A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
Age: Birth - 66+
Healthy Subjects: No
Study Phase: Phase 3
Recruitment Status: Recruiting
Start Date: August 30, 2021
End Date: December 30, 2028
- Taken part in either of the prior PRM-151 studies: PRM-151-202 or WA42293.
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception.
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.
- Acute respiratory or systemic bacterial, viral, or fungal infection at the first visit of the OLE, or within 2 weeks of the first visit for patients joining Cohort A (from Study PRM-151-202).
- History of smoking within 3 months prior to the first visit in the OLE.
- History of alcohol or substance use disorder within 2 years prior to the first visit of the OLE or known or suspected active alcohol or substance-use disorder.
- History of severe allergic reaction or anaphylactic reaction to PRM-151.
- Clinically significant abnormality on ECG during eligibility assessment including prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) based on the Fridericia correction formula; or laboratory tests (hematology, serumchemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.