An Efficacy and Safety Study of Ustekinumab (CNTO 1275) in Participants With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Placebo (CP); Ustekinumab 45 mg (CP); Ustekinumab 90 mg (CP); Placebo A (After CP); Placebo B (After CP); Ustekinumab 45 mg (After CP); Ustekinumab 90 mg (After CP)
Intervention description: Placebo 0.5 ml and 1.0 ml will be administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).; Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) will be administered SC on Weeks 0 and 4 during controlled period (Weeks 0-12).; Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) will be administered SC on Weeks 0 and 4 during controlled period (Weeks 0-12).; After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group will be randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) will be administered SC at Weeks 12, 16, 28, 40, and 52.; After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group will be randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) will be administered SC at Weeks 12, 16, 28, 40, and 52.; After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group will receive placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.; After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group will receive placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Intervention MeSH terms: Ustekinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 158.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Psoriasis; Ustekinumab; CNTO 1275

Summary:

      The purpose of this study is to evaluate the safety and efficacy of ustekinumab (CNTO 1275)
      compared with placebo in participants with moderate to severe plaque type psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants diagnosed with psoriasis (psoriasis vulgaris and psoriatic arthritis) at
             least 6 months before registration

          -  Participants with plaque type psoriasis covering at least 10 percent of total body
             surface area at the time of informed consent and at registration

          -  Participants with a PASI score of greater than or equal to 12 at the time of informed
             consent and at registration

          -  Female participants of childbearing potential or males, whose partner can be pregnant,
             must agree that he/she will continuously take an appropriate contraceptive measure for
             1 year from the day of informed consent to termination of the final investigational
             treatment; in the case of childbearing potential females, pregnancy test at screening
             must be negative

          -  Participants must agree not to receive Bacillus Calmette-Guérin (BCG) vaccination and
             live vaccine inoculation for 1 year after final treatment with the investigational
             product

        Exclusion Criteria:

          -  Participants with guttate psoriasis, erythrodermic psoriasis, or pustular psoriasis

          -  Participants with a medical history of tuberculosis infection or suspected
             tuberculosis infection

          -  Participants with present or past history of chronic or recurrent infection (e.g.,
             chronic or recurrent urinary tract infection or respiratory infection)

          -  Participants with a current serious infection (e.g., sepsis, hepatitis, pneumonia, or
             pyelonephritis) or those who experienced a serious infection within the 2 month period
             before registration and including participants who received intravenous administration
             of antibiotics or antiviral agents within the 2 month period before registration

          -  Participants with a current or past history of malignant tumors (except for basal cell
             carcinoma, intraepidermal squamous cell carcinoma in the skin and uterine cervical
             squamous cell carcinoma, whose treatment was completed and no sign suggesting a
             recurrence has been observed, and squamous cell carcinoma in the skin whose treatment
             was completed and no sign suggesting a recurrence has been observed in the past 5
             years)