Guselkumab for Psoriatic Arthritis
(APEX Trial)
Recruiting in Palo Alto (17 mi)
+330 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Janssen Research & Development, LLC
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
Do I need to stop my current medications to join the trial?
The trial requires that you stop taking any systemic immunosuppressants at least 4 weeks before starting the study. Other medications like biologics and JAK inhibitors are also not allowed. The protocol does not specify about other medications, so it's best to discuss with the trial team.
What data supports the idea that Guselkumab for Psoriatic Arthritis is an effective drug?
The available research shows that Guselkumab is effective for treating Psoriatic Arthritis. In the DISCOVER-2 study, patients who took Guselkumab experienced greater improvements in symptoms compared to those who took a placebo. This was observed in both the short term and over a period of two years. Additionally, Guselkumab was shown to improve specific symptoms like enthesitis and dactylitis, which are common in Psoriatic Arthritis. Another study highlighted that Guselkumab was effective in patients who had not previously used biologic treatments, showing significant clinical improvements. Overall, these studies suggest that Guselkumab is a beneficial option for managing Psoriatic Arthritis.
12345What safety data is available for Guselkumab in treating psoriatic arthritis?
Safety data for Guselkumab in treating psoriatic arthritis includes pooled results from phase II/III studies, showing safety over up to 2 years in both TNFi-naïve and experienced patients. It was generally well tolerated in trials, including the DISCOVER-2 study, which demonstrated safe improvement in clinical outcomes for biologic-naive patients.
12678Is the drug Guselkumab a promising treatment for psoriatic arthritis?
Yes, Guselkumab is a promising treatment for psoriatic arthritis. It has shown to improve symptoms in patients who have not used biologic treatments before, and its benefits last for up to two years. It is also approved for treating moderate-to-severe psoriasis, which often occurs with psoriatic arthritis, making it a useful option for patients with these conditions.
12789Eligibility Criteria
This trial is for people with active psoriatic arthritis who've tried other treatments like DMARDs, apremilast, or NSAIDs without enough relief. They should have symptoms like swollen and tender joints, a certain level of inflammation in their blood, and joint damage visible on X-rays. It's not for those with other inflammatory diseases that could affect results or anyone allergic to the study drug.Inclusion Criteria
I have active psoriasis with a plaque larger than 2cm or nail changes.
I have Psoriatic Arthritis with at least 3 swollen and 3 tender joints, and my CRP levels are high.
I have been diagnosed with Psoriatic Arthritis for at least 6 months.
+3 more
Exclusion Criteria
I haven't taken any immune system suppressing drugs in the last 4 weeks.
I do not have conditions like RA, AS, lupus, or Lyme disease that could affect treatment results.
Has known allergies, hypersensitivity, or intolerance to study intervention or its excipients
+2 more
Participant Groups
The trial tests Guselkumab's effectiveness against PsA by comparing it to a placebo. Participants will be randomly assigned to receive either Guselkumab or an inactive substance (placebo) to see if there's a significant improvement in their PsA symptoms.
3Treatment groups
Experimental Treatment
Group I: Group 3: Placebo Followed by GuselkumabExperimental Treatment2 Interventions
Participants will receive placebo SC and will cross over to receive SC guselkumab. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.
Group II: Group 2: GuselkumabExperimental Treatment1 Intervention
Participants will receive guselkumab SC. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.
Group III: Group 1: Guselkumab and PlaceboExperimental Treatment2 Interventions
Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind. Participants who have not discontinued will be eligible to enter a long-term extension (LTE) and will receive guselkumab and placebo SC. After the study is unblinded to the investigative sites, participants will receive guselkumab and no longer be required to dose with placebo to maintain the blind.
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:
Arthritis And Osteoporosis ClinicWaco, TX
Eastern Regional Health Authority St Clares Mercy HospitalSt Johns, Canada
Arthritis & Osteoporosis ClinicWaco, TX
Adriana Pop Moody MD Clinic PACorpus Christi, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Janssen Research & Development, LLCLead Sponsor
References
Efficacy of Guselkumab on Axial-Related Symptoms Through up to 2 Years in Adults with Active Psoriatic Arthritis in the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Study. [2023]Guselkumab previously showed greater improvements versus placebo in axial symptoms in patients with psoriatic arthritis (PsA) (assessed by Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] and Ankylosing Spondylitis Disease Activity Score [ASDAS]), in post hoc analyses of the phase 3, placebo-controlled, randomized DISCOVER-1 and DISCOVER-2 studies. We now evaluate durability of response in axial-related outcomes through 2 years of DISCOVER-2.
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.
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).
Six-Month Persistence and Multi-domain Effectiveness of Guselkumab in Adults with Psoriatic Arthritis: Real-World Data from the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry. [2023]The aim of this work is to evaluate treatment persistence and clinical outcomes after 6 months of on-label guselkumab use in patients with rheumatologist-diagnosed active psoriatic arthritis (PsA) enrolled in the CorEvitas PsA/Spondyloarthritis Registry.
Composite Measures of Disease Activity in Psoriatic Arthritis: Comparative Instrument Performance Based on the Efficacy of Guselkumab in an Interventional Phase II Trial. [2020]To assess performance of psoriatic arthritis (PsA) composite indices and evaluate guselkumab's effect on achieving low disease activity or remission.
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: 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.