Evaluating High-Dose and Extended-Interval Versus Standard-Dose Guselkumab for Moderate to Severe Plaque Psoriasis in Chinese Adults

What this Trial Is About

Researchers are evaluating the effectiveness, safety, tolerability, and drug survival of guselkumab given at a high dose with extended intervals compared to the standard dose in Chinese adults with moderate to severe plaque psoriasis. This study aims to determine if the high-dose extended-interval treatment works as well as the standard dose by measuring skin improvement at Week 86. It includes participants with plaque-type psoriasis lasting at least 6 months and assesses multiple aspects of skin disease severity and quality of life. The study includes two groups one receiving 200 mg guselkumab by subcutaneous injection twice at Weeks 0, 8, 20, 36, 56, and 76 the other receiving 100 mg guselkumab by subcutaneous injection once at Weeks 0, 4, 12, and every 8 weeks thereafter through Week 86. The study is open-label and lasts from screening through Week 98, including active treatment and follow-up phases. Participants will undergo safety checks including vital signs, tuberculosis evaluation, chest X-rays, and pregnancy tests for women of childbearing potential. Effectiveness is assessed using psoriasis severity indexes and quality of life questionnaires at multiple time points through Week 86. Laboratory tests, biomarker and genetic evaluations are also performed. Researchers will monitor adverse events and other health changes through Week 98, with participant involvement lasting over 2 years in total.

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