Open‑Label Multi‑Center Extension Study of Admilparant for Long‑Term Safety and Tolerability in Patients with Idiopathic or Progressive Pulmonary Fibrosis

The primary objective is to evaluate the long‑term safety and tolerability of oral admilparant in participants with idiopathic pulmonary fibrosis or other progressive pulmonary fibrosis when administered over an extended period.

1388 participants were enrolled, comprising both male and female patients with progressive pulmonary fibrosis and idiopathic pulmonary fibrosis who had previously received the investigational drug admilparant and completed the end‑of‑treatment visit in the IM027068 or IM0271015 studies. Age eligibility required participants with IPF to be ≥40 years and those with PPF to be ≥21 years at consent, resulting in an adult population ranging from early adulthood to older age. All participants were in generally stable health concerning their fibrotic lung disease and were required to adhere to specific reproductive safety measures: women of child‑bearing potential needed to use a highly effective, user‑independent contraception and provide a negative pregnancy test at baseline, while male partners of women of child‑bearing potential were required to use condoms. The cohort represented a broad patient group without restriction to specific lifestyle habits beyond the contraception requirements.

The study is an open‑label, multi‑center, long‑term extension trial evaluating the safety and tolerability of the oral LPA1 antagonist admilparant in participants with progressive pulmonary fibrosis, including idiopathic pulmonary fibrosis. Eligible participants must have completed prior treatment in the parent studies and satisfy age and contraceptive requirements. After a screening visit to confirm eligibility, participants receive admilparant 9999 mg once daily as a film‑coated tablet. Follow‑up visits are scheduled at regular intervals (e.g., monthly for the first six months, then quarterly) to monitor adverse events, laboratory parameters, ECGs, and vital signs. The trial duration spans up to three years, concluding with an end‑of‑study visit that assesses cumulative safety outcomes. Primary endpoints include the incidence of treatment‑emergent adverse events, serious adverse events, discontinuations due to adverse events, mortality, and longitudinal changes from baseline in laboratory values, ECG findings, and vital signs. Participants remain in the study until the scheduled end‑of‑study visit unless early termination criteria are met, such as a serious adverse event, inability to continue the investigational product, or withdrawal of consent.

The investigational product identified as LPA1 antagonist (active substance admilparant) is supplied as a film‑coated tablet for oral use. Each tablet contains a dose of 9999 mg and is administered once daily by swallowing with water. Dosing is performed under supervised conditions at each study visit, and ongoing adherence is assessed through patient‑reported dosing diaries and pill‑count reconciliation at scheduled assessments.

A second investigational agent, designated BMS-986278, also contains the active substance admilparant and is formulated as a film‑coated tablet for oral use. The administered dose is 9999 mg taken once daily. Compliance monitoring mirrors that of the LPA1 antagonist, employing electronic dosing logs and periodic tablet counts to ensure protocol‑defined adherence.

No placebo or active comparator is employed in this open‑label extension; participants continue any background therapy deemed appropriate for their underlying pulmonary fibrosis condition, with concomitant medications recorded but not altered by the study protocol.