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

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriasis

In brief

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 facts

Study ID

NCT00307437

Run by

Centocor Research & Development, Inc.

People needed

1230

Starts

2005-05-01

Expected to finish

2011-10-01

Last updated by the study team

2013-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Plaque-type psoriasis diagnosed >= 6 months prior
• Plaque-type psoriasis covering at least 10% of total body surface areas
• Psoriasis area-and-severity index score of >=12 at screening and baseline
• Considered by treating dermatologist to be a candidate for phototherapy or systemic treatment of psoriasis
• Women of childbearing potential and all men must agree to use adequate birth control measures throughout the trials and for 12 months following the last injection of study agent
• Have no history of latent or active tuberculosis (TB)

You may not qualify if…

• Currently have nonplaque forms of psoriasis or drug-induced psoriasis
• Women who are pregnant or nursing, or men and women planning pregnancy while enrolled in the study
• Patients who have used any therapeutic agent targeted at reducing IL-12 or IL-23
• Patients who have had a Bacillus Calmette-Guerin (BCG) vaccination within the previous 12 months prior to screening
• Patients who have a history of chronic or recurrent infectious disease or who have or have had a serious infection requiring hospitalization or intravenous antibiotics within the previous 2 months prior to screening
• Patients who have or ever have had a nontuberculous mycobacterial infection or opportunistic infection
• Patients known to be infected with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
• Patients who have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
• Patients with a malignancy or who have a history of malignancy (with the exception of certain skin cancers and pre-invasive cervical cancer)
• Patients participating in another trial using an investigational agent or procedure
• Systemic immunosuppressants within 4 weeks of the first administration of study agent

Where it is running

• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Plymouth Meeting, Pennsylvania, United States
• Study site — Mt. Pleasant, South Carolina, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Graz, Austria
• Study site — Innsbruck, Austria
• Study site — Vienna, Austria
• Study site — Calgary, Alberta, Canada
• Study site — Edmonton, Alberta, Canada
• Study site — Surrey, British Columbia, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Moncton, New Brunswick, Canada
• Study site — Halifax, Nova Scotia, Canada
• Study site — Barrie, Ontario, Canada
• Study site — Hamilton, Ontario, Canada
• Study site — London, Ontario, Canada
• Study site — North Bay, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Waterloo, Ontario, Canada
• Study site — Windsor, Ontario, Canada
• Study site — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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