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 (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.

Conditions

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 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

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. Subject 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 (exceptions: excised and cured basal/squamous cell skin carcinomas and cervical carcinoma in situ with no recurrence in 5 years). 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

Recruiting Locations

Tulane University Health Sciences Center
New Orleans, Louisiana 70112

More Details

Status
Recruiting
Sponsor
Celgene

Study Contact

Associate Director Clinical Trial Disclosure
1-888-260-1599
clinicaltrialdisclosure@celgene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.