Status:
RECRUITING
Elucidating Shared Mechanisms Contributing to NAFLD and PsA Disease Severity With Guselkumab Therapy
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Janssen Scientific Affairs, LLC
Conditions:
Psoriatic Arthritis
Eligibility:
All Genders
Phase:
NA
Brief Summary
While many studies examine Nonalcoholic fatty liver disease (NAFLD), little is known about its progression to high-risk nonalcoholic steatohepatitis (NASH) in PsA patients. Shared disease mechanisms m...
Detailed Description
Nonalcoholic fatty liver disease (NAFLD), ranging from benign steatosis to severe nonalcoholic steatohepatitis (NASH), is increasingly common and linked to cirrhosis. Patients with psoriatic arthritis...
Eligibility Criteria
Inclusion
- Adults with diagnosis of PsA fulfilling the classification for PsA (CASPAR) criteria.
- Must have:
- 1 or more swollen joint(s) and/or one or more active sites of enthesitis
- 3\. AND/OR
- 1 or more psoriatic plaques
- 4\. No changes in the regular medication regimen within the last three months, and no use of systemic and/or chronic steroids within 8 weeks leading up to the study.
- 5\. Overweight or obese by BMI ≥ 25.0 kg/m2 or ≥ 23.0 for Asian participants
- 6\. Patients are starting Guselkumab therapy for PsA as indicated by primary rheumatologist
- 7\. Elevated liver fat on controlled attenuation parameter (CAP) ≥ 288 dB/m, which is consistent with NAFLD after exclusion of secondary causes of liver disease.
Exclusion
- Patients with prior exposure to IL12/23i, IL-17i, JAKi, or TYK2i. Patients with exposure to more than 2 TNFi.
- Evidence of other causes of chronic liver disease
- Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg).
- Previous or current infection with Hepatitis C as defined by presence of hepatitis C virus Abin serum (anti-HCV Ab).
- Autoimmune hepatitis as defined by anti-nuclear antibody (ANA) of 1:160 or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy.
- Autoimmune cholestatic liver disorders as defined by elevation of alkaline phosphatase and anti-mitochondrial antibody of greater than 1:80 or liver histology consistent with primary biliary cirrhosis or elevation of alkaline phosphatase and liver histology consistent with sclerosing cholangitis.
- Wilson disease as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease.
- Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency.
- Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y or compound heterozygosity for C282Y/H63D.
- Drug-induced liver disease as defined on the basis of typical exposure and history.
- Bile duct obstruction as shown by imaging studies.
- History of gastrointestinal bypass surgery or ingestion of medications known to produce steatosis, such as corticosteroids, high-dose estrogen, tamoxifen, amiodarone or tetracycline in the previous 6 months.
- Evidence of cirrhosis or previously known cirrhosis based on the results from previous liver biopsy or history of portal hypertension presented by ascites, hepatic encephalopathy or varices
- Presence of regular and/or excessive use of alcohol (defined as \>30g/day for males and \>15g/day for females) for a period longer than 2 years at any times in the last 10 years
- Serum creatinine \> 2.0 mg/dL
- The subject is a pregnant or nursing female or is planning to become pregnant
- Life expectancy less than 5 years
- History of known HIV infection
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06586281
Start Date
June 1 2025
End Date
December 1 2026
Last Update
April 3 2025
Active Locations (1)
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1
University of California, San Diego
San Diego, California, United States, 92037