Psoriatic ArthritisNCT06586281
Elucidating Shared Mechanisms Contributing to NAFLD and PsA Disease Severity With Guselkumab Therapy
A study testing Guselkumab in people with Psoriatic Arthritis, run by University of California, San Diego at 1 site in United States.
Trial 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 may explain the increased severity in PsA. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Guselkumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Diego
San Diego, California, 92037
Monica Guma, MD, PhD, 858-246-4721, mguma@health.ucsd.edu
About this study
Official title: Elucidating Shared Mechanisms Contributing to Non-Alcoholic Fatty Liver Disease (NAFLD) and Psoriatic Arthritis (PsA) Disease Severity With Guselkumab Therapy
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.
Read the 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 (PsA) are at higher risk for NAFLD and NASH, partly due to methotrexate (MTX) use, which is associated with hepatotoxicity. Key cytokines involved in PsA, such as TNF, IL-17, and IL-23, may also contribute to NAFLD progression.
The proposed study aims to explore shared pathogenic pathways in NAFLD and PsA by evaluating the role of IL-17/23 through imaging, metabolomics, and synovial biopsies. Ultrasound-guided synovial biopsy, a safe and effective method, will be used to obtain tissue samples, enabling the identification of new molecular signatures and therapeutic targets to improve treatment of joint diseases.
- Conditions
- Psoriatic Arthritis
- Being tested
- Guselkumab
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuselkumabDrug
Also called Tremfya
This is a longitudinal study consisting of a two-time visit by psoriatic arthritis patients. The aim of the study is to determine the effect of biological therapies in liver disorders in patients with psoriatic arthritis.
| Study group | Role | What they receive |
|---|---|---|
| psoriatic arthritis patients | Experimental | Adults with active PsA and diagnosed NAFLD Receives: Drug: Guselkumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NAFLD severity
Defined by MRI-PDFF responders (relative change in liver fat ≥30%) vs non-responders (relative change in liver fat <30%) at Week 24.
Measured: 24 weeks
Secondary outcomes (3)
Change from baseline in skin psoriasis severity
Defined by PASI90 (Psoriasis Area and Severity Index) response in patients with plaque psoriasis at baseline
Measured: 24 weeks
Change in joint arthritis
Defined by change of 7.25 of DAPSA (Disease activity in Psoriatic Arthritis) from baseline in patients with at least 1 swollen joint at baseline.
Measured: 24 weeks
Change in ALT Levels
Defined by at least 17 U/L in patients with elevated ALT at baseline (defined as ≥30 U/L).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jun 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Principal investigator, Monica Guma, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586281
- Sponsor's protocol ID
- 809662
- Status last verified
- Jun 2026
- First submitted
- 29 Aug 2024
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating Shared Mechanisms Contributing to Non-Alcoholic Fatty Liver Disease (NAFLD) and Psoriatic Arthritis (PsA) Disease Severity With Guselkumab Therapy
- ClinicalTrials.gov ID
- NCT06586281
- Acronym / sponsor ID
- 809662
- Conditions
- Psoriatic Arthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (PsA) are at higher risk for NAFLD and NASH, partly due to methotrexate (MTX) use, which is associated with hepatotoxicity. Key cytokines involved in PsA, such as TNF, IL-17, and IL-23, may also contribute to NAFLD progression.
The proposed study aims to explore shared pathogenic pathways in NAFLD and PsA by evaluating the role of IL-17/23 through imaging, metabolomics, and synovial biopsies. Ultrasound-guided synovial biopsy, a safe and effective method, will be used to obtain tissue samples, enabling the identification of new molecular signatures and therapeutic targets to improve treatment of joint diseases.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| psoriatic arthritis patients | Experimental | Drug: GuselkumabAdults with active PsA and diagnosed NAFLD |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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
- History of known HIV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GuselkumabAlso: TremfyaThis is a longitudinal study consisting of a two-time visit by psoriatic arthritis patients. The aim of the study is to determine the effect of biological therapies in liver disorders in patients with psoriatic arthritis. | Drug | psoriatic arthritis patients |
Primary outcome
Change in NAFLD severity
Time frame: 24 weeks
Defined by MRI-PDFF responders (relative change in liver fat ≥30%) vs non-responders (relative change in liver fat <30%) at Week 24.
3 secondary outcomes
Change from baseline in skin psoriasis severity
Time frame: 24 weeks
Change in joint arthritis
Time frame: 24 weeks
Change in ALT Levels
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guselkumab in people with Psoriatic Arthritis, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica Guma (8588226523, mguma@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NAFLD severity (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.