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

NCT05321420 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: LYT-100-2022-204
• Study Type: interventional
• Target: 240
• Locations: 14 countries
• Sites: 103

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

IPF; lung fibrosis; respiratory disease

Outcome Measures

Primary Outcomes (1)

• Rate of decline in Forced Vital Capacity over 26 weeks (Part A)

  Rate of decline in Forced Vital Capacity (FVC; in mL)

  26 weeks

Secondary Outcomes (6)

• Forced Vital Capacity (FVC) percent predicted change (Part A)

  Baseline to Week 26

• Time to hospitalization or mortality (Part A)

  26 weeks

• Time to Idiopathic Pulmonary Fibrosis (IPF) progression (Part A)

  26 weeks

• Forced Vital Capacity (FVC) percent predicted change (Part B)

  26 Weeks

• Rate of decline in Forced Vital Capacity over 26 weeks (Part B)

  26 Weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo oral administration

Drug: Placebo

pirfenidone 801 mg TID

ACTIVE COMPARATOR

pirfenidone 801 mg TID oral administration

Drug: Pirfenidone

LYT-100 550 mg TID

EXPERIMENTAL

LYT-100 (Deupirfenidone) 550 mg TID oral administration

Drug: Deupirfenidone

LYT-100 825 mg TID

EXPERIMENTAL

LYT-100 (Deupirfenidone) 825 mg TID oral administration

Drug: Deupirfenidone

Interventions

Placebo DRUG

placebo

Placebo

Pirfenidone DRUG

pirfenidone 801 mg TID

pirfenidone 801 mg TID

Deupirfenidone DRUG

Deupirfenidone

LYT-100 550 mg TID; LYT-100 825 mg TID

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PureTech: lead

Study Sites (103)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

Location

Science 37

Los Angeles, California, 90230, United States

Location

NewportNativeMD, Inc.

Newport Beach, California, 92663, United States

Location

Paradigm Clinical Research Centers, Inc.

Redding, California, 96001, United States

Location

Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center

Torrance, California, 90502, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Accel Research Sites Network

DeLand, Florida, 32720, United States

Location

Harmony Medical Research Institute, Inc

Hialeah, Florida, 33016, United States

Location

Piedmont Healthcare, Inc.

Atlanta, Georgia, 30309, United States

Location

Clinical Research Investments

Decatur, Georgia, 30030, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Pulmonix

Greensboro, North Carolina, 27403, United States

Location

Southeastern Research Center

Winston-Salem, North Carolina, 27103, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Clinical Trials Center of Middle Tennessee

Franklin, Tennessee, 37067, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37204, United States

Location

Baylor Scott & White Research Institute

Dallas, Texas, 75204, United States

Location

Renovatio Clinical - The Woodlands Research Center

The Woodlands, Texas, 77380, United States

Location

Pulmonary Associates of Richmond

Richmond, Virginia, 23230, United States

Location

TPMG Clinical Research

Williamsburg, Virginia, 23188, United States

Location

Instituto Médico de la Fundación de Estudios Clinicos / Fundación Estudios

Rosario, Santa Fe Province, 2000, Argentina

Location

Aprillus Asistencia e Investigación

Buenos Aires, 1406, Argentina

Location

CEMER Centro Medico de Enfermedades Respiratorias

Buenos Aires, 1602, Argentina

Location

Instituto de Medicina Respiratoria - IMER

Córdoba, X5003DCE, Argentina

Location

Respira Salud Clinica Integral

Godoy Cruz, 5501, Argentina

Location

Instituto Ave Pulmo - Fundacion Enfisema

Mar del Plata, 7600, Argentina

Location

Polo de Salud Vistalba

Mendoza, 1428, Argentina

Location

CIMRO- Centro de Investigación Médica Respiratoria Oncológica

Mendoza, 5600, Argentina

Location

INSARES - Instituto de Salud Respiratoria

Mendoza, M5500CCG, Argentina

Location

Centro Médico Dharma

Mendoza, M5500, Argentina

Location

Instituto de Enfermedades Respiratorias e Investigación Clínica

San Juan Bautista, 1888, Argentina

Location

Investigaciones en Patologías Respiratorias

San Miguel de Tucumán, 4000, Argentina

Location

Instituto del Buen Aire

Santa Fe, 3000, Argentina

Location

Clinica Central S.A.

Villa Regina, 8336, Argentina

Location

Clinica Maule

Maule, 3530000, Chile

Location

Centro de Estudios Clinicos

Santiago, 7550000, Chile

Location

Clinica Universidad de Los Andes

Santiago, 7550000, Chile

Location

Centro Respiratorio Integral

Valparaíso, Chile

Location

Fundacion Cardiomet CEQUIN

Armenia, Colombia

Location

Instituto Neumologico del Oriente S.A.

