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Phase 3 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
Open (Enrolling)
Both
Psoriasis

Thank you

Trial Information

Phase 3 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:



- Are 18 years or older with diagnosis for at least 12 months of moderate to severe
plaque psoriasis covering as least 10%of body surface area

- a Psoriasis Area and Severity Index (PASI) score of 12 and are considered to be
candidates for systemic or light therapy

- 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 subjects achieving a PGA of "clear" or "almost clear"

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:

A3921078

NCT ID:

NCT01276639

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
Pfizer Investigational Site Birmingham, Alabama  35205
Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Atlanta, Georgia  30342
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Federal Way, Washington  98003
Pfizer Investigational Site Aurora, Colorado  80012
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site Carmel, Indiana  46032
Pfizer Investigational Site North Adams, Massachusetts  01247
Pfizer Investigational Site Asheville, North Carolina  28801
Pfizer Investigational Site Bartlesville, Oklahoma  74006
Pfizer Investigational Site Eugene, Oregon  97401
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Farmington, Connecticut  06030-3805
Pfizer Investigational Site Milwaukee, Wisconsin  53215
Pfizer Investigational Site Omaha, Nebraska  68198
Pfizer Investigational Site Bristol, Tennessee  37620
Pfizer Investigational Site Providence, Rhode Island  02906