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Date of registration	May. 07, 2024
Last modified on	Sept. 20, 2024
Trial ID	jRCT2051240025

Scientific Title	A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF)
Public Title	A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF)

Contact for Scientific Queries	Name	Cosgrove P. Gregory
	Affiliation	Pliant Therapeutics Inc
	Address	331 Oyster Point Boulevard, South San Francisco, CA, USA
	Telephone	303-919-7536
	E-mail	gcosgrove@pliantrx.com
Contact for Public Queries	Name	Kanmuri Kazuhiro
	Affiliation	Ascent Development Services, Inc.
	Address	Shibuya SOLASTA 3F, 1-21-1, Dogenzaka, Shibuya-ku, Tokyo
	Telephone	+81-3-4590-9005
	E-mail	kazuhiro.kanmuri@pharmalex.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 13, 2024
Actual date of first enrollment
Target sample size		1113
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. 40 years of age or above prior to screening 2. IPF diagnosis 7 years or less prior to screening based upon American Thoracic Society / European Respiratory Society / Japanese Respiratory Society / Latin American Thoracic Association 2018 guidelines and confirmed with central review (Raghu et al 2018). An HRCT scan performed within 2 years prior to screening may be used for eligibility. 3. FVCpp 45% or above 4. DLCOpp (hemoglobin-adjusted) 30% or above and < 90% 5. Current treatment for IPF with background therapy is allowed, if at a stable dose for 12 weeks or more prior to screening 6. If not currently receiving treatment for IPF (either treatment naive or discontinued prior treatment), participant must not have taken background therapy within 8 weeks prior to screening 7. Estimated glomerular filtration rate 30 mL/min or above, according to the Cockcroft-Gault equation for creatinine clearance 8. Female participant of nonchildbearing potential must be surgically sterile or postmenopausal 9. Female participant of childbearing potential must use a highly effective contraceptive method with a failure rate of <1% per year during Screening and the Treatment Period and for 4 weeks after the last dose of study drug(s) 10. Male participant with female partner of childbearing potential must agree to use a highly effective contraceptive method with a failure rate of <1% per year and to use a condom during Screening and the Treatment Period and for at least 12 weeks after the last dose of study drug(s) 11. Agree to abstain from sperm or egg donation for the duration of the study, through 12 weeks or 4 weeks, respectively, after administration of the last dose of study drug(s) 12. Understand the study procedures and agree to participate in the study by giving written informed consent
	Exclusion Criteria	1. Receiving pharmacologic therapy for pulmonary hypertension 2. Forced expiratory volume in the first second (FEV1)/FVC ratio < 0.7 at screening 3. Clinical evidence of active infection, including, but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening or at randomization 4. Active viral infection with human immunodeficiency virus, hepatitis A, hepatitis B, or hepatitis C 5. Any other condition that prevents the correct assessment of spirometry performance (for example a broken rib or chest pain of other origin that prevents adequate forced breathing) 6. Known acute IPF exacerbation or suspicion by the Investigator of such, 6 months prior to screening 7. Extent of emphysema that is greater than the extent of fibrotic changes on the most recent HRCT scan (as determined by central reader); an HRCT scan performed within 2 years prior to the screening date may be used 8. Self-reported smoking of any kind (not limited to tobacco) within 12 weeks prior to screening or unwilling to avoid smoking throughout the study 9. Lower respiratory tract infection requiring antibiotics within 4 weeks prior to screening and/or during the Screening Period 10. 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 11. Documented hepatic impairment characterized as liver dysfunction with a Child-Pugh classification of A, B, or C, or end-stage liver disease. 12. Renal impairment, defined as estimated glomerular filtration rate < 30 mL/min, according to the Cockcroft-Gault equation, or end-stage kidney disease requiring dialysis 13. History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the 6 months prior to screening
	Age Minimum	40age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		idiopathic pulmonary fibrosis
Intervention(s)		Bexotegrast160mg 320mg, or 0mg (placebo) will be taken once daily at approximately 24-hour intervals.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		To characterize the effect of bexotegrast versus placebo on the change in FVC in participants with idiopathic pulmonary fibrosis (IPF) at Week 52
Secondary Outcome(s)		-To characterize the effect of bexotegrast versus placebo over 52 weeks of treatment on disease progression -To characterize the effect of bexotegrast versus placebo on the change in FVC in participants with and without background therapy at baseline with IPF at Week 52 -To characterize the effect of bexotegrast versus placebo after 52 weeks of treatment on overall symptom and functional improvement associated with IPF -To characterize the effect of bexotegrast versus placebo on change in lung fibrosis by high-resolution computed tomography (HRCT) at Week 52 -To characterize the safety and tolerability of bexotegrast versus placebo in participants with IPF over 52 weeks of treatment

