A pivotal phase 3 study of PBI-4050 to treat idiopathic pulmonary fibrosis (IPF).

Trial Profile

A pivotal phase 3 study of PBI-4050 to treat idiopathic pulmonary fibrosis (IPF).

Planning
Phase of Trial: Phase III

Latest Information Update: 30 Jan 2018

At a glance

  • Drugs PBI 4050 (Primary) ; Nintedanib
  • Indications Idiopathic pulmonary fibrosis
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 30 Jan 2018 New trial record
    • 29 Jan 2018 According to a ProMetic Life Sciences media release, an interim analysis will be conducted at 26 weeks. Dr. Joseph Parker is overseeing the study. Patient enrolment will initiate mid-year 2018.
    • 29 Jan 2018 According to a ProMetic Life Sciences media release, based on recommendations from the FDA in a Type C meeting, the company has reached final agreement on the design and decided this trial as "all comers study". The study will enroll patients with mild-to-moderate IPF, regardless of whether they are on background standard of care with nintedanib (OFEV) or not.
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