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Study on the Effects of Deupirfenidone and Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis

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What is this study about?

This clinical trial is focused on studying a lung disease called Idiopathic Pulmonary Fibrosis (IPF). IPF is a condition where the lungs become scarred and stiff, making it difficult to breathe. The study is testing a new treatment called Deupirfenidone (LYT-100), which is a modified version of an existing medication known as Pirfenidone. The trial will compare the effects of Deupirfenidone with Pirfenidone and a placebo to see how well they work and how safe they are for patients with IPF.

The purpose of the study is to gather information about the safety, how well patients tolerate the treatment, and how effective it is in treating IPF. Participants in the study will be randomly assigned to one of four groups. Some will receive Deupirfenidone, others will receive Pirfenidone, and some will receive a placebo. The study will last for about 26 weeks, during which time participants will take the medication in the form of tablets or capsules. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving which treatment, to ensure unbiased results.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The main focus will be on measuring changes in lung function and overall health. The study aims to find the best dose of Deupirfenidone that provides the most benefit with the fewest side effects. This research is important for developing better treatments for people living with IPF.

1 joining the study

Upon joining the study, informed consent is required. This involves understanding the study’s purpose and agreeing to participate.

Eligibility is confirmed based on specific criteria, such as age and health condition related to idiopathic pulmonary fibrosis (IPF).

2 part A: initial treatment phase

The initial treatment phase lasts for 26 weeks.

Participants receive one of the following orally: Deupirfenidone (LYT-100) in tablet or capsule form, Pirfenidone, or a placebo.

The goal is to evaluate the safety, tolerability, and effectiveness of the medication.

3 monitoring and assessments

Regular assessments are conducted to monitor lung function and overall health.

The primary focus is on the rate of decline in lung capacity, measured in milliliters over the 26-week period.

Secondary assessments include changes in quality of life and any hospitalizations due to respiratory issues.

4 part B: extended treatment phase

Participants who complete Part A may continue to Part B, which extends the treatment to 52 weeks.

Continued treatment is based on the investigator’s assessment of the participant’s suitability.

The focus remains on lung function, quality of life, and any respiratory-related hospitalizations.

5 completion and follow-up

Upon completion of the study, a follow-up period is included to monitor any long-term effects.

Participants are advised on any necessary precautions or lifestyle adjustments post-study.

Who Can Join the Study?

  • Provide written or electronic consent before any study procedures.
  • Men must be surgically sterile, abstinent, or have a female partner who is postmenopausal, surgically sterile, or using effective birth control. This must be maintained until the study ends and for at least 90 days after the last dose of the study medication. A male condom must also be used.
  • Men should not donate sperm for at least 90 days after the last dose of the study medication.
  • Female partners of male participants and female participants must report any pregnancy within 90 days after stopping the study medication.
  • For Part B of the study, sign informed consent before any study procedures.
  • For Part B, participants must have completed Part A of the study through Day 183 of treatment.
  • For Part B, the investigator must consider the participant a good candidate for continued treatment.
  • Participants must be male or female and at least 40 years old at the time of consent.
  • Participants must be able and willing to follow all study procedures and requirements.
  • Participants should be new to treatment or have less than 6 months of exposure to nintedanib, with a doctor-diagnosed condition based on specific guidelines.
  • Participants must have a specific lung condition confirmed by a high-resolution CT scan within 12 months of the first visit.
  • The extent of lung scarring must be greater than the extent of emphysema on the most recent CT scan.
  • The ability of the lungs to transfer carbon monoxide, corrected for hemoglobin, must be between 30% and 90% of the predicted normal value.
  • The forced vital capacity (FVC), a measure of lung function, must be at least 45% of the predicted normal value.
  • Women who can become pregnant must not be pregnant or breastfeeding. They must abstain from heterosexual intercourse or use effective double contraception, which includes a male condom and one other method like hormonal contraception or an intrauterine device (IUD).

Who Cannot Join the Study?

  • Patients who have a different lung condition other than Idiopathic Pulmonary Fibrosis (IPF) cannot participate. IPF is a disease that causes scarring of the lungs for an unknown reason.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had a recent major surgery or are planning to have surgery during the study cannot participate.
  • Patients who have a history of drug or alcohol abuse cannot participate.
  • Patients who have allergies to the study medication or its ingredients cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Hospital of Infectious Diseases and Pneumology Victor Babes, Timisoara Timisoara Romania
General University Hospital Of Patras Patras Greece
Ngtltgwjor Skybtr Iasi Romania
Lpijn Glwptbr Hzqzpbsc Oj Acsbxo Athens Greece
Sxhtlqcx dm Pophigqpvbd Dfx Lcepgln Dtikozjyw Sbffq Oradea Romania
Uatpxehvon Gcfcidn Hutpttii Ahjvvgn Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Greece Greece
Not recruiting
28.01.2023
Romania Romania
Not recruiting
28.01.2023

Trial locations

Investigated drugs:

LYT-100 is a medication being studied for its potential to treat patients with idiopathic pulmonary fibrosis (IPF). The trial aims to evaluate how well LYT-100 works, how safe it is, and how patients tolerate it. The study is also looking to find the best dosing regimen for this medication. LYT-100 is being tested to see if it can help improve lung function and reduce symptoms in people with IPF.

Investigated diseases:

Idiopathic Pulmonary Fibrosis – Idiopathic Pulmonary Fibrosis (IPF) is a chronic lung disease characterized by the progressive scarring of lung tissue, which leads to a decline in lung function over time. The exact cause of IPF is unknown, and it primarily affects middle-aged and older adults. As the disease progresses, the lung tissue becomes thickened and stiff, making it difficult for oxygen to pass into the bloodstream. Patients with IPF often experience symptoms such as shortness of breath, a persistent dry cough, and fatigue. The progression of the disease can vary, with some individuals experiencing a rapid decline in lung function, while others may have a slower progression. The scarring in the lungs is irreversible, and the disease can significantly impact the quality of life.

Trial ID:
2024-511330-13-00
Protocol code:
LYT-100-2022-204
NCT ID:
NCT05321420
Trial Phase:
Therapeutic exploratory (Phase II)

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