Psoriasis (PsO)EMERGENCT07255781
Shared Pathways Between Non-Alcoholic Fatty Liver Disease and Psoriatic Disease With Guselekumab Therapy
An observational study of Psoriasis (PsO) and PsA (Psoriatic Arthritis), run by University of California, San Diego.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis (PsO), PsA (Psoriatic Arthritis), NAFLD (Nonalcoholic Fatty Liver Disease)
- What is being tested?
- Guselkumab Prefilled Syringe [Tremfya]
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2025to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
About this study
Official title: Shared Mechanisms Contributing to Non-Alcoholic Fatty Liver Disease (NAFLD) and Psoriatic Disease (PD) Severity With Guselkumab Therapy [EMERGE]
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.
- Being tested
- Guselkumab Prefilled Syringe [Tremfya]
- Keywords
- psoriasis, psoriatic arthritis, guselkumab, NAFLD, non-alcoholic fatty liver disease
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Guselkumab Prefilled Syringe [Tremfya] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
Improvement in skin psoriasis severity as defined by PASI90 (Psoriasis Area and Severity Index) response
Measured: 6 months
Improvement in joint arthritis as defined by an improvement of ≥ 5 of DAPSA (Disease Activity in Psoriatic Arthritis)
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start30 Nov 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Why it stopped: The sponsor determined that enrollment would not meet their expectations and decided to withdraw the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis (PsO)Studies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
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
- NCT07255781
- Sponsor's protocol ID
- CNTO1959PSA4014
- Acronym
- EMERGE
- Status last verified
- Feb 2026
- First submitted
- 24 Sep 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Mechanisms Contributing to Non-Alcoholic Fatty Liver Disease (NAFLD) and Psoriatic Disease (PD) Severity With Guselkumab Therapy [EMERGE]
- ClinicalTrials.gov ID
- NCT07255781
- Acronym / sponsor ID
- EMERGE / CNTO1959PSA4014
- Keywords
- psoriasis, psoriatic arthritis, guselkumab, NAFLD, non-alcoholic fatty liver disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The sponsor determined that enrollment would not meet their expectations and decided to withdraw the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 1 Dec 2025 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Psoriatic Disease | – | Drug: Guselkumab Prefilled Syringe [Tremfya]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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
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 |
|---|---|---|
| Guselkumab 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 | Drug | Active Psoriatic Disease |
Primary outcome
Improvement in NAFLD severity
Time frame: 6 months
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
3 secondary outcomes
Improvement in skin psoriasis severity as defined by PASI90 (Psoriasis Area and Severity Index) response
Time frame: 6 months
Improvement in joint arthritis as defined by an improvement of ≥ 5 of DAPSA (Disease Activity in Psoriatic Arthritis)
Time frame: 6 months
17 units per liter improvement in alanine aminotransferase(ALT) in those patients with elevated ALT at baseline.
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis (PsO) and PsA (Psoriatic Arthritis), run by University of California, San Diego.
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 4 inclusion and 15 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: withdrawn, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in NAFLD severity (time frame: 6 months). 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 23 Feb 2026.