All studies
Active not recruitingPHASE3INTERVENTIONAL

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

This research study is testing a new drug, BMS-986278, for individuals who have progressive pulmonary fibrosis, a lung condition where scarring in the lungs gets worse over time. The main goals are to check if this new medicine can help manage the condition and if it's safe to use. Some participants will receive the new drug, while others will get a placebo (a dummy drug). This helps researchers understand whether any changes are due to the active medication. It's a 'Phase 3' study, meaning it's a larger study that follows earlier successful tests and is a crucial step towards potentially making the drug available more widely.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Bristol-Myers Squibb
Enrolment target
1,057
Start
25 Oct 2023
Estimated completion
27 Dec 2027

What is this study about?

This study is investigating a new potential treatment, BMS-986278, for a serious lung condition called progressive pulmonary fibrosis.

Pulmonary fibrosis causes scarring in the lungs, making it harder to breathe. For some people, this scarring gets worse over time, which is known as progressive pulmonary fibrosis. This study aims to find out if BMS-986278 can help slow down this progression and improve the health of those affected. Researchers will also be looking closely at any side effects to make sure the treatment is safe.

To ensure the results are accurate, some participants will receive the active medication, BMS-986278, while others will receive a placebo. A placebo looks like the real medication but doesn't contain any active drug. This allows researchers to compare the real drug's effects against no treatment, helping them understand if the new drug truly makes a difference. This type of study is common and necessary in medical research to get reliable results that could benefit many patients in the future.

Key takeaways

  • This study is testing a new drug, BMS-986278, for progressive pulmonary fibrosis.
  • It aims to see if the drug is effective and safe.
  • Some participants will receive the active drug, others a placebo.
  • Regular clinic visits, tests, and medication will be involved.
  • Participation is voluntary, and you can withdraw at any time.
  • The study includes men and women with specific health and medication histories.

Who may be eligible?

To join this study, you must have a diagnosis of progressive pulmonary fibrosis that has shown signs of getting worse in the last two years. Doctors will confirm this using detailed lung scans.

If you are already taking certain medications for your lung condition, like pirfenidone, nintedanib, or other similar drugs (e.g., mycophenolate mofetil, azathioprine, tacrolimus, or some arthritis medications like methotrexate or specific biologics), you might still be able to join. However, you must have been on a stable dose of these medications for at least three months before the study starts. If you've recently stopped taking any of these, there might be a waiting period.

There are also some reasons why you wouldn't be able to join, such as having a specific type of lung fibrosis called Idiopathic Pulmonary Fibrosis with UIP confirmed at the start of the study, or if you've had a stroke or a mini-stroke (TIA). All participants, both men and women, will need to agree to use effective birth control methods if there's any chance of pregnancy.

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.

  1. Do I have progressive pulmonary fibrosis that has worsened in the last two years?
  2. If I'm on lung condition medications, have I been on a stable dose for at least 3 months?
  3. Have I had a stroke or mini-stroke (TIA) before?
  4. Am I willing to use effective birth control if there's a chance of pregnancy?
Answer every question to see your result.

What does participation involve?

Taking part in this study means you will receive either the study medication (BMS-986278) or a placebo. You won't know which one you are getting, and neither will your study doctor. You'll have regular visits to the clinic for medical check-ups, blood tests, and lung function tests to see how you're responding to the treatment.

These visits will help measure the effectiveness of the drug and monitor for any side effects. You'll also be asked about your health and any changes you notice. The study involves taking the medication as prescribed and attending all scheduled appointments. The total duration of your participation, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

There is a possibility that this new medication could help slow down your pulmonary fibrosis, but it's important to remember that this is not guaranteed, and some participants will receive a placebo. Every medication has potential side effects, and the study team will carefully monitor you for any unwanted effects. You'll be given detailed information about known potential risks. Remember, taking part in any clinical trial is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (459)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Local Institution - 0046
    Verified postcode
    Birmingham, United States
  • Local Institution - 0314
    Verified postcode
    Phoenix, United States
  • Local Institution - 0336
    Verified postcode
    La Jolla, United States
  • Local Institution - 0212
    Verified postcode
    Los Angeles, United States
  • Local Institution - 0019
    Verified postcode
    Los Angeles, United States
  • Local Institution - 0535
    Verified postcode
    Newport Beach, United States
  • Local Institution - 0366
    Verified postcode
    Orange, United States
  • Local Institution - 0341
    Verified postcode
    Sacramento, United States
  • Local Institution - 0015
    Verified postcode
    San Francisco, United States
  • Local Institution - 0352
    Verified postcode
    Stanford, United States
  • Local Institution - 0321
    Verified postcode
    Aurora, United States
  • Local Institution - 0376
    Verified postcode
    Denver, United States

Common questions

What is progressive pulmonary fibrosis?

It's a lung condition where scar tissue builds up in your lungs, making it harder to breathe, and this scarring gets worse over time.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the actual medicine but doesn't contain any active drug. It helps researchers compare the real drug's effects.

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

No, neither you nor your study doctor will know if you're receiving the active drug or the placebo. This helps ensure fair and accurate results.

What are the main goals of this study?

The study aims to find out if the new medication (BMS-986278) is effective in treating progressive pulmonary fibrosis and if it is safe to use.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, and this will not affect your usual medical care.

How to find out more

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

Discussion

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