An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis
Condition: Palmoplantar Pustulosis
MeSH terms: Psoriasis
Intervention: Guselkumab; Placebo
Intervention description: Participants will receive two or one syringe of guselkumab 100 mg subcutaneously at Week 0, 4, 12 and every 8 weeks thereafter through Week 60 in group 1 or 2. Group 3a or 3b participants will receive two or one syringe of guselkumab 100 mg at Week 16, 20 and every 8 weeks thereafter through Week 60.; Participants in group 1 will receive placebo at Week 16. Participants in group 2 will receive placebo at Week 0, 4, 12, 16, 20 and every 8 weeks thereafter through Week 60. Participants in group 3 will receive placebo at Week 0, 4, 12, then at Week 16, 20 and every 8 weeks thereafter through Week 60 for group 3b.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 159.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Guselkumab; CNTO 1959; Placebo; Palmoplantar Pustulosis

Summary:

      The purpose of this study is to evaluate the efficacy and safety of guselkumab for the
      treatment of participants with palmoplantar pustulosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a diagnosis of palmoplantar pustulosis (with or without pustulotic
             arthro-osteitis, concurrent extra-palmoplantar lesions) for at least 24 weeks before
             screening

          -  Has a >= 12 PPPASI total score at screening and at baseline

          -  Has a moderate or more severe pustules/vesicle on the palms or soles (>= 2 PPPASI
             severity score) at screening and baseline

          -  Has inadequate response to the treatment with topical steroid and/or topical vitamin
             D3 derivative preparations and/or the phototherapy and/or systemic etretinate prior to
             or at screening. Inadequate response is defined as a case judged by the investigator

          -  Before the first administration of study drug, a woman must be either: Not of
             childbearing potential: premenarchal; postmenopausal or Of childbearing potential and
             practicing a highly effective method of birth control

        Exclusion Criteria:

          -  Has a diagnosis of plaque-type psoriasis

          -  Has obvious improvement during screening (>= 5 PPPASI total score improvement during
             the screening)

          -  Has a history or current signs or symptoms of severe, progressive, or uncontrolled
             renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic,
             hematologic, rheumatologic, psychiatric, or metabolic disturbances

          -  Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg,
             unstable angina, rapid atrial fibrillation) in the last 12 weeks or a cardiac
             hospitalization within the last 12 weeks before screening

          -  Currently has a malignancy or has a history of malignancy within 5 years before
             screening (with the exception of a nonmelanoma skin cancer that has been adequately
             treated with no evidence of recurrence for at least 12 weeks before screening or
             cervical carcinoma in situ that has been treated with no evidence of recurrence for at
             least 12 weeks before screening)