Primary Sponsor	Pliant Therapeutics Inc

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Kobe City Medical Center West Hospital Institutional Review Board
Address	1-2-4 Nagata-ku, Kobe City, Hyogo
Telephone	+81-78-576-5251
E-Mail
Approval Status	Approval
Date of approval	Aug. 13, 2024

Name of Certified Review Board	The Institutional Review Board of Sapporo Medical University Hospital
Address	291, South 1, West 16, Chuo-ku, Sapporo City, Hyogo
Telephone	+81-11-611-2111
E-Mail
Approval Status	Not approval
Date of approval	Aug. 13, 2024

Name of Certified Review Board	Juntendo University Hospital Institutional Review Board
Address	3-1-3 Hongo, Bunkyo-ku, Hyogo
Telephone	+81-3-3813-3111
E-Mail
Approval Status	Not approval
Date of approval	Aug. 13, 2024

Name of Certified Review Board	Saitama Red Cross Hospital Institutional Review Board
Address	1-5 Shintoshin, Chuo-ku Saitama City, Hyogo
Telephone	+81-48-852-1111
E-Mail
Approval Status	Approval
Date of approval	Aug. 13, 2024

Name of Certified Review Board	Tokyo Medical and Dental University Hospital Institutional Review Board
Address	1-5-45 Yushima, Bunkyo-ku, Hyogo
Telephone	+81-3-5803-4575
E-Mail
Approval Status	Not approval
Date of approval	Aug. 13, 2024

Name of Certified Review Board	Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory Center Institutional Review Board
Address	6-16-1, Tomiokahigashi, Kanazawa-ku, Yokohama City, Hyogo
Telephone	+81-45-701-9581
E-Mail
Approval Status	Not approval
Date of approval	Aug. 13, 2024

Name of Certified Review Board	National Hospital Organization Kyushu Medical Center Institutional Review Board
Address	1-8-1 Jigyohama, Chuo-ku, Fukuoka City, Hyogo
Telephone	+81-92-852-0700
E-Mail
Approval Status	Not approval
Date of approval	Aug. 13, 2024

Name of Certified Review Board	National Hospital Organization Kinki-Chuo Chest Medical Center Institutional Review Board
Address	1180 Nagasone-cho, Kita-ku, Sakai City, Hyogo
Telephone	+81-72-252-3021
E-Mail
Approval Status	Not approval
Date of approval	Aug. 13, 2024

Name of Certified Review Board	All Tohoku Clinical Trial Review and Audit Organization Institutional Review Board
Address	1-1 Seiryo-machi, Aoba-ku, Sendai City, Hyogo
Telephone	+81-22-346-0325
E-Mail
Approval Status	Not approval
Date of approval	Aug. 13, 2024

Name of Certified Review Board	Toho University Omori Medical Center Institutional Review Board
Address	6-11-1 Omorinishi, Ota-ku, Hyogo
Telephone	+81-3-3762-4151
E-Mail
Approval Status	Not approval
Date of approval	Aug. 13, 2024

Name of Certified Review Board	Kobe City Medical Center General Hospital Institutional Review Board
Address	2-1-1, Minatojima-minamimachi, Chuo-ku, Kobe City, Hyogo
Telephone	+81-78-302-4321
E-Mail
Approval Status	Approval
Date of approval	Aug. 13, 2024

Name of Certified Review Board	Hamamatsu University Hospital Institutional Review Board
Address	1-20-1 Handayama,Chuo-ku, Hamamatsu City, Hyogo
Telephone	+81-53-435-2850
E-Mail
Approval Status	Not approval
Date of approval	Aug. 13, 2024

