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A Phase 3, Multi-Site, Randomized, Mixed-Blind, Parallel-Group Treatment Withdrawal And Re-Treatment Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

Phase 3
18 Years
Not Enrolling

Thank you

Trial Information

A Phase 3, Multi-Site, Randomized, Mixed-Blind, Parallel-Group Treatment Withdrawal And Re-Treatment Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Proportion of participants maintaining a PASI75 response (at least a 75% reduction PASI relative to baseline) during the 16 week double blind active or placebo treatment period (CP- 690,550 treatment withdrawal; Period B)

Outcome Time Frame:

Weeks 28,32,36,40

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2010

Completion Date:

January 2013

Related Keywords:

  • Psoriasis
  • chronic
  • moderate
  • severe
  • treatment
  • safety
  • treatment withdrawal
  • retreatment
  • CP-690
  • 550
  • Psoriasis Vulgaris
  • Plaque Psoriasis
  • Psoriasis



Rhode Island Hospital Providence, Rhode Island  02903
Duke University Medical Center Durham, North Carolina  27710
University of California San Francisco San Francisco, California  941104206
Jewish Hospital Cincinnati, Ohio  45236
Springfield Clinic, LLP Springfield, Illinois  62703
Minnesota Clinical Study Center Fridley, Minnesota  55432
Center For Clinical Studies Houston, Texas  77030
Associates In Research, Inc. Fresno, California  93720
New England Research Associates, Llc Trumbull, Connecticut  06611
Altman Dermatology Associates Arlington Heights, Illinois  60004
University Hospitals Case Medical Center Cleveland, Ohio  44106
Miami Research Associates Miami, Florida  33173
Park Avenue Dermatology, PA 1543 Kingsley Ave, Bldg 1 and 16 Orange Park, Florida  32073
Comprehensive Clinical Research Berlin, New Jersey  08009
Springfield Clinic Springfield, Illinois  62703
Dermatology Research Associates Los Angeles, California  90045
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Horizon Research Group, Inc. Mobile, Alabama  36608
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Oregon Medical Research Center, PC Portland, Oregon  97223
Deaconess Clinic Downtown Evansville, Indiana  47713
Ameriderm Research Jacksonville, Florida  32216
Radiant Research, Inc. Greer, South Carolina  29651
Florida Academic Dermatology Center Miami, Florida  33136
DermResearch, PLLC Louisville, Kentucky  40217
Radiant Research, Inc. Chandler, Arizona  85225
Radiant Research, Inc. Akron, Ohio  44311
Dermatology Specialists, Inc. Oceanside, California  92056
Expresscare Medical Los Angeles, California  90045
DMIA Louisville, Kentucky  40207
Quest Diagnostics Louisville, Kentucky  40217
Michigan Center for Research Corporation dba Michigan Center for Skin Care Research Clinton Township, Michigan  48038
Dermatology Associates Wilmington, North Carolina  28401
New Hanover Medical Research Wilmington, North Carolina  28401
Triad Dermatology, PA Winston-Salem, North Carolina  27103
Piedmont Imaging Winston-Salem, North Carolina  27103
Office of Stephen Miller, MD, PA San Antonio, Texas  78229
Mountain State Clinical Research Clarksburg, West Virginia  26301
Center for Dermatology Clinical Research, Inc. Fremont, California  94538
Longmont Clinic, PC Longmont, Colorado  80501
Northeast Dermatology Associates Beverly, Massachusetts  01915
ActivMed Practices and Research, Inc. Haverhill, Massachusetts  01830
PMG Research of Wilmington LLC Wilmington, North Carolina  28401
New Hanover Medical Group, PA Wilmington, North Carolina  28401
Medical Research South, LLC Charleston, South Carolina  29407
Dermatology & Laser Center of Charleston Charleston, South Carolina  29414
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