A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis

Sponsor
Janssen-Cilag Ltd.
Study ID
NCT03998683
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

The purpose of this study is to evaluate the efficacy of guselkumab for the treatment of palmoplantar psoriasis.

Key Dates

Start date
Sep 3, 2019
Status verified
Dec 2021
Primary completion
Mar 2, 2021
Completion
Nov 30, 2021

Study Design

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

Arms

  • Experimental: Guselkumab Group
    Participants will receive guselkumab 100 mg SC injections at Weeks 0, 4, 12 and placebo subcutaneous (SC) injection at Week 16 in double-blind phase followed by guselkumab 100 mg SC injections at Weeks 20, 28, 36, and 44 in open-label phase.
  • Placebo Comparator: Placebo Group
    Participants will receive placebo SC injection at Weeks 0, 4, 12 and guselkumab 100 mg SC injection at Week 16 in double-blind phase followed by guselkumab 100 mg SC injection at Week 20, 28, 36, and 44 in open-label phase.

Primary Outcome Measure

Percentage of Participants who Achieve Palmoplantar Pustulosis Psoriasis Area and Severity Index 75 (ppPASI75) Response at Week 16 [ Time Frame: Week 16 ]

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