We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT05321420
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05321420
Recruitment Status : Recruiting
First Posted : April 11, 2022
Last Update Posted : August 19, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: Placebo Drug: Pirfenidone Drug: Deupirfenidone Phase 2

Detailed Description:
This study is a randomized, double-blind, being conducted at 60 centers globally to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in 240 treatment naive adult patients with IPF ≥40 to ≤80 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : July 29, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : March 2024


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




Primary Outcome Measures :
  1. Rate of decline in Forced Vital Capacity over 26 weeks [ Time Frame: 26 weeks ]
    Rate of decline in Forced Vital Capacity (FVC; in mL)


Secondary Outcome Measures :
  1. FVC percent predicted change [ Time Frame: Baseline to Week 26 ]
    FVC percent predicted (FVCpp) change from baseline to Week 26

  2. Time to hospitalization or mortality [ Time Frame: 26 weeks ]
    Time to hospitalization or mortality due to respiratory cause through 26 weeks

  3. Time to IPF progression [ Time Frame: 26 weeks ]
    Time to IPF progression through 26 weeks, as defined by a decline in FVC% of 5% or greater or death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Treatment naïve patients 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% 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05321420


Contacts
Layout table for location contacts
Contact: Liza Micioni 732-614-8073 clinicaltrials@puretechhealth.com

Locations
Layout table for location information
United States, California
Paradigm Clinical Research Centers, Inc. Recruiting
Redding, California, United States, 96001
United States, Florida
Central Florida Pulmonary Group Not yet recruiting
Altamonte Springs, Florida, United States, 32701
Harmony Medical Research Institute, Inc Not yet recruiting
Hialeah, Florida, United States, 33016
Central Florida Pulmonary Group P.A. CFPG - Downtown Orlando Not yet recruiting
Orlando, Florida, United States, 32803
United States, North Carolina
Southeastern Research Center Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Tennessee
Clinical Trials Center of Middle Tennessee Recruiting
Franklin, Tennessee, United States, 37067
United States, Virginia
TPMG Clinical Research Not yet recruiting
Williamsburg, Virginia, United States, 23188
Sponsors and Collaborators
PureTech
Investigators
Layout table for investigator information
Study Director: Simon J Hatch, MD PureTech
Layout table for additonal information
Responsible Party: PureTech
ClinicalTrials.gov Identifier: NCT05321420    
Other Study ID Numbers: LYT-100-2022-204
First Posted: April 11, 2022    Key Record Dates
Last Update Posted: August 19, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PureTech:
IPF
lung fibrosis
respiratory disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Pirfenidone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents