Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis
a study on Fibrosis Idiopathic Pulmonary Fibrosis
Summary
- Eligibility
- for people ages 40 years and up (full criteria)
- Location
- at UC Davis UCSF
- Dates
- study startedcompletion 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 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.
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
- ≥ 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
You CAN'T join if...
- 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)
- Forced expiratory volume in the first second (FEV1)/FVC ratio <0.7 at screening
- Clinical evidence of active infection, including, but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening or at randomization
- Known acute IPF exacerbation, or suspicion by the Investigator of such, 6 months prior to screening
Locations
- University of California Davis Comprehensive Cancer Center
not yet accepting patients
Sacramento California 95807 United States - UCSF Medical Center - Pulmonary Practice
accepting new patients
San Francisco California 94143 United States - Cedars Sinai Medical Center
accepting new patients
Los Angeles California 90048 United States - Newport Native MD, Inc
accepting new patients
Newport Beach California 92663 United States - University of Southern California - Keck School of Medicine
not yet accepting patients
Los Angeles California 90033 United States - VA Palo Alto Health Care System
accepting new patients
Palo Alto California 94304 United States - Stanford Health Care
accepting new patients
Stanford California 94305 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Pliant Therapeutics, Inc.
- Links
- Trial website
- ID
- NCT06097260
- Phase
- Phase 2 research study
- Study Type
- Interventional
- Participants
- Expecting 360 study participants
- Last Updated