Guselkumab for Psoriatic Arthritis

(APEX Trial)

Not currently recruiting at 405 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must not be taking: Biologics, JAK inhibitors

Disqualifiers: Rheumatoid arthritis, Lupus, 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: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether guselkumab can reduce symptoms in people with active psoriatic arthritis, a condition that causes joint pain and swelling. Participants will receive either guselkumab, a placebo, or a combination of both to evaluate the treatment's effectiveness. Suitable candidates for this trial include individuals who have struggled with psoriatic arthritis symptoms despite previous treatments and have noticeable joint pain or swelling. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants early access to a potentially effective treatment.

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking any systemic immunosuppressants at least 4 weeks before starting the study treatment. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that guselkumab is generally safe for individuals with active psoriatic arthritis (PsA). Previous studies have demonstrated that it significantly reduces symptoms in PsA patients and found no new safety concerns for at least one year.

Additionally, researchers have tested guselkumab for safety in related conditions, such as moderate to severe plaque psoriasis. It has a strong safety record, with data supporting its use for up to five years. This suggests it is safe for long-term use in similar conditions, reassuring its use in PsA.

Overall, based on past research, guselkumab appears to be a safe option, with no major safety issues reported. ^{1 2 3 4 5}

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

Guselkumab is unique because it targets the interleukin-23 (IL-23) pathway, a specific part of the immune system involved in inflammation, which is different from many current treatments that focus on TNF inhibitors. This new mechanism of action may provide relief for those who don't respond well to standard therapies like methotrexate or other biologics. Additionally, guselkumab is administered subcutaneously, which can be convenient for patients compared to intravenous options. Researchers are excited about its potential to offer a more tailored and possibly more effective treatment for psoriatic arthritis.

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

Research has shown that guselkumab effectively treats psoriatic arthritis (PsA). Studies have found that it significantly reduces the signs and symptoms of active PsA. For instance, most patients (70.3%) experienced notable improvements in joint issues, as confirmed by MRI scans. Beyond symptom reduction, guselkumab also helps slow joint damage. Over a year, patients using guselkumab demonstrated better disease control and continued the treatment due to its sustained effectiveness. In this trial, participants will be assigned to different groups: some will receive guselkumab alone, others will receive a placebo followed by guselkumab, and some will receive a combination of guselkumab and placebo to maintain the blind. These results suggest that guselkumab could be a promising option for managing PsA. ^{2 6 7 8 9}

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 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.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous administration of guselkumab or placebo to evaluate efficacy in reducing signs and symptoms of active psoriatic arthritis

24 weeks

Regular visits for administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 168 weeks

Long-term Extension

Participants who have not discontinued will be eligible to enter a long-term extension and will receive guselkumab

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Guselkumab
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Group 3: Placebo Followed by Guselkumab Experimental Treatment 2 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: Guselkumab Experimental Treatment 1 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 Placebo Experimental Treatment 2 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

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 phase II trial involving 149 patients with active psoriatic arthritis, guselkumab significantly improved symptoms of enthesitis and dactylitis compared to placebo, with these improvements sustained through week 56.

Patients who switched from placebo to guselkumab treatment experienced similar benefits in enthesitis and dactylitis as those who received guselkumab from the start, indicating its effectiveness regardless of when treatment began.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Mease, PJ., Gladman, DD., Deodhar, A., et al.[2021]

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 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 a study of 114 patients with active psoriatic arthritis (PsA) who started on guselkumab, 78.9% continued treatment after 6 months, showing strong treatment persistence.

Patients experienced significant improvements in joint and skin symptoms, with a mean reduction in disease activity index (cDAPSA) of -5.4 and notable decreases in pain and psoriasis severity, confirming guselkumab's efficacy in a real-world setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six-Month Persistence and Multi-domain Effectiveness of Guselkumab in Adults with Psoriatic Arthritis: Real-World Data from the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry. Mease, PJ., Ogdie, A., Tesser, J., 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 study of 246 patients with psoriatic arthritis and imaging-confirmed sacroiliitis, guselkumab treatment led to significant and durable improvements in axial symptoms and disease activity over 2 years, with many patients achieving at least a 50% improvement in their symptoms.

