≥10% absolute decline in FVCpp from baseline or all-cause mortality through Week 52'}, {'measure': 'To characterize the effect of bexotegrast versus placebo on the change in FVC in participants with and without background therapy at baseline with IPF', 'timeFrame': '52 weeks', 'description': 'Change from baseline in absolute FVC (mL) at Week 52\n\n* In participants on background therapy at baseline\n* In participants not on background therapy at baseline'}, {'measure': 'Change from baseline in Living with Pulmonary Fibrosis (L-PF) Dyspnoea and Cough Domain score', 'timeFrame': '52 Weeks', 'description': "The Living with Pulmonary Fibrosis (L-PF) questionnaire assesses symptoms and quality of life in patients with fibrosing interstitial lung diseases (ILDs). Its Dyspnoea and Cough domains, whose items' responses are based on a 24-hour recall, have scores ranging from 0 to 100, with higher scores indicating greater symptom severity. Domain and total scores range from 0 to 100, with higher scores indicating greater impairment."}, {'measure': "Change from baseline in King's Brief Interstitial Lung Disease (K-BILD) questionnaire Total score", 'timeFrame': '52 Weeks', 'description': "The KBILD(King's Brief Interstitial Lung Disease Questionnaire) is a self-completed health status questionnaire that comprises 15 items and a seven-point Likert response scale.1 It has three domains: psychological, breathlessness and activities and chest symptoms. The KBILD domain and total score ranges are 0-100; 100 represents best health status"}, {'measure': 'To characterize the effect of bexotegrast versus placebo on change in lung fibrosis by high-resolution computed tomography', 'timeFrame': '52 Weeks', 'description': 'Absolute change from baseline in quantitative lung fibrosis (QLF) extent (%)'}, {'measure': 'To characterize the safety and tolerability of bexotegrast versus placebo in participants with IPF', 'timeFrame': 'Up to 52 weeks', 'description': 'Proportion of participants with treatment-emergent adverse events and serious adverse events'}, {'measure': 'To characterize the safety and tolerability of bexotegrast versus placebo in participants with IPF over 52 weeks of treatment', 'timeFrame': 'Over 52 Weeks', 'description': 'Number of participants with Adverse Events (AEs) Number of participants with Serious AEs (SAEs)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IPF', 'idiopathic pulmonary fibrosis', 'pulmonary fibrosis', 'bexotegrast', 'Beacon', 'BEACON-IPF'], 'conditions': ['Idiopathic Pulmonary Fibrosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.beaconipf.com/', 'label': 'Trial website'}]}, 'descriptionModule': {'briefSummary': 'A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF).', 'detailedDescription': 'This is a randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of 2 doses of bexotegrast (PLN-74809) \\[160 and 320 mg\\] taken for 52 weeks by participants with IPF taking and not taking background therapy (ie, nintedanib or pirfenidone).\n\nThe study will consist of an up to 35-day Screening Period, a 52-week Treatment Period, and a 14 day Safety Follow-up Period. Of note, participants who are not taking background therapy at study entry will be allowed to initiate it at any time during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥ 40 years of age prior to screening\n2. IPF diagnosis ≤ 7 years prior to screening\n3. FVCpp ≥ 45%\n4. Diffusing capacity for carbon monoxide percent predicted (hemoglobin-adjusted) ≥ 30% and \\< 90%\n5. Current treatment for IPF with background therapy is allowed, if at a stable dose for ≥ 12 weeks prior to screening\n6. If not currently receiving treatment for IPF (either treatment naïve or discontinued prior treatment), participant must not have taken background therapy for at least 8 weeks prior to screening\n\nExclusion Criteria:\n\n1. Receiving pharmacologic therapy for pulmonary hypertension\n2. Self-reported smoking of any kind (not limited to tobacco)\n3. History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, resected noninvasive cutaneous squamous cell carcinoma, or treated cervical carcinoma in situ\n4. Hepatic impairment or end-stage liver disease\n5. Renal impairment or end-stage kidney disease requiring dialysis\n6. Pregnant or lactating female participant\n7. Uncontrolled systemic arterial hypertension\n8. Receiving any unapproved or investigational agent intended for treatment of fibrosis in IPF\n9. Prior administration of bexotegrast\n10. Likely to have lung transplantation during the study (being on transplantation list is not an exclusion)\n11. Forced expiratory volume in the first second (FEV1)/FVC ratio \\<0.7 at screening\n12. Clinical evidence of active infection, including, but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening or at randomization\n13. Known acute IPF exacerbation, or suspicion by the Investigator of such, 6 months prior to screening'}, 'identificationModule': {'nctId': 'NCT06097260', 'briefTitle': 'Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pliant Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Evaluate the Efficacy and Safety of Bexotegrast (PLN-74809) for the Treatment of Idiopathic Pulmonary Fibrosis (BEACON-IPF)', 'orgStudyIdInfo': {'id': 'PLN-74809-IPF-206'}, 'secondaryIdInfos': [{'id': 'BEACON-IPF', 'type': 'OTHER', 'domain': 'Pliant Therapeutics Inc'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Bexotegrast (PLN-74809) 160 mg Dose', 'description': 'Bexotegrast (PLN-74809) 160 mg Dose - 52 weeks', 'interventionNames': ['Drug: PLN-74809']}, {'type': 'EXPERIMENTAL', 'label': 'Bexotegrast (PLN-74809) 320 mg Dose', 'description': 'Bexotegrast (PLN-74809) 320 mg Dose - 52 weeks', 'interventionNames': ['Drug: PLN-74809']}], 'interventions': [{'name': 'PLN-74809', 'type': 'DRUG', 'description': 'PLN-74809', 'armGroupLabels': ['Bexotegrast (PLN-74809) 160 mg Dose', 'Bexotegrast (PLN-74809) 320 mg Dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Pulmonary Specialists', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Dignity Health-St. Josephs Hospital and Medical Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Newport Native MD, Inc', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Palmtree Clinical Research', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'VA Palo Alto Health Care System', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '96001', 'city': 'Redding', 'state': 'California', 'country': 'United States', 'facility': 'Paradigm Clinical Research Institute Inc - ClinEdge', 'geoPoint': {'lat': 40.58654, 'lon': -122.39168}}, {'zip': '95807', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Comprehensive Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Medical Center - Pulmonary Practice', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Jeffrey S. 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