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Long‑term Safety and Tolerability of Admilparant in Adults with Idiopathic or Progressive Pulmonary Fibrosis

Verified siteInvestigationalNo placebo
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What is this trial about?

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

The study focuses on two lung conditions, Progressive pulmonary fibrosis and Idiopathic pulmonary fibrosis, in which scar tissue builds up in the lungs and makes breathing harder. The treatment being examined is an oral tablet called Admilparant, which belongs to a group of medicines that aim to reduce the formation of scar tissue. The tablet is taken by mouth and is designed for long‑term use.

The purpose of the study is to determine whether Admilparant can be used safely over an extended period without causing serious side effects. Participants will take the medication each day and will attend regular visits where healthcare staff will check vital signs such as blood pressure and heart rate, review simple blood tests, and perform a basic heart test known as an ECG, which records the heart’s electrical activity. Any side effects that arise will be recorded and evaluated.

The study will continue for many months to gather enough information about safety and tolerability. Throughout the study, participants will be asked to report any new symptoms or problems, and they will receive routine medical check‑ups to monitor their overall health while using the medication.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial enrollment

    After joining the study, you will sign the consent form and confirm eligibility.

    Baseline assessments will be performed, including lab tests, ecg, and measurement of vital signs such as blood pressure and heart rate.

  2. Step 2

    Start medication

    You will begin taking admilparant, a lpa1 antagonist provided as a 9999 mg film‑coated tablet for oral use.

    The medication will be taken according to the study schedule for the duration of the long‑term extension period, which may last up to three years.

  3. Step 3

    Regular safety visits

    Periodic visits will be scheduled to monitor safety.

    At each visit, lab tests, ecg, and vital signs will be checked and compared with the baseline measurements.

    Any side effects, including serious ones, will be recorded.

  4. Step 4

    Ongoing monitoring

    Throughout the study, you will continue to take the medication and attend scheduled visits.

    The study team will track the number of side effects, any discontinuations, and any deaths that occur.

    The overall safety and tolerability of the medication will be evaluated over the entire study period.

  5. Step 5

    Study completion

    At the end of the estimated study period (december 2029), the final assessments will be performed.

    Data on safety and tolerability will be compiled and analyzed.

Who can join the trial?

4 criteria

  • You must have already finished taking the study medication and completed the final study visit in one of the earlier studies named IM027068 or IM0271015.
  • If you have IPF (Idiopathic Pulmonary Fibrosis), you need to be at least 40 years old; if you have PPF (Progressive Pulmonary Fibrosis), you need to be at least 21 years old when you sign the consent form.
  • Women who could become pregnant must use a very reliable birth‑control method that works without needing the user to do anything each time (for example, an IUD), and must take a urine or blood pregnancy test on the first day of the study to confirm they are not pregnant.
  • Men who have sex with women who could become pregnant must agree to use condoms during sexual activity.

Who cannot join the trial?

3 criteria

  • Having symptoms of heart failure while resting – meaning the heart cannot pump blood well enough even when you are not active.
  • Having had lung surgery that removed part of a lung (called a lobectomy) or having received a lung transplant in the past.
  • Having pulmonary arterial hypertension (high blood pressure in the arteries of the lungs) that now needs more than one medication to control.
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Investigated drugs

  • LPA1 antagonist

    is an oral tablet taken by mouth. It works by blocking a protein called LPA1 that can contribute to the scarring and stiffening of lung tissue. In this study, the medicine is being given to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) to see if it can be used safely for a long time without causing serious side effects.

  • BMS-986278

    is the same type of oral tablet that also blocks the LPA1 protein. Although it has a different code name, it contains the same active ingredient and is intended to stop the processes that lead to lung scarring. The trial is testing this medicine in participants with IPF or PPF to determine its long‑term safety and tolerability.

What is already known about the treatment

Admilparant - This medication is taken by mouth as a film‑coated tablet. It is currently an investigational orphan drug being studied in clinical trials and is not yet approved for general medical use. The drug is aimed at treating progressive pulmonary fibrosis and idiopathic pulmonary fibrosis, conditions that cause scarring of the lungs. It works by blocking the LPA1 receptor, which reduces signals that lead to tissue scarring, and is classified as an LPA1 receptor antagonist with anti‑fibrotic activity.

Investigated diseases

  • Idiopathic pulmonary fibrosis

    Idiopathic pulmonary fibrosis is a lung disease in which scar tissue forms in the lungs without a known cause. The scar tissue makes the lung walls stiff, reducing the ability to expand and take in oxygen. Over time, breathing becomes increasingly difficult and a dry cough may develop. The condition usually progresses slowly, with symptoms gradually getting worse. It mainly affects the small airways and the spaces where gas exchange occurs.

  • Progressive pulmonary fibrosis

    Progressive pulmonary fibrosis describes a group of lung disorders in which scarring of lung tissue gets worse over time. The fibrosis thickens the walls of the airways and reduces lung flexibility, leading to shortness of breath during everyday activities. As the disease advances, a persistent cough and fatigue often become more noticeable. The worsening scarring can spread to larger areas of the lungs, further limiting breathing capacity. The course of the disease is marked by a steady decline in lung function.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522373-10-00Protocol codeIM0271016Estimated enrolment1 706 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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