Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
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 Liver Extracts 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 not yet accepting 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