Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06097260
• Other study ID #: PLN-74809-IPF-206
• Secondary ID: BEACON-IPF
• Status: Recruiting
• Phase: Phase 2
• Start date: November 16, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: April 2024
• Source: Pliant Therapeutics, Inc.
• Contact: Pliant Therapeutics Medical Monitor
• Phone: clintrials@pliantrx.com
• Email: clintrials[@]pliantrx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: September 30, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• PLN-74809
PLN-74809
• Placebo
Placebo

Locations

Country	Name	City	State
Argentina	Centro Médico Dra de Salvo	Buenos Aires	Ciudad Autónoma De BuenosAires
Argentina	Consultorios Médicos Organización de Buen Ayre SRL	Ciudad Autónoma de Buenos Aires
Argentina	Instituto de Medicina Respiratoria	Córdoba
Argentina	Instituto Ave Pulmo	Mar Del Plata	Buenos Aires
Argentina	Fundacion Scherbovsky	Mendoza
Argentina	INSARES	Mendoza
Argentina	Clinica Privada Independencia	Munro	Buenos Aires
Argentina	Centro Respiratorio Quilmes	Quilmes	Buenos Aires
Argentina	Instituto Médico de la Fundación Estudios Clínicos	Rosario	Santa Fe
Argentina	Sanatorio Parque de Rosario	Rosario	Santa Fe
Argentina	Centro Integral de Medicina Respiratoria (CIMER)	San Miguel De Tucumán	Tucumán
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Lung Research Qld	Chermside	Queensland
Australia	Monash Medical Centre	Clayton	Victoria
Australia	Austin Health	Heidelberg	Victoria
Australia	Respiratory Clinical Trials	Kent Town	South Australia
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Institute for Respiratory Health - Midland	Midland
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	TrialsWest	Spearwood	Western Australia
Australia	The Queen Elizabeth Hospital	Woodville South	South Australia
Canada	Dynamic Drug Advancement	Ajax	Ontario
Canada	Centre intégré de santé et de services sociaux (CISSS) de la Montérégie-Centre	Greenfield Park	Quebec
Canada	Kelowna Respirology and Allergy Research	Kelowna	British Colombia
Canada	Centre d'investigation Clinique Mauricie	Trois-Rivieres	Quebec
Canada	Pacific Lung Research Center	Vancouver	British Columbia
Chile	Biocinetic	Santiago
Chile	CEC SpA	Santiago
Czechia	Fakultni nemocnice Brno	Brno	Jihomoravský Kraj
Czechia	Fakultni Nemocnice Olomouc	Olomouc	Olomoucký Kraj
Czechia	Fakultni Thomayerova Nemocnice	Praha 4
Denmark	Aarhus Universitetshospital	Aarhus
Denmark	Gentofte Hospital	Hellerup
Denmark	Odense Universitetshospital	Odense	South Denmark
France	Hôpital Pontchaillou	Rennes	Ille-et-Vilaine
Germany	Zentralklinik Bad Berka	Bad Berka	Thüringen
Germany	Evangelische Lungenklinik Berlin	Berlin
Germany	Fachkrankenhaus Coswig	Coswig	Sachsen
Germany	Ruhrlandklinik	Essen	Nordrhein-Westfalen
Germany	Universitätsklinikum Gießen (UKGM)	Gießen	Hessen
Germany	Medizinische Hochschule Hannover	Hannover	Niedersachsen
Germany	Universitätsklinikum Schleswig-Holstein, Campus Kiel	Kiel	Schleswig-Holstein
Germany	Kliniken der Stadt Koln	Köln	Nordrhein-Westfalen
Germany	LMU Klinikum der Universität München - Campus Großhadern	München	Bayern
Germany	Krankenhaus Bethanien	Solingen	Nordrhein-Westfalen
Greece	University General Hospital of Alexandroupolis	Alexandroupoli	Evros
Greece	Sotiria Thoracic Diseases Hospital of Athens	Athens	Attiki
Greece	University General Hospital of Ioannina	Ioánnina	Ioannina
Greece	University General Hospital of Patras	Patras	Achaïa
Israel	Barzilai Medical Center	Ashkelon	HaDarom
Israel	Tel Aviv Sourasky Medical Center	Ashkelon	Tel-Aviv
Israel	Lady Davis Carmel Medical Center	Haifa
Israel	Rambam Medical Center	Haifa
Israel	Shaare Zedek Medical Center	Jerusalem	Yerushalayim
Israel	Rabin Medical Center	Petach Tikva
Israel	Sheba Medical Center	Ramat Gan	Tel-Aviv
Israel	Kaplan Medical Center	Re?ovot	HaMerkaz
Italy	Policlinico Universitario Fondazione Agostino Gemelli - Roma	Roma
Korea, Republic of	Inje University Busan Paik Hospital	Busan	Gyeongsangnamdo
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Hanyang University Medical Center	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Korea University Anam Hospital	Seoul	Seoul Teugbyeolsi
Netherlands	VU Medisch Centrum	Amsterdam	Noord-Holland
New Zealand	Greenlane Clinical Centre	Auckland	North Island
New Zealand	Christchurch Hospital	Christchurch	Canterbury
New Zealand	Dunedin Hospital	Dunedin	Otago
New Zealand	Waikato Hospital	Hamilton	Waikato
Poland	Twoja Przychodnia NCM	Nowa Sól	Lubuskie
Portugal	Hospital de Braga	Braga
Taiwan	Kaohsiung Medical University - Chung-Ho Memorial Hospital	Kaohsiung City
Taiwan	Far Eastern Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United Kingdom	Castle Hill Hospital	Cottingham	North Humberside
United Kingdom	Royal Brompton Hospital	London
United Kingdom	Southampton General Hospital	Southampton	Hampshire
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Emory Clinic	Atlanta	Georgia
United States	Augusta University	Augusta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Bend Memorial Clinic/Summit Medical Group - Eastside	Bend	Oregon
