LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
NCT ID: NCT05321420
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
240 participants
INTERVENTIONAL
2022-07-22
2025-12-31
Brief Summary
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Detailed Description
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After completion of the double-blind period of the study, patients may participate in a long-term extension to evaluate tolerability and long-term safety. Patients receiving LYT-100 in the double-blind period will continue the dose throughout the long-term extension. Patients receiving pirfenidone or placebo in the double-blind period will be re-randomized in a 1:1 ratio to receive LYT-100 550mg or 825mg TID dose throughout the long-term extension.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo oral administration
Placebo
placebo
pirfenidone 801 mg TID
pirfenidone 801 mg TID oral administration
Pirfenidone
pirfenidone 801 mg TID
LYT-100 550 mg TID
LYT-100 (Deupirfenidone) 550 mg TID oral administration
Deupirfenidone
Deupirfenidone
LYT-100 825 mg TID
LYT-100 (Deupirfenidone) 825 mg TID oral administration
Deupirfenidone
Deupirfenidone
Interventions
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Placebo
placebo
Pirfenidone
pirfenidone 801 mg TID
Deupirfenidone
Deupirfenidone
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
40 Years
ALL
No
Sponsors
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PureTech
INDUSTRY
Responsible Party
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Principal Investigators
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Camilla Graham, MD
Role: STUDY_DIRECTOR
PureTech
Locations
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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
Countries
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Related Links
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Recruiting website for patients in the United States
Other Identifiers
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LYT-100-2022-204
Identifier Type: -
Identifier Source: org_study_id
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