Overview

A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis

Status:
Completed
Trial end date:
2013-08-05
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Inc.
Treatments:
Adalimumab
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.