Status:
COMPLETED
A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Psoriasis
Lead Sponsor:
Centocor Research & Development, Inc.
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
Although numerous therapeutic options exist for the treatment of psoriasis, there is still a significant unmet medical need due to the limited effectiveness and/or significant side effect profile of c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
1230 Patients enrolled
Trial Details
Trial ID
NCT00307437
Start Date
May 1 2005
End Date
October 1 2011
Last Update
January 24 2013
Active Locations (62)
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1
Birmingham, Alabama, United States
2
Little Rock, Arkansas, United States
3
La Jolla, California, United States
4
Los Angeles, California, United States