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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: CP-690,550
* Drug: CP-690,550
* Drug: CP-690,550
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: CP-690,550<br>* tablets, 2 mg BID for 12 weeks<br>|
| Experimental: 2<br> | Drug: CP-690,550<br>* tablets, 5 mg BID for 12 weeks<br>|
| Experimental: 3<br> | Drug: CP-690,550<br>* tablets, 15 mg BID for 12 weeks<br>|
| Placebo Comparator: 4<br> | Drug: Placebo<br>* tablets, BID for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at 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). | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Physician's Global Assessment (PGA) Score of Clear or Almost Clear | 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. | Week 2, 4, 8, 12, 14, 16 | 
| Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score | 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). | Week 2, 4, 8, 14, 16 | 
| Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score | 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). | Week 2, 4, 8, 12, 14, 16 | 
| Percentage of Participants Achieving a 90% Improvement in Psoriasis Area and Severity Index (PASI 90) Score | 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). | Week 12 | 
| Psoriasis Area and Severity Index (PASI) Component Scores and Total Score | 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). | Baseline, Week 2, 4, 8, 12, 14, 16 | 
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 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). | Baseline, Week 2, 4, 8, 12, 14, 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dose response; PASI 75 response endpoint; subjects with moderate to severe chronic plaque psoriasis