Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis
Phase 3 – large-scale trial before approval
Conditions:
Pulmonary Fibrosis
Sponsor: Bristol-Myers Squibb
trial.available_in:
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Overview
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)).
Who can participate
Inclusion Criteria:
\- Participants must have completed participation in either IM027068 or IM0271015 (defined as receiving study intervention (IMP) until completion of EOT visit).
Exclusion Criteria:
* Clinically significant AE that resulted in discontinuation or interruption of IMP (Investigational Medicinal Product) in IM027068 or IM0271015 without reinitiation of IMP.
* Exhibit symptoms of heart failure at rest.
* History of lung reduction surgery or lung transplant. Note: Being on the transplantation list is allowed.
* 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.
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