Skip to main content
OpenTrials
Completed

NCT Number: NCT00678210

Effectiveness and Safety of 3 Dosing Regimens of CP-690,550 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

The purpose of this study is to determine the effectiveness and safety, over 12 weeks, of 3 dosing regimens of CP-690,550 for the treatment of adults with moderate to severe chronic plaque psoriasis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have been diagnosed with plaque psoriasis for at least 6 months.
  • Have plaque psoriasis covering at least 15% of their total body.
  • Be a candidate for phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment).
  • Be willing and able to comply with scheduled visits, treatment plan and other study procedures.

Exclusion criteria

  • Currently have non-plaque forms of psoriasis or drug-induced psoriasis.
  • Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy.
  • Subject is participating in another trial using an investigational agent or procedure.
  • Women who are pregnant or breast-feeding or considering becoming pregnant.

Treatment and study plan

CP-690,550

Drug

tablets, 2 mg BID for 12 weeks

Placebo

Drug

tablets, BID for 12 weeks

Primary outcomes

  1. Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12

    Time frame: Week 12

    Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

Secondary outcomes

  1. Percentage of Participants Achieving Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear"

    Time frame: Week 2, 4, 8, 12, 14, 16

    Physician global assessment of psoriasis is global consideration of the erythema, induration and scaling across all psoriatic lesions, rated separately over the whole body according to a 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the treatment area overall severity of psoriasis score and category. The score of 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.

  2. Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score

    Time frame: Week 2, 4, 8, 14, 16

    Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

  3. Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score

    Time frame: Week 2, 4, 8, 12, 14, 16

    Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

  4. Percentage of Participants Achieving a 90% Improvement in Psoriasis Area and Severity Index (PASI 90) Score

    Time frame: Week 12

    Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

  5. Psoriasis Area and Severity Index (PASI) Component Scores and Total Score

    Time frame: Baseline, Week 2, 4, 8, 12, 14, 16

    Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

  6. Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16

    Time frame: Baseline, Week 2, 4, 8, 12, 14, 16

    Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 2B, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial Evaluating The Efficacy And Safety Of Dose Regimens With Oral CP-690,550 In The Treatment Of Subjects With Moderate To Severe Chronic Plaque Psoriasis

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 15, 2008
Registry last updated
Dec 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.