Shared Pathways Between Non-Alcoholic Fatty Liver Disease and Psoriatic Disease With Guselekumab … (NCT07255781) | Clinical Trial Compass
WithdrawnNot Applicable
Shared Pathways Between Non-Alcoholic Fatty Liver Disease and Psoriatic Disease With Guselekumab Therapy
Stopped: The sponsor determined that enrollment would not meet their expectations and decided to withdraw the study.
0Started 2025-11-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* 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 defi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.