A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Guselkumab; Placebo; Secukinumab
Intervention description: Participants will receive 1 injection of active guselkumab at Weeks 0, 4, 12, 20, 28, 36, and 44.; Participants will receive 1 injection of placebo at Weeks 0, 4, 12, 20, 28, 36, and 44 and 2 injections of placebo at Weeks 1, 2, 3, 8, 16, 24, 32, and 40.; Participants will receive 2 injections of active secukinumab at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1048.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab
      for the treatment of participants with moderate to severe plaque-type psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of plaque-type psoriasis (with or without [Psoriatic Arthritis]PsA)
             for at least 6 months before the first administration of study drug

          -  A woman of childbearing potential must have a negative urine pregnancy test at
             screening and at Week 0 and agree to urine pregnancy testing before receiving
             injections

          -  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

          -  Agree not to receive a Bacille Calmette-Guérin (BCG) vaccination during the study, or
             within 12 months after the last administration of study drug

          -  Agree to avoid prolonged sun exposure and avoid use of tanning booths or other
             ultraviolet light sources during study

        Exclusion Criteria:

          -  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 previously received guselkumab or secukinumab

          -  Has a history of chronic or recurrent infectious disease, including but not limited to
             chronic renal infection, chronic chest infection (example bronchiectasis), recurrent
             urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis),
             fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin
             wounds or ulcers

          -  Has a history of lymphoproliferative disease, including lymphoma; a history of
             monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive
             of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly

          -  Is unable or unwilling to undergo multiple venipunctures because of poor tolerability
             or lack of easy access to veins