A multi-center pivotal, double-blind, placebo-controlled study with IPF patients on pirfenidone or nintedanib randomized to receive either PBI-4050 or a placebo

Trial Profile

A multi-center pivotal, double-blind, placebo-controlled study with IPF patients on pirfenidone or nintedanib randomized to receive either PBI-4050 or a placebo

Planning
Phase of Trial: Phase II/III

Latest Information Update: 25 Sep 2017

At a glance

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

    • 25 Sep 2017 According to a ProMetic Life Sciences media release, an Data and Safety Monitoring Board (DSMB) will conduct an interim 26-week analysis, and based on the safety and efficacy results, will recommend whether the study should continue into phase III stage and which dose of PBI-4050 should be continued.
    • 25 Sep 2017 According to a ProMetic Life Sciences media release, the company has received clearance of an IND to initiate pivotal PBI-4050 Phase 2/3 trial in patients with idiopathic pulmonary fibrosis. The company plans to supplement the IND with a protocol for a study of PBI-4050 monotherapy in IPF patients in October 2017. The clinical trial applications in Canada, Europe, Australia and Japan are anticipated throughout Q4 2017.
    • 18 Apr 2017 According to a ProMetic Life Sciences media release, company has recieved concurrence from the US Food and Drug Administration ("FDA") on the design of this trial.
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