Elucidating Shared Mechanisms Contributing to NAFLD and PsA Disease Severity With Guselkumab Therapy
Eligible age
All ages
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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 may explain the increased severity in PsA. This study involves two visits from PsA patients with NAFLD and active disease signs (e.g., swollen joint, enthesitis, or psoriatic plaque). It aims to assess the impact of biological therapies on liver disorders, joints, and skin in PsA patients.
Sponsor: University of California, San Diego
You may qualify if…
- ✓ 1. Adults with diagnosis of PsA fulfilling the classification for PsA (CASPAR) criteria.
- ✓ 2. 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
You may not qualify if…
- ✕ 1. Patients with prior exposure to IL12/23i, IL-17i, JAKi, or TYK2i. Patients with exposure to more than 2 TNFi.
- ✕ 2. 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.
Where it's recruiting
San Diego
Source: ClinicalTrials.gov · NCT06586281 · last updated 2026-06-10