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

February 29, 2024 updated by: PureTech

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1406
        • Recruiting
        • APRILLUS Asistencia e Investigacion
      • Buenos Aires, Argentina, 1602
        • Recruiting
        • CEMER Centro Medico de Enfermedades Respiratorias
      • Córdoba, Argentina, X5003DCE
        • Recruiting
        • Instituto de Medicina Respiratoria - Imer
      • Florencio Varela, Argentina, 1888
        • Recruiting
        • Instituto de Enfermedades Respiratorias e Investigación Clínica
      • Godoy Cruz, Argentina, 5501
        • Recruiting
        • Respira Salud Clinica Integral
      • Mar Del Plata, Argentina, 7600
        • Recruiting
        • Instituto Ave Pulmo - Fundación enfisema
      • Mendoza, Argentina, 1428
        • Recruiting
        • Polo de Salud Vistalba
      • Mendoza, Argentina, 5600
        • Recruiting
        • CIMRO- Centro de Investigación Médica Respiratoria Oncológica
      • Mendoza, Argentina, M5500CCG
        • Recruiting
        • INSARES - Instituto de Salud Respiratoria
      • Mendoza, Argentina, M5500
        • Recruiting
        • Centro Medico Dharma
      • Santa Fe, Argentina, 3000
        • Recruiting
        • Instituto Del Buen Aire
      • Tucuman, Argentina, 4000
        • Recruiting
        • Investigaciones en Patologias Respiratorias
      • Villa Regina, Argentina, 8336
        • Recruiting
        • Clinica Central S.A.
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Recruiting
        • Instituto Médico de la Fundación de Estudios Clinicos / Fundación Estudios
  • Chile
      • Maule, Chile, 3530000
        • Recruiting
        • Clinica Maule
      • Santiago, Chile, 7550000
        • Not yet recruiting
        • Centro de Estudios Clinicos
      • Santiago, Chile, 7550000
        • Recruiting
        • Clínica Universidad de los Andes
      • Valparaiso, Chile
        • Recruiting
        • Centro Respiratorio Integral
  • Colombia
      • Armenia, Colombia
        • Recruiting
        • Fundacion Cardiomet CEQUIN
      • Bucaramanga, Colombia
        • Recruiting
        • Instituto Neumologico del Oriente S.A.
      • Cali, Colombia, 760036
        • Not yet recruiting
        • Centro de Investigaciones Clinicas S.A.S
  • Georgia
      • Tbilisi, Georgia, 0160
        • Recruiting
        • LTD Aversi Clinic
      • Tbilisi, Georgia, 0159
        • Not yet recruiting
        • LTD Academician Nikoloz Kipshidze Central University Clinic
      • Tbilisi, Georgia, 0144
        • Recruiting
        • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
      • Tbilisi, Georgia, 0159
        • Recruiting
        • Emergency Cardiology Center by Academician G. Chapidze LLC
      • Tbilisi, Georgia, 0180
        • Recruiting
        • LTD The First Medical Center
      • Tbilisi, Georgia, 0101
        • Withdrawn
        • National Ceneter for Tuberculosis and Lung Diseases JSC
  • Greece
      • Alexandroupolis, Greece, 68100
        • Recruiting
        • University Hospital Alexandroupolis
      • Athens, Greece, 15125
        • Recruiting
        • Athens Medical Center
      • Athens, Greece, 12462
        • Recruiting
        • University General Hospital "Attikon"
      • Athens, Greece, 11527
        • Recruiting
        • "Sotiria" Chest Diseases Hospital of Athens
      • Heraklion, Greece, 71110
        • Recruiting
        • University General Hospital of Heraklion
      • Larissa, Greece, 41110
        • Not yet recruiting
        • University General Hospital of Larissa
      • Patras, Greece, 26504
        • Recruiting
        • University General Hospital of Patras
      • Thessaloniki, Greece, 57010
        • Recruiting
        • General Hospital of Thessaloniki "G. Papanikolaou"
  • India
      • Belagave, India, 590016
        • Recruiting
        • BHS Lakeview Heart
    • Gujarat
      • Vadodara, Gujarat, India, 390022
        • Recruiting
        • Rhythm Heart Institute Vadodara
    • Karnataka
      • Bengaluru, Karnataka, India, 560001
        • Recruiting
        • Sparsh Super Specialty Hospital
    • Maharashtra
      • Aurangabad, Maharashtra, India, 431004
        • Not yet recruiting
        • Government Medical College and Hospital Aurangabad
      • Aurangabad, Maharashtra, India, 431003
        • Recruiting
        • Mgm Medical College And Hospital, Aurangabad
      • Aurangabad, Maharashtra, India, 431005
        • Recruiting
        • Oriion Citicare Super Specialty Hospital
      • Nagpur, Maharashtra, India, 440012
        • Recruiting
