Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis

Study Overview
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Brief Summary
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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).

Detailed Description
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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). The study will consist of an up to 28-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.

Official Title
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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)

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: PLN-74809
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 40 years of age prior to screening IPF diagnosis ≤ 7 years prior to screening FVCpp ≥ 45% Diffusing capacity for carbon monoxide percent predicted (hemoglobin-adjusted) ≥ 30% and < 90% Current treatment for IPF with background therapy is allowed, if at a stable dose for ≥ 12 weeks prior to screening 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: Receiving pharmacologic therapy for pulmonary hypertension Self-reported smoking of any kind (not limited to tobacco) 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 Hepatic impairment or end-stage liver disease Renal impairment or end-stage kidney disease requiring dialysis Pregnant or lactating female participant Uncontrolled systemic arterial hypertension Receiving any unapproved or investigational agent intended for treatment of fibrosis in IPF Prior administration of bexotegrast Likely to have lung transplantation during the study (being on transplantation list is not an exclusion)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|
| Experimental: Bexotegrast (PLN-74809) 160 mg Dose<br>Bexotegrast (PLN-74809) 160 mg Dose - 52 weeks | Drug: PLN-74809<br>* PLN-74809<br>|
| Experimental: Bexotegrast (PLN-74809) 320 mg Dose<br>Bexotegrast (PLN-74809) 320 mg Dose - 52 weeks | Drug: PLN-74809<br>* PLN-74809<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in absolute FVC (mL) |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression | Time to first occurrence of ≥10% absolute decline from baseline in forced vital capacity percent predicted (FVCpp), respiratory-related hospitalization, or all cause mortality through Week 52 | Up to 52 weeks | 
| Change from baseline in absolute FVC (mL) at Week 52 | In participants on background therapy at baseline In participants not on background therapy at baseline | 52 weeks | 
| Change from baseline in Living with Pulmonary Fibrosis total score at Week 52 |  | Up to 52 weeks | 
| Proportion of participants with treatment-emergent adverse events and serious adverse events |  | Up to 54 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IPF, idiopathic pulmonary fibrosis, pulmonary fibrosis, bexotegrast, Beacon, BEACON-IPF