drugset / Trial / NCT04048876
Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2019-08-14
- Primary completion
- 2021-09-28
- Completion
- 2021-09-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CC-90001 | Small molecule | 100 mg | Oral |
| Subject | CC-90001 | Small molecule | 200 mg | Oral |
| Subject | CC-90001 | Small molecule | 400 mg | Oral |