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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT07532486
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab — DRUG
    Participants will receive 2 injections of active guselkumab (as 200 mg, SC) at Weeks 0, 8, 20, 36, 56, and 76.
  • Guselkumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 10, 2024
Status verified
Feb 2026
Primary completion
Jul 10, 2027
Completion
Jul 10, 2027

Study Design

Enrollment
400 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Guselkumab in high-dose and extended-interval
    Participants will receive 2 injections of active guselkumab as 200 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 8, 20, 36, 56, and 76.
  • Active Comparator: Guselkumab in standard-dose
    Participants will receive 1 injection of active guselkumab 100 mg SC at Weeks 0, 4, 12, and q8w thereafter through Week 86.

Primary Outcome Measure

Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 86 [ Time Frame: Week 86 ]

Central Contacts

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