1943: Safety & Efficacy of SEL in Patients w/ NASH & Bridging Fibrosis

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

• IRAS ID

  222163

• Contact name

  Mark Thursz

• Contact email

  m.thursz@imperial.ac.uk

• Sponsor organisation

  Gilead Sciences, Inc.,

• Eudract number

  2016-004374-18

• Clinicaltrials.gov Identifier

  125393, IND Number; NCT03053050, Clinical Trials.gov Identifier

• Duration of Study in the UK

  6 years, 1 months, 30 days

• Research summary

  This is a Phase 3, randomised, double-blind, placebo-controlled study evaluating the safety and efficacy of the study medication (SEL) in participants with NASH and bridging (F3) fibrosis. The purpose of this study is to see whether the study medication (SEL) causes fibrosis regression and reduce progression of cirrhosis and its associated complications.

  Nonalcoholic Steatohepatitis (NASH) is an inflammatory disease of the liver caused by build-up of fat. The body’s immune system responds to the fat by attacking and damaging liver cells, forming scar tissue where healthy cells used to be leading to permanent liver damage (cirrhosis). Over time, NASH may result in progressive liver fibrosis, ultimately resulting in cirrhosis; which has no cure. Subsequently, advanced liver fibrosis (bridging fibrosis or cirrhosis) is associated with increased morbidity and mortality and in the US, it is estimated that 2% to 5% of the population have NASH (approximately 16 million adults) presenting an unmet medical need.

  Participation in this study can last up to 252 weeks, including an 8 week screening period, 240 week treatment period and 4 week follow up period. Total study duration is expected as 7 years. 800 male and female participants between 18-70 will be enrolled at 400 centres globally. Eligible participants will visit the clinic at least 32 times. Participants who meet the study criteria will be randomly assigned in a 2:2:1 ratio to one of the 3 treatment groups:

  Group A: SEL 6mg + Placebo 18mg QD
  Group B: SEL 18mg + Placebo 6mg QD
  Group C: Placebo 6mg and Placebo 18mg QD

  If the participant experiences a significant worsening of their liver function (confirmed by a Hepatic Events Adjudication Committee) then they will be offered the option to receive SEL 18mg in the open label phase of the study or will be withdrawn from the study.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  17/LO/0848

• Date of REC Opinion

  31 Jul 2017

• REC opinion

  Further Information Favourable Opinion