A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Ustekinumab; Guselkumab; Placebo for ustekinumab; Placebo for guselkumab
Intervention description: 45 mg or 90 mg given by subcutaneous injection at Weeks 0 and 4 for all participants. Participants with an IGA score of 0 or 1 at Week 16 will also receive ustekinumab every 12 weeks (q12w) from Week 16 to Week 40.; 100 mg given by subcutaneous injection at Weeks 16 and 20 and every 8 weeks (q8w) thereafter through Week 44.; Subcutaneous injection at Weeks 16, 28, and 40 to maintain the blind for participants randomized to treatment with guselkumab.; Subcutaneous injection at Weeks 16 and 20 and q8w thereafter through Week 44 to maintain the blind for participants randomized to treatment with ustekinumab.
Intervention MeSH terms: Ustekinumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 872.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Psoriasis; Plaque-type psoriasis; Guselkumab; Ustekinumab; CNTO 1959; Monoclonal antibody

Summary:

      The purpose of this study is to evaluate the efficacy and safety of guselkumab (CNTO 1959) in
      the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash)
      who had inadequate response to ustekinumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis for at
             least 6 months before the first administration of study drug

          -  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) >=3 at Screening and at Baseline

          -  Have an involved body surface area (BSA) >= 10 percent (%) at Screening and at
             Baseline

          -  Be a candidate for phototherapy or systemic treatment for psoriasis (either naïve or
             history of previous treatment)

        Exclusion Criteria:

          -  Has a 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 unstable cardiovascular disease, defined as a recent clinical deterioration
             (example [eg], unstable angina, rapid atrial fibrillation) in the last 3 months or a
             cardiac hospitalization within the last 3 months

          -  Currently has a malignancy or has a history of malignancy within 5 years before
             Screening (with the exception of a nonmelanoma skin cancer that has been adequately
             treated with no evidence of recurrence for at least 3 months before the first study
             drug administration, or cervical carcinoma in situ that has been treated with no
             evidence of recurrence for at least 3 months before the first study drug
             administration)

          -  Has previously received guselkumab or ustekinumab