Guselkumab for Psoriatic Arthritis

(STAR Trial)

Recruiting at 285 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests guselkumab, a medication that may reduce symptoms and inflammation in people with psoriatic arthritis, particularly those with related back pain. Researchers aim to compare the effectiveness of guselkumab to a placebo (a treatment with no active medicine). They seek participants who have had psoriatic arthritis for at least 6 months, experience joint swelling and tenderness, and suffer from back pain due to the condition. Those who have tried other treatments without success and have noticeable skin or nail psoriasis may find this trial suitable. As a Phase 4 trial, guselkumab is already FDA-approved and proven effective, and this research seeks to understand its benefits for more patients.

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 is the safety track record for these treatments?

Studies have shown that guselkumab is generally safe for people with psoriatic arthritis. In past research, participants did not report any new or unexpected safety issues with the drug, which reassures those considering joining a clinical trial.

Guselkumab has a proven safety record, supported by several years of data. It has been used safely for over five years to treat moderate to severe plaque psoriasis, a skin condition. Additionally, past studies demonstrated that guselkumab effectively reduced symptoms and helped prevent joint damage in people with psoriatic arthritis.

In summary, current evidence suggests that guselkumab is safe for use, particularly for those with conditions like psoriatic arthritis. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Guselkumab is unique because it targets interleukin-23 (IL-23), a specific protein involved in the inflammatory process of psoriatic arthritis. Unlike traditional treatments like methotrexate or TNF inhibitors, which have broader effects, guselkumab's precise targeting may offer improved symptom control with potentially fewer side effects. Researchers are excited about this treatment's ability to directly tackle the underlying cause of inflammation, which could lead to better long-term outcomes for patients with psoriatic arthritis.

What is the effectiveness track record for guselkumab in treating psoriatic arthritis?

Research has shown that guselkumab effectively treats psoriatic arthritis (PsA). Studies have found that it significantly reduces symptoms such as joint pain and swelling. In one study, 70.3% of patients showed improvements in sacroiliac joint issues, as observed in MRI scans. Guselkumab also helps prevent further joint damage in PsA. Over a year, patients continued to experience benefits in their condition. This trial will evaluate guselkumab in different treatment groups, including those receiving guselkumab alone and those receiving a placebo followed by guselkumab. These findings make guselkumab a promising choice for managing PsA symptoms. ^{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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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

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 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]

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]

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]

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 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]

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 ...