What side effects are associated with this type of intervention?

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) are the antifibrotic medications nintedanib and pirfenidone. Nintedanib is frequently associated with gastrointestinal side effects, particularly diarrhea, which can be severe and lead to treatment discontinuation. Other side effects include nausea, vomiting, and liver enzyme elevation. Pirfenidone commonly causes gastrointestinal issues such as nausea, dyspepsia, and diarrhea, as well as skin-related side effects like rash and photosensitivity. Both medications aim to slow disease progression but do not cure IPF.

What prior FDA approvals exist?

The FDA has approved two primary drugs for the treatment of Idiopathic Pulmonary Fibrosis (IPF): nintedanib and pirfenidone. Nintedanib works by blocking multiple tyrosine kinases involved in fibrogenic growth factor pathways, thereby slowing disease progression. Pirfenidone is an antifibrotic agent that has demonstrated efficacy in reducing lung function decline and mortality in IPF patients. These treatments are relevant to the ongoing trial of LYT-100, which is being compared to pirfenidone.

What other types of research exist?

Promising alternatives to LYT-100 for IPF patients include: <ol> <li>Nintedanib: Shown to retard lung function decline and potentially reverse lung fibrosis.</li> <li></li> </ol> Pirfenidone: Demonstrated to slow disease progression and reduce mortality. 3. TD139: A Galectin-3 inhibitor that has shown safety and tolerability in early trials. 4. INS1009: An inhaled treprostinil prodrug that inhibits pulmonary fibrosis in preclinical models. 5. Pamrevlumab: An anti-connective tissue growth factor therapy that has shown efficacy in clinical trials.

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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 0 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial tests LYT-100, a new drug, in adults aged 40+ with Idiopathic Pulmonary Fibrosis who haven't been treated before. It aims to see if the drug can slow down the decline in lung function.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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:

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I know the cause of my lung condition, such as radiation or an infection.

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I have not had a heart attack in the last 6 months.

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I was hospitalized for COVID-19 or a serious lung infection within the last 3 months.

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I have taken pirfenidone before.

Timeline

Screening ~ 28 days1 visit

Treatment ~ 26 weeks9 visits

Follow Up ~ 0 months0 visits

Screening ~ 28 days

Treatment ~ 26 weeks

Follow Up ~0 months

This trial's timeline: 28 days for screening, 26 weeks for treatment, and 0 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of decline in Forced Vital Capacity over 26 weeks

Secondary study objectives

FVC percent predicted change

Time to IPF progression

Time to hospitalization or mortality

Awards & Highlights

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.

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

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) are the antifibrotic medications nintedanib and pirfenidone. Nintedanib works by inhibiting multiple tyrosine kinases involved in the signaling pathways that lead to fibrosis, thereby slowing the progression of lung scarring. Pirfenidone, on the other hand, exerts its effects by reducing the production of fibrogenic mediators and cytokines, which also helps to slow the progression of fibrosis. These treatments are crucial for IPF patients as they help to manage the disease by slowing lung function decline and reducing the frequency of acute exacerbations, thereby potentially improving quality of life and survival.

Epithelial-Mesenchymal Transition: A Major Pathogenic Driver in Idiopathic Pulmonary Fibrosis?TGF-beta-induced EMT: mechanisms and implications for fibrotic lung disease.[Experimental models for the study of pulmonary fibrosis: current usefulness and future promise].