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

Idiopathic Pulmonary Fibrosis Clinical Trial

— ELEVATE  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05321420
• Other study ID #: LYT-100-2022-204
• Status: Active, not recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

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

External Links

•   Recruiting website for patients in the United States