Shared Pathways Between Non-Alcoholic Fatty Liver Disease and Psoriatic Disease With Guselekumab Therapy

NCT07255781 | Withdrawn FDA Drug

• 1 other identifier: CNTO1959PSA4014
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this research study is to better understand if there is an association between non-alcoholic fatty liver disease (NAFLD) and active psoriatic disease (PD), and to assess the effect of Guselkumab (a medication approved by the FDA instead of the standard of care to treat PD), for NAFLD patients who receive Guselkumab for their PD.

Conditions

Psoriasis (PsO); PsA (Psoriatic Arthritis); NAFLD (Nonalcoholic Fatty Liver Disease)

Keywords

psoriasis; psoriatic arthritis; guselkumab; NAFLD; non-alcoholic fatty liver disease

Outcome Measures

Primary Outcomes (1)

• Improvement in NAFLD severity

  Improvement of NAFLD severity is defined by MRI-PDFF responders (relative decline in liver fat ≥30%) vs non-responders (relative decline in liver fat \<30%) at Week 24

  6 months

Secondary Outcomes (3)

• Improvement in skin psoriasis severity as defined by PASI90 (Psoriasis Area and Severity Index) response

  6 months

• Improvement in joint arthritis as defined by an improvement of ≥ 5 of DAPSA (Disease Activity in Psoriatic Arthritis)

  6 months

• 17 units per liter improvement in alanine aminotransferase(ALT) in those patients with elevated ALT at baseline.

  6 months

Study Arms (1)

Active Psoriatic Disease

Patients with active psoriatic disease (diagnosed with psoriasis and/or psoriatic arthritis) who are planning to start Guselkumab as part of their standard of care.

Drug: Guselkumab Prefilled Syringe [Tremfya]

Interventions

Guselkumab Prefilled Syringe [Tremfya] DRUG

This trial aims to recruit patients who have psoriatic disease, have evidence of fatty liver disease, and have a BMI over 25, who are planning to start Guselkumab(Tremfya) as recommended by their primary rheumatologist or dermatologist

Active Psoriatic Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total sample of approximately 20 PD patients from UCSD rheumatology clinics. 50% of patients screened will meet the inclusion criteria for NAFLD. To provide equal representation of the Psoriatic Disease population, 10 patients who meet the inclusion criteria for moderate to severe plaque psoriasis, and approximately 10 patients who meet the inclusion criteria for active psoriatic arthritis, will be enrolled.

You may qualify if:

• Adults with a diagnosis of PsA fulfilling the classification for PsA (CASPAR) criteria.
• Overweight or obese by BMI ≥ 25.0 kg/m2 or ≥ 23.0 for Asian participants
• Patients are starting Guselkumab therapy as indicated by primary rheumatologist

You may not qualify if:

• 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 Ab in 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 a 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 time in the last 10 years
• The subject is a pregnant or nursing female
• History of known HIV infection

Sponsors & Collaborators

• University of California, San Diego: lead
• Janssen Scientific Affairs, LLC: collaborator

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic; Non-alcoholic Fatty Liver Disease

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: December 1, 2025
• Study Start: November 30, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02