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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PLN-74809
Placebo
Sponsored by
Pliant Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring IPF, idiopathic pulmonary fibrosis, pulmonary fibrosis, bexotegrast, Beacon, BEACON-IPF

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ≥ 40 years of age prior to screening IPF diagnosis ≤ 7 years prior to screening FVCpp ≥ 45% Diffusing capacity for carbon monoxide percent predicted (hemoglobin-adjusted) ≥ 30% and < 90% Current treatment for IPF with background therapy is allowed, if at a stable dose for ≥ 12 weeks prior to screening 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: Receiving pharmacologic therapy for pulmonary hypertension Self-reported smoking of any kind (not limited to tobacco) 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 Hepatic impairment or end-stage liver disease Renal impairment or end-stage kidney disease requiring dialysis Pregnant or lactating female participant Uncontrolled systemic arterial hypertension Receiving any unapproved or investigational agent intended for treatment of fibrosis in IPF Prior administration of bexotegrast Likely to have lung transplantation during the study (being on transplantation list is not an exclusion)

Sites / Locations

  • Paradigm Clinical Research Institute Inc - ClinEdge
  • Clinical Site Partners - Leesburg
  • IU Health Advanced Heart and Lung Care
  • Creighton University
  • PulmonIx, LLC
  • Southeastern Research CenterRecruiting
  • Bend Memorial Clinic/Summit Medical Group - Eastside
  • Clinical Research Associates Of Central PA , LLC
  • University of Pittsburgh Medical Center
  • Lowcountry Lung and Critical Care PA
  • Clinical Trials Center of Middle Tennessee
  • El Paso Pulmonary Association
  • Metroplex Pulmonary and Sleep Medicine CenterRecruiting
  • Research Centers of AmericaRecruiting
  • University of Utah
  • Institute for Respiratory Health - Midland

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Placebo

Bexotegrast (PLN-74809) 160 mg Dose

Bexotegrast (PLN-74809) 320 mg Dose

Arm Description

Placebo

Bexotegrast (PLN-74809) 160 mg Dose - 52 weeks

Bexotegrast (PLN-74809) 320 mg Dose - 52 weeks

Outcomes

Primary Outcome Measures

Change from baseline in absolute FVC (mL)

Secondary Outcome Measures

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
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
Change from baseline in Living with Pulmonary Fibrosis total score at Week 52
Proportion of participants with treatment-emergent adverse events and serious adverse events

Full Information

First Posted
October 18, 2023
Last Updated
October 18, 2023
Sponsor
Pliant Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06097260
Brief Title
Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pliant Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
Detailed 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
IPF, idiopathic pulmonary fibrosis, pulmonary fibrosis, bexotegrast, Beacon, BEACON-IPF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
267 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Experimental
Arm Description
Placebo
Arm Title
Bexotegrast (PLN-74809) 160 mg Dose
Arm Type
Experimental
Arm Description
Bexotegrast (PLN-74809) 160 mg Dose - 52 weeks
Arm Title
Bexotegrast (PLN-74809) 320 mg Dose
Arm Type
Experimental
Arm Description
Bexotegrast (PLN-74809) 320 mg Dose - 52 weeks
Intervention Type
Drug
Intervention Name(s)
PLN-74809
Intervention Description
PLN-74809
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change from baseline in absolute FVC (mL)
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Time to disease progression
Description
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
Time Frame
Up to 52 weeks
Title
Change from baseline in absolute FVC (mL) at Week 52
Description
In participants on background therapy at baseline In participants not on background therapy at baseline
Time Frame
52 weeks
Title
Change from baseline in Living with Pulmonary Fibrosis total score at Week 52
Time Frame
Up to 52 weeks
Title
Proportion of participants with treatment-emergent adverse events and serious adverse events
Time Frame
Up to 54 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 40 years of age prior to screening IPF diagnosis ≤ 7 years prior to screening FVCpp ≥ 45% Diffusing capacity for carbon monoxide percent predicted (hemoglobin-adjusted) ≥ 30% and < 90% Current treatment for IPF with background therapy is allowed, if at a stable dose for ≥ 12 weeks prior to screening 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: Receiving pharmacologic therapy for pulmonary hypertension Self-reported smoking of any kind (not limited to tobacco) 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 Hepatic impairment or end-stage liver disease Renal impairment or end-stage kidney disease requiring dialysis Pregnant or lactating female participant Uncontrolled systemic arterial hypertension Receiving any unapproved or investigational agent intended for treatment of fibrosis in IPF Prior administration of bexotegrast Likely to have lung transplantation during the study (being on transplantation list is not an exclusion)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pliant Therapeutics Medical Monitor
Phone
clintrials@pliantrx.com
Email
clintrials@pliantrx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pliant Therapeutics Medical Monitor
Organizational Affiliation
Pliant Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Paradigm Clinical Research Institute Inc - ClinEdge
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Site Partners - Leesburg
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34738
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
IU Health Advanced Heart and Lung Care
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
PulmonIx, LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Southeastern Research Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
Bend Memorial Clinic/Summit Medical Group - Eastside
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Research Associates Of Central PA , LLC
City
DuBois
State/Province
Pennsylvania
ZIP/Postal Code
15801
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Lowcountry Lung and Critical Care PA
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Trials Center of Middle Tennessee
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
El Paso Pulmonary Association
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Metroplex Pulmonary and Sleep Medicine Center
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Centers of America
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Institute for Respiratory Health - Midland
City
Midland
ZIP/Postal Code
6056
Country
Australia
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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