Last updated 5 days ago
Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis
360 patients around the world
Available in Chile, Argentina
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.
Pliant Therapeutics, Inc.
12Research sites
360Patients around the world
This study is for people with
Pulmonary fibrosis
Idiopathic pulmonary fibrosis
Requirements for the patient
From 40 Years
All Gender
Medical requirements
- ≥ 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.
- 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.
Sites
Centro Respiratorio Quilmes - Buenos Aires
Consultorios Médicos del Buen Ayre
Instituto de Medicina Respiratoria IMER - Córdoba
Consultorios Médicos Dr. Isaac Scherbovsky - Mendoza
Instituto INSARES - Mendoza
Instituto Ave Pulmo
Clínica Privada Independencia - Buenos Aires
Centro Médico Dra. De Salvo
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Sanatorio Parque - Rosario
StudyBEACON-IPF
SponsorPliant Therapeutics, Inc.
Conditions
Idiopathic pulmonary fibrosis
Requirements
From 40 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06097260
