The study of an investigational drug, Cenicriviroc, for the treatment of liver fibrosis in patients with Nonalcoholic Steatohepatitis (NASH).

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects with Nonalcoholic Steatohepatitis - STELLARIS

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004566-26-DE

Enrollment

2000

Registered

2017-02-22

Start date

2017-10-02

Completion date

Unknown

Last updated

2017-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver fibrosis in Subjects with Nonalcoholic Steatohepatitis MedDRA version: 20.0 Level: PT Classification code 10053219 Term: Non-alcoholic steatohepatitis System Organ Class: 10019805 - Hepatobiliary disorders

Interventions

Product Name: Cenicriviroc Mesylate Product Code: CVC Pharmaceutical Form: Tablet INN or Proposed INN: CENICRIVIROC MESYLATE CAS Number: 497223-25-3 Current Sponsor code: CENICRIVIROC Other descripti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female subjects aged between 18-75 years 2. Ability to understand and sign a written informed consent form (ICF) 3. Histological evidence of NASH based on central reading of the biopsy slides 4. Histological evidence of Stage 2 to 3 liver fibrosis per the NASH CRN System based on central reading of the biopsy slides 5. Females of childbearing potential and males participating in the study must agree to use at least 2 approved methods of contraception throughout the duration of the study and for 30 days after stopping study drug. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1800 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

Exclusion criteria: 1. Inability to undergo a liver biopsy 2. Hepatitis B surface antigen (HBsAg) positive 3. Hepatitis C antibody (HCVAb) positive 4. Human immunodeficiency virus (HIV)-1 or HIV-2 infection 5. Prior or planned liver transplantation 6. Other known causes of chronic liver disease 7. History or presence of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding 8. Alcohol consumption greater than 21 units/week for males or 14 units/week for females 9. AST > 200 IU/L in males and females at Screening 10. ALT > 250 IU/L in males and > 200 IU/L in females at Screening 11. HbA1c > 10% at Screening 12. Serum albumin 1.5 mg/dL (subjects with hyperbilirubinemia associated with documented Gilbert’s syndrome may be eligible upon review by the medical monitor) 16. International normalized ratio (INR) > 1.3 17. Model of end stage liver disease (MELD) score > 12 18. Weight reduction through bariatric surgery in the past 5 years or planned during the conduct of the study (including gastric banding) 19. History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, or resected noninvasive cutaneous squamous cell carcinoma 20. Active, serious infections that require parenteral antibiotic or antifungal therapy within 30 days prior to Screening Visit 21. Clinically significant cardiovascular or cerebrovascular disease within the past 3 months 22. Females who are pregnant or breastfeeding 23. Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic agents and immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) 24. Receiving a glucagon-like peptide 1 (GLP-1) receptor agonist, a dipeptidyl peptidase 4 (DPP-4) inhibitor, a sodium–glucose cotransporter 2 (SGLT2) inhibitor, or a thiazolidinedione (TZD) for less than 6 months of stable therapy prior to the liver biopsy at Screening 25. Receiving ongoing therapy with any disallowed medication between Screening and Baseline visits. 26. Allergy to the study drug or its components 27. Receiving any investigational products within 30 days prior to Screening or anticipated use during the trial 28. Participated in a clinical trial with any investigational product being evaluated for the treatment of liver fibrosis or NASH in the 12 months before Day 1 29. Participation in any other clinical trial at Screening without approval from the sponsor 30. Any other clinically significant disorders or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing and protocol requirements

