Not yet recruitingPHASE3INTERVENTIONAL

Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis

This study is checking the long-term safety and how well people tolerate a treatment called Admilparant. It's for individuals who have previously taken part in other studies for pulmonary fibrosis – specifically, studies IM027-068 for idiopathic pulmonary fibrosis (IPF) or IM027-1015 for progressive pulmonary fibrosis (PPF). By continuing to monitor these participants, doctors hope to gain a better understanding of Admilparant's effects over a longer period. This will help them learn more about how to best manage pulmonary fibrosis, a condition that causes scarring in the lungs.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

2,277

Start

16 Dec 2026

Estimated completion

30 Mar 2030

Pulmonary Fibrosis

What is this study about?

This research is looking further into a medicine called Admilparant, which is being studied as a possible treatment for pulmonary fibrosis. Pulmonary fibrosis is a lung disease where the lung tissue becomes scarred and thick, making it harder to breathe. There are different types, including idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).

The main aim of this study is to see how safe Admilparant is over a longer time and how well people can take it without too many problems. This is important because medicines often need to be taken for long periods for chronic conditions like pulmonary fibrosis, so understanding the long-term effects is key.

This particular study is designed for people who have already been taking part in earlier trials of Admilparant (named IM027-068 or IM027-1015). By continuing to monitor these patients, researchers can gather valuable information that helps them understand the full picture of Admilparant's effects, both good and bad, over an extended period. This knowledge can then help doctors decide if and how Admilparant could be a safe and helpful treatment option in the future.

Key takeaways

This study is for people already in Admilparant drug trials.
It aims to check the long-term safety of Admilparant.
It helps researchers understand how people tolerate the medicine over time.
It focuses on participants with Idiopathic or Progressive Pulmonary Fibrosis.
Joining helps advance understanding of pulmonary fibrosis treatments.

Who may be eligible?

To join this study, you must have already finished one of the previous Admilparant studies, either IM027-068 or IM027-1015. This means you must have received the study medicine until your final visit in one of those earlier trials.

There are certain reasons why you might not be able to take part. For example, if you had a serious health problem during the previous study that caused you to stop the medicine and you didn't restart it, you wouldn't be eligible. Also, if you have symptoms of heart failure when resting, or if you've had lung reduction surgery or a lung transplant, you wouldn't be able to join. Being on a waiting list for a lung transplant is allowed, however.

Finally, if you have a condition called Pulmonary Arterial Hypertension (PAH) and your treatment for it has recently changed from a single medicine to multiple medicines, you also wouldn't be able to participate. The study team will check all your health details carefully to see if you meet all the requirements.

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.

Have I completed a previous Admilparant study (IM027-068 or IM027-1015)?
Did I stop the study medicine in the previous study due to a serious problem and NOT restart it?
Do I have symptoms of heart failure when resting?
Have I had lung reduction surgery or a lung transplant?
Am I on treatment for Pulmonary Arterial Hypertension (PAH) that has recently changed from one to multiple medicines?

Answer every question to see your result.

What does participation involve?

The details of what taking part involves would be fully explained by the study team. Generally, you would continue to receive the study medicine, Admilparant, which you were taking in the previous study. You would have regular appointments at the study clinic, where doctors and nurses would perform examinations and tests to check your health, how you are feeling, and if the medicine is causing any side effects. This might include blood tests, breathing tests, and other assessments.

The study would track your health over a long period. The exact number of visits and the total duration in the study would be given to you in detail if you are considering joining. You would get all your study medication from the clinic.

Potential risks and benefits

Potential benefits of staying in the study could include continued access to Admilparant, which might help manage your pulmonary fibrosis, and contributing important information to medical research that could help others in the future. As with any medication, there are potential risks, and Admilparant may cause side effects. These would have been discussed with you in previous studies and would continue to be monitored. You would be fully informed about all known and potential risks throughout the study. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (272)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Local Institution - 0013
Unverified
Florida, Vicente López, Argentina
Local Institution - 0014
Verified postcode
Mar del Plata, Argentina
Local Institution - 0007
Verified postcode
Quilmes, Argentina
Local Institution - 0009
Verified postcode
San Juan Bautista, Argentina
Local Institution - 0003
Verified postcode
Mar del Plata, Argentina
Local Institution - 0001
Verified postcode
Córdoba, Argentina
Local Institution - 0005
Unverified
CABA, Argentina
Local Institution - 0002
Verified postcode
Godoy Cruz, Argentina
Local Institution - 0011
Verified postcode
Mendoza, Argentina
Local Institution - 0015
Verified postcode
Rosario, Argentina
Local Institution - 0012
Verified postcode
San Miguel de Tucumán, Argentina
Local Institution - 0010
Verified postcode
Buenos Aires, Argentina

Common questions

What is pulmonary fibrosis?

Pulmonary fibrosis is a condition where your lungs become scarred and stiff, making it harder to breathe and get enough oxygen.

What is Admilparant?

Admilparant is a medicine being tested in clinical trials as a potential treatment for pulmonary fibrosis.

Do I need to have been in another study to join this one?

Yes, this study is specifically for people who have already completed one of the previous Admilparant studies (IM027-068 or IM027-1015).

Is this study for a specific type of pulmonary fibrosis?

It's for people who were in previous studies for either idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF).

Can I leave the study if I change my mind?

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

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Clinical.Trials@bms.com 855-907-3286 Official trial record

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