NCT03162796

A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s)

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti-TNF Alpha Agents

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 383 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active Psoriatic Arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Detailed description

This is a study of guselkumab in participants with active Psoriatic Arthritis (PsA) who had inadequate response to standard therapies. It will evaluate the clinical efficacy of guselkumab in the reduction of signs and symptoms and the safety profile of guselkumab in the treatment of PsA. The study will consists of 4 phases: a screening phase of up to 6 weeks, a blinded treatment phase of approximately 1 year (that is, 52 weeks), including a placebo controlled period from Week 0 to Week 24 and double-blind active treatment period from Week 24 to Week 52, and a safety follow-up phase of 8 weeks after Week 52 (Week 52 to 60) and will be 12 weeks from the last administration of study agent (at Week 48) to the final safety follow-up visit. Efficacy, safety, pharmacokinetic, immunogenicity, and biomarker evaluations will be performed in the study at defined schedule.

Conditions

• Arthritis, Psoriatic

Interventions

Type	Name	Description
DRUG	Guselkumab	Participants will receive 100mg of guselkumab as a sterile liquid for SC injection.
DRUG	Placebo	Participants will receive matching placebo as SC injection.

Timeline

• Start date: 2017-08-24
• Primary completion: 2019-03-14
• Completion: 2019-11-18
• First posted: 2017-05-22
• Last updated: 2021-02-03
• Results posted: 2020-10-14

Locations

95 sites across 13 countries: United States, Australia, Canada, Czechia, Germany, Hungary, Malaysia, Poland, Russia, South Korea, Spain, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study