Guselkumab for Juvenile Psoriatic Arthritis
(TRILOGY Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Janssen Research & Development, LLC
Must be taking: Guselkumab
Disqualifiers: Pregnancy, Employee, Investigator, others
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 long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the drug Guselkumab for treating juvenile psoriatic arthritis?
Guselkumab has been shown to be effective in treating psoriatic arthritis in adults, improving both joint and skin symptoms, and reducing disease activity over time. It has also been effective in reducing radiographic progression, which means it helps prevent joint damage, in patients with active psoriatic arthritis.12345
Is guselkumab generally safe for humans?
How does the drug Guselkumab differ from other treatments for juvenile psoriatic arthritis?
Guselkumab is unique because it targets a specific protein involved in inflammation called interleukin-23 (IL-23), which is different from other treatments like secukinumab and golimumab that target tumor necrosis factor (TNF). This different mechanism of action may offer an alternative for patients who do not respond well to TNF blockers.910111213
Research Team
JR
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Eligibility Criteria
This trial is for children with certain autoimmune conditions like ulcerative colitis, Crohn's disease, or juvenile psoriatic arthritis who've seen improvements with guselkumab. Participants need consent from parents or guardians and must follow specific contraception guidelines if applicable.Inclusion Criteria
I have finished all my doses in the guselkumab study for children.
* Must have received benefit from continued guselkumab therapy in the opinion of the investigator * Before enrollment, a participant must be either: (a) Not of childbearing potential, OR (b) Of childbearing potential and not sexually active, practicing abstinence or a highly effective method of contraception and agrees to remain on a highly effective method while receiving study intervention and until 12 weeks after the last dose - the end of relevant systemic exposure
My child's legal guardian or I have signed the consent form for the study.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive subcutaneous guselkumab every 4 or 8 weeks based on prior study regimen
Up to 6 years and 9 months
Visits every 4 or 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Guselkumab (Monoclonal Antibodies)
Trial OverviewThe study tests the long-term safety of guselkumab, a medication given by injection to pediatric patients. It aims to understand how well it works over an extended period for those with moderate to severe symptoms of specific autoimmune diseases.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Guselkumab (Every 8 weeks)Experimental Treatment1 Intervention
Participants treated with guselkumab in one of the three primary studies (CNTO1959PUC3001 \[NCT06260163\], CNTO1959PBCRD3007 \[NCT05923073\], CNTO1275JPA3001 \[NCT05083182\]) will be enrolled in this long-term extension (LTE) study, if in investigator's opinion, participant will benefit from continued guselkumab therapy and will have continued access to guselkumab (every 8 weeks \[q8w\]). Participants coming from double-blinded arm of primary studies CNTO1959PUC3001 and CNTO1959PBCRD3007 will be assigned to q8w dosing. Based on investigator's discretion and participant's clinical status, they have option to switch to q4w once during LTE study prior to unblinding of primary study assignment. Once the primary study is unblinded, dosing frequency may be adjusted to match what the participant had received before enrolling in LTE study. Participants coming from study CNTO1275JPA3001 will continue same dosing regimen from primary study (q8w) and cannot change their dosing interval during LTE study.
Group II: Guselkumab (Every 4 weeks)Experimental Treatment1 Intervention
Participants treated with guselkumab in one of the three primary studies (CNTO1959PUC3001 \[NCT06260163\], CNTO1959PBCRD3007 \[NCT05923073\], CNTO1275JPA3001 \[NCT05083182\]) will be enrolled in this LTE study, if in the investigator's opinion, the participant will benefit from continued guselkumab therapy. Participants will have continued access to guselkumab (q4w). Participants coming from the open-label arm of the primary studies CNTO1959PUC3001 and CNTO1959PBCRD3007 will be assigned to q4w dosing. No dose adjustments are permitted. Participants coming from the jPsA primary study (CNTO1275JPA3001) will continue the same dosing regimen from the primary study (q4w) and cannot change their dosing interval during the LTE study.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of UtahSalt Lake City, UT
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Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Trials
1022
Patients Recruited
6,408,000+
Findings from Research
Guselkumab (GUS) demonstrated a favorable safety profile in patients with psoriatic arthritis (PsA), showing low adverse event (AE) rates for both TNFi-naïve (139.7/100 patient-years) and TNFi-experienced patients (174.0/100 patient-years) over a period of up to 2 years.
