Overview
A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
Status:
Recruiting
Recruiting
Trial end date:
2029-07-11
2029-07-11
Target enrollment:
0
0
Participant gender:
All
All
Summary
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).Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Hoffmann-La Roche
Criteria
Inclusion Criteria:- 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.
Exclusion Criteria:
- 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.