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A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis

NCT04594707

TerminatedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: PRM-151 (Zinpentraxin Alfa)

Countries: United States, Argentina, Australia, Belgium, Canada, China, Czechia, Denmark

This study will evaulate the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, administered by intravenous (IV) infusion to participants with idiopathic pulmonary fibrosis (IPF).

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.
* Prolonged corrected QT interval \> 450 ms (for men) or \> 470 ms (for women) based on the Fridericia correction formula.
* Clinically significant laboratory test abnormalities (hematology, serumchemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.

Locations (248)

Birmingham, Alabama, United States
Sacramento, California, United States
San Diego, California, United States
San Francisco, California, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Brandon, Florida, United States
Celebration, Florida, United States
Daytona Beach, Florida, United States
Jacksonville, Florida, United States
Loxahatchee Groves, Florida, United States
Sarasota, Florida, United States
Wesley Chapel, Florida, United States
Winter Park, Florida, United States
Evanston, Illinois, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
Chesterfield, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
New York, New York, United States
Greensboro, North Carolina, United States
Wilmington, North Carolina, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
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