Clinical trial NCT05321420: LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: IPF
lung fibrosis
respiratory disease
Lead sponsor: PureTech
Sponsor class: INDUSTRY
First posted: 2022-04-11
Enrollment: 240
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of decline in Forced Vital Capacity over 26 weeks (Part A)
timeFrame: 26 weeks
Secondary outcomes:
measure: Forced Vital Capacity (FVC) percent predicted change (Part A)
timeFrame: Baseline to Week 26
measure: Time to hospitalization or mortality (Part A)
timeFrame: 26 weeks
measure: Time to Idiopathic Pulmonary Fibrosis (IPF) progression (Part A)
timeFrame: 26 weeks
measure: Forced Vital Capacity (FVC) percent predicted change (Part B)
timeFrame: 26 Weeks
measure: Rate of decline in Forced Vital Capacity over 26 weeks (Part B)
timeFrame: 26 Weeks
measure: Time to Idiopathic Pulmonary Fibrosis (IPF) progression (Part B)
timeFrame: 26 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: Science 37
state: California
city: Newport Beach
country: United States
facility: NewportNativeMD, Inc.
state: California
city: Redding
country: United States
facility: Paradigm Clinical Research Centers, Inc.
state: California
city: Torrance
country: United States
facility: Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
state: California
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: DeLand
country: United States
facility: Accel Research Sites Network
state: Florida
city: Hialeah
country: United States
facility: Harmony Medical Research Institute, Inc
state: Florida
city: Atlanta
country: United States
facility: Piedmont Healthcare, Inc.
state: Georgia
city: Decatur
country: United States
facility: Clinical Research Investments
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Greensboro
country: United States
facility: Pulmonix
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Franklin
country: United States
facility: Clinical Trials Center of Middle Tennessee
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Woodlands
country: United States
facility: Renovatio Clinical - The Woodlands Research Center
state: Texas
city: Richmond
country: United States
facility: Pulmonary Associates of Richmond
state: Virginia
city: Williamsburg
country: United States
facility: TPMG Clinical Research
state: Virginia
city: Rosario
country: Argentina
facility: Instituto Médico de la Fundación de Estudios Clinicos / Fundación Estudios
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Aprillus Asistencia e Investigación
city: Buenos Aires
country: Argentina
facility: CEMER Centro Medico de Enfermedades Respiratorias
city: Córdoba
country: Argentina
facility: Instituto de Medicina Respiratoria - IMER
city: Florencio Varela
country: Argentina
facility: Instituto de Enfermedades Respiratorias e Investigación Clínica
city: Godoy Cruz
country: Argentina
facility: Respira Salud Clinica Integral
city: Mar Del Plata
country: Argentina
facility: Instituto Ave Pulmo - Fundacion Enfisema
city: Mendoza
country: Argentina
facility: Polo de Salud Vistalba
city: Mendoza
country: Argentina
facility: CIMRO- Centro de Investigación Médica Respiratoria Oncológica
city: Mendoza
country: Argentina
facility: INSARES - Instituto de Salud Respiratoria
city: Mendoza
country: Argentina
facility: Centro Médico Dharma
city: Santa Fe
country: Argentina
facility: Instituto del Buen Aire
city: Tucuman
country: Argentina
facility: Investigaciones en Patologías Respiratorias
city: Villa Regina
country: Argentina
facility: Clinica Central S.A.
city: Maule
country: Chile
facility: Clinica Maule
city: Santiago
country: Chile
facility: Centro de Estudios Clinicos
city: Santiago
country: Chile
facility: Clinica Universidad de Los Andes
city: Valparaiso
country: Chile
facility: Centro Respiratorio Integral
city: Armenia
country: Colombia
facility: Fundacion Cardiomet CEQUIN
city: Bucaramanga
country: Colombia
facility: Instituto Neumologico del Oriente S.A.
