405 Participants Needed

Guselkumab for Psoriatic Arthritis

(STAR Trial)

Recruiting at 253 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Janssen Research & Development, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

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.12345

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.23456

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.35789

Who Is on the Research Team?

JR

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.
See 2 more

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.
See 2 more

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?
3Treatment groups
Experimental Treatment
Group I: Group 3: Placebo followed by GuselkumabExperimental Treatment2 Interventions
Group II: Group 2: GuselkumabExperimental Treatment1 Intervention
Group III: Group 1: Guselkumab and PlaceboExperimental Treatment2 Interventions

Guselkumab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Tremfya for:
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Approved in European Union as Tremfya for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

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 profile image

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 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.
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.
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.
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]

Citations

Guselkumab safely improved clinical outcomes in biologic-naive patients with psoriatic arthritis. [2020]
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]
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]
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]
Composite Measures of Disease Activity in Psoriatic Arthritis: Comparative Instrument Performance Based on the Efficacy of Guselkumab in an Interventional Phase II Trial. [2020]
Safety of Guselkumab With and Without Prior Tumor Necrosis Factor Inhibitor Treatment: Pooled Results Across 4 Studies in Patients With Psoriatic Arthritis. [2023]
Guselkumab: A Review in Moderate to Severe Plaque Psoriasis. [2019]
Guselkumab: First Global Approval. [2019]
Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study. [2020]
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