STELLAR-3: Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

Sponsor

Gilead Sciences (Industry)

Overall Status

Terminated

CT.gov ID

NCT03053050

Collaborator

(none)

808

Enrollment

298

Locations

Arms

28.1

Actual Duration (Months)

2.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.

Condition or Disease	Intervention/Treatment	Phase
Nonalcoholic Steatohepatitis	Drug: SEL Drug: Placebo to match SEL 6 mg Drug: Placebo to match SEL 18 mg	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

808 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Feb 13, 2017

Actual Primary Completion Date :

Jun 19, 2019

Actual Study Completion Date :

Jun 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SEL 18 mg Randomized Phase: Selonsertib (SEL) 18 mg tablet + placebo to match SEL 6 mg tablet for 240 weeks Open-Label (OL) Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase.	Drug: SEL Tablets administered orally once daily Other Names: selonsertib GS-4997 Drug: Placebo to match SEL 6 mg Tablets administered orally once daily
Experimental: SEL 6 mg Randomized Phase: SEL 6 mg tablet + placebo to match SEL 18 mg tablet for 240 weeks OL Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase.	Drug: SEL Tablets administered orally once daily Other Names: selonsertib GS-4997 Drug: Placebo to match SEL 18 mg Tablets administered orally once daily
Placebo Comparator: Placebo Randomized Phase: Placebo to match SEL 6 mg tablet + placebo to match SEL 18 mg tablet for 240 weeks OL Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase.	Drug: Placebo to match SEL 6 mg Tablets administered orally once daily Drug: Placebo to match SEL 18 mg Tablets administered orally once daily

Arm

Intervention/Treatment

Experimental: SEL 18 mg

Randomized Phase: Selonsertib (SEL) 18 mg tablet + placebo to match SEL 6 mg tablet for 240 weeks Open-Label (OL) Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase.

Drug: SEL