A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Psoriasis

Conditions

• Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo; Ustekinumab (CNTO 1275) 45 or 90 mg — DRUG
  Placebo at Weeks 0 and 4 and blinded SC injections of ustekinumab, 45 or 90 mg, at Weeks 12 and 16; followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264
• Ustekinumab (CNTO 1275) 45 mg — DRUG
  Ustekinumab, 45 mg, at Weeks 0 and 4 and every 12 weeks for Weeks 16 to 28. Followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264
• Ustekinumab (CNTO 1275) 90 mg — DRUG
  Ustekinumab, 90 mg, at Weeks 0 and 4 and every 12 weeks for Weeks 16 to 28. Followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264

Study Details

The primary objective of this study is to evaluate the efficacy and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.

Key Dates

Start date

May 31, 2005

Status verified

Jan 2013

Primary completion

Dec 31, 2006

Completion

Oct 31, 2011

Study Design

Enrollment

1,230 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Group I: Placebo
• Experimental: Group II: Ustekinumab 45 mg
• Experimental: Group III: Ustekinumab 90 mg

Primary Outcome Measure

Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12 [ Time Frame: Week 0 to Week 12 ]

Locations (28)

Find similar trials in Birmingham, AL

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