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

ArmDescriptionAssigned Intervention
Experimental
CC-90001 400 mg once daily (QD)
CC-90001 400 mg QD
  • Drug: CC-90001
    oral
Experimental
CC-90001 200 mg once daily
CC-90001 200 mg QD
  • Drug: CC-90001
    oral
Experimental
CC-90001 100 mg once daily
CC-90001 100 mg QD
  • Drug: CC-90001
    oral
Placebo Comparator
Placebo once daily
Placebo QD
  • Drug: Placebo
    oral

More Details

Status
Terminated
Sponsor
Celgene

Study Contact