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary Objective (Part 1): •Demonstrate the superiority of CVC compared to placebo on liver histology at Month 12 relative to the Screening biopsy, by assessing the proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) AND no worsening of steatohepatitis (no worsening of lobular inflammation or hepatocellular ballooning grade) Primary Objective (Part 2): •Demonstrate the superiority of CVC compared to placebo on the composite endpoint of histopathologic progression to cirrhosis, liver-related clinical outcomes, and all-cause mortality, as measured by the time to first occurrence of any of the listed adjudicated events (clinical outcomes composite endpoint) – (all subjects) ;Secondary Objective: Part 1 and 2: (1)Evaluate the effect of CVC compared to placebo on liver histology relative to the Screening biopsy for the proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system), regardless of effect on steatohepatitis (months 12 and 60, as applicable). Part 1 and 2: (2)Evaluate the safety and tolerability of CVC for the treatment of liver fibrosis in adult subjects with NASH. Part 2: (3)Evaluate the effect of CVC compared to placebo on liver histology relative to the Screening biopsy for the proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system), AND no worsening of steatohepatitis (no worsening of lobular inflammation or hepatocellular ballooning grade), (months 12 and 60, as applicable)).;Primary end point(s): (Part 1): Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) AND no worsening of steatohepatitis (no worsening of lobular inflammation or hepatocellular ballooning grade) on liver histology relative to the Screening biopsy (Part 2): Time to first occurrence of any of the following adjudicated events: Death (all cause), Histopathologic progression to cirrhosis, Hepatocellular carcinoma, Liver transplant, MEL	—

Measure

Time frame

Main Objective: Primary Objective (Part 1): •Demonstrate the superiority of CVC compared to placebo on liver histology at Month 12 relative to the Screening biopsy, by assessing the proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) AND no worsening of steatohepatitis (no worsening of lobular inflammation or hepatocellular ballooning grade) Primary Objective (Part 2): •Demonstrate the superiority of CVC compared to placebo on the composite endpoint of histopathologic progression to cirrhosis, liver-related clinical outcomes, and all-cause mortality, as measured by the time to first occurrence of any of the listed adjudicated events (clinical outcomes composite endpoint) – (all subjects) ;Secondary Objective: Part 1 and 2: (1)Evaluate the effect of CVC compared to placebo on liver histology relative to the Screening biopsy for the proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system), regardless of effect on steatohepatitis (months 12 and 60, as applicable). Part 1 and 2: (2)Evaluate the safety and tolerability of CVC for the treatment of liver fibrosis in adult subjects with NASH. Part 2: (3)Evaluate the effect of CVC compared to placebo on liver histology relative to the Screening biopsy for the proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system), AND no worsening of steatohepatitis (no worsening of lobular inflammation or hepatocellular ballooning grade), (months 12 and 60, as applicable)).;Primary end point(s): (Part 1): Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) AND no worsening of steatohepatitis (no worsening of lobular inflammation or hepatocellular ballooning grade) on liver histology relative to the Screening biopsy (Part 2): Time to first occurrence of any of the following adjudicated events: Death (all cause), Histopathologic progression to cirrhosis, Hepatocellular carcinoma, Liver transplant, MEL

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Secondary

Measure	Time frame
Secondary end point(s): Parts 1 and 2: Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system), regardless of effect on steatohepatitis, relative to the Screening biopsy Part 2: Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) AND no worsening of steatohepatitis (no worsening of lobular inflammation or hepatocellular ballooning grade) on liver biopsy relative to the Screening biopsy;Timepoint(s) of evaluation of this end point: Months 12 and 60	—

Measure

Time frame

Secondary end point(s): Parts 1 and 2: Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system), regardless of effect on steatohepatitis, relative to the Screening biopsy Part 2: Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) AND no worsening of steatohepatitis (no worsening of lobular inflammation or hepatocellular ballooning grade) on liver biopsy relative to the Screening biopsy;Timepoint(s) of evaluation of this end point: Months 12 and 60

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Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, France, Germany, Hong Kong, Hungary, Israel, Italy, Mauritius, Mexico, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Singapore, Spain, Switzerland, Taiwan, United Kingdom, United States

Contacts

Public ContactKarl Trass (Regulatory Affairs)

Tobira Therapeutics, a subsidiary of Allergan plc

Karl.Trass@allergan.com+1650878 6728

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026