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 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.

Official Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study To Evaluate The Efficacy and Safety Of CC-90001 In Subjects With Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis

Keywords

Non-alcoholic Fatty Liver Disease Liver Cirrhosis Non-Alcoholic Steatohepatitis 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 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

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).
  • Participant 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 within the last 5 years (exceptions: excised and cured basal/squamous cell skin carcinomas and cervical carcinoma in situ).
  • Pregnancy or lactation.

Locations

  • UC San Diego School of Medicine
    La Jolla California 92093-0960 United States
  • Southern California GI & Liver Centers
    San Clemente California 92673 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT04048876
Phase
Phase 2
Study Type
Interventional
Last Updated