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

Phase 2

Completed

• Conditions: Psoriasis
• Interventions: Drug: CP-690,550; Drug: Placebo

• Registration Number: NCT00678210
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-13
• Study First Submitted QC: 2008-05-13
• Study First Posted: 2008-05-15
• Study Start: 2008-07
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Disposition First Submitted: 2011-03-24
• Disposition First Submitted QC: 2011-03-24
• Disposition First Posted: 2011-04-01
• Status Verified: 2012-11
• Results First Submitted: 2012-11-19
• Results First Submitted QC: 2012-11-19
• Last Update Submitted: 2012-11-19
• Results First Posted: 2012-12-19
• Last Update Posted: 2012-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CP-690,550	-
2	CP-690,550	-
3	CP-690,550	-
4	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12	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 Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇦 Quebec, Canada