Guselkumab for Juvenile Psoriatic Arthritis

(TRILOGY Trial)

Recruiting at 22 trial locations

Overseen By Study Contact

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must be taking: Guselkumab

Disqualifiers: Pregnancy, Employee, Investigator, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: Up to 6 years and 9 months

196 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the long-term safety of guselkumab, a medication for children and teens with juvenile psoriatic arthritis (a type of arthritis causing joint pain and skin issues) or inflammatory bowel diseases like ulcerative colitis and Crohn's disease. Participants will receive guselkumab injections every 4 or 8 weeks. It suits those who have previously received guselkumab in earlier studies and benefited from it. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to the potential availability of this treatment.

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.

Is there any evidence suggesting that this trial's treatment is likely to be safe?

Research has shown that guselkumab, a treatment under study for juvenile psoriatic arthritis, has a strong safety record from previous studies. Adults with conditions like psoriasis and psoriatic arthritis have used it safely, handling it well with consistent safety results.

The FDA has already approved the treatment for children with moderate to severe plaque psoriasis, indicating confidence in its safety for kids. This approval means the treatment underwent careful safety checks for children.

Overall, the available data suggest that guselkumab is generally well-tolerated, with no major safety concerns reported in these studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for juvenile psoriatic arthritis?

Guselkumab is unique because it targets a specific part of the immune system called interleukin-23 (IL-23), which plays a critical role in the inflammation process seen in juvenile psoriatic arthritis. Unlike traditional treatments that often involve broad immunosuppressants, guselkumab specifically inhibits IL-23, potentially leading to more effective and targeted management with fewer side effects. Researchers are excited about guselkumab because it offers a promising new approach to reducing joint inflammation and pain with a more precise mechanism of action, which could improve quality of life for young patients with this condition.

What evidence suggests that guselkumab might be an effective treatment for juvenile psoriatic arthritis?

Research shows that guselkumab effectively treats psoriasis-related conditions. In adults, this medication has consistently been safe and effective for psoriasis and psoriatic arthritis. Studies indicate that it also works well in children with moderate to severe plaque psoriasis, leading to significant skin improvement. The U.S. FDA has approved guselkumab for treating plaque psoriasis in children, suggesting it might also help with juvenile psoriatic arthritis. Guselkumab blocks a specific protein that causes inflammation, reducing symptoms. Early research in children with similar conditions suggests that guselkumab could also be helpful for juvenile psoriatic arthritis. Participants in this trial will receive guselkumab either every 8 weeks or every 4 weeks, depending on their previous study regimen and clinical status. ^{1 2 3 4 6}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Guselkumab

Trial Overview The 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.

How Is the Trial Designed?

Group I: Guselkumab (Every 8 weeks) Experimental Treatment 1 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 Treatment 1 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.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

In a study of 10 juvenile idiopathic arthritis (JIA) patients treated with secukinumab, all patients showed improvement in MRI findings after at least 3 months of therapy, indicating its efficacy in managing resistant cases of JIA.

While secukinumab was generally well-tolerated, one patient experienced a flare of uveitis, suggesting that caution is needed when prescribing this treatment to patients with a history of uveitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab Therapy in Refractory Juvenile Idiopathic Arthritis. Nelson, MC., Manos, CK.[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]

Golimumab is an effective treatment for both adult and pediatric patients with active psoriatic arthritis and juvenile idiopathic arthritis, as it works by blocking tumor necrosis factor-alpha (TNF-a) to reduce inflammation.

The use of golimumab has been associated with minimal adverse events, making it a safe option for children aged 2-17, especially for those who do not respond to other treatments like adalimumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Golimumab for Polyarticular Juvenile Idiopathic Arthritis and Psoriatic Arthritis: Pharmacologic and Clinical Considerations. McIntosh, SM., Kerut, C., Hollenshead, PP., et al.[2023]

In a study of 18 juvenile psoriatic arthritis patients, anti-TNFα therapy was found to be effective in treating arthritis, with 83% achieving a significant response after 3 months and 100% after 15 months.

While the treatment effectively managed arthritis, it did not significantly improve psoriatic skin lesions, and four patients developed new psoriasis during the study, highlighting the need for further research on the optimal duration of therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumour necrosis factor (TNF)-blocking agents in juvenile psoriatic arthritis: are they effective? Otten, MH., Prince, FH., Ten Cate, R., et al.[2015]

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]

Juvenile psoriatic arthritis (JPsA) is a rare form of juvenile idiopathic arthritis, making up about 5% of cases, and is characterized by arthritis and psoriasis or related symptoms, but its classification may overlook distinct patient subgroups with different characteristics and prognoses.

There is a lack of specific clinical trials for biological treatments in JPsA, despite the emergence of new therapies for adults, highlighting the need for more research to understand the genetic factors and treatment options for this condition in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Insights on Juvenile Psoriatic Arthritis. Brunello, F., Tirelli, F., Pegoraro, L., et al.[2022]

The PAMPA study is investigating the efficacy of guselkumab, an IL-23p19 inhibitor, in preventing the progression of psoriatic arthritis (PsA) in patients with psoriasis at increased risk, involving 200 participants over a 24-week treatment period followed by a 72-week follow-up.

