Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Key Inclusion Criteria Diagnosis of non-alcoholic steatohepatitis (NASH) with presence of Stage 2, Stage 3 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
Exclusion Criteria
- Key Exclusion Criteria 1. History or evidence of decompensated liver disease, 2. Hepatitis and fibrosis more likely related to etiologies other than non-alcoholic steatohepatitis (NASH). 3. Participant has urine ethyl glucuronide (EtG) > 500 ng/mL at Screening. 4. 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]). 5. History of hepatitis B and/or hepatitis C. 6. History of malignancy within the last 5 years (exceptions: excised and cured basal/squamous cell skin carcinomas and cervical carcinoma in situ). 7. Pregnancy or lactation.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental CC-90001 400 mg once daily (QD) |
CC-90001 400 mg QD |
|
Experimental CC-90001 200 mg once daily |
CC-90001 200 mg QD |
|
Experimental CC-90001 100 mg once daily |
CC-90001 100 mg QD |
|
Placebo Comparator Placebo once daily |
Placebo QD |
|
More Details
- Status
- Terminated
- Sponsor
- Celgene