Summary

Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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).

Official Title

A Phase III Open-label Extension Study to Evaluate Long-term Safety and Efficacy of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Details

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.

Keywords

Idiopathic Pulmonary Fibrosis Pulmonary Fibrosis Fibrosis PRM-151

Eligibility

You can join if…

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCSF Medical Center
    San Francisco California 94143-0748 United States
  • William Sansum Diabetes Center
    Santa Barbara California 93105 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT04594707
Phase
Phase 3
Study Type
Interventional
Last Updated