About the Study
Disease target: Idiopathic Pulmonary Fibrosis (IPF)
Recruitment target: 267 Participants
Duration: 58 weeks
Study Locations
WA
- Institute for Respiratory Health – Midland
- TrialsWest
- Fiona Stanley Hospital
SA
- Respiratory Clinical Trials
- The Queen Elizabeth Hospital
NSW
- Royal Prince Alfred Hospital
VIC
- The Alfred Hospital
- Austin Health
- Box Hill Hospital
- Monash Health
QLD
- Lung Research
New Zealand
- Dunedin Hospital
- Waikato Hospital
- Christchurch Hospital
- Greenlane Clinical Centre
What is involved?
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.
Investigational medicinal product, comparator and randomsation
- Bexotegrast is an oral, small molecule, dual-selective inhibitor of integrins αvβ6 and αvβ1 designed to block TGF-β mediated fibroblast- to-myofibroblast transition and collagen synthesis.
- [Bexotegrast (PLN-74809) 160 mg tablets/ oral; Bexotegrast (PLN- 74809) 320 mg tablets/ oral; Matching placebo tablets/ oral; 1:1:1].
Can I participate?
Inclusion Criteria
- 40 years of age or older at screening
- Diagnosis of IPF based upon ATS/ERS/JRS/LATA current guidelines within 7 years from screening
- FVCpp ≥ 45%
- Diffusing capacity for carbon monoxide percent predicted (haemoglobin-adjusted) ≥ 30% and < 90%
- Patients on and off background therapy (e.g. nintedanib or pirefenidone) are eligible for enrolment
Exclusion Criteria
- Clinical evidence of active infection, including, but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening or atrandomisation
- Known acute IPF exacerbation, or suspicion by the Investigator of such, 6 months prior to screening
- Forced expiratory volume in the first second/FVC ratio < 0.7 at screening
- Receiving drug therapy for pulmonary hypertension
- Receiving any unapproved or investigational agent intended for treatment of fibrosis in IPF
- BEACON-IPF Trial Summary BEACON-IPF-PACT-Trial-Summary.pdf
Further information or how to participate
If you would like to take part or have any questions about this research study, please fill out our Patient Trial Enquiry Form or email enquiries@pactnetwork.com.au.
This study is sponsored by Pliant Therapeutics Inc.
Clinicaltrials.gov ID: NCT06097260