An Efficacy and Safety Study of Ustekinumab (CNTO 1275) in Participants With Plaque Psoriasis

Sponsor
Janssen Pharmaceutical K.K.
Study ID
NCT00723528
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Placebo (CP) — DRUG
    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 (CP) — DRUG
    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 (CP) — DRUG
    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).
  • Placebo A (After CP) — DRUG
    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.
  • Placebo B (After CP) — DRUG
    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.
  • Ustekinumab 45 mg (After CP) — DRUG
    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.
  • Ustekinumab 90 mg (After CP) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 31, 2008
Status verified
Apr 2014
Primary completion
Jan 31, 2009
Completion
Mar 31, 2010

Study Design

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

Arms

  • Placebo Comparator: Placebo (CP)
    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).
  • Active Comparator: Ustekinumab 45 mg (CP)
    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).
  • Active Comparator: Ustekinumab 90 mg (CP)
    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).
  • Placebo Comparator: Placebo A (After CP)
    After the controlled period (that is \[i.e.\], 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.
  • Placebo Comparator: Placebo B (After CP)
    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.
  • Active Comparator: Ustekinumab 45 mg (After CP)
    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.
  • Active Comparator: Ustekinumab 90 mg (After CP)
    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.

Primary Outcome Measure

Percentage of Participants With Greater Than or Equal to 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score [ Time Frame: Week 12 ]

Related Studies