A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
This study will evaulate the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) administered by intravenous (IV) infusion to participants with idiopathic pulmonary fibrosis (IPF).
- Idiopathic Pulmonary Fibrosis
- Eligible Ages
- All ages
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- Phase 3
- Study Type
- Intervention Model
- Single Group Assignment
- Primary Purpose
- None (Open Label)
|Corhort A: Participants entering, following participation in study PRM-151-202. Cohort B: Participants entering, following participation in study WA42293.||
- Hoffmann-La Roche
Study ContactReference Study ID Number: WA42294 www.roche.com/about_roche/roche_worldwide.htm
888-662-6728 (U.S. and Canada)
This study is being conducted for the treatment of eligible participants who have taken part in Study PRM-151-202 and received the open-label study drug or completed the Phase III Study WA42293 with PRM-151. Participants who have discontinued treatment from or have completed Study WA42293 and do not want to receive PRM-151 in this study, will be invited to enroll in survival follow-up.