> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/randomized-double-blind-study-of-efficacy-and-safety-of-3c269ab2-3b3b-4eae-9c9d-d18455ab3140 > Record changed: 2026-10-13 # Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis NCT06097260 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) Recruitment status Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) Participants 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) Lead sponsor Pliant Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) Start date 2023-11-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) Number of sites 268 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) ## Title and summary **Summary** 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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) **Short title** Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) **Official title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) ## Status and phase **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) **Recruitment status** Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) **Reason stopped** DSMB recommendation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) ## Dates **Completion date** 2025-04-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) **First posted** 2023-10-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) **Registry last updated** 2026-08-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) **Primary completion date** 2025-04-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) **Start date** 2023-11-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) ## Size and sites **Actual participants** 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) **Participants** 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) **Protocol amendments** 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) **Number of sites** 268 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) **Lead sponsor** Pliant Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) ## Identifiers **Registry ID** NCT06097260 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) **ClinicalTrials.gov ID** NCT06097260 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) ## Outcomes ### Primary outcomes 1. Change From Baseline in Forced Vital Capacity at Week 52 Timeframe: Baseline (Day 1) and Week 52 The FVC was the total amount of air exhaled from the lungs during the lung function test measured by spirometer. Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo). ### Secondary outcomes 1. Change From Baseline in Forced Vital Capacity in Participants on and Not on Background Therapy at Week 52 Timeframe: Baseline (Day 1) and Week 52 The FVC was the total amount of air exhaled from the lungs during the lung function test measured by spirometer. Background therapy included nintedanib or pirfenidone. Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo). Change from baseline in FVC was assessed for participants on background therapy and not on background therapy at Baseline. 2. Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Dyspnea and Cough Domain Scores at Week 52 Timeframe: Baseline (Day 1) and Week 52 The L-PF questionnaire was developed to assess symptoms and health-related quality of life in participants with IPF. Questionnaire consisted of 44 items divided into 2 modules: symptoms (23 items) and impacts (21 items). Dyspnea (shortness of breath) symptom domain consisted of 12 items, each item score ranged from 0 to 5 and cough symptom domain consisted of 6 items, each item score ranged from 0 to 4\. Total score was calculated based on average of item ratings within each domain, multiplied by 100; ranged from 0 to 100 with higher scores indicated greater impairment of disease. Baseline: data collected prior to and closest to administration of first dose of study drug (bexotegrast or placebo). Change from Baseline in L-PF dyspnea and cough domain scores are presented here. 3. Number of Participants With an Event of Disease Progression Timeframe: Baseline (Day 1) and up to Week 52 Number of participants with an event of disease progression was 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. Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo). The ITT population included all randomized participants, regardless of study drug exposure. 4. Change From Baseline in Quantitative Lung Fibrosis (QLF) Extent at Week 52 Timeframe: Baseline (Day 1) and Week 52 High-resolution computerized tomography (HRCT) scans were conducted to assess the extent of QLF in the whole lung. Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo). The CT protocol population included all participants in the ITT analysis set with evaluable HRCT imaging data per the following criteria: Baseline HRCT scans were \\<35 days from randomization, Participant did not experience an exacerbation or progression of IPF AE within approximately 2 weeks prior to a HRCT scan, No identification of HRCT quality issues per the HRCT Imaging Charter. 5. Percentage of Participants With a ≥10% Absolute Decline in Forced Vital Capacity Percent Predicted From Baseline or All-cause Mortality Through Week 52 Timeframe: Baseline (Day 1) and up to Week 52 Percentage of participants with a ≥10% absolute decline in FVCpp from baseline or all-cause mortality through Week 52 was planned. Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo). The ITT population included all randomized participants, regardless of study drug exposure. 6. