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.

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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.

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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.

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

293

Study ID:

NCT01483599

Recruitment Status:

Completed

Sponsor:

Janssen Inc.

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There is 1 Location for this study

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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

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

293

Study ID:

NCT01483599

Recruitment Status:

Completed

Sponsor:


Janssen Inc.

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