🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in India / NCT05321420
Active, not recruiting Phase 2

LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

NCT05321420 · tracked via the Priya Life Science India tracker
Sponsor
PureTech
Phase
Phase 2
Started
2022-07-22
Last updated
2025-10-16

Condition(s) studied

Idiopathic Pulmonary Fibrosis

Investigational drug(s) / intervention(s)

PlaceboPirfenidoneDeupirfenidone

Placebo: placebo

Pirfenidone: pirfenidone 801 mg TID

Deupirfenidone: Deupirfenidone

Study summary

This study a randomized, double-blind, four arm study to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in adults with Idiopathic Pulmonary Fibrosis.

Eligibility

Sex
ALL
Min age
40 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: * Treatment naïve patients or those with \<6 months of exposure to nintedanib with physician diagnosed IPF based on ATS/ERS/JRS/ALAT 2018 guidelines * Idiopathic Pulmonary Fibrosis on HRCT, performed within 12 months of Visit 1 as confirmed by central readers * DLCO corrected for Hemoglobin (Hb) \[visit 1\] ≥ 30% and ≤90% of predicted of normal * FVC ≥ 45% of predicted normal Key Exclusion Criteria: * Primary obstructive airway physiology (pre-bronchodilator FEV1/FVC \< 0.7 at Visit 1) * Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis, and cancer * Diagnosis of any connective tissue disease, including but not limited to scleroderma/systemic sclerosis, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis * Major extrapulmonary physiological restriction (e.g., chest wall abnormality, large pleural effusion) * Cardiovascular diseases, any of the following: * Uncontrolled hypertension, within 3 months of Visit 1 * Myocardial infarction within 6 months of Visit 1 * Unstable cardiac angina within 6 months of Visit 1 * Prior hospitalization for confirmed COVID-19, acute exacerbation of IPF or any lower respiratory tract infection within 3-months of Visit 1

Primary outcome measure(s)

Trial sites (103)

FacilityCityRegionStatus
University of Alabama Birmingham Birmingham Alabama
Science 37 Los Angeles California
NewportNativeMD, Inc. Newport Beach California
Paradigm Clinical Research Centers, Inc. Redding California
Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center Torrance California
University of Connecticut Health Center Farmington Connecticut
Accel Research Sites Network DeLand Florida
Harmony Medical Research Institute, Inc Hialeah Florida
Piedmont Healthcare, Inc. Atlanta Georgia
Clinical Research Investments Decatur Georgia
Indiana University School of Medicine Indianapolis Indiana
University of Kansas Medical Center Kansas City Kansas
Pulmonix Greensboro North Carolina
Southeastern Research Center Winston-Salem North Carolina
University of Cincinnati Cincinnati Ohio
Temple University Philadelphia Pennsylvania
Clinical Trials Center of Middle Tennessee Franklin Tennessee
Vanderbilt University Medical Center Nashville Tennessee
Baylor Scott & White Research Institute Dallas Texas
Renovatio Clinical - The Woodlands Research Center The Woodlands Texas
Pulmonary Associates of Richmond Richmond Virginia
TPMG Clinical Research Williamsburg Virginia
Instituto Médico de la Fundación de Estudios Clinicos / Fundación Estudios Rosario Santa Fe Province
Aprillus Asistencia e Investigación Buenos Aires Argentina
CEMER Centro Medico de Enfermedades Respiratorias Buenos Aires Argentina
Instituto de Medicina Respiratoria - IMER Córdoba Argentina
Respira Salud Clinica Integral Godoy Cruz Argentina
Instituto Ave Pulmo - Fundacion Enfisema Mar del Plata Argentina
Polo de Salud Vistalba Mendoza Argentina
CIMRO- Centro de Investigación Médica Respiratoria Oncológica Mendoza Argentina
INSARES - Instituto de Salud Respiratoria Mendoza Argentina
Centro Médico Dharma Mendoza Argentina
Instituto de Enfermedades Respiratorias e Investigación Clínica San Juan Bautista Argentina
Investigaciones en Patologías Respiratorias San Miguel de Tucumán Argentina
Instituto del Buen Aire Santa Fe Argentina
Clinica Central S.A. Villa Regina Argentina
Clinica Maule Maule Chile
Centro de Estudios Clinicos Santiago Chile
Clinica Universidad de Los Andes Santiago Chile
Centro Respiratorio Integral Valparaíso Chile

+ 63 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05321420 on ClinicalTrials.gov ↗ ← All trials in India