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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



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