NCT07532486

A Study to Evaluate Comparative Efficacy and Safety of Guselkumab in High-dose and Extended-interval Versus Standard-dose in Chinese Participants of Moderate-to-severe Plaque Psoriasis

An Open-label, Parallel Group, Multicenter Study Evaluating the Comparative Efficacy and Safety of Guselkumab in High-dose and Extended-interval Versus Standard-dose in Chinese Participants With Moderate to Severe Plaque Psoriasis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety, tolerability and drug survival of guselkumab in high-dose and extended-interval versus standard-dose in Chinese participants with moderate to severe plaque psoriasis.

Detailed description

The study consists of Screening Phase (4 weeks before administration of study drug), Active Treatment Phase (Week 0-Week 86), Follow-up Phase (Week 86-Week 98). During various study periods, safety assessments (example \[e.g\] recording of adverse events, Vital signs, Tuberculosis evaluation, Chest radiograph, Urine pregnancy test); Efficacy assessments (e.g PASI, IGA, ss-IGA, NAPSI, DLQI); Clinical laboratory assessments (e.g hematology, chemistry); Biomarkers/Genetic evaluations, will be performed per the study procedures. The primary hypotheses are that guselkumab treatment with high-dose and extended-interval is non-inferior to standard dose as assessed by proportion of participants achieving PASI 90 and IGA 0/1 response at Week 86 with noninferiority margin of 13%.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Guselkumab	Participants will receive 2 injections of active guselkumab (as 200 mg, SC) at Weeks 0, 8, 20, 36, 56, and 76.
DRUG	Guselkumab	Participants will receive 1 injection of active guselkumab (100 mg, SC) at Weeks 0, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76 and 84.

Timeline

• Start date: 2024-07-10
• Primary completion: 2027-07-10
• Completion: 2027-07-10
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: China