Guselkumab for Psoriatic Arthritis
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Diego
Must be taking: Guselkumab
Must not be taking: Corticosteroids, Estrogen, Tamoxifen, others
Disqualifiers: Hepatitis B, Hepatitis C, Cirrhosis, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but you must not have changed your regular medication regimen in the last three months and cannot have used systemic or chronic steroids in the 8 weeks before the study.
What data supports the effectiveness of the drug Guselkumab for treating psoriatic arthritis?
Guselkumab has been shown to be effective in treating moderate-to-severe plaque psoriasis, and studies have also evaluated its use in patients with psoriatic arthritis, showing positive results in improving symptoms like enthesitis (inflammation where tendons or ligaments attach to bone) and dactylitis (swelling of fingers or toes).
12345Is Guselkumab safe for humans?
Guselkumab has been generally well tolerated in studies for conditions like plaque psoriasis and psoriatic arthritis, with safety data pooled from multiple studies showing it is safe for up to 2 years of use.
12367What makes the drug Guselkumab unique for treating psoriatic arthritis?
Guselkumab is unique because it specifically targets and blocks interleukin-23 (IL-23), a protein involved in inflammation, by binding to its p19 subunit. This makes it different from other treatments that may not target IL-23 as selectively, offering a novel approach for patients with psoriatic arthritis, especially those who have not responded well to other treatments like tumor necrosis factor inhibitors.
12389Eligibility Criteria
This trial is for patients with Psoriatic Arthritis (PsA) who also have Nonalcoholic fatty liver disease (NAFLD). Participants should show active signs of PsA, like swollen joints or skin plaques. Specific eligibility criteria are not provided, but typically include factors like age, overall health, and the severity of conditions.Inclusion Criteria
I am starting Guselkumab for Psoriatic Arthritis as recommended by my rheumatologist.
My regular medications have been the same for the last 3 months and I haven't taken steroids in the last 8 weeks.
Overweight or obese by BMI ≥ 25.0 kg/m2 or ≥ 23.0 for Asian participants
+3 more
Exclusion Criteria
I do not have chronic liver disease, HIV, or plan to become pregnant, and my life expectancy is over 5 years.
I have been treated with specific immune-targeting drugs or more than 2 TNF blockers.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Guselkumab therapy to assess its impact on NAFLD and PsA
24 weeks
2 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests Guselkumab therapy's effects on NAFLD and PsA severity. It involves two visits from participants to assess how this biological therapy impacts liver health as well as joint and skin symptoms associated with PsA.
1Treatment groups
Experimental Treatment
Group I: psoriatic arthritis patientsExperimental Treatment1 Intervention
Adults with active PsA and diagnosed NAFLD
Guselkumab is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Tremfya for:
- Moderate to severe plaque psoriasis
- Psoriatic arthritis
- Moderately to severely active ulcerative colitis
🇪🇺 Approved in European Union as Tremfya for:
- Moderate to severe plaque psoriasis
- Psoriatic arthritis
- Moderately to severely active ulcerative colitis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, San DiegoSan Diego, CA
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Who Is Running the Clinical Trial?