Name of Certified Review Board	National Hospital Organization Ibarakihigashi National Hospital Institutional Review Board
Address	825 Terunuma, Tokaimura, Naka-gun, Hyogo
Telephone	+81-29-282-1151
E-Mail
Approval Status	Not approval
Date of approval	Aug. 13, 2024

Name of Certified Review Board	Kumamoto University Hospital Institutional Review Board
Address	1-1-1 Honjo, Chuo-ku, Kumamoto City, Hyogo
Telephone	+81-96-373-5842
E-Mail
Approval Status	Not approval
Date of approval	Aug. 13, 2024

Name of Certified Review Board	Saitama Prefectural Cardiovascular and Respiratory Center Institutional Review Board
Address	1696 Itai Kumagaya City, Hyogo
Telephone	+81-48-536-9900
E-Mail
Approval Status	Not approval
Date of approval	Aug. 13, 2024

Name of Certified Review Board	Fukuoka University Hospital Institutional Review Board
Address	7-45-1 Nanakuma, Jonan-ku, Fukuoka City, Hyogo
Telephone	+81-92-801-1011
E-Mail
Approval Status	Not approval
Date of approval	Aug. 13, 2024

Name of Certified Review Board	Medical Corporation Shintokai Yokohama Minoru Clinic Institutional Review Board
Address	1-13-8 Bessho, Minami-ku, Yokohama City, Hyogo
Telephone	+81-45-722-8655
E-Mail
Approval Status	Not approval
Date of approval	Aug. 13, 2024

Name of Certified Review Board	Hiroshima Prefectural Hospital Institutional Review Board
Address	1-5-54 Ujina-kanda, Minami-ku, Hiroshima City, Hyogo
Telephone	+81-82-254-1818
E-Mail
Approval Status	Not approval
Date of approval	Aug. 13, 2024

Name of Certified Review Board	Hospital of University of Occupational and Environmental Health Institutional Review Board
Address	1-1, Iseigaoka, Yahatanishi-ku Kitakyushu City, Hyogo
Telephone	+81-93-691-7503
E-Mail
Approval Status	Not approval
Date of approval	Aug. 13, 2024

Name of Certified Review Board	IRB of Okayama University Hospital
Address	2-5-1 Shikata-cho, Kita-ku, Okayama City, Hyogo
Telephone	+81-86-235-7534
E-Mail
Approval Status	Not approval
Date of approval	Aug. 13, 2024

Name of Certified Review Board	Nippon Medical School Hospital Institutional Review Board
Address	1-1-5 Sendagi, Bunkyo-ku, Hyogo
Telephone	+81-3-3822-2131
E-Mail
Approval Status	Not approval
Date of approval	Aug. 13, 2024

Name of Certified Review Board	Tokushima University Hospital Institutional Review Board
Address	2-50-1, Kuramoto-cho, Tokushima City, Hyogo
Telephone	+81-88-633-9294
E-Mail
Approval Status	Not approval
Date of approval	Aug. 13, 2024

Name of Certified Review Board	Shimane University Hospital Institutional Review Board
Address	89-1,Enya-cho, Izumo City, Hyogo
Telephone	+81-853-23-2111
E-Mail
Approval Status	Not approval
Date of approval	Aug. 13, 2024

Name of Certified Review Board	Aso Iizuka Hospital Institutional Review Board
Address	3-83 Yoshio-Machi, Iizuka City, Hyogo
Telephone	+81-948-22-3800
E-Mail
Approval Status	Approval
Date of approval	Aug. 13, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT06097260
Issuing Authority	ClinicalTrials.Gov

Countries of Recruitment（Except Japan）	United States/Canada/Argentina/Brazil/Chile/Colombia/Mexico/Belgium/Czech Republic/Denmark/France/Germany/Greece/Ireland/Israel/Italy/Netherlands/Poland/Portugal/Spain/United Kingdom/Australia/Taiwan/New Zealand/South Korea

History of Changes

No	Publication date
4	Sept. 20, 2024	(this page)	Changes
3	Sept. 18, 2024	Detail	Changes
2	Aug. 06, 2024	Detail	Changes
1	May. 07, 2024	Detail

List of change history