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Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis
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).
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
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
| DRUG: Placebo
|
EXPERIMENTAL: Bexotegrast (PLN-74809) 160 mg Dose
| DRUG: PLN-74809
|
EXPERIMENTAL: Bexotegrast (PLN-74809) 320 mg Dose
| DRUG: 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 |
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