Save

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

PHASE2RECRUITING

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).

Simpliy with AI

Study details:

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.

Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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)

Forced expiratory volume in the first second (FEV1)/FVC ratio <0.7 at screening

Clinical evidence of active infection, including, but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening or at randomization

Known acute IPF exacerbation, or suspicion by the Investigator of such, 6 months prior to screening

Simplify with AI

Eligibility

Age eligible for study : 40 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-11-16

Primary completion: 2025-08-31

Study completion finish: 2025-09-30

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT06097260

Intervention or treatment

DRUG: PLN-74809

DRUG: Placebo

Conditions

• Idiopathic Pulmonary Fibrosis

Image related to Idiopathic Pulmonary Fibrosis

Condition: Idiopathic Pulmonary Fibrosis
DRUG: PLN-74809 and other drugs
Melbourne, Victoria, Australia and more
Sponsor: Pliant Therapeutics, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

The Alfred Hospital

Research sites nearby

Select from list below to view details:

The Alfred Hospital
Melbourne, Victoria, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Lung Research Qld
Chermside, Queensland, Australia
Respiratory Clinical Trials
Kent Town, South Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Placebo Placebo	DRUG: Placebo Placebo
EXPERIMENTAL: Bexotegrast (PLN-74809) 160 mg Dose Bexotegrast (PLN-74809) 160 mg Dose - 52 weeks	DRUG: PLN-74809 PLN-74809
EXPERIMENTAL: Bexotegrast (PLN-74809) 320 mg Dose Bexotegrast (PLN-74809) 320 mg Dose - 52 weeks	DRUG: PLN-74809 PLN-74809

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Change from baseline in absolute FVC (mL)	Not Specified	52 weeks

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome 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 (L-PF) total score at Week 52	Not Specified	Up to 52 weeks
Proportion of participants with treatment-emergent adverse events and serious adverse events	Not Specified	Up to 54 weeks
Time to disease progression, defined as time to first occurrence of adjudicated respiratory-related hospitalization, adjudicated acute IPF exacerbation or all-cause mortality	Not Specified	Up to 52 weeks
Change from baseline in Living with Pulmonary Fibrosis (L-PF) Dyspnoea and Cough Domain score	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.	52 Weeks
Change from baseline in King's Brief Interstitial Lung Disease (K-BILD) questionnaire Total score	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	52 Weeks
Absolute change from baseline in quantitative lung fibrosis (QLF) extent (%)	Not Specified	52 Weeks
To characterize the safety and tolerability of bexotegrast versus placebo in participants with IPF over 52 weeks of treatment	Number of participants with Adverse Events (AEs) Number of participants with Serious AEs (SAEs)	52 Weeks

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

No questions submitted. Be the first to ask a question!

You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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