Guselkumab for Psoriatic Arthritis

(STAR Trial)

Recruiting at 256 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 4

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)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

405 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing guselkumab, a medication that reduces inflammation, in patients with psoriatic arthritis affecting the spine. It works by blocking a protein called IL-23 to help reduce symptoms and inflammation. Guselkumab is the first IL-23 specific inhibitor approved for the treatment of moderate-to-severe psoriasis.

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. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

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 joint pain and swelling, and it has been effective in reducing symptoms over a long period, up to two years. It has also been shown to be safe and effective in patients who have not previously used biologic treatments. ^{1 2 3 4 5}

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 3 6 7 8}

How is 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 through subcutaneous injection and has shown effectiveness in improving symptoms in patients who have not previously used biologic treatments. ^{1 3 7 8 9}

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for individuals with active psoriatic arthritis axial disease, diagnosed at least 6 months ago. Participants must have at least 3 swollen and tender joints, elevated CRP levels, MRI-confirmed PsA axial disease, a BASDAI score of ≥4, spinal pain VAS score of ≥4, and may have plaque psoriasis or nail changes. Those who've had biologic treatments or suffer from other inflammatory diseases like RA or lupus can't join.

Inclusion Criteria

I have active psoriasis with a plaque larger than 2 cm or nail changes.

My back pain and stiffness are severe, scoring at least 4 out of 10.

I have PsA with swelling and tenderness in at least 3 joints and high CRP levels despite previous treatments.

Exclusion Criteria

I have taken a JAK inhibitor medication before.

I do not have conditions like RA, AS, lupus, or Lyme disease that could affect treatment results.

I have received biological therapy before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 6 weeks

Treatment

Participants receive guselkumab or placebo subcutaneously, with a placebo-controlled period from Week 0 to Week 24 and an active-controlled treatment phase from Week 24 to Week 48

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Guselkumab
• Placebo

Trial Overview The study tests the effectiveness of Guselkumab in reducing symptoms and inflammation in patients with PsA axial disease compared to a placebo. Patients will receive either Guselkumab or an inactive substance (placebo) through subcutaneous injections to see if there's an improvement in their condition.

Participant Groups

Group I: Group 3: Placebo followed by Guselkumab Experimental Treatment 2 Interventions

Participants will receive matching placebo and will cross over to receive guselkumab SC.

Group II: Group 2: Guselkumab Experimental Treatment 1 Intervention

Participants will receive guselkumab SC.

Group III: Group 1: Guselkumab and Placebo Experimental Treatment 2 Interventions

Participants will receive guselkumab and matching placebo subcutaneously (SC) 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 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 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 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 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]

References

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

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

2. 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]

3. 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]

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

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

Guselkumab: First Global Approval. [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]