BEACON-IPF

• Research type

  Research Study

• Full title

  A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF)

• IRAS ID

  1008893

• Contact name

  Chris Keenan

• Contact email

  ckeenan@pliantrx.com

• Sponsor organisation

  Pliant Therapeutics Inc.

• Research summary

  Idiopathic pulmonary fibrosis (IPF) is a condition in which the tiny air sacs in the lungs become damaged. IPF is caused by scarring and the build-up of scar tissue (called fibrosis) around the tiny air sacs in the lungs. The scar tissue makes it more difficult for oxygen to move through the tiny air sacs in the lungs and into the bloodstream, and causes the lungs to become stiffer, making breathing more difficult.
  The study drug, bexotegrast, is thought to reduce fibrosis and may be an effective treatment for IPF. The purpose of this study is to evaluate the safety and efficacy of bexotegrast (160mg and 320mg) and to assess how it may improve lung capacity.

  Following a screening period (up to 4 weeks), eligible participants will be enrolled into 1 of 3 groups. The first 267 participants will be in Group 1 and participant 268 onwards will be in Group 2. Participants in both Groups 1 and 2 will be randomised in a 1:1:1 ratio to receive bexotegrast 160 mg, bexotegrast 320 mg, or placebo. Group 2 will end when the dose for Group 3 has been determined following results from Group 1. The remaining participants will be enrolled into Group 3 and be randomised in a 1:1 ratio to receive either bexotegrast (160 or 320mg) or placebo. Participants will receive study drug for 52 week and be followed up for 2 weeks. The maximum time a participant may be in the study is 58 weeks.

  Study procedures will include blood and urine samples, vital signs, physical examinations, ECGs, questionnaires, scans to look at the lungs and breathing tests.
  Approximately 771 participants 40 years and older will take part in this study globally, with approximately 22 expected in the UK.

  This study is sponsored by Pliant Therapeutics Inc.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  24/NW/0004

• Date of REC Opinion

  6 Feb 2024

• REC opinion

  Further Information Favourable Opinion