Pulmonary Fibrosis
Conditions
Keywords
LPA1 receptor antagonist, Idiopathic pulmonary fibrosis, Progressive pulmonary fibrosis, Long-term extension, IPF, PPF, IM027068, IM0271015, Follow up
Brief summary
The purpose of this study is to evaluate the long-term safety and tolerability of Admilparant in participants who completed participation in parent studies IM027-068 (for idiopathic pulmonary fibrosis (IPF)) and IM027-1015 (for progressive pulmonary fibrosis (PPF)).
Interventions
Specified dose on specified days
Sponsors
Study design
Eligibility
Inclusion criteria
\- Participants must have participated in either IM027068 or IM0271015 without discontinuing treatment permanently due to withdrawal of informed consent in either IM027068 or IM0271015.
Exclusion criteria
* Any disease/condition that, in the investigator's judgment, may pose an unacceptable safety risk for study participation. * Any AE that resulted in permanent discontinuation of IMP in IM027068 or IM0271015. * Exhibit symptoms of heart failure at rest. * History of lung reduction surgery or lung transplant. * Participants with known PAH (Pulmonary Arterial Hypertension) who has been on single-drug therapy that now requires multi-drug therapy. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to Week 100 |
| Number of Participants With Serious Adverse Events (SAEs) | Up to Week 100 |
| Number of Participants With AEs leading to Discontinuation | Up to Week 100 |
| Number of Participants With AEs leading to Deaths | Up to Week 100 |
| Number of Participants With Clinically Significant Laboraty Abnormalities | Up to Week 100 |
| Number of Participants With Clinically Significant Electocardiogram (ECG) Abnormalities | Up to Week 100 |
| Number of Participants With Clinically Significant Vital Sign Abnormalities | Up to Week 100 |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Peru, Portugal, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
Bristol-Myers Squibb