Status:
COMPLETED
A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis
Lead Sponsor:
Janssen Inc.
Conditions:
Psoriasis
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of CNTO 1959 in the treatment of patients with moderate to severe plaque psoriasis.
Detailed Description
This is a multicenter, dose-ranging study of CNTO 1959 in patients with moderate to severe plaque psoriasis. Patients who satisfy all inclusion and exclusion criteria will be assigned by chance to one...
Eligibility Criteria
Inclusion
- Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent
- Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment)
- Must be considered, in the opinion of the investigator, suitable candidates for adalimumab therapy
- If a woman, she must be postmenopausal, or if premenopausal, she must be either surgically sterile, practicing a highly effective method of birth control, or not heterosexually active during the study and for 5 months after receiving the last dose of study drug
- If a man, he must agree to use a double-barrier method of birth control (or must have been surgically sterilized) and to not donate sperm during the study and for 5 months after receiving the last dose of study drug.
Exclusion
- History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
- Has a contra-indication to anti-TNF therapy
- Has a history of chronic or recurrent infectious disease
- Has a nonplaque form of psoriasis or has drug-induced psoriasis
- Has been previously treated with adalimumab
- Has received any therapeutic agent directly targeted to IL-12, IL-17, or IL-23, (including but not limited to ustekinumab, briakinumab \[ABT-874\], AIN457, and SCH900222) within 6 months of the first administration of study agent.
Key Trial Info
Start Date :
November 10 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2013
Estimated Enrollment :
293 Patients enrolled
Trial Details
Trial ID
NCT01483599
Start Date
November 10 2011
End Date
August 5 2013
Last Update
August 2 2017
Active Locations (40)
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1
Birmingham, Alabama, United States
2
Bakersfield, California, United States
3
Los Angeles, California, United States
4
Santa Monica, California, United States