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ADMILPARANT

Clinical trials are investigating ADMILPARANT in people with lung scarring diseases. These studies are checking whether it can improve breathing test results, and they are also looking at safety and tolerability. The target groups are adults with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis.

Table of Contents

Clinical trial overview

ADMILPARANT is being studied in two Phase 3 interventional studies, which means researchers are giving a study treatment and comparing results in large groups of participants.[1][2]

Both studies are authorised and are designed to evaluate efficacy, safety, and tolerability in people with scarring lung disease.[1][2]

Idiopathic pulmonary fibrosis study

One study is for participants with idiopathic pulmonary fibrosis, a disease that causes lung scarring and has no known cause.[1]

This trial is titled as a study of BMS-986278, and the brief summary says it is evaluating admilparant compared with placebo.[1]

The study plans to enroll 1,201 participants and will look at the change in Forced Vital Capacity (FVC) from the start of the study to Week 52.[1]

Progressive pulmonary fibrosis study

The second study is for participants with progressive pulmonary fibrosis, which means the lung scarring gets worse over time.[2]

This trial also refers to BMS-986278 in the title, and the brief summary says it is testing two doses of admilparant compared with placebo in participants with PPF.[2]

The planned enrollment is 1,092 participants, and the main outcome is the absolute change in FVC from baseline at Week 52.[2]

Who can participate

Based on the trial records, the target populations are adults with either idiopathic pulmonary fibrosis or progressive pulmonary fibrosis.[1][2]

The records provided here do not list the full inclusion or exclusion rules, so the exact entry criteria cannot be confirmed from this source alone.

What the trials measure

The main endpoint in both studies is absolute change in FVC from baseline at Week 52, which is a way to see whether lung function changes over time.[1][2]

In simple terms, the researchers are checking whether participants can blow out more air after treatment than they could at the start of the study.[1][2]

The trial descriptions also state that the studies are evaluating safety and tolerability, meaning how well the treatment can be used and how participants handle it during the study.[1][2]

Key terms explained

Placebo means a look-alike treatment with no active study medicine, used so results can be compared fairly.[1][2]

Baseline means the starting point before the study treatment begins, and Week 52 means the one-year time point used in both studies.[1][2]

Interventional means the researchers are assigning a treatment to participants rather than only observing them.[1][2]

Trial ID Phase Condition studied Status Enrollment
2023-503697-21-01 Phase 3 Idiopathic pulmonary fibrosis Authorised 1201
2023-503699-25-00 Phase 3 Progressive pulmonary fibrosis Authorised 1092

FAQ

  • What conditions are being studied with ADMILPARANT? The trials are studying idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. Both are long-term lung diseases that can make it harder to breathe.
  • Who can take part in these trials? The studies are for participants with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis. The trial records do not list the full eligibility rules here.
  • What phase are the ADMILPARANT trials? Both trials are Phase 3 studies. Phase 3 trials are large studies that compare a treatment with placebo and measure how well it works and how safe it is.
  • What are the trials mainly measuring? The main measure is the change in Forced Vital Capacity, or FVC, from the start of the study to Week 52. FVC is a breathing test that shows how much air a person can blow out.
  • How many people are planned for these studies? One trial plans to enroll 1,201 participants, and the other plans to enroll 1,092 participants. These are large studies designed to give stronger evidence.

Ongoing Clinical Trials on ADMILPARANT

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

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Denmark Finland France +9

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

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Denmark Finland France +9

Glossary

  • Idiopathic pulmonary fibrosis: A lung disease that causes scarring in the lungs. 'Idiopathic' means the cause is not known.
  • Progressive pulmonary fibrosis: A group of lung diseases where scarring gets worse over time. 'Progressive' means it keeps moving forward or getting worse.
  • Phase 3: A late stage of clinical research. These studies are usually large and compare a treatment with placebo or another treatment.
  • Interventional study: A study in which researchers give a treatment to see what happens.
  • Placebo: An inactive treatment that looks like the study drug. It helps researchers compare results fairly.
  • Forced Vital Capacity (FVC): A breathing test that measures how much air a person can forcefully breathe out after taking a deep breath.
  • Baseline: The starting point before treatment begins.
  • Week 52: The 52-week time point, which is about one year after the study starts.
  • Efficacy: How well a treatment works.
  • Safety: How well a treatment can be used without causing serious problems.
  • Tolerability: How well people can handle a treatment during the study.

References

  1. https://clinicaltrials.gov/study/2023-503697-21-01
  2. https://clinicaltrials.gov/study/2023-503699-25-00