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

  • Idiopathic Pulmonary Fibrosis
Trial Status:

Recruiting

This trial runs in
Countries
  • Argentina
  • Australia
  • Belgium
  • Canada
  • China
  • Czechia
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Portugal
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Turkey
  • United States
Trial Identifier:

NCT04594707 2020-001429-30 WA42294

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial Summary

      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).

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT04594707 , WA42294 , 2020-001429-30 Trial Identifier
      PRM-151 (Zinpentraxin Alfa) Treatments
      Idiopathic Pulmonary Fibrosis Condition
      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)

      Eligibility Criteria

      All Gender
      No Healthy Volunteers
      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.

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