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

The primary objective is to evaluate the efficacy of two doses of admilparant compared to placebo by measuring the absolute change in forced vital capacity from baseline at Week 52 in participants with progressive pulmonary fibrosis. 5, 4, 13.

Secondary objectives include:

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

This study involves 843 participants diagnosed with progressive pulmonary fibrosis. The study population consists of both male and female patients. Eligible participants are aged 18 to 64 years. Selection is based on a diagnosis of interstitial lung disease with features consistent with progressive disease within 24 months prior to screening and a minimum of 10% extent of fibrosis on high-resolution computed tomography. Requirements regarding pirfenidone, nintedanib, or other immunosuppressive medications include maintaining a stable dose for at least 90 days or adhering to a specific washout period. Women of childbearing potential must utilize highly effective contraception.

This multicenter, randomized, double-blind, placebo-controlled, Phase 3 study is designed to evaluate the efficacy, safety, and tolerability of admilparant in individuals with progressive pulmonary fibrosis. The primary objective is to demonstrate improvement in the absolute change in forced vital capacity (FVC) from baseline at Week 52. Participants will be randomized to receive one of two doses of the LPA1 antagonist or a placebo. The study includes a screening visit to confirm eligibility, which requires a diagnosis of interstitial lung disease and specific high-resolution computed tomography findings. Following screening, participants will undergo a treatment period, with assessments including a 6-minute walk test to evaluate secondary endpoints. The total duration of participant involvement is planned through Week 52. Early termination from the study may occur based on predefined clinical criteria or safety protocols.

The experimental medication is an LPA1 antagonist referred to as admilparant. This substance is administered as a film-coated tablet via oral use at a dosage of 9999 mg.

The study utilizes a placebo as a comparator treatment. This placebo is intended for use in comparison with BMS-986278.

The efficacy of the LPA1 antagonist will be evaluated in participants with progressive pulmonary fibrosis. 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 six-minute walk test (6MWT) from baseline at Week 52.