A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Guselkumab; Placebo Injection
Intervention description: Participants will receive 100 mg guselkumab subcutaneously at Weeks 0, 4, 12 and 20 (group 1), at weeks 28, 36, 44, 52, 60 (group 2a and 2c), and at weeks 36 and 52 (group 2b). Group 2d and 3c are the re-treatment groups and will receive three injections after loss of disease control.; Participants of group 2b will receive matching placebo injection subcutaneously at weeks 28, 44 and 60.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 880.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to demonstrate that Super-Responders (SRe; defined as psoriasis
      participants who receive on-label guselkumab treatment until week 20 and respond with a
      Psoriasis Area and Severity Index score (PASI) = 0 at weeks 20 and 28) maintain control of
      disease until week 68 with prolonged treatment intervals of 16 weeks (guselkumab 100 mg every
      16 weeks).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a disease duration of plaque psoriasis of either less than or equal to (<=2) years
             or (greater than (>2) years calculated from date at which first symptoms [plaque] were
             reported by subject to date of screening visit at screening; approximately 40
             percentage (%) of participants must have a disease duration <=2 years

          -  Has moderate-to-severe plaque-psoriasis defined by a Psoriasis Area and Severity Index
             (PASI) score >10 or affected body surface area (BSA) >10%) and additionally a
             Dermatology Life Quality Index (DLQI) score >10 at baseline (week 0)

          -  Have no signs or symptoms suggestive of active tuberculosis (TB) upon medical history
             and/or physical examination

          -  Agrees not to receive a live virus or live bacterial vaccination during the study, or
             within 3 months after the last administration of study drug

          -  Agrees not to receive a Bacille Calmette-Guerin (BCG) vaccination during the study, or
             within 12 months after the last administration of study drug

        Exclusion Criteria:

          -  Has previously received any therapeutic agent directly targeted to interleukin (IL)
             -23 (including but not limited to guselkumab, tildrakizumab [MK3222], risankizumab
             [BI-655066])

          -  Has received any systemic immunosuppressant (for example, methotrexate, azathioprine,
             cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, tacrolimus,
             fumaric acid esters), or anakinra within 4 weeks of the first administration of study
             drug.

          -  Tests positive for hepatitis B virus (HBV) infection or who are seropositive for
             antibodies to hepatitis C virus (HCV), unless they have 2 negative HCV RNA test
             results 6 months apart after completing antiviral treatment and prior to baseline and
             have a third negative HCV RNA test result at baseline

          -  Has received natalizumab, belimumab, or agents that modulate B cells or T cells (e.g.,
             rituximab, alemtuzumab, abatacept, or visilizumab) within 12 months of the first
             administration of study drug

          -  Has received any anti - tumor necrosis factor (TNF)-α biologic therapy within 3 months
             before the first administration of study drug