A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Guselkumab 100 mg; Placebo for guselkumab; Adalimumab; Placebo for adalimumab
Intervention description: 100 mg by subcutaneous injection at Weeks 0, 4 and q8w thereafter through Week 252 (Group 1). 100 mg by subcutaneous injection at Weeks 16, 20 and q8w thereafter through Week 252 (Group II). 100 mg by subcutaneous injection at Week 52 and q8w thereafter through Week 252 (Group III).; Subcutaneous injections to maintain the blind.; 80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 47.; Subcutaneous injections to maintain the blind.
Intervention MeSH terms: Adalimumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 837.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Psoriasis; Plaque-type psoriasis; Guselkumab; Adalimumab; CNTO 1959; Monoclonal antibody

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab
      (CNTO 1959) in 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) at
             least 6 months before the first administration of study agent

          -  Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (>=) 12 at
             Screening and at Baseline

          -  Have an Investigator's Global Assessment (IGA) score >=3 at Screening and at Baseline

          -  Have an involved body surface area (BSA) >=10 percent (%) at Screening and at Baseline

          -  Must be a candidate for either systemic therapy or phototherapy for psoriasis

        Exclusion Criteria:

          -  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)

          -  Participants who have ever received guselkumab or adalimumab

          -  History or current signs or symptoms of severe, progressive, or uncontrolled renal,
             hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic,
             hematologic, rheumatologic, psychiatric, or metabolic disturbances

          -  Has any condition that, in the opinion of the investigator, would make participation
             not be in the best interest (for example, compromise the well-being) of the
             participant or that could prevent, limit, or confound the protocol-specified
             assessments

          -  Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months
             following the last administration of study drug