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

Psoriasis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00678210
• Other study ID #: A3921047
• Status: Completed
• Phase: Phase 2
• First received: May 13, 2008
• Last updated: November 19, 2012
• Start date: July 2008
• Est. completion date: August 2009

Study information

• Verified date: November 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• CP-690,550
tablets, 2 mg BID for 12 weeks
• CP-690,550
tablets, 5 mg BID for 12 weeks
• CP-690,550
tablets, 15 mg BID for 12 weeks
• Placebo
tablets, BID for 12 weeks

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Barrie	Ontario
Canada	Pfizer Investigational Site	Halifax	Nova Scotia
Canada	Pfizer Investigational Site	Halifax	Nova Scotia
Canada	Pfizer Investigational Site	Halifax	Nova Scotia
Canada	Pfizer Investigational Site	Laval	Quebec
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Moncton	New Brunswick
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	North Bay	Ontario
Canada	Pfizer Investigational Site	Quebec
Canada	Pfizer Investigational Site	St. John's	Newfoundland and Labrador
Canada	Pfizer Investigational Site	Vancouver	British Columbia
Canada	Pfizer Investigational Site	Waterloo	Ontario
Canada	Pfizer Investigational Site	Windsor	Ontario
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	East Windsor	New Jersey
United States	Pfizer Investigational Site	Greer	South Carolina
United States	Pfizer Investigational Site	Greer	South Carolina
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Lake Oswego	Oregon
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Mt. Pleasant	South Carolina
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Norfolk	Virginia
United States	Pfizer Investigational Site	Norman	Oklahoma
United States	Pfizer Investigational Site	Oceanside	California
United States	Pfizer Investigational Site	Paramus	New Jersey
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	Saint Louis	Missouri
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	Tucson	Arizona
United States	Pfizer Investigational Site	Webster	Texas
United States	Pfizer Investigational Site	West Dundee	Illinois
United States	Pfizer Investigational Site	Winston Salem	North Carolina
United States	Pfizer Investigational Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   To obtain contact information for a study center near you, click here.