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Cente	Boston	Massachusetts
United States	Brigham and Womans Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital - Pulmonary Associates	Boston	Massachusetts
United States	University of Vermont Medical Center	Burlington	Vermont
United States	Medical University of South Carolina	Charleston	South Carolina
United States	The Lung Research Center	Chesterfield	Missouri
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Baylor Scott and White Health - Advanced Lung Disease Specialists	Dallas	Texas
United States	Nuvance Health Medical Practices, Pulmonary & Sleep Specialists	Danbury	Connecticut
United States	National Jewish Health Main Campus	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	Clinical Research Associates Of Central PA , LLC	DuBois	Pennsylvania
United States	Duke University Medical Center	Durham	North Carolina
United States	El Paso Pulmonary Association	El Paso	Texas
United States	Western Washington Medical Group	Everett	Washington
United States	Clinical Trials Center of Middle Tennessee	Franklin	Tennessee
United States	Malcom Randall VA Medical Center	Gainesville	Florida
United States	PulmonIx, LLC	Greensboro	North Carolina
United States	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Baylor College of Medicine	Houston	Texas
United States	IU Health Advanced Heart and Lung Care	Indianapolis	Indiana
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Statcare Pulmonary Consultants - Knoxville	Knoxville	Tennessee
United States	Critical Care, Pulmonary and Sleep Associates	Lakewood	Colorado
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Clinical Site Partners - Leesburg	Leesburg	Florida
United States	Lexington VA Medical Center	Lexington	Kentucky
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	University of Southern California - Keck School of Medicine	Los Angeles	California
United States	Norton Pulmonary Specialists	Louisville	Kentucky
United States	Loyola University Medical Center	Maywood	Illinois
United States	Metroplex Pulmonary and Sleep Medicine Center	McKinney	Texas
United States	Research Centers of America	McKinney	Texas
United States	University of Minnesota Medical Center, Fairview	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale New Haven Hospital - York Street Campus	New Haven	Connecticut
United States	Tulane Medical Center	New Orleans	Louisiana
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Weill Cornell Medicine	New York	New York
United States	Lowcountry Lung and Critical Care PA	North Charleston	South Carolina
United States	Infinity Medical Research	North Dartmouth	Massachusetts
United States	OU Health Physicians	Oklahoma City	Oklahoma
United States	Creighton University	Omaha	Nebraska
United States	Central Florida Pulmonary Group PA	Orlando	Florida
United States	Palmtree Clinical Research	Palm Springs	California
United States	VA Palo Alto Health Care System	Palo Alto	California
United States	Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania
United States	Arizona Pulmonary Specialists	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Legacy Good Samaritan Hospital	Portland	Oregon
United States	Paradigm Clinical Research Institute Inc - ClinEdge	Redding	California
United States	University of California Davis Comprehensive Cancer Center	Sacramento	California
United States	University of Utah	Salt Lake City	Utah
United States	UCSF Medical Center - Pulmonary Practice	San Francisco	California
United States	Jeffrey S. Sager, MD Medical Corporation	Santa Barbara	California
United States	Stanford Health Care	Stanford	California
United States	GCP Clinical Research	Tampa	Florida
United States	University of Arizona College of Medicine	Tucson	Arizona
United States	MedStar Georgetown University Hospital	Washington	District of Columbia
United States	Southeastern Research Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pliant Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Chile,  Czechia,  Denmark,  France,  Germany,  Greece,  Israel,  Italy,  Korea, Republic of,  Netherlands,  New Zealand,  Poland,  Portugal,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in absolute FVC (mL)		52 weeks
Secondary	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
Secondary	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
Secondary	Change from baseline in Living with Pulmonary Fibrosis (L-PF) total score at Week 52		Up to 52 weeks
Secondary	Proportion of participants with treatment-emergent adverse events and serious adverse events		Up to 54 weeks
Secondary	Time to disease progression, defined as time to first occurrence of adjudicated respiratory-related hospitalization, adjudicated acute IPF exacerbation or all-cause mortality		Up to 52 weeks
Secondary	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
Secondary	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
Secondary	Absolute change from baseline in quantitative lung fibrosis (QLF) extent (%)		52 Weeks
Secondary	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

External Links

•   Trial website