Guselkumab for Psoriatic Arthritis

(APEX Trial)

Recruiting at 331 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

1054 Participants Needed

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.

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.

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. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Guselkumab for treating psoriatic arthritis?

Research shows that Guselkumab helps improve symptoms in people with psoriatic arthritis, including reducing joint pain and swelling, and it has been effective in maintaining these improvements over time. ^{1 2 3 4 5}

What 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. ^{1 2 6 7 8}

Is Guselkumab safe for humans?

Guselkumab has been generally well tolerated in clinical trials for conditions like psoriatic arthritis and plaque psoriasis, with safety data showing it is safe for use in humans over periods of up to 2 years. ^{1 2 6 7 8}

Is 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. ^{1 2 7 8 9}

What makes the drug Guselkumab unique for treating psoriatic arthritis?

Guselkumab is unique because it targets the interleukin 23 (IL-23) pathway, which is different from many other treatments for psoriatic arthritis. It is administered by subcutaneous injection and has shown to improve symptoms in patients who have not previously used biologic treatments. ^{1 2 7 8 9}

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility 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.

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

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

Treatment Details

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.

Participant Groups

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+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires

Findings from Research

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]

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 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]

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 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]

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]

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]

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]

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]

References

1. England 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Guselkumab safely improved clinical outcomes in biologic-naive patients with psoriatic arthritis. [2020]

3. England 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. [2021]

4. England 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. [2023]

5. United States 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. [2020]

6. Canada 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. [2023]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Guselkumab: First Global Approval. [2019]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Guselkumab: A Review in Moderate to Severe Plaque Psoriasis. [2019]

9. England 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. [2020]