A Study to Evaluate the Effectiveness and Safety of CC-90001 in Subjects With Non-alcoholic Steatohepatitis (NASH) and Stage 3 or Stage 4 Liver Fibrosis

Overview

About this study

The purpose of this study is to evaluate the effectiveness and safety 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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: 

  • 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 (e.g., 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Bashar Aqel, M.D.

Open for enrollment

Contact information:

Nicholas Schentag B.S.

(480)342-1335

Schentag.Nick@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20482092

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