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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05321420
Other study ID # LYT-100-2022-204
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date July 29, 2022
Est. completion date August 2025

Study information

Verified date February 2024
Source PureTech
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Active, not recruiting
Enrollment 240
Est. completion date August 2025
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Placebo
placebo
Pirfenidone
pirfenidone 801 mg TID
Deupirfenidone
Deupirfenidone

Locations

Country Name City State
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 Respira Salud Clinica Integral Godoy Cruz
Argentina Instituto Ave Pulmo - Fundacion Enfisema Mar Del Plata
Argentina Centro Médico Dharma Mendoza
Argentina CIMRO- Centro de Investigación Médica Respiratoria Oncológica Mendoza
Argentina INSARES - Instituto de Salud Respiratoria Mendoza
Argentina Polo de Salud Vistalba Mendoza
Argentina Instituto Médico de la Fundación de Estudios Clinicos / Fundación Estudios Rosario Santa Fe
Argentina Instituto del Buen Aire Santa Fe
Argentina Investigaciones en Patologías Respiratorias Tucuman
Argentina Clinica Central S.A. Villa Regina
Chile Clinica Maule Maule
Chile Centro de Estudios Clinicos Santiago
Chile Clinica Universidad de Los Andes Santiago
Chile Centro Respiratorio Integral Valparaiso
Colombia Fundacion Cardiomet CEQUIN Armenia
Colombia Instituto Neumologico del Oriente S.A. Bucaramanga
Colombia Centro de Investigaciones Clinicas S.A.S Cali
Georgia Emergency Cardiology Center by Academician G. Chapidze LLC Tbilisi
Georgia LTD Aversi Clinic Tbilisi
Georgia LTD The First Medical Center Tbilisi
Georgia National Ceneter for Tuberculosis and Lung Diseases JSC Tbilisi
Georgia Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC Tbilisi
Greece University Hospital Alexandroupolis Alexandroupolis
Greece "Sotiria" Chest Diseases Hospital of Athens Athens
Greece Athens Medical Center Athens
Greece University General Hospital "Attikon" Athens
Greece University General Hospital of Patras Patras
Greece General Hospital of Thessaloniki "G. Papanikolaou" Thessaloniki
India Government Medical College and Hospital Aurangabad Aurangabad Maharashtra
India Mgm Medical College And Hospital, Aurangabad Aurangabad Maharashtra
India Oriion Citicare Super Specialty Hospital Aurangabad Maharashtra
India BHS Lakeview Heart Belagave
India Sparsh Super Specialty Hospital Bengaluru Karnataka
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 Getwell Hospital and Research Institute Nagpur Maharashtra
India Rhythm Heart Institute Vadodara Vadodara Gujarat
Korea, Republic of The Catholic University Of Korea Bucheon St. Mary's Hospital Bucheon-si Gyeonggi-do
Korea, Republic of InJe University Haeundae Paik Hospital Busan
Korea, Republic of Keimyung University - Dongsan Medical Center Daegu
Korea, Republic of Hanyang University - Myongji Hospital Goyang-si Gyeonggi-do
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 Asan Medical Center Seoul
Korea, Republic of Hanyang University Seoul Hospital Seoul
Korea, Republic of Kyung Hee University Hospital 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
Malaysia Hospital Sultanah Bahiyah Alor Setar 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
Mexico CALPULAB Calpulalpan
Mexico Hospital Universitario Dr. José Eleuterio González Monterrey Nuevo Leon
Mexico Oaxaca Site Management Organization Oaxaca
Mexico Integral Health Medical Unit San Nicolas de los Garza Nuevo Leon
Mexico ONCARE Group San Pedro Garza Garcia
Philippines Philippine General Hospital Manila
Philippines Lung Center of the Philippines Quezon City
Philippines St. Luke's Medical Center - Global City Taguig
Romania S.C. Netconsult SRL Iasi
Romania S.C. Lavinia Davidescu Clinic SRL Oradea
Romania "Dr. Victor Babes" Clinical Hospital of Infectious Diseases and Pneumophtisiology Timisoara
South Africa Durban Lung Centre Durban
South Africa Ahmed Kathrada Lenmed Private Hospital Johannesburg
South Africa WITS Clinical Research Johannesburg
South Africa Netcare Milpark Hospital Parktown
South Africa Ryexo Clinical Research Pretoria
Thailand Siriraj Hospital Bangkok
Thailand Khon Kaen University Khon Kaen
Thailand Central Chest Institute Of Thailand Nonthaburi
Thailand Songklanagarind Hospital Songkhla
United States Piedmont Healthcare, Inc. Atlanta Georgia
United States University of Alabama Birmingham Birmingham Alabama
United States University of Cincinnati Cincinnati Ohio
United States Baylor Scott & White Research Institute Dallas Texas
United States Clinical Research Investments Decatur Georgia
United States Accel Research Sites Network DeLand Florida
United States University of Connecticut Health Center Farmington Connecticut
United States Clinical Trials Center of Middle Tennessee Franklin Tennessee
United States Pulmonix Greensboro North Carolina
United States Harmony Medical Research Institute, Inc Hialeah Florida
United States Indiana University School of Medicine Indianapolis Indiana
United States University of Kansas Medical Center Kansas City Kansas
United States Science 37 Los Angeles California
United States Vanderbilt University Medical Center Nashville Tennessee
United States NewportNativeMD, Inc. Newport Beach California
United States Temple University Philadelphia Pennsylvania
United States Paradigm Clinical Research Centers, Inc. Redding California
United States Pulmonary Associates of Richmond Richmond Virginia
United States Renovatio Clinical - The Woodlands Research Center The Woodlands Texas
United States Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center Torrance California
United States TPMG Clinical Research Williamsburg Virginia
United States Southeastern Research Center Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
PureTech

Countries where clinical trial is conducted

United States,  Argentina,  Chile,  Colombia,  Georgia,  Greece,  India,  Korea, Republic of,  Malaysia,  Mexico,  Philippines,  Romania,  South Africa,  Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Forced Vital Capacity (FVC) percent predicted change (Part A) FVC percent predicted (FVCpp) change from baseline to Week 26 Baseline to Week 26
Secondary Time to hospitalization or mortality (Part A) Time to hospitalization or mortality due to respiratory cause through 26 weeks 26 weeks
Secondary Time to Idiopathic Pulmonary Fibrosis (IPF) progression (Part A) Time to IPF progression through 26 weeks, as defined by a decline in FVC% of 5% or greater or death 26 weeks
Secondary Forced Vital Capacity (FVC) percent predicted change (Part B) FVC percent predicted (FVCpp) change from Week 26 to Week 52 26 Weeks
Secondary Rate of decline in Forced Vital Capacity over 26 weeks (Part B) Rate of decline in Forced Vital Capacity (FVC; in mL) from Week 26 to Week 52 26 Weeks
Secondary Time to Idiopathic Pulmonary Fibrosis (IPF) progression (Part B) Time to IPF progression from Week 26 to Week 52, as defined by a decline in FVC% of 5% or greater or death 26 Weeks
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