Last updated 28 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
Centro Respiratorio Quilmes - Buenos Aires
Hipolito Yrigoyen 856, Quilmes, Buenos Aires
Consultorios Médicos del Buen Ayre
Fitz Roy 2468 1er Piso, C1425FVH CABA, Argentina
Instituto de Medicina Respiratoria IMER - Córdoba
Av. Colon 2057, Córdoba
Consultorios Médicos Dr. Isaac Scherbovsky - Mendoza
José Federico Moreno 2760, Mendoza
Instituto INSARES - Mendoza
Rondeau 335, Mendoza
Instituto Ave Pulmo
Carlos Alvear 3345, B7602DCK Mar del Plata, Provincia de Buenos Aires, Argentina
Clínica Privada Independencia - Buenos Aires
Luis María Drago 5681, Munro, Provincia de Buenos Aires, Argentina
Centro Médico Dra. De Salvo
Av. Cabildo 1548, CABA, Buenos Aires
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Italia 428, Rosario - Santa Fe
Sanatorio Parque - Rosario
Boulevard Oroño 860, Rosario, Santa Fe
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