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.
- Non-alcoholic Fatty Liver Disease
- Liver Cirrhosis
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- Phase 2
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
CC-90001 400 mg once daily (QD)
|CC-90001 400 mg QD||
CC-90001 200 mg once daily
|CC-90001 200 mg QD||
CC-90001 100 mg once daily
|CC-90001 100 mg QD||
Placebo once daily
Study ContactAssociate Director Clinical Trial Disclosure