Bucaramanga, Colombia

Location

Centro de Investigaciones Clinicas S.A.S

Cali, 760036, Colombia

Location

National Ceneter for Tuberculosis and Lung Diseases JSC

Tbilisi, 0101, Georgia

Location

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

Tbilisi, 0144, Georgia

Location

Emergency Cardiology Center by Academician G. Chapidze LLC

Tbilisi, 0159, Georgia

Location

LTD Aversi Clinic

Tbilisi, 0160, Georgia

Location

LTD The First Medical Center

Tbilisi, 0180, Georgia

Location

University Hospital Alexandroupolis

Alexandroupoli, 68100, Greece

Location

"Sotiria" Chest Diseases Hospital of Athens

Athens, 11527, Greece

Location

University General Hospital "Attikon"

Athens, 12462, Greece

Location

Athens Medical Center

Athens, 15125, Greece

Location

University General Hospital of Patras

Pátrai, 26504, Greece

Location

General Hospital of Thessaloniki "G. Papanikolaou"

Thessaloniki, 57010, Greece

Location

Rhythm Heart Institute Vadodara

Vadodara, Gujarat, 390022, India

Location

Sparsh Super Specialty Hospital

Bengaluru, Karnataka, 560001, India

Location

Mgm Medical College And Hospital, Aurangabad

Aurangabad, Maharashtra, 431003, India

Location

Government Medical College and Hospital Aurangabad

Aurangabad, Maharashtra, 431004, India

Location

Oriion Citicare Super Specialty Hospital

Aurangabad, Maharashtra, 431005, India

Location

Getwell Hospital and Research Institute

Nagpur, Maharashtra, 440012, India

Location

Govt. General and Chest Hospital

Hyderabad, Telangana, 500038, India

Location

Apollo Spectra Hospital

Kanpur, Uttar Pradesh, 208001, India

Location

Nil Ratan Sircar Medical College And Hospital, Kolkata

Kolkata, West Bengal, 700014, India

Location

BHS Lakeview Heart

Belagāve, 590016, India

Location

Hospital Sultanah Bahiyah

Alor Star, Kedah, 05460, Malaysia

Location

Hospital Pulau Pinang

George Town, 10450, Malaysia

Location

Hospital Serdang

Kajang, Malaysia

Location

Institut Perubatan Respiratori

Kuala Lumpur, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Location

Hospital Tengku Ampuan Afzan

Kuantan, Malaysia

Location

Hospital Universitario Dr. José Eleuterio González

Monterrey, Nuevo León, 64460, Mexico

Location

Integral Health Medical Unit

San Nicolás de los Garza, Nuevo León, 66465, Mexico

Location

CALPULAB

Calpulalpan, 90204, Mexico

Location

Oaxaca Site Management Organization

Oaxaca City, 68000, Mexico

Location

ONCARE Group

San Pedro Garza García, 66220, Mexico

Location

St. Luke's Medical Center - Global City

City of Taguig, 1634, Philippines

Location

Philippine General Hospital

Manila, 1000, Philippines

Location

Lung Center of the Philippines

Quezon City, 1100, Philippines

Location

S.C. Netconsult SRL

Iași, 700141, Romania

Location

S.C. Lavinia Davidescu Clinic SRL

Oradea, 410163, Romania

Location

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

Timișoara, 300312, Romania

Location

Durban Lung Centre

Durban, 4051, South Africa

Location

WITS Clinical Research

Johannesburg, 2193, South Africa

Location

Ahmed Kathrada Lenmed Private Hospital

Johannesburg, South Africa

Location

Netcare Milpark Hospital

Parktown, 2193, South Africa

Location

Ryexo Clinical Research

Pretoria, 0084, South Africa

Location

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

Bucheon-si, Gyeonggi-do, 14647, South Korea

Location

Hanyang University - Myongji Hospital

Goyang-si, Gyeonggi-do, 10475, South Korea

Location

InJe University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

Keimyung University - Dongsan Medical Center

Daegu, 42601, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

CHA Bundang Medical Center

Gyeonggi-do, 13496, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Kyung Hee University Hospital

Seoul, 02447, South Korea

Location

Hanyang University Seoul Hospital

Seoul, 04763, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

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

Seoul, 07345, South Korea

Location

Ulsan University Hospital

Ulsan, 44033, South Korea

Location

Siriraj Hospital

Bangkok, Thailand

Location

Khon Kaen University

Khon Kaen, Thailand

Location

Central Chest Institute Of Thailand

Nonthaburi, Thailand

Location

Songklanagarind Hospital

Songkhla, Thailand

Location

Related Links

• Recruiting website for patients in the United States

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Respiration Disorders

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Camilla Graham, MD

  PureTech

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2022
• First Posted: April 11, 2022
• Study Start: July 22, 2022
• Primary Completion: October 15, 2024
• Study Completion: December 31, 2025
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

MY (6); CO (3); RO (3); KR (13); TH (4); GR (6); CL (4); US (22); IN (10); GE (5); ME (5); PH (3); ZA (5); AR (14)