A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment
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, 12, and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon randomized treatment group and PASI response (Group I). 100 mg by subcutaneous injection at Weeks 16 and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon PASI response (Group II). Starting at Week 28, participants will receive guselkumab 100 mg through Week 72 depending upon PASI response (Group III). All participants will receive guselkumab q8w starting at Week 76 through Week 252.; Placebo for guselkumab at Week 16, starting at Week 28, participants will continue to receive placebo for guselkumab through Week 72 depending on randomized treatment group and PASI response (Group I), at weeks 0, 4, 12 and starting at week 28 thereafter up to week 72 depending upon PASI response (Group II), at weeks 0, 4, 12, 16, and 20, starting at week 28 through week 72 depending upon PASI response (Group III).; 80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 23.; Placebo for adalimumab [two 0.8 milliliter (mL) injections] at week 0 followed by one 0.8 mL injection at weeks 1, 3, 5, and every 2 week (q2w) through Week 23 (Group I and II).
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: 992.0
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
      (scaly skin rash).
    

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