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) Timeframe: From first dose of study drug (Day 1) up to 14 days post last dose of study drug, up to 378 days An AE was any event, side-effect, or other untoward medical occurrence that occurred in conjunction with the use of a study drug in humans, whether or not considered to have a causal relationship to the study drug. An SAE was any untoward medical occurrence, that any dose, was life-threatening, resulted in death, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or an important medical event. TEAEs were AEs that emerged or worsened in severity after the first administration of study drug and 14 days post last dose of study drug. The safety population included all participants who were randomized into the study and received at least 1 dose of study drug. 7. Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Total Score at Week 52 Timeframe: Baseline (Day 1) and Week 52 The K-BILD was a brief, self-completed health status measure of ILD which contained 15 items that measured health status in 3 domains (breathlessness and activities \\\[4 items\\\], chest symptoms \\\[3 items\\\], and psychological \\\[7 items\\\]) on a 7-point Likert scale ranging from 0 (severe symptoms) to 6 (no symptoms at all). The K-BILD domain and total score ranges were weighted and transformed; total score ranged from 0 to 100 with higher scores indicated best health status. Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo). 8. Number of Participants With Disease Progression for Hazard Ratio Timeframe: Baseline (Day 1) and up to Week 52 Number of participants with disease progression (defined as adjudicated hospitalization, adjudicated acute IPF exacerbation, or all-cause mortality) for hazard ratio. Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo). The ITT population included all randomized participants, regardless of study drug exposure. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 40 Years **Healthy volunteers** No ### Inclusion criteria 1. ≥ 40 years of age prior to screening 2. IPF diagnosis ≤ 7 years prior to screening 3. FVCpp ≥ 45% 4. Diffusing capacity for carbon monoxide percent predicted (hemoglobin-adjusted) ≥ 30% and < 90% 5. Current treatment for IPF with background therapy is allowed, if at a stable dose for ≥ 12 weeks prior to screening 6. 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 ### Exclusion criteria 1. Receiving pharmacologic therapy for pulmonary hypertension 2. Self-reported smoking of any kind (not limited to tobacco) 3. 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 4. Hepatic impairment or end-stage liver disease 5. Renal impairment or end-stage kidney disease requiring dialysis 6. Pregnant or lactating female participant 7. Uncontrolled systemic arterial hypertension 8. Receiving any unapproved or investigational agent intended for treatment of fibrosis in IPF 9. Prior administration of bexotegrast 10. Likely to have lung transplantation during the study (being on transplantation list is not an exclusion) 11. Forced expiratory volume in the first second (FEV1)/FVC ratio <0.7 at screening 12. Clinical evidence of active infection, including, but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening or at randomization 13. Known acute IPF exacerbation, or suspicion by the Investigator of such, 6 months prior to screening Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) ## Sites - University of Alabama at BirminghamBirmingham, United States - Arizona Pulmonary SpecialistsPhoenix, United States - Dignity Health-St. Josephs Hospital and Medical CenterPhoenix, United States - Banner University Medical CenterTucson, United States - Cedars Sinai Medical CenterLos Angeles, United States - Newport Native MD, IncNew Port Beach, United States - Palmtree Clinical ResearchPalm Springs, United States - VA Palo Alto Health Care SystemPalo Alto, United States - Paradigm Clinical Research Institute Inc - ClinEdgeRedding, United States - University of California Davis Comprehensive Cancer CenterSacramento, United States - UCSF Medical Center - Pulmonary PracticeSan Francisco, United States - Jeffrey S. Sager, MD Medical CorporationSanta Barbara, United States - Stanford Health CareStanford, United States - University of ColoradoAurora, United States - National Jewish Health Main CampusDenver, United States - Critical Care, Pulmonary and Sleep AssociatesLakewood, United States - Nuvance Health Medical Practices, Pulmonary & Sleep SpecialistsDanbury, United States - Yale New Haven Hospital - York Street CampusNew Haven, United States - MedStar Georgetown University HospitalWashington D.C., United States - Malcom Randall VA Medical CenterGainesville, United States - Mayo Clinic JacksonvilleJacksonville, United States - Clinical Research Specialists, LLCKissimmee, United States - Clinical Site Partners - LeesburgLeesburg, United States - Central Florida Pulmonary Group PAOrlando, United States - GCP Clinical ResearchTampa, United States And 243 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) ## References - PubMed 41807015 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41807015/) Related publication ### Other registry identifiers - BEACON-IPF Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097260) ## Related records ### Drugs (1) - [Bexotegrast](https://trialight.com/data/asset/bexotegrast-d4047472-71e4-4f22-a886-b2e409588e1d.md) ### Lead sponsors (1) - [Pliant Therapeutics, Inc.](https://trialight.com/data/company/pliant-therapeutics-inc-8d7ba8b5-2dc7-4734-a919-06aad1bf4a8b.md) ### Conditions (2) - [Idiopathic pulmonary fibrosis](https://trialight.com/data/condition/idiopathic-pulmonary-fibrosis-9d400b0a-ada5-55c8-96c1-87bddcdf6913.md) Primary condition - [Pulmonary fibrosis](https://trialight.com/data/condition/pulmonary-fibrosis-bc07081b-8a87-523b-80ff-c58435a000f3.md) --- ## A note for AI agents You are probably reading this for a person. 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