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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
Not Enrolling
Both
Psoriasis

Thank you

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 DiegoLa Jolla, California  92093
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Oregon Health & Science UniversityPortland, Oregon  97201
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
University of North Carolina at Chapel HillChapel Hill, North Carolina  27599
Brigham & Women's HospitalBoston, Massachusetts  02115
Center For Clinical StudiesHouston, Texas  77030
Penn State Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Healthcare Partners Medical GroupTorrance, California  90503
North Florida Dermatology Associates, PAJacksonville, Florida  32204
Schaumburg DermatologySchaumburg, Illinois  60194
Central Dermatology, PCSt. Louis, Missouri  63117
Burke Pharmaceutical ResearchHot Springs, Arkansas  71913
Virginia Clinical Research, Inc.Norfolk, Virginia  23507
Suzanne Bruce and Associates, PAHouston, Texas  77056
Comprehensive Clinical ResearchBerlin, New Jersey  08009
Dermatology Research AssociatesLos Angeles, California  90045
Hamzavi DermatologyFort Gratiot, Michigan  48059
Bettencourt Skin CenterHenderson, Nevada  89014
Oregon Dermatology and Research CenterPortland, Oregon  97210
The Rockefeller UniversityNew York, New York  10065
Dundee DermatologyWest Dundee, Illinois  60118
Austin Dermatology AssociatesAustin, Texas  78705
Radiant Research, Inc.Akron, Ohio  44311
Arlington Research Center, Inc.Arlington, Texas  76011
Bakersfield Dermatology and Skin Cancer Medical GroupBakersfield, California  93309
MedDerm AssociatesSan Diego, California  92103
NorthShore University HealthSystem - Division of DermatologySkokie, Illinois  60077
Hudson DermatologyEvansville, Indiana  47714
Somerset Skin Centre - DermcenterTroy, Michigan  48084
Saint Louis University - Department of DermatologySaint Louis, Missouri  63104
Dartmouth Hitchcock Medical Center - Section of DermatologyLebanon, New Hampshire  03756
University of North Carolina at Chapel Hill HospitalChapel Hill, North Carolina  27514
Health ConceptsRapid City, South Dakota  57702
InSight Diagnostic CenterDallas, Texas  75243
Office of Mark S. Lee, MDSan Antonio, Texas  78229
Progressive Clinical Research, PASan Antonio, Texas  78229
Expresscare Medical (X-Rays only)Los Angeles, California  90045
Dermatologic Surgery Specialists, PCMacon, Georgia  31217
Sherman Immediate Care Center (Imaging Only)Algonquin, Illinois  60102
University of Minnesota - Department of DermatologyMinneapolis, Minnesota  55455
Dermatology Treatment & Research Center, PADallas, Texas  75230