RecruitingRare disease

Study on Senicapoc for Patients with Progressive Fibrotic Interstitial Lung Disease to Prevent Disease Progression

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Senicapoc in patients with a condition known as Progressive Fibrotic Interstitial Lung Disease (PF-ILD) or Idiopathic Pulmonary Fibrosis (IPF). These are lung diseases where the tissue in the lungs becomes scarred and stiff over time, making it difficult to breathe. The trial will compare the effects of Senicapoc to a placebo, which is a tablet that looks like the medication but does not contain any active ingredients.

The purpose of the study is to evaluate the safety and effectiveness of Senicapoc in addition to the usual care patients receive. Participants will take the medication or placebo orally in tablet form for a period of 26 weeks. During this time, researchers will monitor the rate at which the patients' lung function declines, specifically looking at a measure called forced vital capacity (FVC), which is the amount of air a person can forcibly exhale from their lungs after taking the deepest breath possible.

Throughout the study, other aspects of the patients' health will also be observed, such as changes in their quality of life, any hospitalizations, and any side effects they might experience. The study aims to provide valuable information on whether Senicapoc can help slow down the progression of these lung diseases and improve the overall well-being of the patients involved.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will have already been diagnosed with Progressive Fibrotic Interstitial Lung Disease within the last five years.
The patient must have a history of a chest HRCT scan performed within 24 months prior to inclusion and meet specific lung function criteria.
Step 2
Initial assessment
The patient will undergo an initial assessment to confirm eligibility, which includes reviewing medical history and lung function tests.
The patient must have an annual decline in lung function of at least 5% based on previous measurements.
Step 3
Treatment phase
The patient will receive either Senicapoc or a placebo in the form of a tablet for oral use.
The treatment will be administered in addition to the local standard of care for a duration of 26 weeks.
Step 4
Monitoring and follow-up
Throughout the 26-week period, the patient's lung function will be monitored to evaluate the rate of decline in forced vital capacity (FVC).
Additional assessments will include monitoring for any adverse events, changes in quality of life, and other health outcomes.
Step 5
Completion of the study
At the end of the 26-week treatment period, the patient will undergo a final assessment to evaluate the overall impact of the treatment.
The study aims to determine the safety and effectiveness of Senicapoc compared to the placebo.

Who can join the trial?

6 criteria

You must have been diagnosed with **Progressive Fibrotic Interstitial Lung Disease** within the last 5 years.
You need to be able and willing to follow the study's rules and have signed a form agreeing to participate.
You must be a male or female who is at least 40 years old.
You should have had a **chest HRCT** (a special type of lung scan) done within the last 24 months.
Your **Forced Vital Capacity (FVC)**, which measures how much air you can exhale, should be more than 45% of what is expected for you. Also, your **FEV1/FVC** ratio should be more than 0.7 or above the lower limit of normal (LLN).
Your FVC should have decreased by at least 5% over the past year, based on at least three measurements taken within 6 to 24 months before joining the study.

Who cannot join the trial?

5 criteria

Patients who have a different lung condition that is not Progressive Fibrotic Interstitial Lung Disease cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who belong to a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who have any other medical condition that might interfere with the study or make it unsafe for them cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Aarhus University Hospital
Aarhus, Denmark
Verified
Odense University Hospital
Odense, Denmark
Verified
Rigshospitalet
Copenhagen, Denmark

Trial locations

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Investigated drugs

Senicapoc is a medication being studied for its potential to help patients with Progressive Fibrotic Interstitial Lung Disease (ILD) or Idiopathic Pulmonary Fibrosis (IPF). The goal of using Senicapoc in this trial is to see if it can slow down the worsening of lung function, which is measured by how much air a person can exhale after taking a deep breath. This is done over a period of 26 weeks. Senicapoc is given in addition to the usual treatments that patients are already receiving for their condition.

What is already known about the treatment

Senicapoc – Senicapoc is administered orally in tablet form. It is currently being studied in clinical trials for its potential use in treating Progressive Fibrotic Interstitial Lung Disease (ILD) and Idiopathic Pulmonary Fibrosis (IPF). The main therapeutic indication is to prevent the progression of these lung diseases. At the molecular level, Senicapoc works by blocking specific ion channels, which may help reduce inflammation and fibrosis in lung tissues. It is classified as an ion channel blocker in pharmacology.

Investigated diseases

Progressive Fibrotic Interstitial Lung Disease – This disease is characterized by the gradual scarring and thickening of the lung tissue, which leads to a decline in lung function over time. The scarring, or fibrosis, makes it difficult for the lungs to work properly, reducing the ability to breathe deeply and efficiently. As the disease progresses, individuals may experience increasing shortness of breath and a persistent dry cough. The condition can affect the ability to perform daily activities due to reduced oxygen levels in the blood. It is considered a rare disease and can vary in severity and progression among individuals. The rate of lung function decline is often measured by the decrease in forced vital capacity (FVC), which is a key indicator of disease progression.