The safety outcomes, including rates of serious AEs and treatment discontinuation, were consistent between GUS-treated patients and those receiving placebo, indicating that GUS is a safe treatment option for PsA regardless of prior TNFi use.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Safety of Guselkumab With and Without Prior Tumor Necrosis Factor Inhibitor Treatment: Pooled Results Across 4 Studies in Patients With Psoriatic Arthritis.Rahman, P., Boehncke, WH., Mease, PJ., et al.[2023]
In the DISCOVER-2 trial, guselkumab was tested in biologic-naive patients with active psoriatic arthritis, demonstrating significant efficacy in reducing disease activity compared to placebo.
The study's double-blind, randomized, placebo-controlled design ensures robust results, highlighting guselkumab as a promising treatment option for patients who have not previously received biologic therapies.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Guselkumab safely improved clinical outcomes in biologic-naive patients with psoriatic arthritis.Schattner, A.[2020]
In a phase II trial involving 149 patients with active psoriatic arthritis, guselkumab significantly improved disease activity scores compared to placebo, with notable reductions in composite indices like PASDAS and DAPSA at week 24 (P < 0.001).
Guselkumab-treated patients were more likely to achieve low or very low disease activity states, with 35% reaching low activity on the PASDAS compared to only 4% in the placebo group, indicating its efficacy in managing psoriatic arthritis.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Composite Measures of Disease Activity in Psoriatic Arthritis: Comparative Instrument Performance Based on the Efficacy of Guselkumab in an Interventional Phase II Trial.Helliwell, PS., Deodhar, A., Gottlieb, AB., et al.[2020]
A total of 24,312 adverse event reports related to guselkumab were identified from over 22 million reports in the FDA adverse event reporting system, indicating a significant volume of data for analysis.
The study revealed unexpected adverse events associated with guselkumab, including onychomadesis, malignant melanoma in situ, endometrial cancer, and erectile dysfunction, highlighting the need for ongoing safety monitoring and further research.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Adverse events of guselkumab in the real world: emerging signals to target preventive strategies from the FDA adverse event reporting system.Xiang, DC., Chen, W., Fu, ZW., et al.[2023]
References
Safety of Guselkumab With and Without Prior Tumor Necrosis Factor Inhibitor Treatment: Pooled Results Across 4 Studies in Patients With Psoriatic Arthritis. [2023]
Guselkumab safely improved clinical outcomes in biologic-naive patients with psoriatic arthritis. [2020]
Composite Measures of Disease Activity in Psoriatic Arthritis: Comparative Instrument Performance Based on the Efficacy of Guselkumab in an Interventional Phase II Trial. [2020]
Guselkumab effectiveness and survival in patients with psoriasis and psoriatic arthritis: Multicenter analysis in daily clinical practice by the Spanish Psoriasis Group. [2022]
The effect of guselkumab on inhibiting radiographic progression in patients with active psoriatic arthritis: study protocol for APEX, a Phase 3b, multicenter, randomized, double-blind, placebo-controlled trial. [2023]
Pooled Safety Results Through 1 Year of 2 Phase III Trials of Guselkumab in Patients With Psoriatic Arthritis. [2022]
Adverse events of guselkumab in the real world: emerging signals to target preventive strategies from the FDA adverse event reporting system. [2023]
Efficacy of guselkumab, a selective IL-23 inhibitor, in Preventing Arthritis in a Multicentre Psoriasis At-Risk cohort (PAMPA): protocol of a randomised, double-blind, placebo controlled multicentre trial. [2023]
Secukinumab Therapy in Refractory Juvenile Idiopathic Arthritis. [2023]
Golimumab for Polyarticular Juvenile Idiopathic Arthritis and Psoriatic Arthritis: Pharmacologic and Clinical Considerations. [2023]
New Insights on Juvenile Psoriatic Arthritis. [2022]
Tumour necrosis factor (TNF)-blocking agents in juvenile psoriatic arthritis: are they effective? [2015]
Do the features of juvenile psoriatic arthritis change according to age? A comprehensive evaluation of the PeRA Research Group Registry. [2023]