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ACTIVE NOT RECRUITING
NCT05321420
PHASE2

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

Sponsor: PureTech

View on ClinicalTrials.gov

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.

Official title: A Randomized Double-blind, Four-Arm Active and Placebo-controlled Dose-Finding Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2022-07-22

Completion Date

2025-12-31

Last Updated

2025-10-16

Healthy Volunteers

No

Interventions

DRUG

Placebo

placebo

DRUG

Pirfenidone

pirfenidone 801 mg TID

DRUG

Deupirfenidone

Deupirfenidone

Locations (103)

University of Alabama Birmingham

Birmingham, Alabama, United States

Science 37

Los Angeles, California, United States

NewportNativeMD, Inc.

Newport Beach, California, United States

Paradigm Clinical Research Centers, Inc.

Redding, California, United States

Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center

Torrance, California, United States

University of Connecticut Health Center

Farmington, Connecticut, United States

Accel Research Sites Network

DeLand, Florida, United States

Harmony Medical Research Institute, Inc

Hialeah, Florida, United States

Piedmont Healthcare, Inc.

Atlanta, Georgia, United States

Clinical Research Investments

Decatur, Georgia, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Pulmonix

Greensboro, North Carolina, United States

Southeastern Research Center

Winston-Salem, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Temple University

Philadelphia, Pennsylvania, United States

Clinical Trials Center of Middle Tennessee

Franklin, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor Scott & White Research Institute

Dallas, Texas, United States

Renovatio Clinical - The Woodlands Research Center

The Woodlands, Texas, United States

Pulmonary Associates of Richmond

Richmond, Virginia, United States

TPMG Clinical Research

Williamsburg, Virginia, United States

Instituto Médico de la Fundación de Estudios Clinicos / Fundación Estudios

Rosario, Santa Fe Province, Argentina

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

Fundacion Cardiomet CEQUIN

Armenia, Colombia

Instituto Neumologico del Oriente S.A.

Bucaramanga, Colombia

Centro de Investigaciones Clinicas S.A.S

Cali, Colombia

National Ceneter for Tuberculosis and Lung Diseases JSC

Tbilisi, Georgia

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC

Tbilisi, Georgia

Emergency Cardiology Center by Academician G. Chapidze LLC

Tbilisi, Georgia

LTD Aversi Clinic

Tbilisi, Georgia

LTD The First Medical Center

Tbilisi, Georgia

University Hospital Alexandroupolis

Alexandroupoli, Greece

"Sotiria" Chest Diseases Hospital of Athens

Athens, Greece

University General Hospital "Attikon"

Athens, Greece

Athens Medical Center

Athens, Greece

University General Hospital of Patras

Pátrai, Greece

General Hospital of Thessaloniki "G. Papanikolaou"

Thessaloniki, Greece

Rhythm Heart Institute Vadodara

Vadodara, Gujarat, India

Sparsh Super Specialty Hospital

Bengaluru, Karnataka, India

Mgm Medical College And Hospital, Aurangabad

Aurangabad, Maharashtra, India

Government Medical College and Hospital Aurangabad

Aurangabad, Maharashtra, India

Oriion Citicare Super Specialty Hospital

Aurangabad, Maharashtra, India

Getwell Hospital and Research Institute

Nagpur, Maharashtra, India

Govt. General and Chest Hospital

Hyderabad, Telangana, India

Apollo Spectra Hospital

Kanpur, Uttar Pradesh, India

Nil Ratan Sircar Medical College And Hospital, Kolkata

Kolkata, West Bengal, India

BHS Lakeview Heart

Belagāve, India

Hospital Sultanah Bahiyah

Alor Star, Kedah, Malaysia

Hospital Pulau Pinang

George Town, Malaysia

Hospital Serdang

Kajang, Malaysia

Institut Perubatan Respiratori

Kuala Lumpur, Malaysia

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Hospital Tengku Ampuan Afzan

Kuantan, Malaysia

Hospital Universitario Dr. José Eleuterio González

Monterrey, Nuevo León, Mexico

Integral Health Medical Unit

San Nicolás de los Garza, Nuevo León, Mexico

CALPULAB

Calpulalpan, Mexico

Oaxaca Site Management Organization

Oaxaca City, Mexico

ONCARE Group

San Pedro Garza García, Mexico

St. Luke's Medical Center - Global City

City of Taguig, Philippines

Philippine General Hospital

Manila, Philippines

Lung Center of the Philippines

Quezon City, Philippines

S.C. Netconsult SRL

Iași, Romania

S.C. Lavinia Davidescu Clinic SRL

Oradea, Romania

"Dr. Victor Babes" Clinical Hospital of Infectious Diseases and Pneumophtisiology

Timișoara, Romania

Durban Lung Centre

Durban, South Africa

WITS Clinical Research

Johannesburg, South Africa

Ahmed Kathrada Lenmed Private Hospital

Johannesburg, South Africa

Netcare Milpark Hospital

Parktown, South Africa

Ryexo Clinical Research

Pretoria, South Africa

The Catholic University Of Korea Bucheon St. Mary's Hospital

Bucheon-si, Gyeonggi-do, South Korea

Hanyang University - Myongji Hospital

Goyang-si, Gyeonggi-do, South Korea

InJe University Haeundae Paik Hospital

Busan, South Korea

Keimyung University - Dongsan Medical Center

Daegu, South Korea

Chonnam National University Hospital

Gwangju, South Korea

CHA Bundang Medical Center

Gyeonggi-do, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Kyung Hee University Hospital

Seoul, South Korea

Hanyang University Seoul Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea, Yeouido St.Mary's Hospital

Seoul, South Korea

Ulsan University Hospital

Ulsan, South Korea

Siriraj Hospital

Bangkok, Thailand

Khon Kaen University

Khon Kaen, Thailand

Central Chest Institute Of Thailand

Nonthaburi, Thailand

Songklanagarind Hospital

Songkhla, Thailand