Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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)
Secondary ID [1] 0 0
BEACON-IPF
Secondary ID [2] 0 0
PLN-74809-IPF-206
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in absolute FVC (mL)
Timepoint [1] 0 0
52 weeks
Secondary outcome [1] 0 0
Time to disease progression
Timepoint [1] 0 0
Up to 52 weeks
Secondary outcome [2] 0 0
Change from baseline in absolute FVC (mL) at Week 52
Timepoint [2] 0 0
52 weeks
Secondary outcome [3] 0 0
Change from baseline in Living with Pulmonary Fibrosis (L-PF) total score at Week 52
Timepoint [3] 0 0
Up to 52 weeks
Secondary outcome [4] 0 0
Proportion of participants with treatment-emergent adverse events and serious adverse events
Timepoint [4] 0 0
Up to 54 weeks
Secondary outcome [5] 0 0
Time to disease progression, defined as time to first occurrence of adjudicated respiratory-related hospitalization, adjudicated acute IPF exacerbation or all-cause mortality
Timepoint [5] 0 0
Up to 52 weeks
Secondary outcome [6] 0 0
Change from baseline in Living with Pulmonary Fibrosis (L-PF) Dyspnoea and Cough Domain score
Timepoint [6] 0 0
52 Weeks
Secondary outcome [7] 0 0
Change from baseline in King's Brief Interstitial Lung Disease (K-BILD) questionnaire Total score
Timepoint [7] 0 0
52 Weeks
Secondary outcome [8] 0 0
Absolute change from baseline in quantitative lung fibrosis (QLF) extent (%)
Timepoint [8] 0 0
52 Weeks
Secondary outcome [9] 0 0
To characterize the safety and tolerability of bexotegrast versus placebo in participants with IPF over 52 weeks of treatment
Timepoint [9] 0 0
52 Weeks

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
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Lung Research Qld - Chermside
Recruitment hospital [3] 0 0
Respiratory Clinical Trials - Kent Town
Recruitment hospital [4] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [5] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [6] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [7] 0 0
Austin Health - Heidelberg
Recruitment hospital [8] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [9] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [10] 0 0
TrialsWest - Spearwood
Recruitment hospital [11] 0 0
Institute for Respiratory Health - Midland - Midland
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
5067 - Kent Town
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
6050 - Murdoch
Recruitment postcode(s) [10] 0 0
6163 - Spearwood
Recruitment postcode(s) [11] 0 0
6056 - Midland
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
Nebraska
Country [20] 0 0
United States of America
State/province [20] 0 0
New Hampshire
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Oklahoma
Country [25] 0 0
United States of America
State/province [25] 0 0
Oregon
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
South Carolina
Country [28] 0 0
United States of America
State/province [28] 0 0
Tennessee
Country [29] 0 0
United States of America
State/province [29] 0 0
Texas
Country [30] 0 0
United States of America
State/province [30] 0 0
Utah
Country [31] 0 0
United States of America
State/province [31] 0 0
Vermont
Country [32] 0 0
United States of America
State/province [32] 0 0
Washington
Country [33] 0 0
Argentina
State/province [33] 0 0
Buenos Aires
Country [34] 0 0
Argentina
State/province [34] 0 0
Ciudad Autónoma De BuenosAires
Country [35] 0 0
Argentina
State/province [35] 0 0
Santa Fe
Country [36] 0 0
Argentina
State/province [36] 0 0
Tucumán
Country [37] 0 0
Argentina
State/province [37] 0 0
Ciudad Autónoma de Buenos Aires
Country [38] 0 0
Argentina
State/province [38] 0 0
Córdoba
Country [39] 0 0
Argentina
State/province [39] 0 0
Mendoza
Country [40] 0 0
Canada
State/province [40] 0 0
British Colombia
Country [41] 0 0
Canada
State/province [41] 0 0
British Columbia
Country [42] 0 0
Canada
State/province [42] 0 0
Ontario
Country [43] 0 0
Canada
State/province [43] 0 0
Quebec
Country [44] 0 0
Chile
State/province [44] 0 0
Santiago
Country [45] 0 0
Czechia
State/province [45] 0 0
Jihomoravský Kraj
Country [46] 0 0
Czechia
State/province [46] 0 0
Olomoucký Kraj
Country [47] 0 0
Czechia
State/province [47] 0 0
Praha 4
Country [48] 0 0
Denmark
State/province [48] 0 0
South Denmark
Country [49] 0 0
Denmark
State/province [49] 0 0
Aarhus
Country [50] 0 0
Denmark
State/province [50] 0 0
Hellerup
Country [51] 0 0
France
State/province [51] 0 0
Ille-et-Vilaine
Country [52] 0 0
Germany
State/province [52] 0 0
Bayern
Country [53] 0 0
Germany
State/province [53] 0 0
Hessen
Country [54] 0 0
Germany
State/province [54] 0 0
Niedersachsen
Country [55] 0 0
Germany
State/province [55] 0 0
Nordrhein-Westfalen
Country [56] 0 0
Germany
State/province [56] 0 0
Sachsen
Country [57] 0 0
Germany
State/province [57] 0 0
Schleswig-Holstein
Country [58] 0 0
Germany
State/province [58] 0 0
Thüringen
Country [59] 0 0
Germany
State/province [59] 0 0
Berlin
Country [60] 0 0
Greece
State/province [60] 0 0
Achaïa
Country [61] 0 0
Greece
State/province [61] 0 0
Attiki
Country [62] 0 0
Greece
State/province [62] 0 0
Evros
Country [63] 0 0
Greece
State/province [63] 0 0
Ioannina
Country [64] 0 0
Israel
State/province [64] 0 0
HaDarom
Country [65] 0 0
Israel
State/province [65] 0 0
HaMerkaz
Country [66] 0 0
Israel
State/province [66] 0 0
Tel-Aviv
Country [67] 0 0
Israel
State/province [67] 0 0
Yerushalayim
Country [68] 0 0
Israel
State/province [68] 0 0
Haifa
Country [69] 0 0
Israel
State/province [69] 0 0
Petach Tikva
Country [70] 0 0
Italy
State/province [70] 0 0
Roma
Country [71] 0 0
Korea, Republic of
State/province [71] 0 0
Gyeongsangnamdo
Country [72] 0 0
Korea, Republic of
State/province [72] 0 0
Seoul Teugbyeolsi
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Busan
Country [74] 0 0
Netherlands
State/province [74] 0 0
Noord-Holland
Country [75] 0 0
New Zealand
State/province [75] 0 0
Canterbury
Country [76] 0 0
New Zealand
State/province [76] 0 0
North Island
Country [77] 0 0
New Zealand
State/province [77] 0 0
Otago
Country [78] 0 0
New Zealand
State/province [78] 0 0
Waikato
Country [79] 0 0
Poland
State/province [79] 0 0
Lubuskie
Country [80] 0 0
Portugal
State/province [80] 0 0
Braga
Country [81] 0 0
Taiwan
State/province [81] 0 0
Kaohsiung City
Country [82] 0 0
Taiwan
State/province [82] 0 0
Taipei
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Hampshire
Country [84] 0 0
United Kingdom
State/province [84] 0 0
North Humberside
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Birmingham
Country [86] 0 0
United Kingdom
State/province [86] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pliant Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pliant Therapeutics Medical Monitor
Address 0 0
Pliant Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pliant Therapeutics Medical Monitor
Address 0 0
Country 0 0
Phone 0 0
[email protected]
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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