NCT04048876

Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study To Evaluate The Efficacy and Safety Of CC-90001 In Subjects With Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 compared with placebo, in Non-alcoholic Steatohepatitis (NASH) participants with Stage 2, Stage 3 liver 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.

Conditions

• Non-alcoholic Fatty Liver Disease
• Liver Cirrhosis

Interventions

Type	Name	Description
DRUG	CC-90001	oral
DRUG	Placebo	oral

Timeline

• Start date: 2019-08-14
• Primary completion: 2021-09-28
• Completion: 2021-09-28
• First posted: 2019-08-07
• Last updated: 2023-06-07
• Results posted: 2023-06-07

Locations

142 sites across 10 countries: United States, Australia, Canada, France, Germany, Japan, Poland, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study