LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Registration Number
- NCT05321420
- Lead Sponsor
- PureTech
- 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.
- Detailed Description
This study is a randomized, double-blind, being conducted at centers globally to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in 240 treatment naïve adult patients with IPF ≥ 40 years in age. Patients will be randomized in a ratio of 1:1:1:1 to receive treatment of LYT-100, pirfenidone, or placebo to be taken daily for up to 183 days (26 week treatment period) with the primary outcome of Rate of decline in Forced Vital Capacity (FVC; in mL) over 26 weeks. Secondary endpoints, including spirometry, inflammatory biomarkers, and patient-reported outcomes will also be evaluated.
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 240
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LYT-100 825 mg TID Deupirfenidone LYT-100 (Deupirfenidone) 825 mg TID oral administration Placebo Placebo Placebo oral administration pirfenidone 801 mg TID Pirfenidone pirfenidone 801 mg TID oral administration LYT-100 550 mg TID Deupirfenidone LYT-100 (Deupirfenidone) 550 mg TID oral administration
- Primary Outcome Measures
Name Time Method Rate of decline in Forced Vital Capacity over 26 weeks (Part A) 26 weeks Rate of decline in Forced Vital Capacity (FVC; in mL)
- Secondary Outcome Measures
Name Time Method Forced Vital Capacity (FVC) percent predicted change (Part A) Baseline to Week 26 FVC percent predicted (FVCpp) change from baseline to Week 26
Time to hospitalization or mortality (Part A) 26 weeks Time to hospitalization or mortality due to respiratory cause through 26 weeks
Time to Idiopathic Pulmonary Fibrosis (IPF) progression (Part A) 26 weeks Time to IPF progression through 26 weeks, as defined by a decline in FVC% of 5% or greater or death
Forced Vital Capacity (FVC) percent predicted change (Part B) 26 Weeks FVC percent predicted (FVCpp) change from Week 26 to Week 52
Rate of decline in Forced Vital Capacity over 26 weeks (Part B) 26 Weeks Rate of decline in Forced Vital Capacity (FVC; in mL) from Week 26 to Week 52
Time to Idiopathic Pulmonary Fibrosis (IPF) progression (Part B) 26 Weeks Time to IPF progression from Week 26 to Week 52, as defined by a decline in FVC% of 5% or greater or death
Trial Locations
- Locations (103)
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
S.C. Netconsult SRL
🇷🇴Iaşi, Romania
S.C. Lavinia Davidescu Clinic SRL
🇷🇴Oradea, Romania
Instituto del Buen Aire
🇦🇷Santa Fe, Argentina
Investigaciones en Patologías Respiratorias
🇦🇷Tucuman, 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
🇨🇱Valparaiso, Chile
Fundacion Cardiomet CEQUIN
🇨🇴Armenia, Colombia
Instituto Neumologico del Oriente S.A.
🇨🇴Bucaramanga, Colombia
Centro de Investigaciones Clinicas S.A.S
🇨🇴Cali, Colombia
LTD Aversi Clinic
🇬🇪Tbilisi, Georgia
LTD The First Medical Center
🇬🇪Tbilisi, Georgia
University Hospital Alexandroupolis
🇬🇷Alexandroupolis, Greece
Athens Medical Center
🇬🇷Athens, Greece
"Sotiria" Chest Diseases Hospital of Athens
🇬🇷Athens, Greece
Mgm Medical College And Hospital, Aurangabad
🇮🇳Aurangabad, Maharashtra, India
BHS Lakeview Heart
🇮🇳Belagave, India
Hospital Universitario Dr. José Eleuterio González
🇲🇽Monterrey, Nuevo Leon, Mexico
Institut Perubatan Respiratori
🇲🇾Kuala Lumpur, Malaysia
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan
🇲🇾Kuantan, Malaysia
Oaxaca Site Management Organization
🇲🇽Oaxaca, Mexico
ONCARE Group
🇲🇽San Pedro Garza Garcia, Mexico
Philippine General Hospital
🇵🇭Manila, Philippines
Lung Center of the Philippines
🇵🇭Quezon City, Philippines
St. Luke's Medical Center - Global City
🇵🇭Taguig, Philippines
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
Sparsh Super Specialty Hospital
🇮🇳Bengaluru, Karnataka, India
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
🇺🇸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, Argentina
Aprillus Asistencia e Investigación
🇦🇷Buenos Aires, Argentina
CEMER Centro Medico de Enfermedades Respiratorias
🇦🇷Buenos Aires, Argentina
Instituto de Medicina Respiratoria - IMER
🇦🇷Córdoba, Argentina
Instituto de Enfermedades Respiratorias e Investigación Clínica
🇦🇷Florencio Varela, Argentina
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
University General Hospital "Attikon"
🇬🇷Athens, Greece
University General Hospital of Patras
🇬🇷Patras, Greece
General Hospital of Thessaloniki "G. Papanikolaou"
🇬🇷Thessaloniki, Greece
Rhythm Heart Institute Vadodara
🇮🇳Vadodara, Gujarat, 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
The Catholic University Of Korea Bucheon St. Mary's Hospital
🇰🇷Bucheon-si, Gyeonggi-do, Korea, Republic of
Hanyang University - Myongji Hospital
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
InJe University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Keimyung University - Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
CHA Bundang Medical Center
🇰🇷Gyeonggi-do, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Yeouido St.Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Hospital Sultanah Bahiyah
🇲🇾Alor Setar, Kedah, Malaysia
Hospital Pulau Pinang
🇲🇾George Town, Malaysia
Hospital Serdang
🇲🇾Kajang, Malaysia
Integral Health Medical Unit
🇲🇽San Nicolas de los Garza, Nuevo Leon, Mexico
CALPULAB
🇲🇽Calpulalpan, Mexico
"Dr. Victor Babes" Clinical Hospital of Infectious Diseases and Pneumophtisiology
🇷🇴Timisoara, 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
Siriraj Hospital
🇹🇭Bangkok, Thailand
Khon Kaen University
🇹🇭Khon Kaen, Thailand
Central Chest Institute Of Thailand
🇹🇭Nonthaburi, Thailand
Songklanagarind Hospital
🇹🇭Songkhla, Thailand