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

Phase 2

Active, not recruiting

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Deupirfenidone; Drug: Placebo; Drug: Pirfenidone

• 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.

Study Timeline

• Study First Submitted: 2022-04-02
• Study First Submitted QC: 2022-04-02
• Study First Posted: 2022-04-11
• Study Start: 2022-07-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Primary Completion: 2024-10
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 240

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LYT-100 550 mg TID	Deupirfenidone	LYT-100 (Deupirfenidone) 550 mg TID oral administration
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

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)

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Science 37; 🇺🇸 Los Angeles, California, United States

Instituto de Medicina Respiratoria - IMER; 🇦🇷 Córdoba, Argentina

Pulmonix; 🇺🇸 Greensboro, North Carolina, United States

TPMG Clinical Research; 🇺🇸 Williamsburg, Virginia, United States

Aprillus Asistencia e Investigación; 🇦🇷 Buenos Aires, Argentina

Harmony Medical Research Institute, Inc; 🇺🇸 Hialeah, Florida, United States

Clinical Research Investments; 🇺🇸 Decatur, Georgia, United States

Clinical Trials Center of Middle Tennessee; 🇺🇸 Franklin, Tennessee, United States

CEMER Centro Medico de Enfermedades Respiratorias; 🇦🇷 Buenos Aires, Argentina

Centro Respiratorio Integral; 🇨🇱 Valparaiso, Chile

Polo de Salud Vistalba; 🇦🇷 Mendoza, Argentina

Clinica Universidad de Los Andes; 🇨🇱 Santiago, Chile

University Hospital Alexandroupolis; 🇬🇷 Alexandroupolis, Greece

INSARES - Instituto de Salud Respiratoria; 🇦🇷 Mendoza, Argentina

Clinica Central S.A.; 🇦🇷 Villa Regina, Argentina

Investigaciones en Patologías Respiratorias; 🇦🇷 Tucuman, Argentina

BHS Lakeview Heart; 🇮🇳 Belagave, India

Hanyang University Seoul Hospital; 🇰🇷 Seoul, Korea, Republic of

Keimyung University - Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

CHA Bundang Medical Center; 🇰🇷 Gyeonggi-do, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Hospital Serdang; 🇲🇾 Kajang, Malaysia

Oaxaca Site Management Organization; 🇲🇽 Oaxaca, Mexico

Ahmed Kathrada Lenmed Private Hospital; 🇿🇦 Johannesburg, South Africa

St. Luke's Medical Center - Global City; 🇵🇭 Taguig, Philippines

Durban Lung Centre; 🇿🇦 Durban, South Africa

ONCARE Group; 🇲🇽 San Pedro Garza Garcia, Mexico

Lung Center of the Philippines; 🇵🇭 Quezon City, Philippines

WITS Clinical Research; 🇿🇦 Johannesburg, South Africa

Khon Kaen University; 🇹🇭 Khon Kaen, Thailand

Siriraj Hospital; 🇹🇭 Bangkok, Thailand

Ryexo Clinical Research; 🇿🇦 Pretoria, South Africa

University of Alabama Birmingham; 🇺🇸 Birmingham, Alabama, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

NewportNativeMD, Inc.; 🇺🇸 Newport Beach, California, United States

University of Connecticut Health Center; 🇺🇸 Farmington, Connecticut, United States

Paradigm Clinical Research Centers, Inc.; 🇺🇸 Redding, California, United States

Accel Research Sites Network; 🇺🇸 DeLand, Florida, United States

Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center; 🇺🇸 Torrance, California, United States

Piedmont Healthcare, Inc.; 🇺🇸 Atlanta, Georgia, United States

Renovatio Clinical - The Woodlands Research Center; 🇺🇸 The Woodlands, Texas, United States

Baylor Scott & White Research Institute; 🇺🇸 Dallas, Texas, United States

Instituto Ave Pulmo - Fundacion Enfisema; 🇦🇷 Mar Del Plata, Argentina

Respira Salud Clinica Integral; 🇦🇷 Godoy Cruz, Argentina

Instituto de Enfermedades Respiratorias e Investigación Clínica; 🇦🇷 Florencio Varela, Argentina

Centro Médico Dharma; 🇦🇷 Mendoza, Argentina

CIMRO- Centro de Investigación Médica Respiratoria Oncológica; 🇦🇷 Mendoza, Argentina

