Psoriasis Clinical Trial
A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis
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.
Full 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 of 7 treatment groups: a placebo group (a placebo is a treatment identical in appearance to CNTO 1959 but does not contain active drug), 1 of 5 dose groups for CNTO 1959, or adalimumab. Patients assigned to adalimumab will be dosed according to the labeled dosing for psoriasis. At Week 16, patients initially assigned to placebo will begin receiving CNTO 1959. Patients initially assigned to CNTO 1959 will continue to receive the same assigned dose level of study agent from Week 16 through Week 40. Patients receiving adalimumab will continue the labeled dosing regimen. All patients will be reassessed for clinical response every 4 weeks from Week 4 through Week 40. Patients will continue dosing through Week 40, with a subsequent efficacy and safety follow-up visit at Week 52. Patient safety will be monitored throughout the study.
Eligibility 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.
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There is 1 Location for this study
Birmingham Alabama, , United States
Bakersfield California, , United States
Los Angeles California, , United States
Santa Monica California, , United States
Ocala Florida, , United States
Alpharetta Georgia, , United States
Arlington Heights Illinois, , United States
Skokie Illinois, , United States
Indianapolis Indiana, , United States
Louisville Kentucky, , United States
Andover Massachusetts, , United States
Boston Massachusetts, , United States
Saint Louis Missouri, , United States
Albuquerque New Mexico, , United States
New York New York, , United States
Portland Oregon, , United States
Pittsburgh Pennsylvania, , United States
Houston Texas, , United States
Brussel , , Belgium
Gent , , Belgium
Liege , , Belgium
Edmonton Alberta, , Canada
Vancouver British Columbia, , Canada
Moncton New Brunswick, , Canada
Halifax Nova Scotia, , Canada
Hamilton Ontario, , Canada
London Ontario, , Canada
Oakville Ontario, , Canada
Toronto Ontario, , Canada
Waterloo Ontario, , Canada
Montreal Quebec, , Canada
Quebec , , Canada
Hamburg , , Germany
Mahlow , , Germany
Munster , , Germany
Schwerin , , Germany
Gdansk , , Poland
Konskie N/A , , Poland
Lodz , , Poland
Wroclaw , , Poland
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