The study aims to assess changes in musculoskeletal abnormalities and the rate of transition to PsA, providing a unique opportunity for early intervention in a population that typically shows signs of PsA 5-7 years after psoriasis onset.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Haberman, RH., MacFarlane, KA., Catron, S., et al.[2023]

In a study involving 90 patients with psoriatic arthritis (PsA) treated with guselkumab, significant improvements were observed in both skin and joint symptoms over 52 weeks, with the absolute PASI score decreasing from 10.5 to 1.3, indicating effective management of psoriasis.

Guselkumab was well-tolerated with no new safety concerns reported, and 84.4% of patients continued treatment after 2 years, suggesting it is a viable long-term therapeutic option for patients with PsA and psoriasis in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab effectiveness and survival in patients with psoriasis and psoriatic arthritis: Multicenter analysis in daily clinical practice by the Spanish Psoriasis Group. Rocamora, V., Crespi, L., Ferran, M., et al.[2022]

In a study involving 1120 patients with active psoriatic arthritis, guselkumab was found to be well tolerated over one year, with adverse event rates similar to those of the placebo group, indicating its safety as a treatment option.

No serious safety concerns were identified, such as uveitis or major infections, and while mild elevations in liver enzymes and decreased neutrophil counts were observed, they were transient and did not necessitate discontinuation of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pooled Safety Results Through 1 Year of 2 Phase III Trials of Guselkumab in Patients With Psoriatic Arthritis. Rahman, P., Ritchlin, CT., Helliwell, PS., et al.[2022]

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]

In the Phase 3 DISCOVER-2 trial involving 739 biologic-naïve patients with active psoriatic arthritis (PsA), guselkumab significantly reduced radiographic progression compared to placebo, indicating its efficacy in slowing disease progression.

The ongoing APEX trial aims to further assess guselkumab's effects on patients with active PsA who have risk factors for radiographic progression, with a robust sample size designed to ensure high statistical power for detecting treatment differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Ritchlin, CT., Coates, LC., Mease, PJ., et al.[2023]

In a study of 87 children with juvenile psoriatic arthritis (JPsA), it was found that about one-third did not have psoriasis at diagnosis, indicating that skin lesions may not always be present in this condition.

The study revealed distinct patterns between early-onset (younger than 5 years) and late-onset groups, with early-onset patients showing higher rates of uveitis and ANA positivity, while older children exhibited more axial involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do the features of juvenile psoriatic arthritis change according to age? A comprehensive evaluation of the PeRA Research Group Registry. Karadağ, ŞG., Coskuner, T., Demirkan, FG., et al.[2023]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41152645/

Extrapolating Guselkumab Efficacy to Juvenile Psoriatic ... Guselkumab (a fully human, dual-acting, IL-23p19 subunit inhibitor) was shown to be safe and effective in adult PsO and PsA, with consistent ...

2. link.springer.com link.springer.com/article/10.1007/s40272-025-00725-2

Extrapolating Guselkumab Efficacy to Juvenile Psoriatic ... Guselkumab (a fully human, dual-acting, IL-23p19 subunit inhibitor) was shown to be safe and effective in adult PsO and PsA, with consistent ...

3. jnj.com jnj.com/media-center/press-releases/u-s-fda-approves-tremfya-guselkumab-for-the-treatment-of-pediatric-plaque-psoriasis-and-active-psoriatic-arthritis-marking-a-first-and-only-approval-for-an-il-23-inhibitor

U.S. FDA approves TREMFYA® (guselkumab) for the ... TREMFYA® is now approved for pediatric patients living with moderate to severe plaque psoriasis, who are candidates for systemic therapy or ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05083182

NCT05083182 | A Study of Ustekinumab or Guselkumab in ... The purpose of this study is to evaluate the pharmacokinetics (PK), efficacy, safety and immunogenicity of ustekinumab and guselkumab in active juvenile ...

5. jnjmedicalconnect.com jnjmedicalconnect.com/products/tremfya/medical-content/tremfya-use-in-pediatric-patients-with-plaque-psoriasis-or-psoriatic-arthritis

TREMFYA - Use in Pediatric Patients with Plaque Psoriasis ... The response rates for IGA 0/1, PASI 75, and PASI 90 were 64%, 55%, and 36%, respectively at week 20, and improved to 91%, 96%, and 91%, ...

6. the-rheumatologist.org the-rheumatologist.org/article/fda-approval-sought-for-2-pediatric-indications-for-guselkumab/

FDA Approval Sought for 2 Pediatric Indications ... The FDA subsequently approved guselkumab for the treatment of adults with active psoriatic arthritis (PsA) and moderate to severe active ulcerative colitis.