Clinical Trial

Steatohepatitis and Liver Fibrosis Treatment

Study Description

Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Non-alcoholic Steatohepatitis (NASH) and Stage 3 or Stage 4 Liver Fibrosis

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, multinational, dose-finding study evaluating the efficacy of three treatment doses of CC-90001 (100 mg, 200 mg and 400 mg PO QD), compared with placebo, in NASH subjects with Stage 3 and Stage 4 fibrosis. This study is designed to assess response to treatment on measures of fibrosis and other efficacy parameters. It will also assess dose response and overall safety.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Drug - CC-90001

oral

Drug - Placebo

oral

Additional Information

Official Study Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Adaptive, Dose-Finding Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Non-alcoholic Steatohepatitis (NASH) and F3 or F4 Liver Fibrosis

Clinical Trial ID

NCT04048876

ParticipAid ID

b68qVe