A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS)

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01090427
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab - Half-Standard Dosage — DRUG
    Ustekinumab 0.375 mg/kg, 22.5 mg, or 45 mg based on body weight, administered subcutaneously (under the skin) at Weeks 0, 4, 16, 28, and 40.
  • Ustekinumab - Standard Dosage — DRUG
    Ustekinumab 0.75 mg/kg, 45 mg, or 90 mg based on body weight administered subcutaneously at Weeks 0, 4, 16, 28, and 40.
  • Placebo — OTHER
    Placebo administered subcutaneously at Weeks 0 and 4 or at Week 12.

Study Details

This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients with moderate to severe psoriasis.

Key Dates

Start date
May 31, 2010
Status verified
Jan 2015
Primary completion
Jan 31, 2013
Completion
Jan 31, 2014

Study Design

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

Arms

  • Experimental: Ustekinumab Half-standard Dosage
    Participants will receive ustekinumab at half the standard dosage at Weeks 0, 4, 16, 28, and 40. In addition, all participants will receive a single SC dose of placebo at Week 12.
  • Experimental: Ustekinumab Standard Dosage
    Participants will receive ustekinumab at the standard dosage at Weeks 0, 4, 16, 28, and 40. In addition, all participants will receive a single SC dose of placebo at Week 12.
  • Experimental: Placebo
    Participants will receive matching placebo at Week 0 and 4, followed by ustekinumab at half-standard or standard dosage at Weeks 12, 16, 28, and 40.

Primary Outcome Measure

The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 [ Time Frame: Week 12 ]

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