A Study of Guselkumab (TREMFYA) in Chinese Participants With Moderate to Severe Plaque Psoriasis

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04914429
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Guselkumab — DRUG
    Guselkumab 100 mg will be administered as a SC injection.
  • Placebo — DRUG
    Matching placebo will be administered as a SC injection.

Study Details

The purpose of this study is to evaluate the efficacy, safety and tolerability of guselkumab in the treatment of Chinese participants with moderate to severe plaque psoriasis.

Key Dates

Start date
Aug 25, 2021
Status verified
Oct 2023
Primary completion
Sep 26, 2023
Completion
Sep 26, 2023

Study Design

Enrollment
327 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: Guselkumab
    Participants will receive guselkumab 100 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 4, and then every 8 weeks (q8w) through Week 44. Participants will receive matching placebo at Week 16.
  • Placebo Comparator: Group 2: Placebo
    Participants will receive placebo SC injection for guselkumab at Weeks 0, 4, and 12, and then cross over at Week 16 to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and q8w thereafter through Week 44.

Primary Outcome Measure

Percentage of Participants who Achieve a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 [ Time Frame: Week 16 ]

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