Summary

Eligibility
for people ages 40 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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).

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)

Details

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.

Keywords

Idiopathic Pulmonary Fibrosis, IPF, pulmonary fibrosis, bexotegrast, Beacon, BEACON-IPF, Fibrosis, PLN-74809

Eligibility

You can join if…

Open to people ages 40 years and up

  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

You CAN'T join if...

  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)

Locations

  • UCSF Medical Center - Pulmonary Practice not yet accepting patients
    San Francisco California 94143 United States
  • VA Palo Alto Health Care System not yet accepting patients
    Palo Alto California 94304 United States
  • Paradigm Clinical Research Institute Inc - ClinEdge accepting new patients
    Redding California 96001 United States
  • Palmtree Clinical Research accepting new patients
    Palm Springs California 92262 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Pliant Therapeutics, Inc.
Links
Trial website
ID
NCT06097260
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 267 study participants
Last Updated