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Active, Not Recruiting

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.

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

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