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LYT-100 (Deupirfenidone) for Idiopathic Pulmonary Fibrosis (ELEVATE Trial)
Verified Trial
Phase 2
Recruiting
Research Sponsored by PureTech
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Treatment naïve patients or those with <6 months of exposure to nintedanib with physician diagnosed IPF based on ATS/ERS/JRS/ALAT 2018 guidelines
Be older than 18 years old
Must not have
Use of smoked (burnt) tobacco products or vaping/e-cigarettes?
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
Timeline
Screening 28 days
Treatment 26 weeks
Follow Up 26 weeks
Awards & highlights
ELEVATE Trial Summary
ELEVATE is testing a new investigational drug, LYT-100, to see if it has improved safety (better tolerated) than one of the currently approved treatments for idiopathic pulmonary fibrosis, pirfenidone, and to demonstrate if it has improved efficacy (works better) than a placebo.
Who is the study for?
This trial is for adults with Idiopathic Pulmonary Fibrosis (IPF) who are new to treatment or have had less than 6 months of a specific drug. They must be able to follow the study's procedures and not use tobacco products, including vaping. People with other lung diseases, recent serious heart issues, hospitalization due to COVID-19 or IPF flare-ups, or certain infections can't join.Check my eligibility
What is being tested?
The study is testing LYT-100 against pirfenidone (an existing medication for IPF) and placebo in a randomized, double-blind setup where neither participants nor researchers know who gets which treatment until after the results are collected.See study design
What are the potential side effects?
While side effects aren't specified here, common ones from similar drugs include stomach discomfort, skin reactions from sun exposure, fatigue, headache and dizziness. The trial will monitor any adverse effects that arise.
ELEVATE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have IPF diagnosed by a doctor and haven't used nintedanib for more than 6 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I know the cause of my lung condition, such as radiation or an infection.
Select...
I have not had a heart attack in the last 6 months.
Select...
I was hospitalized for COVID-19 or a serious lung infection within the last 3 months.
Select...
I have taken pirfenidone before.
ELEVATE Trial Timeline
Screening ~ 28 days1 visit
Treatment ~ 26 weeks9 visits
Follow Up ~ 26 weeks
Screening ~ 28 days
Treatment ~ 26 weeks
Follow Up ~26 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of decline in Forced Vital Capacity over 26 weeks
Secondary outcome measures
FVC percent predicted change
Time to IPF progression
Time to hospitalization or mortality
ELEVATE Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: LYT-100 825 mg TIDExperimental Treatment1 Intervention
LYT-100 (Deupirfenidone) 825 mg TID oral administration
Group II: LYT-100 550 mg TIDExperimental Treatment1 Intervention
LYT-100 (Deupirfenidone) 550 mg TID oral administration
Group III: pirfenidone 801 mg TIDActive Control1 Intervention
pirfenidone 801 mg TID oral administration
Group IV: PlaceboPlacebo Group1 Intervention
Placebo oral administration
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
PureTechLead Sponsor
5 Previous Clinical Trials
591 Total Patients Enrolled
Wassim Fares, MDStudy DirectorPureTech
Sarah SantipadriStudy DirectorPureTech
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow all study procedures.I have IPF diagnosed by a doctor and haven't used nintedanib for more than 6 months.I know the cause of my lung condition, such as radiation or an infection.I was hospitalized for COVID-19 or a serious lung infection within the last 3 months.I have a known cause for my lung condition, such as radiation treatment or an autoimmune disease.I have taken pirfenidone before.I have not had unstable heart pain in the last 6 months.I have not had a heart attack in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: LYT-100 825 mg TID
- Group 2: LYT-100 550 mg TID
- Group 3: Placebo
- Group 4: pirfenidone 801 mg TID
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 28 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 26 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 0 Months after you stop receiving the treatment.
Idiopathic Pulmonary Fibrosis Patient Testimony for trial: Trial Name: NCT05321420 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are involved in this experiment?
"240 individuals that meet the pre-determined inclusion criteria are required for this clinical trial. Different sites, such as Central Florida Pulmonary Group in Altamonte Springs, North carolina and Southeastern Research Center in Winston-Salem, Tennessee are participating in this research."
Answered by AI
If a potential test subject is under 45, would they be automatically disqualified from the trial?
"This trial is looking for volunteers that are at least 40 years old and no older than 80."
Answered by AI
Are there any long-term side effects of taking Deupirfenidone?
"Since Deupirfenidone is only in Phase 2 clinical trials, there is not yet data supporting its efficacy. However, it has been given a safety score of 2 by our team at Power."
Answered by AI
In how many distinct places is this research being conducted?
"Currently, this trial is taking place in 7 locations. They are situated in Altamonte Springs, Winston-Salem and Franklin as well as 4 other sites. If you wish to enroll, try and choose the location that is closest to you so that travelling is not a significant burden."
Answered by AI
Could I possibly be one of the people who helps test this new medical treatment?
"The ideal candidate for this study should have usual interstitial pneumonia, be between 40 and 80 years old. There is a goal to recruit 240 patients in total."
Answered by AI
Are we currently able to enroll new participants in this clinical trial?
"The details available on clinicaltrials.gov show that this trial is currently recruiting patients. This trial was posted on 7/29/2022 and was most recently edited on 8/17/2022. There are 240 participants needed for the study, which will take place at 7 sites."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
What site did they apply to?
Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
Baylor Scott & White Research Institute
Other
Clinical Trials Center of Middle Tennessee
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
Why did patients apply to this trial?
Last month they found something on my lung and called it a 9mm lung nodule.
PatientReceived 1 prior treatment
I’m currently on Cellcept but may need to move on to an anti fibrotic according to my pulmonologist. Just wanted more details on whether or not this trial would be good for me.
PatientReceived no prior treatments
I have been just diagnosed with mild IPF. My first visit with Pulminologist is March 4. I believe since I have not started medications,my data would be initiatal treatment without other factors. I have a strong biochemistry and understand the significance of this for drug discovery.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Are all expenses, i.e. prescriptions, travel, incentives,etc, covered in the trial?
PatientReceived no prior treatments
How responsive is this trial?
Most responsive sites:
- Clinical Trials Center of Middle Tennessee: < 48 hours
Typically responds via
Phone Call
Average response time
- < 2 Days
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