A Safety and Effectiveness Study of CNTO 1275 in Patients With Moderate to Severe Plaque-type Psoriasis

Sponsor
Centocor, Inc.
Study ID
NCT00320216
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab — DRUG
    Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
  • Placebo — DRUG
    Patients in the placebo group will receive placebo medication.

Study Details

The purpose of this study is to evaluate the efficacy and safety of initial single and multiple subcutaneous injections of CNTO 1275 in the treatment of patients with moderate to severe plaque psoriasis.

Key Dates

Start date
Nov 30, 2003
Status verified
Mar 2015
Primary completion
Jun 30, 2004
Completion
Mar 31, 2005

Study Design

Enrollment
320 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Group I (Placebo)
    Patients in the placebo group will receive placebo at Weeks 0, 1, 2, 3, and 16. At week 20, all patients will receive a single dose of ustekinumab 90 mg.
  • Experimental: Group II (Ustekinumab 45 mg)
    Patients will receive single dose ustekinumab at Week 0 and placebo at Weeks 1, 2, and 3. At Week 16, patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 45 mg. At week 20, all patients will receive placebo.
  • Experimental: Group III (Ustekinumab 90 mg)
    Patients will receive 90 mg single dose ustekinumab at Week 0 and placebo at Weeks 1, 2, and 3. At Week 16 patients with PGA greater than or equal to 3 will receive ustekinumab 90 mg. At week 20, all patients will receive placebo.
  • Experimental: Group IV
    Patients will receive 45 mg of ustekinumab at Weeks 0, 1, 2, and 3. At Week 16, patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 45 mg. At week 20, all patients will receive placebo.
  • Experimental: Group V
    Patients will receive 90 mg of ustekinumab at Weeks 0, 1, 2, and 3. At Week 16 patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 90 mg. At week 20, all patients will receive placebo.

Primary Outcome Measure

Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12 [ Time Frame: Week 12 ]

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