Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Guselkumab; Placebo
Intervention description: Participants will receive 100 mg of Guselkumab as 100 mg/mL solution via SelfDose device.; Participants will receive matching placebo supplied in a PFS assembled in a SelfDose device.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the efficacy, safety, pharmacokinetics,
      immunogenicity, usability, and acceptability of guselkumab delivered using SelfDose device in
      participants with moderate to severe plaque-type psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A woman of childbearing potential must have a negative urine pregnancy test
             (beta-human chorionic gonadotropin) at screening and at Week 0

          -  Before randomization, a woman must be either: a) Not of childbearing potential:
             premenarchal; postmenopausal (greater than [>] 45 years of age with amenorrhea for at
             least 12 months or any age with amenorrhea for at least 6 months and a serum
             follicle-stimulating hormone level (FSH) >40 International Units Per Liter [IU/L]);
             permanently sterile (example, tubal occlusion, hysterectomy, bilateral salpingectomy);
             or otherwise be incapable of pregnancy, b) Of childbearing potential and practicing a
             highly effective method of birth control, consistent with local regulations regarding
             the use of birth control methods for subjects participating in clinical studies:
             example, established use of oral, injected or implanted hormonal methods of
             contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS);
             barrier methods: condom or occlusive cap (diaphragm or cervical/vault caps) plus
             spermicidal foam/gel/ film/cream/suppository (if available in their locale); male
             partner sterilization (the vasectomized partner should be the sole partner for that
             participant); true abstinence (when this is in line with the preferred and usual
             lifestyle of the participant)

          -  Agree not to receive a Bacillus Calmette Guerin (BCG) vaccination during the study, or
             within 12 months after the last administration of study drug

          -  Have a Psoriasis Area and Severity Index (PASI) greater than or equal to [>=] 12 at
             screening and at baseline

          -  Have an involved body surface area (BSA) >= 10 percent (%) at screening and at
             baseline

        Exclusion Criteria:

          -  Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg,
             unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac
             hospitalization within the last 3 months

          -  Has a history of lymphoproliferative disease, including lymphoma; a history of
             monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms
             suggestive of possible lymphoproliferative disease, such as lymphadenopathy or
             splenomegaly

          -  Has a transplanted organ (with exception of a corneal transplant >3 months before the
             first administration of study drug)

          -  Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular)

          -  Has received any anti-tumor necrosis factor alpha (TNF-alpha) biologic therapy within
             3 months before the first administration of study drug