NCT04929210

A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With 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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 411 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) axial disease by assessing reduction in axial symptoms and inflammation.

Detailed description

PsA is a chronic inflammatory musculoskeletal disease that has 6 disease domains, and axial disease represents one of the domains. Guselkumab is a fully human immunoglobulin (Ig) G1 lambda monoclonal antibody (mAb) that by binding to the p19 protein subunit of interleukin (IL)-23, blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23-mediated intracellular signaling, activation, and cytokine production. This study will consist of a screening phase (up to 6 weeks), a treatment phase (up to 48 weeks, including a placebo-controlled period from Week 0 to Week 24 and an active-controlled treatment phase from Week 24 to Week 48), and a safety follow-up phase (up to Week 60). The efficacy assessments will include assessment such as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and the safety assessments will include evaluations of physical examinations, vital signs, electrocardiograms, clinical laboratory tests, and adverse events. The overall duration of the study will be up to 14 months.

Conditions

• Arthritis, Psoriatic

Interventions

Type	Name	Description
DRUG	Guselkumab	Guselkumab will be administered as subcutaneous injection.
DRUG	Placebo	Matching placebo will be administered as subcutaneous injection.

Timeline

• Start date: 2021-08-30
• Primary completion: 2026-08-04
• Completion: 2027-04-13
• First posted: 2021-06-18
• Last updated: 2026-04-13

Locations

240 sites across 26 countries: United States, Argentina, Australia, Bulgaria, Canada, Czechia, Denmark, Georgia, Germany, Hong Kong, Hungary, Israel, Italy, Malaysia, Philippines, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study