Instituto del Buen Aire; 🇦🇷 Santa Fe, Argentina

Centro de Estudios Clinicos; 🇨🇱 Santiago, Chile

Instituto Neumologico del Oriente S.A.; 🇨🇴 Bucaramanga, Colombia

National Ceneter for Tuberculosis and Lung Diseases JSC; 🇬🇪 Tbilisi, Georgia

LTD The First Medical Center; 🇬🇪 Tbilisi, Georgia

University General Hospital "Attikon"; 🇬🇷 Athens, Greece

"Sotiria" Chest Diseases Hospital of Athens; 🇬🇷 Athens, Greece

Athens Medical Center; 🇬🇷 Athens, Greece

General Hospital of Thessaloniki "G. Papanikolaou"; 🇬🇷 Thessaloniki, Greece

Rhythm Heart Institute Vadodara; 🇮🇳 Vadodara, Gujarat, India

University General Hospital of Patras; 🇬🇷 Patras, Greece

Sparsh Super Specialty Hospital; 🇮🇳 Bengaluru, Karnataka, India

Oriion Citicare Super Specialty Hospital; 🇮🇳 Aurangabad, Maharashtra, India

Hanyang University - Myongji Hospital; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of

Kyung Hee University Hospital; 🇰🇷 Seoul, Korea, Republic of

Nil Ratan Sircar Medical College And Hospital, Kolkata; 🇮🇳 Kolkata, West Bengal, India

InJe University Haeundae Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Hospital Pulau Pinang; 🇲🇾 George Town, Malaysia

Hospital Sultanah Bahiyah; 🇲🇾 Alor Setar, Kedah, Malaysia

The Catholic University of Korea, Yeouido St.Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Hospital Universitario Dr. José Eleuterio González; 🇲🇽 Monterrey, Nuevo Leon, Mexico

Integral Health Medical Unit; 🇲🇽 San Nicolas de los Garza, Nuevo Leon, Mexico

Philippine General Hospital; 🇵🇭 Manila, Philippines

CALPULAB; 🇲🇽 Calpulalpan, Mexico

"Dr. Victor Babes" Clinical Hospital of Infectious Diseases and Pneumophtisiology; 🇷🇴 Timisoara, Romania

S.C. Netconsult SRL; 🇷🇴 Iaşi, Romania

S.C. Lavinia Davidescu Clinic SRL; 🇷🇴 Oradea, Romania

Netcare Milpark Hospital; 🇿🇦 Parktown, South Africa

Songklanagarind Hospital; 🇹🇭 Songkhla, Thailand

Central Chest Institute Of Thailand; 🇹🇭 Nonthaburi, Thailand

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

The Catholic University Of Korea Bucheon St. Mary's Hospital; 🇰🇷 Bucheon-si, Gyeonggi-do, Korea, Republic of

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of

Clinica Maule; 🇨🇱 Maule, Chile

Hospital Tengku Ampuan Afzan; 🇲🇾 Kuantan, Malaysia

University Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Malaysia

Fundacion Cardiomet CEQUIN; 🇨🇴 Armenia, Colombia

LTD Aversi Clinic; 🇬🇪 Tbilisi, Georgia

Centro de Investigaciones Clinicas S.A.S; 🇨🇴 Cali, Colombia

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC; 🇬🇪 Tbilisi, Georgia

Emergency Cardiology Center by Academician G. Chapidze LLC; 🇬🇪 Tbilisi, Georgia

Instituto Médico de la Fundación de Estudios Clinicos / Fundación Estudios; 🇦🇷 Rosario, Santa Fe, Argentina

Institut Perubatan Respiratori; 🇲🇾 Kuala Lumpur, Malaysia

Southeastern Research Center; 🇺🇸 Winston-Salem, North Carolina, United States

Pulmonary Associates of Richmond; 🇺🇸 Richmond, Virginia, United States

Government Medical College and Hospital Aurangabad; 🇮🇳 Aurangabad, Maharashtra, India

Mgm Medical College And Hospital, Aurangabad; 🇮🇳 Aurangabad, Maharashtra, India

Getwell Hospital and Research Institute; 🇮🇳 Nagpur, Maharashtra, India

Apollo Spectra Hospital; 🇮🇳 Kanpur, Uttar Pradesh, India

Govt. General and Chest Hospital; 🇮🇳 Hyderabad, Telangana, India

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States