[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

1-877-277-8566

Email address

IR-CTRegistration@allergan.com

Condition

Nonalcoholic Steatohepatitis

Treatment type

Interventional

Investigational product

Cenicriviroc

Phase

Phase 3

Sponsor

Tobira Therapeutics, Inc.

ClinicalTrials.gov identifier

NCT03028740

Study number

3152-301-002

Understanding clinical trials

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About the study

The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult subjects with NASH.

Who can take part?

You may be eligible to participate in the study if you meet the following 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 Screening biopsy
  4. Subjects included in Part1 must have histopathological evidence of Stage 2 or 3 liver fibrosis per the NASH CRN System based on central reading of the Screening biopsy slides. Subjects newly randomized in Part 2 must have histological evidence of Stage 3 liver fibrosis per the NASH CRN System, based on central reading of the Screening period biopsy slides. Historical biopsy can be used, provided the criteria listed on Item 3a above are fulfilled.
  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. Females who are postmenopausal must have documentation of cessation of menses for ≥ 12 months and serum follicle-stimulating hormone (FSH) ≥ 30 mU/mL at Screening.
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 < 3.5 g/dL at Screening
  13. Estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease (MDRD) equation
  14. Platelet count < 100,000/mm3
  15. Total bilirubin > 1.5 mg/dL
  16. International normalized ratio (INR) > 1.3
  17. Model of end stage liver disease (MELD) score > 12
  18. Weight reduction, defined as ≥ 7% of body weight, through bariatric surgery in the past 5 years or bariatric surgery planned during the conduct of the study (including gastric banding and sleeve surgery)
  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 (eg, interleukins, interferons, cyclosporine, tacrolimus) except for vaccines or short-term corticosteroids
  24. Receiving a glucagon-like peptide 1 (GLP-1) receptor agonist, a dipeptidyl peptidase 4 (DPP-4) inhibitor, a sodium-glucose cotransporter 2 (SGLT2) and/or SGLT1 inhibitor, or a thiazolidinedione (TZD) for less than 6 months prior to the Screening period liver biopsy. Subjects on a stable therapy with a GLP-1 receptor agonist, DPP-4 inhibitor, SGLT1 and/or SGLT2 inhibitor, or a TZD for at least 6 months prior to the Screening liver biopsy may be considered eligible. (Important Note: if a historical biopsy is to be used, subjects need to be on stable therapy for at least 6 months prior to the day historical liver biopsy was performed).

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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