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Evaluating Guselkumab for Active Psoriatic Arthritis Axial Disease

A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease

Phase 4 Interventional Janssen Research & Development, LLC · NCT04929210

This study is testing if a new medication called guselkumab can help people with active psoriatic arthritis feel better over 48 weeks.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment405 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsguselkumab, tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib
Locations240 sites (Avondale, Arizona and 239 other locations)
Trial IDNCT04929210 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy of guselkumab, a monoclonal antibody targeting interleukin-23, in participants with active psoriatic arthritis axial disease. The trial includes a screening phase, a treatment phase lasting up to 48 weeks with both placebo and active controls, and a safety follow-up phase. Efficacy will be measured using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score, while safety will be monitored through various clinical assessments. The overall duration of the study is up to 14 months.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with psoriatic arthritis for at least 6 months, exhibiting active axial disease and meeting specific clinical criteria.

Not a fit: Patients who have not previously responded to non-biologic DMARDs or have other forms of arthritis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce symptoms and inflammation in patients with active psoriatic arthritis axial disease.

How similar studies have performed: Previous studies have shown promise with similar biologic treatments for psoriatic arthritis, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Have a diagnosis of psoriatic arthritis (PsA) for at least 6 months prior to the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) criteria at screening
* Have active PsA as defined by: a) at least 3 swollen joints and at least 3 tender joints at screening and at baseline and b) C-reactive protein (CRP) greater than or equal to (\>=) 0.3 milligram/deciliter (mg/dL) at screening from the central laboratory, and despite previous non-biologic disease modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
* Have magnetic resonance imaging (MRI)-confirmed PsA axial disease (positive MRI spine and/or sacroiliac \[SI\] joints, shown by a Spondyloarthritis Research Consortium of Canada \[SPARCC\] score of \>= 3 in either the spine or the sacroiliac joints)
* 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
* 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

Exclusion Criteria:

* Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
* Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS)/non-radiographic-axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease
* Has previously received any biologic treatment
* 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 received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention

Where this trial is running

Avondale, Arizona and 239 other locations

+190 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Arthritis, Psoriatic
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.