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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Centocor Research & Development, Inc.
• Treatments: Interleukin-12; Ustekinumab

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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