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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06097260
Registration number
NCT06097260
Ethics application status
Date submitted
18/10/2023
Date registered
24/10/2023
Titles & IDs
Public title
Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis
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Scientific title
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)
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Secondary ID [1]
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BEACON-IPF
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Secondary ID [2]
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PLN-74809-IPF-206
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis
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0
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Condition category
Condition code
Respiratory
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0
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0
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Other respiratory disorders / diseases
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Inflammatory and Immune System
0
0
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0
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Connective tissue diseases
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Inflammatory and Immune System
0
0
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0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PLN-74809
Treatment: Drugs - Placebo
Experimental: Placebo - Placebo
Experimental: Bexotegrast (PLN-74809) 160 mg Dose - Bexotegrast (PLN-74809) 160 mg Dose - 52 weeks
Experimental: Bexotegrast (PLN-74809) 320 mg Dose - Bexotegrast (PLN-74809) 320 mg Dose - 52 weeks
Treatment: Drugs: PLN-74809
PLN-74809
Treatment: Drugs: Placebo
Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline in absolute FVC (mL)
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Assessment method [1]
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Timepoint [1]
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52 weeks
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Secondary outcome [1]
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Time to disease progression
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Assessment method [1]
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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
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Timepoint [1]
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Up to 52 weeks
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Secondary outcome [2]
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Change from baseline in absolute FVC (mL) at Week 52
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Assessment method [2]
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* In participants on background therapy at baseline
* In participants not on background therapy at baseline
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Timepoint [2]
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52 weeks
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Secondary outcome [3]
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Change from baseline in Living with Pulmonary Fibrosis (L-PF) total score at Week 52
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Assessment method [3]
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Timepoint [3]
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Up to 52 weeks
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Secondary outcome [4]
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Proportion of participants with treatment-emergent adverse events and serious adverse events
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Assessment method [4]
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Timepoint [4]
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Up to 54 weeks
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Secondary outcome [5]
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Time to disease progression, defined as time to first occurrence of adjudicated respiratory-related hospitalization, adjudicated acute IPF exacerbation or all-cause mortality
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Assessment method [5]
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Timepoint [5]
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Up to 52 weeks
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Secondary outcome [6]
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Change from baseline in Living with Pulmonary Fibrosis (L-PF) Dyspnoea and Cough Domain score
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Assessment method [6]
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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.
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Timepoint [6]
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52 Weeks
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Secondary outcome [7]
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Change from baseline in King's Brief Interstitial Lung Disease (K-BILD) questionnaire Total score
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Assessment method [7]
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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
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Timepoint [7]
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52 Weeks
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Secondary outcome [8]
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Absolute change from baseline in quantitative lung fibrosis (QLF) extent (%)
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Assessment method [8]
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Timepoint [8]
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52 Weeks
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Secondary outcome [9]
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To characterize the safety and tolerability of bexotegrast versus placebo in participants with IPF over 52 weeks of treatment
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Assessment method [9]
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Number of participants with Adverse Events (AEs) Number of participants with Serious AEs (SAEs)
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Timepoint [9]
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52 Weeks
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Eligibility
Key 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
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/11/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/09/2025
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Actual
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Sample size
Target
360
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Lung Research Qld - Chermside
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Respiratory Clinical Trials - Kent Town
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The Queen Elizabeth Hospital - Woodville South
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Box Hill Hospital - Box Hill
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Monash Medical Centre - Clayton
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Austin Health - Heidelberg
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The Alfred Hospital - Melbourne
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Fiona Stanley Hospital - Murdoch
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TrialsWest - Spearwood
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Institute for Respiratory Health - Midland - Midland
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2050 - Camperdown
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4032 - Chermside
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5067 - Kent Town
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5011 - Woodville South
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Recruitment postcode(s) [5]
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3128 - Box Hill
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Recruitment postcode(s) [6]
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3168 - Clayton
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3084 - Heidelberg
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3004 - Melbourne
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6050 - Murdoch
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6163 - Spearwood
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Recruitment postcode(s) [11]
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6056 - Midland
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Recruitment outside Australia
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pliant Therapeutics, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT06097260
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pliant Therapeutics Medical Monitor
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Address
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Pliant Therapeutics, Inc.
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Contact person for public queries
Name
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Pliant Therapeutics Medical Monitor
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[email protected]
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06097260