Celgene CC-90001-NASH-001 V1.0
Research type
Research Study
Full 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 Stage 3 or Stage 4 Liver Fibrosis
IRAS ID
264579
Contact name
Philip Newsome
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2018-004431-79
Duration of Study in the UK
3 years, 9 months, 3 days
Research summary
Research of Summary
Celgene is the sponsor carrying out this double-blind, placebo-controlled study to assess the safety and efficacy of CC-90001 in subjects with Non-alcoholic Steatohepatitis (NASH) and Stage 3 or Stage 4 Liver Fibrosis.
Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in the world. When steatosis (abnormal retention of fats) is accompanied by evidence of liver cell injury and cell death, as well as inflammation, it is considered to be nonalcoholic steatohepatitis (NASH). More advanced stages of NASH are accompanied by fibrosis. The stage of fibrosis is the most important determinant of death in patients with advanced NASH. Patients with NASH and advanced fibrosis (i.e., Stage 3 and Stage 4 fibrosis) are at a higher risk for liver-related complications and death over a relatively short time scale.
Dietary changes and lifestyle modifications are considered first-line interventions for patients with NASH.
CC-90001 is a potent and selective inhibitor of c-Jun N-terminal kinase (JNK). JNK is rapidly activated in response to a variety of physical, chemical, and biological cellular stresses. JNK plays a key role in metabolism, inflammation, and fibrosis, and therefore may play a critical role in the development and progression of NASH.
In this study approximately 300 participants with a confirmed diagnosis of NASH and Stage 3 or Stage 4 fibrosis will be randomised 1:1:1:1 to treatment with 3 different doses of oral CC-90001or placebo. The study will have a total duration of up to 114 weeks. The study will consist of an up to 8-week Screening Phase; a 52-week Double-blind Placebo-controlled Treatment Phase; a 50-week Double-blind Active Treatment Phase; and a 4-week Post-Treatment Observational Follow-up Phase. Some of the procedures involved include; liver biopsy, blood tests, Magnetic Resonance imaging, vital signs, ECG, PK sampling, pregnancy test, and questionnaires.
Based on the results of clinical pharmacology studies CC-90001 is generally safe and well tolerated.Research of Results
Not available
REC name
London - Fulham Research Ethics Committee
REC reference
19/LO/1513
Date of REC Opinion
15 Nov 2019
REC opinion
Further Information Favourable Opinion