IM0271016: An Open-label, Multi-center, Long-term Extension Study to Evaluate the Long-term Safety and Tolerability of Admilparant in Participants with Pulmonary Fibrosis
Pulmonary fibrosis is a lung condition that causes scarring, making it harder to breathe over time. This research study is testing a medicine called admilparant to see how safe it is when taken over a longer period. It is an 'open-label extension study', which means all participants receive the active medicine rather than a dummy pill (placebo). The trial is open to adults who have idiopathic pulmonary fibrosis or progressive pulmonary fibrosis, usually following on from an earlier trial of the same medicine. Doctors will closely track any side effects, changes in blood tests, heart rhythm tests (ECGs), and basic health checks like blood pressure. The goal is to understand if admilparant can be taken safely over many months or years, helping researchers learn if it could become a helpful future treatment.
At a glance
What is this study about?
Pulmonary fibrosis is a condition where lung tissue becomes thick, stiff, and scarred over time. This scarring makes it difficult for the lungs to transfer oxygen into the blood, leading to symptoms like breathlessness and a persistent cough. Idiopathic pulmonary fibrosis (IPF) is the most common form, but scarring can also worsen in other types, known as progressive pulmonary fibrosis. Currently, treatments can slow down scarring, but new and better options are urgently needed.
This study is testing an investigational medicine called admilparant (also known as BMS-986278). The drug works by blocking a specific signal in the body called LPA1, which is believed to play a key role in building up scar tissue in the lungs. By turning down this signal, researchers hope the medicine might help protect the lungs from further damage.
Because this is an 'extension study', it is designed to see what happens when people take admilparant over an extended period. In this type of trial, there is no dummy pill (placebo), so every participant receives the real medicine. Doctors will closely monitor participants to ensure the treatment remains safe and well tolerated over months and years.
By following participants over time, the research team will collect important information about any side effects, as well as regular checks on blood, vital signs, and heart health. This helps scientists understand whether admilparant could provide safe, lasting support for people living with lung fibrosis.
Key takeaways
- Tests the long-term safety of admilparant for people with pulmonary fibrosis.
- This is an open-label study, meaning all participants receive the active medicine.
- Designed primarily for adults who have completed an earlier trial with this drug.
- Regular hospital visits will check your blood tests, heart rhythm, and overall health.
- Participation is entirely voluntary and you can stop at any time.
Who may be eligible?
This study is for adults aged 18 and older who have been diagnosed with either idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). Both men and women can take part.
Because this is a long-term extension study, it is generally aimed at people who have already completed a previous clinical trial testing admilparant. To join, participants must be in suitable general health to continue taking the study medicine safely.
Your study doctor will review your full medical history, current treatments, and previous trial records to confirm whether this study is safe and appropriate for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis.
- I have taken part in a previous clinical trial for admilparant.
- I am able to attend regular hospital check-ups and safety tests.
What does participation involve?
Taking part involves taking the study medicine, admilparant, on a regular schedule as guided by the trial team. Because this is an open-label study, you and your doctor will both know that you are taking the active medicine.
You will need to attend regular clinic appointments at a trial hospital. During these visits, the medical team will carry out health checks including measuring your blood pressure and heart rate, taking blood and urine samples, and performing heart tracings (ECGs) to check your heart rhythm. You will also be asked about any changes in how you feel or any symptoms you notice.
The study continues over a prolonged period to look at long-term effects. Your trial doctor will give you exact details about the schedule of visits and how long you can remain on the treatment.
Potential risks and benefits
Locations (14)
- —UnverifiedFinland
- —UnverifiedPortugal
- —UnverifiedHungary
- —UnverifiedIreland
- —UnverifiedPoland
- —UnverifiedGreece
- —UnverifiedFrance
- —UnverifiedBelgium
- —UnverifiedDenmark
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedNetherlands
Common questions
What is an open-label extension study?
An extension study allows people who finished an earlier trial to keep receiving treatment. 'Open-label' means there is no dummy pill (placebo), so everyone receives the active medicine.
Will I have to pay to take part?
No. The study medication and all trial-related tests are provided free of charge, and travel expenses are usually reimbursed.
How is the medicine taken?
Admilparant is taken by mouth. Your study team will provide clear instructions on how and when to take your doses.
What happens if I experience side effects?
The study team will monitor you closely. If you develop any side effects, they can adjust your care, pause the medicine, or stop it completely if needed.
Can I leave the study early?
Yes. You can leave the trial at any time without giving a reason, and your regular doctor will help you decide on your next best treatment options.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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