Actively Recruiting
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
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-04-16
400
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 for at least 6 months before first study drug administration
- Moderate-to-severe plaque psoriasis defined by PASI score ≥3, or Investigator's Global Assessment (IGA) ≥3, or affected Body Surface Area (BSA) ≥10% at baseline
- Suitable for systemic psoriasis treatment, whether biologic-naive or biologic-experienced
- Women of childbearing potential must have a negative urine pregnancy test at screening and at Week 0 and agree to pregnancy testing before injections
- No signs or symptoms suggesting active tuberculosis on medical history or physical exam
- Agree not to receive Bacille Calmette-Guerin (BCG) vaccination during study or within 12 months after last study drug dose
- Agree not to receive live virus or live bacterial vaccinations during study or within 3 months after last study drug dose
- Signed informed consent form indicating understanding and willingness to participate
You will not qualify if you...
- Having nonplaque forms of psoriasis such as erythrodermic, guttate, or pustular psoriasis
- Current drug-induced psoriasis caused by medications like beta-blockers, calcium channel blockers, or lithium
- History or current signs of liver or kidney failure (creatinine clearance below 60 mL/min) or significant uncontrolled heart, lung, gastrointestinal, endocrine, neurological, blood, rheumatologic, psychiatric, or metabolic disorders
- History or current malignancy within 5 years before screening, except treated nonmelanoma skin cancer or cervical carcinoma in situ without recurrence for at least 3 months
- History of lymphoproliferative diseases including lymphoma or monoclonal gammopathy of undetermined significance
- History or ongoing chronic or recurrent infections such as recurrent sinus or lung infections, urinary tract infections, fungal infections, or open infected wounds
- Positive tests for hepatitis B virus or hepatitis C virus antibodies unless multiple negative RNA tests confirm clearance before baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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