In short
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.
Key points
- Clinical trials are studying ADMILPARANT in two serious lung diseases: idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. Both studies are Phase 3 and are authorised. The main goal is to see whether ADMILPARANT improves Forced Vital Capacity, a breathing test, after 52 weeks. One trial plans to include 1,201 people, and the other plans to include 1,092 people. The studies also look at safety and tolerability.
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.
Both studies are authorised and are designed to evaluate efficacy, safety, and tolerability in people with scarring lung disease.
Idiopathic pulmonary fibrosis study
One study is for participants with idiopathic pulmonary fibrosis, a disease that causes lung scarring and has no known cause.
This trial is titled as a study of BMS-986278, and the brief summary says it is evaluating admilparant compared with placebo.
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.
Progressive pulmonary fibrosis study
The second study is for participants with progressive pulmonary fibrosis, which means the lung scarring gets worse over time.
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.
The planned enrollment is 1,092 participants, and the main outcome is the absolute change in FVC from baseline at Week 52.
Who can participate
Based on the trial records, the target populations are adults with either idiopathic pulmonary fibrosis or progressive pulmonary fibrosis.
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.
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.
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.
Key terms explained
Placebo means a look-alike treatment with no active study medicine, used so results can be compared fairly.
Baseline means the starting point before the study treatment begins, and Week 52 means the one-year time point used in both studies.
Interventional means the researchers are assigning a treatment to participants rather than only observing them.