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

a study on Liver Disease Nonalcoholic Fatty Liver Disease Cirrhosis Fibrosis Nonalcoholic Steatohepatitis Steatohepatitis

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

Summary

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.

Official Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Adaptive, Dose-Finding Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Non-alcoholic Steatohepatitis (NASH) and F3 or F4 Liver Fibrosis

Keywords

Non-alcoholic Fatty Liver Disease Liver Cirrhosis Non-Alcoholic Steatohepatitia NASH Non-Alcoholic Fatty Liver Liver Fibrosis CC-90001 Liver Diseases Fatty Liver Fibrosis CC-90001 400 mg once daily (QD) CC-90001 200 mg once daily CC-90001 100 mg once daily

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • Key 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 (eg, 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.

Locations

  • UC San Diego School of Medicine accepting new patients
    La Jolla California 92093-0960 United States
  • Inland Empire Liver Foundation accepting new patients
    Rialto California 92377 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT04048876
Phase
Phase 2
Study Type
Interventional
Last Updated
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