RecruitingPHASE2INTERVENTIONAL

Senicapoc in Patients With Worsening Fibrotic Interstitial Lung Disease

This study is testing a new drug called Senicapoc for people who have lung scarring conditions, such as pulmonary fibrosis. These conditions cause the lungs to scar, making breathing difficult. The main goal is to find out if Senicapoc can prevent this scarring from worsening. Researchers will compare Senicapoc to a placebo, which looks like the real drug but contains no medicine. Participants will take three tablets a day for 26 weeks. During this time, they will have regular check-ups, including lung function tests, and will be asked to complete questionnaires about their quality of life. The study aims to see if Senicapoc offers a better way to manage these challenging lung conditions.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Vejle Hospital

Enrolment target

140

Start

01 Aug 2025

Estimated completion

01 Dec 2028

Pulmonary Fibrosis, Interstitial Lung Disease Idiopathic Pulmonary Fibrosis

What is this study about?

This study is designed to investigate a new medication called Senicapoc for individuals living with conditions that cause scarring in the lungs, typically known as fibrotic interstitial lung diseases (F-ILD), including pulmonary fibrosis. These diseases can make the lungs stiff and reduce their ability to take in oxygen, which can make everyday activities challenging. Currently, there are treatments available that can help slow down the progression of these conditions, but they can have side effects and don't work for everyone.

Senicapoc works by targeting a specific pathway in the body that is thought to play a role in the development of lung scarring. Previous research in lab settings and animal studies has suggested that blocking this pathway could help reduce scarring and even potentially reverse some of the damage. Senicapoc has also been tested in healthy people and those with other conditions without serious safety concerns. This new study is an important step to see if these promising results translate to people with F-ILD.

The main aim is to see if Senicapoc can prevent the lung scarring from getting worse over time. Doctors will be carefully monitoring participants to understand if the drug helps improve or maintain their lung function and overall quality of life. This research could potentially lead to a new treatment option for people with these difficult lung conditions.

Key takeaways

This study is testing a new drug called Senicapoc for lung scarring diseases.
The main goal is to see if Senicapoc can stop the scarring from getting worse.
Participants will take a drug or a dummy pill for 26 weeks.
There will be regular check-ups to monitor lung health and general well-being.
This research hopes to find better treatment options for difficult lung conditions.

Who may be eligible?

To join this study, people generally need to be 18 years or older and have been diagnosed with a progressive fibrotic interstitial lung disease or severe pulmonary fibrosis. Your lung function test results, like FVC, also need to fall within a certain range, and your scarring on previous lung scans (HRCT) must be more than any emphysema. You also need to have shown a certain decline in lung function over the past 6-24 months.

There are also reasons why someone might not be able to join. For example, if you have certain health conditions like sickle cell disease, severe liver or kidney problems, some types of heart issues detected on an ECG, or a history of cancer within the last five years. If you've been part of another similar study for a lung scarring disease in the past six months, you also wouldn't be able to participate. You'll need to be able to walk at least 150 meters in a walking test and answer health questionnaires.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with progressive lung scarring (fibrotic ILD or IPF)?
Have your lung scans (HRCT) shown that your scarring is worse than any emphysema?
Has your lung function (FVC) shown a decline in the last 6-24 months?
Can you walk at least 150 meters in a walking test?
Do you have any serious heart, liver, or kidney problems?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will take three tablets by mouth each day for 26 weeks. Some participants will receive the active drug, Senicapoc, while others will receive a placebo, which looks identical but contains no medicine. Neither you nor your study doctor will know which you are receiving. Over the 26 weeks of taking the medication, you will have four in-person visits to the clinic (at the start, and after 4, 13, and 26 weeks). During these visits, doctors will check your general health, measure your lung function, and you'll complete questionnaires about your quality of life. There will be one final follow-up visit 52 weeks after the study officially starts to see how you're doing after stopping the study medication.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving a new treatment that could help slow the progression of your lung scarring, something current treatments might not fully achieve. However, it's also possible you could receive the placebo and not the active drug. As with any medication, there's a risk of side effects from Senicapoc, although early studies haven't shown serious issues. The frequent clinic visits might also be time-consuming. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Aarhus University Hospital
Aarhus N, Denmark· Recruiting
Kardiologisk Forskningsenhed 2161, Rigshospitalet
Copenhagen, Denmark· Recruiting
Tartu University Hospital,
Tartu, Estonia· Recruiting
Division of Respiratory Sciences, Glenfield Hospital
Leicester, United Kingdom· Not yet recruiting
University of East Anglia
Norwich, United Kingdom· Not yet recruiting

Common questions

What is 'pulmonary fibrosis'?

Pulmonary fibrosis is a lung disease where the lung tissue becomes scarred and stiff, making it harder to breathe and get enough oxygen.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study drug but contains no active medicine. It's used to compare the real drug's effects.

How long will I be taking the study tablets?

You will be asked to take the study tablets three times a day for 26 weeks, which is about six months.

Will I know if I'm getting the real drug or the placebo?

No, this is a 'blinded' study, meaning neither you nor your doctors will know if you're receiving Senicapoc or the placebo during the trial.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and it will not affect your usual medical care.

How to find out more

Line Kølner-Augustson, MD.

line.augustson@rsyd.dk +45 28773005 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.