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NCT07441408
Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis
Conditions: Pulmonary Fibrosis
Sex: All
Healthy volunteers: No
Phase: PHASE3
Enrollment: 2380
Sponsor: Bristol-Myers Squibb
Location: Local Institution - 0113 Birmingham Alabama
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)).
Eligibility Criteria
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/Exclusion criteria apply.
Source: ClinicalTrials.gov (NCT07441408). StuddyBuddy aggregates publicly available trial information.