        • Getwell Hospital and Research Institute
    • Telangana
      • Hyderabad, Telangana, India, 500038
        • Recruiting
        • Govt. General and Chest Hospital
    • Uttar Pradesh
      • Kanpur, Uttar Pradesh, India, 208001
        • Recruiting
        • Apollo Spectra Hospital
    • West Bengal
      • Kolkata, West Bengal, India, 700014
        • Recruiting
        • Nil Ratan Sircar Medical College And Hospital, Kolkata
  • Korea, Republic of
      • Busan, Korea, Republic of, 48108
        • Recruiting
        • Inje University Haeundae Paik Hospital
      • Daegu, Korea, Republic of, 42601
        • Recruiting
        • Keimyung University - Dongsan Medical Center
      • Gwangju, Korea, Republic of, 61469
        • Recruiting
        • Chonnam National University Hospital
      • Gyeonggi-do, Korea, Republic of, 13496
        • Recruiting
        • Cha Bundang Medical Center
      • Incheon, Korea, Republic of, 21565
        • Recruiting
        • Gachon University Gil Medical Center
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 04763
        • Recruiting
        • Hanyang University Seoul Hospital
      • Seoul, Korea, Republic of, 02841
        • Recruiting
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 04401
        • Recruiting
        • Soon Chun Hyang University Hospital Seoul
      • Seoul, Korea, Republic of, 02447
        • Recruiting
        • Kyung Hee University Hospital
      • Seoul, Korea, Republic of, 07345
        • Recruiting
        • The Catholic University of Korea, Yeouido St.Mary's Hospital
      • Suwon, Korea, Republic of, 16499
        • Not yet recruiting
        • Ajou University Hospital
      • Ulsan, Korea, Republic of, 44033
        • Recruiting
        • Ulsan University Hospital
    • Gyeonggi-do
      • Bucheon-si, Gyeonggi-do, Korea, Republic of, 14647
        • Recruiting
        • The Catholic University of Korea Bucheon St. Mary's Hospital
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10475
        • Recruiting
        • Hanyang University - Myongji Hospital
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
        • Recruiting
        • Chonbuk National University Hospital
  • Malaysia
      • George Town, Malaysia, 10450
        • Recruiting
        • Hospital Pulau Pinang
      • Kajang, Malaysia
        • Recruiting
        • Hospital Serdang
      • Kuala Lumpur, Malaysia
        • Recruiting
        • University Malaya Medical Centre
      • Kuala Lumpur, Malaysia
        • Recruiting
        • Institut Perubatan Respiratori
      • Kuala Terengganu, Malaysia, 93586
        • Recruiting
        • Hospital Sultanah Nur Zahirah
      • Kuantan, Malaysia
        • Recruiting
        • Hospital Tengku Ampuan Afzan
      • Kuching, Malaysia, 93586
        • Recruiting
        • Sarawak General Hospital, Clinical Research Centre
    • Kedah
      • Alor Setar, Kedah, Malaysia, 05460
        • Recruiting
        • Hospital Sultanah Bahiyah
  • Mexico
      • Calpulalpan, Mexico, 90204
        • Recruiting
        • CALPULAB
      • Oaxaca, Mexico, 68000
        • Recruiting
        • Oaxaca Site Management Organization
      • San Pedro Garza Garcia, Mexico, 66220
        • Recruiting
        • ONCARE Group
    • Jalisco
      • Zapopan, Jalisco, Mexico, 44220
        • Recruiting
        • Occident Medical Unit
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Recruiting
        • Hospital Universitario Dr. José Eleuterio González
      • San Nicolas de los Garza, Nuevo Leon, Mexico, 66465
        • Recruiting
        • Integral Health Medical Unit
  • Philippines
      • Manila, Philippines, 1000
        • Recruiting
        • Philippine General Hospital
      • Manila, Philippines, 1100
        • Recruiting
        • Philippine Heart Center
      • Quezon City, Philippines, 1100
        • Not yet recruiting
        • Lung Center of the Philippines
      • Taguig, Philippines, 1634
        • Recruiting
        • St. Luke's Medical Center - Global City
  • Romania
      • Bucharest, Romania, 050159
        • Withdrawn
        • "Marius Nasta" Pneumophtisiology Institute
      • Craiova, Romania, 200446
        • Withdrawn
        • "Victor Babes" Clinical Hospital of Infectious Diseases
      • Iaşi, Romania, 700141
        • Recruiting
        • S.C. Netconsult SRL
      • Oradea, Romania, 410163
        • Recruiting
        • S.C. Lavinia Davidescu Clinic SRL
      • Timisoara, Romania, 300312
        • Recruiting
        • "Dr. Victor Babes" Clinical Hospital of Infectious Diseases and Pneumophtisiology
  • South Africa
      • Cape Town, South Africa, 7441
