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
- Study HIC#:2000025390
- Last Updated:07/15/2021
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.
- Age18 years and older
- Start Date03/06/2020
- End Date07/06/2022
Trial Purpose and Description
The primary objective of the study is to evaluate the effect of oral CC-90001, administered QD, compared with placebo, on liver histology in subjects with NASH and Stage 3 fibrosis.
- Key Inclusion Criteria Diagnosis of non-alcoholic steatohepatitis (NASH) with presence of Stage 3 or Stage 4 fibrosis based of the non-alcoholic steatohepatitis (NASH) Clinical Research Network (CRN) Histologic Scoring System and a nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) of 4 or higher
- Key Exclusion Criteria
- History or evidence of decompensated liver disease,
- Hepatitis and fibrosis more likely related to etiologies other than non-alcoholic steatohepatitis (NASH).
- Subject has urine ethyl glucuronide (EtG) > 500 ng/mL at Screening.
- History or positive screen for human immunodeficiency virus (HIV) infection or congenital or human immunodeficiency virus (HIV)-unrelated acquired immunodeficiencies (eg, common variable immunodeficiency [CVID]).
- History of hepatitis B and/or hepatitis C.
- History of malignancy (exceptions: excised and cured basal/squamous cell skin carcinomas and cervical carcinoma in situ with no recurrence in 5 years).
- Pregnancy or lactation.