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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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).

Key facts

Study ID

NCT04594707

Run by

Hoffmann-La Roche

People needed

117

Starts

2021-08-30

Expected to finish

2023-02-10

Last updated by the study team

2024-05-16

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 may not qualify 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 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.

Where it is running

• University of California Davis — Sacramento, California, United States
• Inst. of Healthcare Assessment, Inc. — San Diego, California, United States
• UCSF Medical Center — San Francisco, California, United States
• National Jewish Health Medical Center — Denver, Colorado, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Meris Clinical Research — Brandon, Florida, United States
• Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration — Celebration, Florida, United States
• Advanced Pulmonary & Sleep Research Institute of Florida — Daytona Beach, Florida, United States
• University of Florida Health Pulmonology - Jacksonville — Jacksonville, Florida, United States
• Advanced Pulmonary Research Institute — Loxahatchee Groves, Florida, United States
• Sarasota County Public Hospital — Sarasota, Florida, United States
• Renstar Medical Research — Wesley Chapel, Florida, United States
• Florida Pulmonary Research Institute, LLC — Winter Park, Florida, United States
• NorthShore University HealthSystem — Evanston, Illinois, United States
• University of Iowa Hospitals and Clinics; Investigational Drug Services — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Louisville Health Sciences Center — Louisville, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Minnesota Medical Center — Minneapolis, Minnesota, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• The Lung Research Center — Chesterfield, Missouri, United States
• Washington University — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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