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WithdrawnNCT07255781EMERGEUpdated Feb 23, 2026

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

An observational study in Psoriasis (PsO), PsA (Psoriatic Arthritis) and NAFLD (Nonalcoholic Fatty Liver Disease), sponsored by University of California, San Diego. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-23.

Sponsored by University of California, San Diego · Observational

Why this study was withdrawn
The sponsor determined that enrollment would not meet their expectations and decided to withdraw the study.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This observational research study aims to provide information on the mechanisms behind the transition from NAFLD to high-risk NASH in the PD population. Overlapping mechanisms of disease in NAFLD and PD may account for increased disease prevalence and severity, and shared drivers of disease progression offer the opportunity to ameliorate both disease entities by targeting a single pathway. This is a longitudinal study that requires two visits from individuals with psoriatic disease. Subjects must have NAFLD and at least one criterion for active psoriatic disease: i) at least 1 swollen joint or 1 site of active enthesitis; and/or (ii at least 1 psoriatic plaque to qualify for the study. The aim of the study is to determine the effect of biological therapies in liver disorders in patients with PD, in addition to the effect on joint and skin manifestations.

02

Conditions studied

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

Keywords

  • psoriasis
  • psoriatic arthritis
  • guselkumab
  • NAFLD
  • non-alcoholic fatty liver disease
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

Browse Psoriasis studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • 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
  • Elevated liver fat on controlled attenuation parameter (CAP) ≥ 288 dB/m, which is consistent with NAFLD after exclusion of secondary causes of liver disease8.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DrugGuselkumab Prefilled Syringe [Tremfya]

    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

06

What researchers measure

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

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 6 months

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

    Time frame: 6 months

  3. 17 units per liter improvement in alanine aminotransferase(ALT) in those patients with elevated ALT at baseline.

    Elevated ALT is defined as ≥ 30 U/L.

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07255781
Lead sponsor
University of California, San Diego
Collaborators
Janssen Scientific Affairs, LLC
Responsible party
Monica Guma (Associate Professor, University of California, San Diego) — Principal investigator
First posted
Dec 1, 2025
Start date
Nov 30, 2025
Primary completion
Nov 30, 2025
Completion
Nov 30, 2025
Last update
Feb 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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