Actively Recruiting
An Open-label Study Evaluating Comparative Efficacy and Safety of High-dose Extended-interval Versus Standard-dose Guselkumab in Chinese Adults With Moderate to Severe Plaque Psoriasis
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-04-16
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of plaque-type psoriasis (with or without psoriatic arthritis) for at least 6 months before first study drug administration
- Moderate-to-severe plaque psoriasis with PASI ≥3, or IGA ≥3, or Body Surface Area ≥10% at baseline
- Suitable for systemic psoriasis treatment, regardless of prior biologic use
- Negative urine pregnancy test for women of childbearing potential at screening and Week 0; agreement to pregnancy testing before injections
- No signs or symptoms of active tuberculosis
- Agreement not to receive BCG vaccine during the study or within 12 months after last study drug dose
- Agreement not to receive live virus or live bacterial vaccines during the study or within 3 months after last study drug dose
- Signed informed consent with understanding of study purpose and procedures
You will not qualify if you...
- Nonplaque forms of psoriasis such as erythrodermic, guttate, or pustular psoriasis
- Drug-induced psoriasis currently or recently
- History or current liver or kidney insufficiency with creatinine clearance below 60 mL/min
- Significant, progressive, or uncontrolled cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disorders
- History or current malignancy within 5 years before screening (with specific exceptions)
- History of lymphoproliferative disease or related symptoms
- Chronic or recurrent infectious diseases including recurrent respiratory, urinary, fungal infections, or open/infected skin wounds
- Positive hepatitis B surface antigen or hepatitis C antibody without documented viral clearance and negative RNA tests at baseline and prior follow-up
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 86 weeks
Participants receive guselkumab injections as part of the treatment for moderate-to-severe plaque psoriasis, with safety, efficacy, and laboratory assessments performed throughout the treatment phase.
1 to 12 injections over 86 weeks depending on dosing group with scheduled visits at injection times
Duration - 12 weeks
Participants are monitored for safety and any adverse events after the treatment phase ends.
Approximately 3 visits during follow-up phase
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
X
Xi-Bei CHEN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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