At week 100, approximately 49-54% of patients treated with guselkumab achieved a BASDAI 50 response, indicating substantial effectiveness, regardless of sex or HLA-B*27 status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Mease, PJ., Gladman, DD., Poddubnyy, D., et al.[2023]

Guselkumab is an effective treatment for moderate to severe plaque psoriasis, showing superior results compared to placebo and adalimumab in the VOYAGE trials, with benefits maintained for up to 2 years.

Patients who previously did not respond well to ustekinumab showed significantly better outcomes when switched to guselkumab, indicating its efficacy in treatment-resistant cases, while also improving overall quality of life and being well tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab: A Review in Moderate to Severe Plaque Psoriasis. Al-Salama, ZT., Scott, LJ.[2019]

Guselkumab is an approved treatment for moderate-to-severe plaque psoriasis, specifically designed to inhibit interleukin 23 (IL-23), which plays a key role in the inflammatory process of the disease.

By blocking IL-23 from binding to its receptor, guselkumab disrupts the IL-17 pathway, which is crucial for the activation of type 17 helper T cells, thereby reducing inflammation and symptoms in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab: First Global Approval. Markham, A.[2019]

In a phase 2a trial involving 149 patients with active psoriatic arthritis, guselkumab significantly improved symptoms, with 58% of patients achieving at least a 20% improvement in their condition compared to only 35% in the placebo group, demonstrating its efficacy as a treatment.

Guselkumab was well tolerated over 44 weeks, with a similar rate of adverse events (36% in the treatment group vs. 33% in the placebo group), indicating a favorable safety profile for this novel therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study. Deodhar, A., Gottlieb, AB., Boehncke, WH., et al.[2020]

Citations

1. jnj.com jnj.com/media-center/press-releases/new-data-show-tremfya-guselkumab-is-the-only-il-23-inhibitor-proven-to-significantly-inhibit-progression-of-joint-structural-damage-in-active-psoriatic-arthritis

New data show TREMFYA® (guselkumab) is the only IL-23 ... TREMFYA (guselkumab) significantly reduced both signs and symptoms of active psoriatic arthritis (PsA) and inhibited progression of joint structural damage at ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38598432/

Short-term effectiveness of guselkumab in psoriatic arthritis ... A reduction of 0.80 or larger in the sacroiliac joint lesion score was observed in the majority of patients (70.3%) based on MRI improvements, ...

3. jnjmedicalconnect.com jnjmedicalconnect.com/products/tremfya/medical-content/tremfya-efficacy-outcomes-by-weight-in-adult-patients-with-plaque-psoriasis-or-psoriatic-arthritis

TREMFYA - Efficacy Outcomes by Weight in Adult Patients ... Super response (SR) status was defined as patients who received TREMFYA and achieved PASI 100 (absolute PASI = 0) response at weeks 20 and 28.

4. rheumatologyadvisor.com rheumatologyadvisor.com/news/guselkumab-improves-psa-disease-activity/

Guselkumab Improves Disease Activity and Retention in PsA Treatment with guselkumab led to improvements in disease activity over 1 year among patients with PsA and showed a high retention rate.

5. tremfyahcp.com tremfyahcp.com/plaque-psoriasis/efficacy-in-joints/

Efficacy in Active PsA: Moderate to Severe Plaque PsO Guselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37906417/

Long-Term Safety of Guselkumab in Patients with Psoriatic ... Guselkumab was well tolerated and efficacious across individual pivotal clinical studies in adults with moderate-to-severe psoriasis and/or active psoriatic ...

7. tremfyahcp.com tremfyahcp.com/psoriatic-arthritis/

Active Psoriatic Arthritis (PsA) - TREMFYA ® (guselkumab) TREMFYA ® has a proven safety profile across psoriatic disease with 5 years of data in moderate to severe plaque psoriasis (PsO) and 2 years of data in

8. jrheum.org jrheum.org/content/48/12/1815

Pooled Safety Results Through 1 Year of 2 Phase III Trials ... Guselkumab 100 mg Q4W and Q8W were well tolerated in patients with PsA, with no new safety concerns through 1Y of the phase III DISCOVER trials.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02319759

NCT02319759 | Efficacy and Safety Study of Guselkumab ... The purpose of this study is to evaluate the efficacy, safety and tolerability of guselkumab in participants with Active Psoriatic Arthritis (PsA). Detailed ...