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

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriasis

In brief

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

Key facts

Study ID

NCT00267969

Run by

Centocor Research & Development, Inc.

People needed

766

Starts

2005-12-01

Expected to finish

2011-05-01

Last updated by the study team

2013-06-17

Who can join

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

You may qualify if…

• Patients with plaque-type psoriasis diagnosed at least 6 months prior and covering at least 10% of total body surface areas
• Have psoriasis area-and-severity index score of >=12
• Patients who are considered by treating dermatologist to be a candidate for phototherapy or systemic treatment of psoriasis
• Have no history of latent or active TB

You may not qualify if…

• Currently have nonplaque forms of psoriasis or drug-induced psoriasis
• Have any therapeutic agent targeted at reducing IL-12 or IL-23
• Have had a BCG vaccination within the previous 12 months
• 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
• Have or ever have had a nontuberculous mycobacterial infection or opportunistic infection
• Patients known to be infected with human immunodeficiency virus, hepatitis B, or hepatitis C
• 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)

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — Redwood City, California, United States
• Study site — Santa Monica, California, United States
• Study site — Denver, Colorado, United States
• Study site — Wilmington, Delaware, United States
• Study site — Ocala, Florida, United States
• Study site — Alpharetta, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Newnan, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Boise, Idaho, United States
• Study site — Normal, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Lake Charles, Louisiana, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Fridley, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — East Windsor, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — New York, New York, United States
• Study site — Lake Oswego, Oregon, United States
• Study site — Portland, Oregon, United States
• Study site — Goodlettsville, Tennessee, United States

Full record on ClinicalTrials.gov

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