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Trial ID CC-90001-NASH-001  |   NCT04048876

Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis

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Summary

  • Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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.

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Key Eligibility Criteria

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.

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: CC-90001 100 mg once daily

ASSIGNED INTERVENTION
  • Drug: CC-90001

Study Arms

Experimental: CC-90001 200 mg once daily

ASSIGNED INTERVENTION
  • Drug: CC-90001

Study Arms

Experimental: CC-90001 400 mg once daily (QD)

ASSIGNED INTERVENTION
  • Drug: CC-90001

Study Arms

Placebo Comparator: Placebo once daily

ASSIGNED INTERVENTION
  • Drug: Placebo