What side effects are associated with this type of intervention?

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) include antifibrotic agents like pirfenidone and nintedanib. Pirfenidone is associated with side effects such as gastrointestinal issues (nausea, diarrhea), skin reactions (rash, photosensitivity), and liver enzyme abnormalities. Nintedanib commonly causes gastrointestinal symptoms (diarrhea, nausea, vomiting), liver enzyme elevations, and may increase the risk of bleeding. Both medications require monitoring for adverse effects to manage and mitigate potential complications.

What prior FDA approvals exist?

The FDA has approved two primary antifibrotic medications for the treatment of Idiopathic Pulmonary Fibrosis (IPF): nintedanib and pirfenidone. Nintedanib, a receptor blocker for multiple tyrosine kinases, and pirfenidone, an antifibrotic and anti-inflammatory agent, have both been shown to slow disease progression and reduce the frequency of acute exacerbations in IPF patients. These drugs are not curative but offer significant benefits in managing the disease. Their approval is based on clinical trials demonstrating their efficacy and safety in patients with IPF.

What other types of research exist?

Promising novel alternatives for the treatment of Idiopathic Pulmonary Fibrosis (IPF) in 2024 include the continued use of antifibrotic agents such as nintedanib and pirfenidone, which have demonstrated efficacy in slowing disease progression and reducing acute exacerbations. Additionally, emerging therapies like pamrevlumab, an anti-connective tissue growth factor therapy, have shown potential in clinical trials. These treatments focus on targeting the fibrotic pathways involved in IPF, offering new hope for improved management of the disease.

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Unknown

LTP001 for Idiopathic Pulmonary Fibrosis

Phase 2

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Male and female participants at least 40 years of age

Be older than 18 years old

Must not have

Clinical diagnosis of any connective tissue disease

Airway obstruction (i.e. prebronchodilator FEV1/ FVC < 0.7) or evidence of a bronchodilator response at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, weeks 4, 8, 12, 16, 20, 26

Summary

This trial is testing different individual treatments to see how well they work and how safe they are. It focuses on people with idiopathic pulmonary fibrosis, a serious lung disease. The goal is to find treatments that can improve lung function and reduce symptoms. Nintedanib and pirfenidone are antifibrotic agents that have been used in the treatment of idiopathic pulmonary fibrosis.

Who is the study for?

This trial is for adults at least 40 years old with idiopathic pulmonary fibrosis (IPF), a type of lung scarring. Participants must have certain levels of lung function and be on stable IPF medication if applicable. They shouldn't have major airway blockage, significant emphysema, connective tissue disease, or recent worsening of their condition.

What is being tested?

The study tests the effectiveness and safety of LTP001 against a placebo while all participants continue receiving standard care for IPF. It's blinded so neither the researchers nor participants know who gets the real treatment versus placebo, and people are chosen randomly to receive one or the other.

What are the potential side effects?

While specific side effects aren't listed here, investigational drugs like LTP001 can cause unexpected reactions due to their newness. Placebos typically don't cause side effects but taking part in trials may involve risks like allergic reactions or drug interactions.

Eligibility Criteria

Inclusion Criteria

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

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I am 40 years old or older.

Exclusion Criteria

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

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I have been diagnosed with a connective tissue disease.

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I have breathing issues due to airway obstruction or respond to inhalers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, weeks 4, 8, 12, 16, 20, 26

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, weeks 4, 8, 12, 16, 20, 26

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 4, 8, 12, 16, 20, 26 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from baseline to end of treatment epoch in Forced Vital Capacity (FVC) expressed in percent predicted

Secondary study objectives

Change from baseline to end of treatment epoch in Forced Vital Capacity (FVC)

Change from baseline to the end of treatment epoch in 6-minute walk distance

Change from baseline to the end of treatment epoch in DLCO

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment2 Interventions

Participants will receive LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 26 weeks

Group II: LTP001Experimental Treatment2 Interventions

Participants will receive LTP001 orally once daily in the morning for approximately 26 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Standard of Care (SoC)

2011

Completed Phase 4

~2200

0 / 3Eligibility 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, has anti-inflammatory and antifibrotic properties, which help reduce the production of fibrotic tissue and slow disease progression. These treatments are crucial for IPF patients as they can significantly 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 chronic nature of the disease.

Treatment of idiopathic interstitial pneumonias.