What side effects are associated with this type of intervention?

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) include the antifibrotic medications nintedanib and pirfenidone. Nintedanib is frequently associated with gastrointestinal side effects, particularly diarrhea, as well as anorexia. Pirfenidone commonly causes nausea, rash, and photosensitivity. Both medications can lead to liver enzyme elevations, necessitating regular monitoring. These side effects are significant considerations in the management of IPF.

What prior FDA approvals exist?

The FDA has approved two main antifibrotic drugs for the treatment of Idiopathic Pulmonary Fibrosis (IPF): nintedanib and pirfenidone. Nintedanib works by blocking multiple tyrosine kinases involved in fibrogenic growth factors, while pirfenidone has both antifibrotic and anti-inflammatory properties. Both drugs have been shown to slow the progression of IPF and reduce the frequency of acute exacerbations, representing the current standard of care for this condition.

What other types of research exist?

Promising alternatives to Leramistat for Idiopathic Pulmonary Fibrosis (IPF) include nintedanib, pirfenidone, and pamrevlumab. Nintedanib and pirfenidone have been shown to slow the decline in lung function and reduce mortality in IPF patients. Pamrevlumab, an anti-connective tissue growth factor therapy, has also demonstrated efficacy in clinical trials. These treatments represent viable options for IPF patients considering therapy in 2024.

← Back to Search

Monoclonal Antibodies

Leramistat for Idiopathic Pulmonary Fibrosis

Phase 2

Recruiting

Research Sponsored by Modern Biosciences Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

If on anti-fibrotics, only the approved treatments of nintedanib or pirfenidone are allowed. Participants must be on a stable dose for at least 8 weeks prior to Visit 1

Has an FVC ≥45% of predicted

Must not have

Participants with chronic obstructive pulmonary disease (COPD) or asthma that require >2 maintenance therapies

History of opportunistic, chronic, or recurrent infections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

This trial is testing a new medication called leramistat in people aged 40 and older who have idiopathic pulmonary fibrosis (IPF). The goal is to see if leramistat can reduce lung scarring or inflammation.

Who is the study for?

This trial is for adults over 40 with idiopathic pulmonary fibrosis (IPF), able to walk at least 150 meters, and on stable anti-fibrotic treatment if any. They should have a certain level of lung function and life expectancy of more than a year. Excluded are those with significant heart issues, drug allergies including to leramistat, severe emphysema or COPD, recent cancer except some skin cancers, or history of serious infections.

What is being tested?

The study tests the effects of Leramistat against a placebo in treating IPF over 12 weeks. Participants will take daily oral doses to see if there's an improvement in their condition compared to those taking the non-active placebo.

What are the potential side effects?

While specific side effects for Leramistat aren't listed here, common ones may include digestive discomforts like nausea or diarrhea, potential liver enzyme changes, fatigue or possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been on a stable dose of nintedanib or pirfenidone for at least 8 weeks.

Select...

My lung function is at least 45% of what is expected.

Select...

I can walk at least 150 meters in 6 minutes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I use more than two treatments regularly for my COPD or asthma.

Select...

I have a history of frequent or long-lasting infections.

Select...

More than half of my lungs show signs of emphysema on a high-resolution CT scan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Forced vital capacity (FVC)

Secondary study objectives

% predicted FVC

%DLCO

Acute exacerbations

+2 more

Other study objectives

Adverse effects

Plasma pharmacokinetics

biomarkers in serum and plasma

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LeramistatExperimental Treatment1 Intervention

Leramistat once daily

Group II: PlaceboPlacebo Group1 Intervention

Placebo comparator

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

Nintedanib and pirfenidone are the most common treatments for Idiopathic Pulmonary Fibrosis (IPF). Nintedanib is a tyrosine kinase inhibitor that targets multiple growth factor receptors involved in the fibrotic process, thereby slowing the progression of fibrosis. Pirfenidone, on the other hand, has anti-inflammatory and antifibrotic properties, inhibiting the synthesis of TGF-beta, a key molecule in the fibrotic pathway. These treatments are crucial for IPF patients as they help to slow the decline in lung function, reduce the frequency of acute exacerbations, and potentially improve survival rates, offering a better quality of life despite the disease's progressive nature.

TGF-beta-induced EMT: mechanisms and implications for fibrotic lung disease.[Experimental models for the study of pulmonary fibrosis: current usefulness and future promise].