city: Cali
country: Colombia
facility: Centro de Investigaciones Clinicas S.A.S
city: Tbilisi
country: Georgia
facility: National Ceneter for Tuberculosis and Lung Diseases JSC
city: Tbilisi
country: Georgia
facility: Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
city: Tbilisi
country: Georgia
facility: Emergency Cardiology Center by Academician G. Chapidze LLC
city: Tbilisi
country: Georgia
facility: LTD Aversi Clinic
city: Tbilisi
country: Georgia
facility: LTD The First Medical Center
city: Alexandroupolis
country: Greece
facility: University Hospital Alexandroupolis
city: Athens
country: Greece
facility: "Sotiria" Chest Diseases Hospital of Athens
city: Athens
country: Greece
facility: University General Hospital "Attikon"
city: Athens
country: Greece
facility: Athens Medical Center
city: Patras
country: Greece
facility: University General Hospital of Patras
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "G. Papanikolaou"
city: Vadodara
country: India
facility: Rhythm Heart Institute Vadodara
state: Gujarat
city: Bengaluru
country: India
facility: Sparsh Super Specialty Hospital
state: Karnataka
city: Aurangabad
country: India
facility: Mgm Medical College And Hospital, Aurangabad
state: Maharashtra
city: Aurangabad
country: India
facility: Government Medical College and Hospital Aurangabad
state: Maharashtra
city: Aurangabad
country: India
facility: Oriion Citicare Super Specialty Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Getwell Hospital and Research Institute
state: Maharashtra
city: Hyderabad
country: India
facility: Govt. General and Chest Hospital
state: Telangana
city: Kanpur
country: India
facility: Apollo Spectra Hospital
state: Uttar Pradesh
city: Kolkata
country: India
facility: Nil Ratan Sircar Medical College And Hospital, Kolkata
state: West Bengal
city: Belagave
country: India
facility: BHS Lakeview Heart
city: Bucheon-si
country: Korea, Republic of
facility: The Catholic University Of Korea Bucheon St. Mary's Hospital
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Hanyang University - Myongji Hospital
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: InJe University Haeundae Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University - Dongsan Medical Center
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: CHA Bundang Medical Center
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St.Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Alor Setar
country: Malaysia
facility: Hospital Sultanah Bahiyah
state: Kedah
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang
city: Kajang
country: Malaysia
facility: Hospital Serdang
city: Kuala Lumpur
country: Malaysia
facility: Institut Perubatan Respiratori
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. José Eleuterio González
state: Nuevo Leon
city: San Nicolas de los Garza
country: Mexico
facility: Integral Health Medical Unit
state: Nuevo Leon
city: Calpulalpan
country: Mexico
facility: CALPULAB
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization
city: San Pedro Garza Garcia
country: Mexico
facility: ONCARE Group
city: Manila
country: Philippines
facility: Philippine General Hospital
city: Quezon City
country: Philippines
facility: Lung Center of the Philippines
city: Taguig
country: Philippines
facility: St. Luke's Medical Center - Global City
city: Iaşi
country: Romania
facility: S.C. Netconsult SRL
city: Oradea
country: Romania
facility: S.C. Lavinia Davidescu Clinic SRL
city: Timisoara
country: Romania
facility: "Dr. Victor Babes" Clinical Hospital of Infectious Diseases and Pneumophtisiology
city: Durban
country: South Africa
facility: Durban Lung Centre
city: Johannesburg
country: South Africa
facility: WITS Clinical Research
city: Johannesburg
country: South Africa
facility: Ahmed Kathrada Lenmed Private Hospital
city: Parktown
country: South Africa
facility: Netcare Milpark Hospital
city: Pretoria
country: South Africa
facility: Ryexo Clinical Research
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Khon Kaen
country: Thailand
facility: Khon Kaen University
city: Nonthaburi
country: Thailand
facility: Central Chest Institute Of Thailand
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital
Study officials:
affiliation: PureTech
name: Camilla Graham, MD
role: STUDY_DIRECTOR
References: