A randomized, double-blind, dose-ranging, placebo-controlled Phase 2a evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosis (IPF) (INTEGRIS-IPF)
Pliant Therapeutics Inc.
Duration of Study in the UK
0 years, 9 months, 3 days
Idiopathic Pulmonary Fibriosis (IPF) is the most common interstital lung disease, a condition in which the tiny air sacs in the lungs become damaged. This causes scarring and the build-up of scar tissue (called fibrosis). The scar tissue causes the lungs to become stiffer, making breathing increasingly difficult. The symptoms of IPF can include shortness of breath, persistent dry cough, tiredness, weight loss, and rounded and enlarged fingertips.
Patients diagnosed with mild-to-moderate IPF and who do not present with other major health conditions that could affect the study drug or co-found the study outcomes will be recruited in the clinical study.
PLN-74809-000 is being developed for Idiopathic Pulmonary Fibriosis (IPF). PLN-74809 is a small molecule and is expected to exert anti-fibrotic effects through mechanisms that are different from those of current standards of care for IPF. The proposed trial is a randomised, double-blind, dose-ranging, placebo-controlled Phase 2a study evaluationg he safety, tolerability and PK of 12 weeks treatment with PLN-74809 40mg or placebo.
The total time taking part in this study will be no longer than 17 weeks. This includes the following study periods:
1. Screening Period (period where the Sponsor will ensure that you are suitable for the study and the study is suitable for you) of up to 28 days
2. Treatment Period (period where you will receive PLN-74809 or placebo) of approximately 12 weeks.
3. Follow-up Period 1 week after your last dose of the study medication (PLN-74809 or placebo) to check your overall health.
London - Central Research Ethics Committee
Date of REC Opinion
6 Nov 2020
Further Information Favourable Opinion