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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centocor Research & Development, Inc.
• Treatments: Ustekinumab

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)