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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 Stage 3 or Stage 4 Liver Fibrosis

Clinical Trial Details

This is a phase 2, randomized, double-blind, placebo-controlled, multicenter, multinational, dose-finding study evaluating the efficacy of three study drug doses of CC-9000, compared with placebo, in non-alcoholic steatohepatitis (NASH) subjects with stage 3 or 4 liver fibrosis. NASH is a type of fatty liver disease in which fat builds up in the liver and over time causes inflammation (swelling) and liver cell damage. 

The purpose of this study is to see the effect of the investigational/experimental drug CC-9001 on the liver and how well your body tolerates CC-9001 and slows the process of NASH and liver fibrosis. The study drug CC-9001 has not been approved by the United States Food and Drug Administration (FDA) for the treatment of NASH. 

If an individual agrees to participate and meets all requirements, they will be randomized to one of the following study doses: 

  • CC-90001 100mg 
  • CC-90001 200mg 
  • CC-90001 400mg 
  • Matching placebo 

The matching placebo will look like CC-9001 but will not contain active medicine/ingredients.CC-9001 and placebo will be supplied by Celgene Corporation, which is the sponsor of this study, at no cost to the participant. 

Participation in this study will last about 114 weeks. During this time, participants will be required to visit the clinic at least 28 times, including the screening visit. Participants will be compensated for their time. 

Key Eligibility: 
  • Adults diagnosed with NASH
  • Detailed eligibility reviewed when you contact the study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1905020063

ClinicalTrials.gov:

NCT04048876

Sponsor:

CC-9001-NASH-001

Status

Open to Enrollment

Age Group

Adult

Sponsor