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)

PLN-74809-IPF-206

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).

2023-11-16

2025-08-31

2025-09-30

Recruiting

Early phase I

360

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 360, 'type': 'ESTIMATED'}}

2024-04-26