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

Phase 2

Active, not recruiting

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Placebo; Drug: PLN-74809

• Registration Number: NCT06097260
• Lead Sponsor: Pliant Therapeutics, Inc.

Brief 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).

Detailed Description

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 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.

Study Timeline

• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-10-18
• Study First Posted: 2023-10-24
• Study Start: 2023-11-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-08-31
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Bexotegrast (PLN-74809) 160 mg Dose	PLN-74809	Bexotegrast (PLN-74809) 160 mg Dose - 52 weeks
Bexotegrast (PLN-74809) 320 mg Dose	PLN-74809	Bexotegrast (PLN-74809) 320 mg Dose - 52 weeks

Primary Outcome Measures

Name	Time	Method
To characterize the effect of bexotegrast versus placebo on the change in forced vital capacity (FVC) in participants with idiopathic pulmonary fibrosis (IPF)	52 weeks	Change from baseline in absolute FVC (mL) at Week 52

Secondary Outcome Measures

Name	Time	Method
To characterize the effect of bexotegrast versus placebo over 52 weeks of treatment on disease progression	Up to 52 weeks	• 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
Time to disease progression defined as	Up to 52 weeks	Time to first occurrence of adjudicated respiratory-related hospitalization, adjudicated acute IPF exacerbation or all-cause mortality through Week 52
Proportion of participants with disease progression defined as	Up to 52 weeks	Proportion of participants with a ≥10% absolute decline in FVCpp from baseline or all-cause mortality through Week 52
To characterize the effect of bexotegrast versus placebo on the change in FVC in participants with and without background therapy at baseline with IPF	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
Change from baseline in Living with Pulmonary Fibrosis (L-PF) Dyspnoea and Cough Domain score	52 Weeks	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.
Change from baseline in King's Brief Interstitial Lung Disease (K-BILD) questionnaire Total score	52 Weeks	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
To characterize the effect of bexotegrast versus placebo on change in lung fibrosis by high-resolution computed tomography	52 Weeks	Absolute change from baseline in quantitative lung fibrosis (QLF) extent (%)
To characterize the safety and tolerability of bexotegrast versus placebo in participants with IPF	Up to 52 weeks	Proportion of participants with treatment-emergent adverse events and serious adverse events
To characterize the safety and tolerability of bexotegrast versus placebo in participants with IPF over 52 weeks of treatment	Over 52 Weeks	Number of participants with Adverse Events (AEs) Number of participants with Serious AEs (SAEs)

Trial Locations

Locations (260)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Arizona Pulmonary Specialists; 🇺🇸 Phoenix, Arizona, United States

Dignity Health-St. Josephs Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

University of Arizona College of Medicine; 🇺🇸 Tucson, Arizona, United States

University of Southern California - Keck School of Medicine; 🇺🇸 Los Angeles, California, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Newport Native MD, Inc; 🇺🇸 Newport Beach, California, United States

Palmtree Clinical Research; 🇺🇸 Palm Springs, California, United States

VA Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States

Paradigm Clinical Research Institute Inc - ClinEdge; 🇺🇸 Redding, California, United States

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