An Efficacy and Safety of CNTO 1959 (Guselkumab) in Participants With Moderate to Severe Plaque-type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: CNTO 1959 50 mg; CTNO 1959 100 mg; Placebo 50 mg; Placebo 100 mg
Intervention description: Participants will receive subcutaneous injection of CNTO 1959 50 mg.; Participants will receive subcutaneous injection of CNTO 1959 100 mg.; Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 50 mg.; Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 100 mg.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 192.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Psoriasis; CNTO 1959; Guselkumab; Placebo

Summary:

      The purpose of this study is to demonstrate the superiority of CNTO 1959 (guselkumab) to
      placebo in the treatment of participants with moderate to severe plaque-type psoriasis (A
      common genetically determined, chronic, inflammatory skin disease characterized by rounded
      erythematous, dry, scaling patches).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at
             least 6 months before Screening

          -  Have a PASI greater than or equal to (>=) 12 at Screening and at Baseline

          -  Have an 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 naive or
             history of previous treatment)

        Exclusion Criteria:

          -  Has a history of or current signs or symptoms of severe, progressive, or uncontrolled
             cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic,
             psychiatric, or metabolic disturbances

          -  Has unstable cardiovascular disease, defined as a recent clinical deterioration
             (example, unstable angina, atrial fibrillation) in the last 3 months or a cardiac
             hospitalization within the last 3 months before Screening

          -  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 Screening

          -  Has a history of lymphoproliferative disease, including lymphoma; a history of
             monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms
             suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or
             splenomegaly

          -  Has a history of chronic or recurrent infectious disease, including but not limited to
             chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent
             urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis),
             fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin
             wounds or ulcers