A Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Guselkumab; Fumaric Acid Esters
Intervention description: Participants will receive 100 mg of Guselkumab as 100 mg/mL solution subcutaneously.; Participants will receive Fumaderm initial/ Fumaderm tablets through self-administration.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to compare the efficacy of Guselkumab with commercially available
      active comparator Fumaderm initial/Fumaderm tablets for the treatment of adult participants
      with moderate to severe plaque-type psoriasis who have not yet received any systemic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of plaque-type psoriasis for at least 6 months before the first
             administration of study drug

          -  Have a Psoriasis Area and Severity Index (PASI) greater than (>)10 or Body Surface
             Area (BSA) >10 at screening and at baseline

          -  Have a Dermatology Life Quality Index (DLQI) >10 at screening and at baseline

          -  Agree not to receive a live virus or live bacterial vaccination during the study, or
             within 3 months after the last administration of study drug; for information on
             Bacille Calmette-Guérin (BCG) vaccination, agree not to receive a BCG vaccination
             during the study, or within 12 months after the last administration of study drug

          -  No dipstick detection of proteins or glucose in urine. If there are signs of proteins
             and/or glucose on urine test strip, the urine sample must be analyzed centrally. Here,
             protein and glucose levels must not exceed trace levels, example, <=(+); one re-test
             (central urine analysis) is allowed

        Exclusion Criteria:

          -  Has a history or current signs or symptoms of severe, progressive, or uncontrolled
             liver or renal insufficiency, significant cardiac, vascular, pulmonary,
             gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or
             metabolic disturbances

          -  Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate,
             or pustular) or with current drug-induced psoriasis (for example, a new onset of
             psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel
             blockers, or lithium)

          -  Known allergies, hypersensitivity, or intolerance to Guselkumab or its excipients

          -  Is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this
             study or within 12 weeks after the last dose of study drug

          -  Any condition for which, in the opinion of the investigator, participation would not
             be in the best interest of the participant (for example, compromise the well-being) or
             that could prevent, limit, or confound the protocol-specified assessments