A pivotal phase 3 study of PBI-4050 to treat mild-to-moderate idiopathic pulmonary fibrosis (IPF)
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
- Sponsors ProMetic Life Sciences
- 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.