A Phase 3, Multi-Site, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 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
N/A
18 Years
N/A
Not Enrolling
Both
Psoriasis
Both
Psoriasis
Trial Information
A Phase 3, Multi-Site, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 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 for at least 12 months of moderate to severe plaque
psoriasis covering at least 10% of body surface area
- A Psoriasis Area and Severity Index (PASI) score of 12 or greater
- Are considered to be candidates for systemic or light therapy
- Have no evidence of active or latent tuberculosis
Exclusion Criteria:
- Non-plaque or drug-induced forms of psoriasis
- Cannot discontinue current oral, injectible or topical therapy for psoriasis or
cannot discontinue phototherapy (PUVA or UVB)
- Any uncontrolled significant medical condition
Type of Study:
Interventional
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:
Physician's Global Assessment (PGA)response, ie, the proportion of participants achieving a PGA of "clear" or "almost clear" at week 16
Outcome Time Frame:
week 16
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A3921079
NCT ID:
NCT01309737
Start Date:
March 2011
Completion Date:
April 2013
Related Keywords:
- Psoriasis
- chronic
- severe
- moderate
- treatment
- safety
- efficacy
- CP-690,550
- Plaque Psoriasis
- Psoriasis Vulgaris
- Psoriasis
Name | Location |
|---|---|
| University of California San Diego | La Jolla, California 92093 |
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
| Oregon Health & Science University | Portland, Oregon 97201 |
| Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
| University of North Carolina at Chapel Hill | Chapel Hill, North Carolina 27599 |
| Brigham & Women's Hospital | Boston, Massachusetts 02115 |
| Center For Clinical Studies | Houston, Texas 77030 |
| Penn State Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
| Healthcare Partners Medical Group | Torrance, California 90503 |
| North Florida Dermatology Associates, PA | Jacksonville, Florida 32204 |
| Schaumburg Dermatology | Schaumburg, Illinois 60194 |
| Central Dermatology, PC | St. Louis, Missouri 63117 |
| Burke Pharmaceutical Research | Hot Springs, Arkansas 71913 |
| Virginia Clinical Research, Inc. | Norfolk, Virginia 23507 |
| Suzanne Bruce and Associates, PA | Houston, Texas 77056 |
| Comprehensive Clinical Research | Berlin, New Jersey 08009 |
| Dermatology Research Associates | Los Angeles, California 90045 |
| Hamzavi Dermatology | Fort Gratiot, Michigan 48059 |
| Bettencourt Skin Center | Henderson, Nevada 89014 |
| Oregon Dermatology and Research Center | Portland, Oregon 97210 |
| The Rockefeller University | New York, New York 10065 |
| Dundee Dermatology | West Dundee, Illinois 60118 |
| Austin Dermatology Associates | Austin, Texas 78705 |
| Radiant Research, Inc. | Akron, Ohio 44311 |
| Arlington Research Center, Inc. | Arlington, Texas 76011 |
| Bakersfield Dermatology and Skin Cancer Medical Group | Bakersfield, California 93309 |
| MedDerm Associates | San Diego, California 92103 |
| NorthShore University HealthSystem - Division of Dermatology | Skokie, Illinois 60077 |
| Hudson Dermatology | Evansville, Indiana 47714 |
| Somerset Skin Centre - Dermcenter | Troy, Michigan 48084 |
| Saint Louis University - Department of Dermatology | Saint Louis, Missouri 63104 |
| Dartmouth Hitchcock Medical Center - Section of Dermatology | Lebanon, New Hampshire 03756 |
| University of North Carolina at Chapel Hill Hospital | Chapel Hill, North Carolina 27514 |
| Health Concepts | Rapid City, South Dakota 57702 |
| InSight Diagnostic Center | Dallas, Texas 75243 |
| Office of Mark S. Lee, MD | San Antonio, Texas 78229 |
| Progressive Clinical Research, PA | San Antonio, Texas 78229 |
| Expresscare Medical (X-Rays only) | Los Angeles, California 90045 |
| Dermatologic Surgery Specialists, PC | Macon, Georgia 31217 |
| Sherman Immediate Care Center (Imaging Only) | Algonquin, Illinois 60102 |
| University of Minnesota - Department of Dermatology | Minneapolis, Minnesota 55455 |
| Dermatology Treatment & Research Center, PA | Dallas, Texas 75230 |
