Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis

This research study is investigating a new medication, BMS-986278, for individuals living with Idiopathic Pulmonary Fibrosis (IPF). IPF is a serious lung condition that causes scarring of the lungs. The main goals of this study are to carefully assess how effective the new medicine is at treating IPF, to understand any potential side effects, and to see if patients find it tolerable. Participants in the study will either receive the new medicine or a placebo (a dummy medicine that looks the same but contains no active drug). This is a Phase 3 study, meaning it’s a later stage of research after initial tests have shown promise, involving a larger group of people to confirm the findings.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

1,255

Start

14 Sep 2023

Estimated completion

04 Jun 2027

Idiopathic Pulmonary Fibrosis

What is this study about?

Idiopathic Pulmonary Fibrosis (IPF) is a chronic illness where the lungs become scarred and stiff over time, making it harder to breathe. Researchers are constantly working to find new and more effective ways to manage this condition. This particular study is focusing on an investigational medicine known as BMS-986278. An investigational medicine means it's not yet approved for general use but is being carefully studied to see if it can help people with IPF.

The main purpose of this study is to find out if BMS-986278 can slow down the progression of IPF, improve symptoms, or have other positive effects on the lungs. Researchers will also be looking closely at any potential side effects to make sure the medicine is safe. By comparing the new medicine to a placebo, they can get a clearer picture of its true benefits.

Taking part in a study like this is a crucial step in developing new treatments. The information gathered from participants helps medical experts understand more about IPF and how new medicines might make a difference for future patients. It also helps to confirm the findings from earlier, smaller studies.

Key takeaways

This study is testing a new medicine (BMS-986278) for Idiopathic Pulmonary Fibrosis (IPF).
It's a Phase 3 study, meaning it's a critical stage before potential approval.
Participants will receive either the new medicine or a placebo, with close medical monitoring.
The study aims to check how well the medicine works, its safety, and how people tolerate it.
You need to be at least 40 years old with a confirmed IPF diagnosis to be considered.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you would generally need to be at least 40 years old and have received a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) within the past seven years. This diagnosis would need to be confirmed by a special type of CT scan of your chest.

If you are currently taking other common IPF medications like pirfenidone or nintedanib, you would need to have been on a consistent dose for at least three months before joining. If you've recently stopped taking these medications, you'd need to have been off them for at least 28 days.

However, some things would prevent you from joining. For example, if you've had a stroke or a mini-stroke (TIA) in the last three months, or if you have symptoms of heart failure while resting. You also wouldn't be able to participate if you currently have cancer, or if you've had cancer in the last two years that might return. Other specific medical conditions, as defined by the study rules, might also make you ineligible.

Quick self-check

Are you at least 40 years old?
Have you been diagnosed with IPF within the last 7 years?
Is your IPF diagnosis confirmed by a special CT scan (HRCT)?
If you're on other IPF medicines, have you been on a stable dose for at least 3 months?
Do you not have a history of stroke or mini-stroke in the last 3 months?
Do you not have active cancer or a recent history of cancer (within 2 years)?

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

What does participation involve?

If you decide to participate in this study, you would first go through a screening process to ensure you meet all the requirements. This would involve medical checks, tests, and discussions about your health history. Once enrolled, you would regularly attend appointments at the clinic. These visits would involve various assessments, including physical examinations, blood tests, and lung function tests, to monitor your health and how the treatment is affecting you.

For the duration of the study, you would be given either the investigational medicine BMS-986278 or a placebo, which looks identical but contains no active drug. You wouldn't know which one you are receiving. The medicine would be taken as instructed by the study team. Throughout the study, the research team would closely monitor your progress and any side effects. After the main treatment period, there would likely be follow-up visits to continue tracking your health. The total duration of your involvement in the study, from start to finish, would be explained to you in detail.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as gaining access to a new, investigational medicine for your IPF before it's widely available, and receiving close medical monitoring for your condition. However, there are also potential risks; the new medicine might cause side effects, some of which may be serious or unexpected, or it might not be effective for your condition. You might also receive the placebo, meaning you wouldn’t get any active study drug. It's crucial to understand that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (390)

Local Institution - 0189
Birmingham, United States
Local Institution - 0361
Phoenix, United States
Local Institution - 0396
La Jolla, United States
Local Institution - 0193
Los Angeles, United States
Local Institution - 0398
Los Angeles, United States
Local Institution - 0389
Orange, United States
Local Institution - 0405
Sacramento, United States
Local Institution - 0185
San Francisco, United States
Local Institution - 0186
Stanford, United States
Local Institution - 0363
Aurora, United States
Local Institution - 0194
Denver, United States
Local Institution - 0175
New Haven, United States

+378 more sites — see the official record for the full list.

Common questions

What is Idiopathic Pulmonary Fibrosis (IPF)?

IPF is a serious lung condition where scar tissue builds up in your lungs, making them stiff and gradually making it harder to breathe.

What is a Phase 3 study?

A Phase 3 study is a large-scale research stage where a new medicine is tested on many people to confirm its effectiveness, monitor side effects, and compare it to existing treatments.

Will I know if I'm getting the actual medicine or a placebo?

No, this is a 'blinded' study, meaning neither you nor the study team will know whether you are receiving the active medicine or the placebo. This helps ensure unbiased results.

What if I'm already taking medicine for IPF?

If you are on existing IPF medicines like pirfenidone or nintedanib, you might still be eligible, but you must have been on a stable dose for at least three months.

Can I stop participating in the study at any time?

Yes, your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and it will not affect your future medical care.