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A study to evaluate the effectiveness and safety of admilparant in patients with progressive pulmonary fibrosis

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to evaluate the efficacy and safety of a study drug known as BMS-986278, also referred to as admilparant, in individuals living with Progressive Pulmonary Fibrosis. Progressive Pulmonary Fibrosis is a condition where the lung tissue becomes thick and scarred over time, making it harder to breathe. The treatment being tested is an LPA1 antagonist, which is a type of medication designed to block specific signals in the body that may contribute to the scarring of the lungs. This medication is taken as an oral use film-coated tablet.

Participants in the study will be randomly assigned to receive either the active medication or a placebo. The study is double-blind, meaning that neither the participants nor the researchers will know which specific treatment is being administered during the course of the trial. The process involves monitoring changes in Forced Vital Capacity, which is a measurement of the total amount of air a person can exhale from their lungs after taking a deep breath. The study will track these changes and other health factors over a period of time to see how the medication affects the progression of the disease.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Medication administration

    You will receive either the test medication, known as admilparant, or a placebo, which is an inactive substance that looks like the medicine.

    The admilparant is an lpa1 antagonist, a type of medicine designed to target specific pathways in the body, and is taken as a film-coated tablet by oral use (swallowed by mouth).

    The dose of admilparant is 9999 mg.

  2. Step 2

    Monitoring and evaluation

    The medication will be taken for a duration of 52 weeks.

    During the study, changes in forced vital capacity (fvc), which is a measure of how much air the lungs can hold, will be assessed at week 52.

    The progression of the progressive pulmonary fibrosis (a condition where lung tissue becomes scarred over time) will be monitored from day 1 through the final evaluation.

    Your walking distance, measured by a 6-minute walk test (6mwt), will also be recorded at week 52 to evaluate changes from the start of the study.

Who can join the trial?

13 criteria

  • You must be at least 21 years old when you sign the study agreement.
  • You must have a diagnosis of interstitial lung disease, which is a condition where there is scarring or inflammation in the lungs, that shows signs of getting worse within the last 24 months.
  • A special type of detailed lung scan called a high-resolution computed tomography (HRCT) must show that at least 10% of your lung tissue has fibrosis, which is permanent scarring.
  • If you are currently taking the medicines pirfenidone or nintedanib, you must have been taking a steady, unchanging dose for at least 90 days.
  • If you are not taking pirfenidone or nintedanib, you must not have taken them in the 28 days before joining the study.
  • You may take certain immune-system medicines like mycophenolate mofetil, mycophenolic acid, azathioprine, or tacrolimus, but only if your dose has been stable for at least 90 days.
  • If you are not taking those specific medicines, you must not have taken them in the 28 days before the study starts.
  • You may take traditional disease-modifying antirheumatic drugs (DMARDs), which are medicines used to slow down diseases that affect the immune system, such as methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine, as long as your dose has been stable for at least 90 days.
  • If you are not taking these DMARDs, you must not have taken them in the 28 days before the study begins.
  • You may take biologic DMARDs (medicines made from living organisms, such as TNF blockers or IL-1 inhibitors) or Janus kinase (JAK) inhibitors (medicines that block specific proteins to reduce inflammation, such as tofacitinib or upadacitinib), provided your dose has been stable for at least 90 days.
  • If you are not taking these biologic or JAK inhibitors, you must not have taken them in the 28 days before the study starts.
  • Women who are able to become pregnant must use a very effective form of contraception (birth control) and must have a negative pregnancy test using urine or blood at the start of the study and before receiving the medication.
  • Men who are sexually active with women who can become pregnant must agree to use barrier contraception, such as a condom.

Who cannot join the trial?

7 criteria

  • People who have idiopathic pulmonary fibrosis, which is a specific type of lung scarring that causes unknown causes, with usual interstitial pneumonia (UIP), which is a specific pattern of lung damage seen on medical tests, cannot join.
  • Anyone who has had a stroke (a sudden loss of blood flow to the brain) or a transient ischemic attack (a temporary blockage of blood flow to the brain that acts as a warning sign for a stroke) in the 3 months before starting the study.
  • People who show signs of heart failure, a condition where the heart cannot pump enough blood to meet the body's needs, while resting.
  • People who currently have malignancy, which is another word for cancer.
  • People who had cancer in the past but have been cancer-free for less than 2 years.
  • People who have had a biopsy, which is a medical procedure to remove a small piece of tissue for testing, that shows signs of cancer that cannot be ruled out.
  • People using systemic corticosteroids, which are strong medicines used to reduce inflammation, at a dose equivalent to more than 15 mg of prednisone per day within 4 weeks before the study or during the study.
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Investigated drugs

Admilparant is an experimental medicine being tested to see if it can help improve lung function in people with progressive pulmonary fibrosis. It is taken as a tablet by mouth and works by blocking a specific protein in the body that may contribute to the progression of the disease.

What is already known about the treatment

Admilparant - This medication is an experimental oral film-coated tablet currently being studied in clinical trials for its potential to treat progressive pulmonary fibrosis. As an LPA1 antagonist, it works by blocking a specific protein receptor that triggers inflammation and scarring in the lungs. By preventing these harmful signals at a molecular level, the drug aims to slow down the buildup of scar tissue in respiratory tissues. This substance is classified as a receptor antagonist and is not yet approved for general medical use.

Investigated diseases

Progressive Pulmonary Fibrosis - This condition involves the gradual thickening and scarring of the lung tissue. As the disease advances, the lung tissue becomes stiff and loses its elasticity. This changes how the lungs expand and contract during breathing. The scarring process occurs over time and continues to develop. It primarily affects the respiratory system by reducing the ability of the lungs to function properly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503699-25-00Protocol codeIM0271015Estimated enrolment1 092 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).