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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Non-alcoholic Fatty Liver Disease, Liver Cirrhosis

In brief

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 facts

Study ID

NCT04048876

Run by

Celgene

People needed

56

Starts

2019-08-14

Expected to finish

2021-09-28

Last updated by the study team

2023-06-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• Mayo Clinic Phoenix — Phoenix, Arizona, United States
• UC San Diego School of Medicine — La Jolla, California, United States
• Cedars-Sinai Comprehensive Transplant Center — Los Angeles, California, United States
• California Liver Research Institute — Pasadena, California, United States
• Inland Empire Liver Foundation — Rialto, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• Southern California GI & Liver Centers — San Clemente, California, United States
• University of Colorado, School of Medicine - Hepatology Clinic - Anschutz — Aurora, Colorado, United States
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
• South Denver Gastroenterology — Englewood, Colorado, United States
• Bridgeport Hospital — Bridgeport, Connecticut, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Florida Digestive Health Specialists — Lakewood Rch, Florida, United States
• Local Institution - 176 — Lakewood Rch, Florida, United States
• University of Miami Schiff Center for Liver Diseases — Miami, Florida, United States
• IMIC, Inc. — Palmetto Bay, Florida, United States
• Advanced Medical Research Center — Port Orange, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Gastrointestinal Specialists of Georgia, PC — Marietta, Georgia, United States
• Rush University Medical Center - University Cardiovascular Surgeons — Chicago, Illinois, United States
• University of Chicago Medicine — Chicago, Illinois, United States
• WestGlen Gastrointestinal Consultants, P.A. — Shawnee Mission, Kansas, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Saint Joseph's Hosptial and Medical Center - Barrow Neurological Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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