        • Recruiting
        • Wellness and Clinical Trial Centre
      • Durban, South Africa, 4051
        • Recruiting
        • Durban Lung Centre
      • Johannesburg, South Africa
        • Recruiting
        • Ahmed Kathrada Lenmed Private Hospital
      • Johannesburg, South Africa, 2193
        • Recruiting
        • Charlotte Maxeke Johannesburg Academic Hospital
      • Parktown, South Africa, 2193
        • Recruiting
        • Netcare Milpark Hospital
      • Pretoria, South Africa, 0084
        • Recruiting
        • RYEXO Clinical Research
  • Thailand
      • Bangkok, Thailand
        • Recruiting
        • Siriraj Hospital
      • Khon Kaen, Thailand
        • Not yet recruiting
        • Khon Kaen University
      • Nonthaburi, Thailand
        • Recruiting
        • Central Chest Institute of Thailand
      • Songkhla, Thailand
        • Recruiting
        • Songklanagarind Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama Birmingham
    • California
      • Los Angeles, California, United States, 90089
        • Recruiting
        • University of Southern California
      • Los Angeles, California, United States, 90230
        • Recruiting
        • Science 37
      • Newport Beach, California, United States, 92663
        • Recruiting
        • NewportNativeMD, Inc.
      • Redding, California, United States, 96001
        • Recruiting
        • Paradigm Clinical Research Centers, Inc.
      • Torrance, California, United States, 90502
        • Recruiting
        • Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Not yet recruiting
        • University of Connecticut Health Center
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Withdrawn
        • Central Florida Pulmonary Group
      • DeLand, Florida, United States, 32720
        • Recruiting
        • Accel Research Sites Network
      • Hialeah, Florida, United States, 33016
        • Recruiting
        • Harmony Medical Research Institute, Inc
      • Orlando, Florida, United States, 32803
        • Withdrawn
        • Central Florida Pulmonary Group P.A. CFPG - Downtown Orlando
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Healthcare, Inc.
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • Clinical Research Investments
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University School of Medicine
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Withdrawn
        • University of New Mexico School of Medicine
    • North Carolina
      • Greensboro, North Carolina, United States, 27403
        • Recruiting
        • Pulmonix
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Southeastern Research Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Recruiting
        • Clinical Trials Center of Middle Tennessee
      • Nashville, Tennessee, United States, 37204
        • Not yet recruiting
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75204
        • Recruiting
        • Baylor Scott & White Research Institute
      • McKinney, Texas, United States, 75069
        • Recruiting
        • Metroplex Pulmonary & Sleep Center P.A.
      • The Woodlands, Texas, United States, 77380
        • Recruiting
        • Renovatio Clinical - The Woodlands Research Center
    • Virginia
      • Richmond, Virginia, United States, 23230
        • Recruiting
        • Pulmonary Associates of Richmond
      • Williamsburg, Virginia, United States, 23188
        • Recruiting
        • TPMG Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo oral administration
Drug: Placebo
placebo
Active Comparator: pirfenidone 801 mg TID
pirfenidone 801 mg TID oral administration
Drug: Pirfenidone
pirfenidone 801 mg TID
Experimental: LYT-100 550 mg TID
LYT-100 (Deupirfenidone) 550 mg TID oral administration
Drug: Deupirfenidone
Deupirfenidone
Experimental: LYT-100 825 mg TID
LYT-100 (Deupirfenidone) 825 mg TID oral administration
Drug: Deupirfenidone
Deupirfenidone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of decline in Forced Vital Capacity over 26 weeks (Part A)
Time Frame: 26 weeks
Rate of decline in Forced Vital Capacity (FVC; in mL)
26 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PureTech

Investigators

  • Study Director: Carol Satler, MD, PureTech

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2022

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

April 2, 2022

First Submitted That Met QC Criteria

April 2, 2022

First Posted (Actual)

April 11, 2022

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LYT-100-2022-204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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