IM0271016 - LTE Study of Admilparant in Participants with Pulmonary Fibrosis
Research type
Research Study
Full title
An Open-label, Multi-center, Long-term Extension Study to Evaluate the Long-term Safety and Tolerability of Admilparant in Participants with Pulmonary Fibrosis.
IRAS ID
1013331
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Bristol-Myers Squibb Services Unlimited Company
Eudract number
2025-522373-10
Clinicaltrials.gov Identifier
Research summary
There remains a large unmet need for a well‑tolerated and effective therapy for idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) that improves pulmonary function, delays disease progression, and reduces mortality. Admilparant, a lysophosphatidic acid receptor 1 antagonist, is an orally administered investigational product being developed for the treatment of patients with IPF and PPF.
In an earlier study (Phase 2), admilparant was found to be well-tolerated and helpful for people with lung scarring, both when used alone and with other medicines. In later studies (Phase 3), admilparant did not show any new safety problems after one year of treatment. These results suggest that admilparant may be a potential treatment for people with IPF and PPF, and therefore more research is being done to understand its long‑term safety.
IM0271016 is a Phase 3, open‑label, multi‑center, long‑term research study. This means that all participants will receive admilparant, and there is no placebo. Participants are allowed to continue taking other medicines for lung scarring like nintedanib or pirfenidone. The study is designed as a long‑term extension for people who have previously taken part in earlier admilparant studies for IPF or PPF and have completed their study treatment and end‑of‑treatment visit. The study will have two groups; one group (IPF) will include people from the IM027068 study, and the other group (PPF) will include people from the IM0271015 study.
Each participant will take admilparant by mouth twice a day for up to approximately two years and will attend regular clinic visits, every three months. The main aim of this study is to understand the long‑term safety and tolerability of admilparant. Based on earlier studies, the risks are considered low, and the potential benefits of learning more about this treatment are considered to outweigh the risks.
REC name
Wales REC 5
REC reference
26/WA/0099
Date of REC Opinion
8 Jul 2026
REC opinion
Further Information Favourable Opinion