← Back to Search

Monoclonal Antibodies

Guselkumab for Psoriatic Arthritis (STAR Trial)

Phase 4
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have active plaque psoriasis, with at least 1 psoriatic plaque of >= 2 centimeter (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis
Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4, and have a spinal pain score (on a visual analog scale [VAS]) of at least 4
Must not have
Has ever received a Janus kinase (JAK) inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational JAK inhibitor
Has previously received any biologic treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 weeks
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of Guselkumab include allergic reactions, injection site reactions such as redness and swelling, upper respiratory infections due to immune system suppression by the drug, headache and fatigue. The exact side effects experienced can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have active psoriasis with a plaque larger than 2 cm or nail changes.
Select...
My back pain and stiffness are severe, scoring at least 4 out of 10.
Select...
I have PsA with swelling and tenderness in at least 3 joints and high CRP levels despite previous treatments.
Select...
I have been diagnosed with psoriatic arthritis for at least 6 months.
Select...
My MRI shows Psoriatic Arthritis in my spine or sacroiliac joints.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have taken a JAK inhibitor medication before.
Select...
I have received biological therapy before.
Select...
I haven't taken any immune system suppressing drugs in the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 24
Secondary study objectives
Change from Baseline in Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein (ASDAS-CRP) at Week 24
Change from Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Week 24
Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24
+16 more

Side effects data

From 2020 Phase 4 trial • 1027 Patients • NCT03573323
1%
Nasopharyngitis
1%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ixekizumab Post-Treatment Follow Up
Ixekizumab
Guselkumab
Guselkumab Post-Treatment Follow Up

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group 3: Placebo followed by GuselkumabExperimental Treatment2 Interventions
Participants will receive matching placebo and will cross over to receive guselkumab SC.
Group II: Group 2: GuselkumabExperimental Treatment1 Intervention
Participants will receive guselkumab SC.
Group III: Group 1: Guselkumab and PlaceboExperimental Treatment2 Interventions
Participants will receive guselkumab and matching placebo subcutaneously (SC) to maintain the blind.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
2015
Completed Phase 4
~5990
Placebo
1995
Completed Phase 3
~2670

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Psoriatic Arthritis (PsA) treatments often target specific pathways involved in the disease's inflammatory process. IL-23 inhibitors like guselkumab work by blocking the IL-23 cytokine, which is crucial for the proliferation and survival of Th17 cells that drive inflammation in PsA. This helps reduce symptoms and prevent joint damage. IL-17 inhibitors, such as secukinumab, target the IL-17 cytokine, another key player in the inflammatory cascade. TNF-alpha inhibitors, like adalimumab, block the TNF-alpha cytokine, which is involved in systemic inflammation. These treatments are essential for PsA patients as they help manage symptoms, reduce inflammation, and prevent long-term joint damage, improving overall quality of life.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
987 Previous Clinical Trials
6,385,254 Total Patients Enrolled
2 Trials studying Psoriatic Arthritis
399 Patients Enrolled for Psoriatic Arthritis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
753 Previous Clinical Trials
3,961,054 Total Patients Enrolled
2 Trials studying Psoriatic Arthritis
399 Patients Enrolled for Psoriatic Arthritis

Media Library

Guselkumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04929210 — Phase 4
Psoriatic Arthritis Research Study Groups: Group 3: Placebo followed by Guselkumab, Group 1: Guselkumab and Placebo, Group 2: Guselkumab
Psoriatic Arthritis Clinical Trial 2023: Guselkumab Highlights & Side Effects. Trial Name: NCT04929210 — Phase 4
Guselkumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04929210 — Phase 4
~72 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top