A Study To Evaluate The Effects And Safety Of Treatment, Treatment Withdrawal, Followed By Re-Treatment With CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriasis

In brief

The primary objectives of the study are to 1) compare the efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) versus placebo following 24 weeks of CP 690,550 treatment and subsequent withdrawal of active treatment at various timepoints during the 16 week double blind active or placebo treatment period; 2) evaluate the regain of efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) following 4 -16 weeks of CP 690,550 treatment withdrawal and subsequent re treatment; and 3) evaluate the safety and tolerability of CP 690,550 (5 mg BID and 10 mg BID) in subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

Key facts

Study ID

NCT01186744

Run by

Pfizer

People needed

666

Starts

2010-09-01

Expected to finish

2013-01-01

Last updated by the study team

2018-12-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years or older with diagnosis of plaque-type psoriasis (psoriasis vulgaris) for at least 12 months prior to first dose of study drug;
• Psoriasis Area and Severity Index (PASI) score of 12 or greater, AND Physician's Global Assessment (PGA) score of 3 (moderate) or 4 (severe); Psoriasis covering at least 10% of body surface area;
• No evidence of active or latent or inadequately treated infection with Tuberculosis or other serious infections.

You may not qualify if…

• Non-plaque or drug induced forms of psoriasis;
• Cannot discontinue current oral, injectable or topical therapy for psoriasis or cannot discontinue phototherapy (Psoralen Ultraviolet A; Ultraviolet B).
• Any uncontrolled significant medical condition.

Where it is running

• Radiant Research, Inc. — Tucson, Arizona, United States
• Center for Dermatology Clinical Research, Inc. — Fremont, California, United States
• Associates In Research, Inc. — Fresno, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Expresscare Medical — Los Angeles, California, United States
• Dermatology Specialists, Inc. — Oceanside, California, United States
• University of California San Francisco — San Francisco, California, United States
• Longmont Clinic, PC — Longmont, Colorado, United States
• New England Research Associates, LLC — Trumbull, Connecticut, United States
• Florida Academic Dermatology Center — Miami, Florida, United States
• International Dermatology Research, Inc. — Miami, Florida, United States
• Park Avenue Dermatology, PA — Orange Park, Florida, United States
• Ameriderm Research — Ormond Beach, Florida, United States
• Miami Research Associates — South Miami, Florida, United States
• Altman Dermatology Associates — Arlington Heights, Illinois, United States
• Springfield Clinic, LLP — Springfield, Illinois, United States
• Springfield Clinic — Springfield, Illinois, United States
• Deaconess Clinic Downtown — Evansville, Indiana, United States
• DMIA — Louisville, Kentucky, United States
• DermResearch, PLLC — Louisville, Kentucky, United States
• Quest Diagnostics — Louisville, Kentucky, United States
• Northeast Dermatology Associates — Beverly, Massachusetts, United States
• ActivMed Practices and Research, Inc. — Haverhill, Massachusetts, United States
• Michigan Center for Research Corporation dba Michigan Center for Skin Care Research — Clinton Township, Michigan, United States
• Horizon Research Group, Inc. — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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