University of California, San DiegoLead Sponsor
Janssen Scientific Affairs, LLCIndustry Sponsor
References
Guselkumab: First Global Approval. [2019]Guselkumab (Tremfya™) is a human monoclonal IgG1λ antibody being developed by Janssen Biotech, Inc. that has been approved in the USA as a treatment for moderate-to-severe plaque psoriasis. Guselkumab inhibits the binding of interleukin 23 (IL-23) to its cell surface receptor, disrupting the type 17 helper T cell/IL-17 pathway. This article summarizes the milestones in the development of guselkumab leading to this first approval for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Guselkumab: A Review in Moderate to Severe Plaque Psoriasis. [2019]Guselkumab (Tremfya®) is a human immunoglobulin G1 λ (IgG1λ) monoclonal antibody (mAb) that blocks the interleukin-23 (IL-23)-mediated signalling pathway and is the first in its class to be approved in adults with moderate to severe plaque psoriasis in several countries, including the USA and EU. In the VOYAGE trials, guselkumab was superior to placebo and to adalimumab at week 16 in terms of the proportion of patients achieving an Investigator Global Assessment (IGA) score of 0/1 and ≥ 90% improvement from baseline in Psoriasis Area and Severity index score (PASI 90 response), with benefits of guselkumab over adalimumab maintained at week 24. To date, the beneficial effects of guselkumab treatment in these trials were maintained for up to 2 years. Inadequate responders to ustekinumab who were then randomized to guselkumab in NAVIGATE showed better responses than those randomized to ustekinumab between weeks 28-40, with a significantly greater mean number of visits at which patients had IGA 0/1 and ≥ 2-grade improvement in IGA score, as well as higher proportions of patients achieving PASI 90 and PASI 100 at week 52. Treatment with guselkumab improved health-related quality of life (HR-QOL) and patient-reported outcomes in all trials and was generally well tolerated. Guselkumab, administered by subcutaneous injection, is a useful new option for patients with moderate to severe plaque psoriasis.
Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study. [2020]Guselkumab, a human monoclonal antibody that binds to the p19 subunit of interleukin 23, has been approved for the treatment of moderate-to-severe psoriasis. Psoriatic arthritis is a common comorbidity of psoriasis with an umet need for novel treatments. We assessed the efficacy and safety of guselkumab in patients with active psoriatic arthritis.
Efficacy and safety of guselkumab in patients with active psoriatic arthritis who are inadequate responders to tumour necrosis factor inhibitors: results through one year of a phase IIIb, randomised, controlled study (COSMOS). [2022]To evaluate efficacy and safety of guselkumab, an anti-interleukin-23p19-subunit antibody, in patients with psoriatic arthritis (PsA) with prior inadequate response (IR) to tumour necrosis factor inhibitors (TNFi).
Impact of guselkumab, an interleukin-23 p19 subunit inhibitor, on enthesitis and dactylitis in patients with moderate to severe psoriatic arthritis: results from a randomised, placebo-controlled, phase II study. [2021]To evaluate the effect of guselkumab on enthesitis and dactylitis in a phase II trial of patients with active psoriatic arthritis (PsA).
Safety of Guselkumab With and Without Prior Tumor Necrosis Factor Inhibitor Treatment: Pooled Results Across 4 Studies in Patients With Psoriatic Arthritis. [2023]Assess pooled safety results through the end of the phase II/III studies of guselkumab (GUS; ≤ 2 years) in tumor necrosis factor inhibitor (TNFi)-naïve and -experienced patients with psoriatic arthritis (PsA).
Guselkumab safely improved clinical outcomes in biologic-naive patients with psoriatic arthritis. [2020]Label="SOURCE CITATION">Mease PJ, Rahman P, Gottlieb AB, et al. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395:1126-36. 32178766.
Guselkumab: the First Selective IL-23 Inhibitor for Active Psoriatic Arthritis in Adults. [2021]Guselkumab is a subcutaneously administered human monoclonal antibody, selectively blocking IL-23 through binding to its p19 subunit. It was initially approved for the treatment of patients with moderate-to-severe plaque-psoriasis who are candidates for systemic therapy or phototherapy. Pubmed and Embase databases were searched for publications, using the following search terms: psoriasis, psoriatic arthritis, guselkumab, risankizumab, tildrakizumab, p19, interleukin 23, guidelines, treatment recommendations, DISCOVER, ECLIPSE, and VOYAGE.
Effect of guselkumab on serum biomarkers in patients with active psoriatic arthritis and inadequate response to tumor necrosis factor inhibitors: results from the COSMOS phase 3b study. [2023]Guselkumab is a selective interleukin (IL)-23 inhibitor targeting the IL-23p19 subunit. In the phase 3b COSMOS trial, guselkumab demonstrated efficacy in treating participants with active psoriatic arthritis (PsA) and inadequate response (IR; lack of efficacy or intolerance) to tumor necrosis factor inhibitors (TNFi).