A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Admilparant in Participants with Idiopathic Pulmonary Fibrosis

The primary objective of this study is to evaluate the efficacy of admilparant compared to placebo by measuring the absolute change in forced vital capacity (FVC) from baseline at week 52 in patients with idiopathic pulmonary fibrosis. The secondary objectives include:

• Assessment of the effect of admilparant on disease progression from baseline through the primary endpoint visit.
• Evaluation of the impact on quality of life and morbidity from baseline to week 52.

The study involves 962 participants diagnosed with idiopathic pulmonary fibrosis. The study population includes both male and female patients within the age range of 40 to 65 years. Inclusion requires a diagnosis of the condition within 7 years prior to screening, supported by high-resolution computed tomography and verification of usual interstitial pneumonia. Participants currently receiving pirfenidone or nintedanib must have maintained a stable dose for at least 90 days, while those not on these medications must have had no exposure within 28 days prior to screening. Women of childbearing potential are required to use highly effective contraception and provide negative pregnancy test results, and sexually active men must utilize male barrier methods.

This Phase 3, multicenter, randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy, safety, and tolerability of the LPA1 antagonist admilparant in participants diagnosed with idiopathic pulmonary fibrosis. The primary objective is to assess the absolute change in forced vital capacity from baseline at Week 52. Secondary endpoints include a 4-component composite endpoint for disease progression and changes in walking distance measured by the 6-minute walk test. The study methodology involves a screening visit to verify diagnosis via high-resolution computed tomography and ensure stability of existing medications, such as pirfenidone or nintedanib. Following screening, participants are randomized to receive either the active film-coated tablet or a placebo. The trial duration and participant involvement extend through the primary endpoint assessment, with specific protocols for monitoring safety and efficacy over the 52-week period.

The experimental treatment consists of admilparant, an LPA1 antagonist. This substance is administered in the form of a film-coated tablet via oral use at a dosage of 9999 mg.

The control group receives a placebo corresponding to BMS-986278.

The efficacy of admilparant in participants with idiopathic pulmonary fibrosis is evaluated using several parameters. The primary endpoint is the absolute change in forced vital capacity (FVC) from baseline at Week 52.

Secondary efficacy assessments include:

• A disease progression 4-component composite endpoint, defined as the time to the first disease progression event from Day 1 through the primary endpoint visit.
• Change in walking distance as measured by the 6-minute walk test (6MWT) from baseline at Week 52.