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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 SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteBartlesville, Oklahoma  74006
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteFarmington, Connecticut  06030-3805
Pfizer Investigational SiteMilwaukee, Wisconsin  53215
Pfizer Investigational SiteOmaha, Nebraska  68198
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteProvidence, Rhode Island  02906