PLN-74809-IPF-202
Research type
Research Study
Full title
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)
IRAS ID
277008
Contact name
Toby Maher
Contact email
Sponsor organisation
Pliant Therapeutics Inc.
Eudract number
2019-002709-23
Duration of Study in the UK
0 years, 9 months, 3 days
Research summary
Summary of Research
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.Summary of Results
INTEGRIS-IPF: A study to assess the safety and pharmacokinetics (the way our
body absorbs, distributes, and gets rid of a drug) of PLN-74809 (bexotegrast) in
patients with idiopathic pulmonary fibrosis (IPF).
• IPF is a rare, life-threatening condition, characterized by progressive scarring and
stiffness of the lungs.
• This study was done to test the safety, tolerability (side effects), and
pharmacokinetics (the way our body absorbs, distributes, and gets rid of a drug) of
bexotegrast in participants with IPF.
• The study had 4 parts (Parts A, B, C, and D). Part A of the study was closed, and
Parts B and C of the study were opened when new scientific information became
available.
• One participant took part in Part A of the study, was between 60 and 65 years old
with mild IPF, and received bexotegrast 40 mg.
• Participants in Parts B, C, and D of the study had mild-to-moderate IPF, were
between 54 and 87 years old, and 84% were men and 16% were women.
Participants were enrolled from 7 countries in Europe, North America, and Asia-
Pacific.
• In Parts B, C, and D, 22 participants took bexotegrast 40 mg once daily, 23
participants took bexotegrast 80 mg once daily, 22 participants took bexotegrast 160
mg once daily,
22 participants took bexotegrast 320 mg once daily, and 31 participants took
placebo once daily (the placebo did not contain any medicine).
• Overall, for Parts B, C, and D, 22% of participants who took bexotegrast and 32%
of participants who took placebo had side effects during the study. The most
common side effect with bexotegrast was diarrhoea. The most common side effect
with placebo was nausea (feeling sick in the stomach).
• Bexotegrast, given once daily for up to about 40 weeks, was well tolerated and
showed acceptable safety for further study at doses of up to 320 mg in participants
with IPF.REC name
London - Central Research Ethics Committee
REC reference
20/LO/0879
Date of REC Opinion
6 Nov 2020
REC opinion
Further Information Favourable Opinion