Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

Pfizer74 sites in 4 countries901 target enrollmentMarch 2011

ConditionsPsoriasis

InterventionsCP-690,550 Placebo/CP-690,550

DrugsCP-690,550 Placebo/CP-690,550

Overview

Phase: Phase 3
Intervention: CP-690,550
Conditions: Psoriasis
Sponsor: Pfizer
Enrollment: 901
Locations: 74
Primary Endpoint: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

April 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Are 18 years or older with diagnosis for at least 12 months of moderate to severe plaque psoriasis covering as least 10%of body surface area
•a Psoriasis Area and Severity Index (PASI) score of 12 and are considered to be candidates for systemic or light therapy
•No evidence of active or latent tuberculosis

Exclusion Criteria

•Non-plaque or drug induced forms of psoriasis
•cannot discontinue current oral, injectible or topical therapy for psoriasis or cannot discontinue phototherapy (PUVA or UVB)
•any uncontrolled significant medical condition

Arms & Interventions

Active Treatment 10 mg BID

Intervention: CP-690,550

ActiveTreatment 5 mg BID

Intervention: CP-690,550

Placebo Treatment

Intervention: Placebo/CP-690,550

Outcomes

Primary Outcomes

Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16

Time Frame: Week 16

The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).

Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16

Time Frame: Week 16

The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline.

Secondary Outcomes

Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52(Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
36-Item Short-Form Health Survey Version 2, Acute (SF-36)(Baseline, Week 16, 28, 52)
Hospital Anxiety and Depression Scale (HADS) Score(Baseline, Week 4, 16, 28, 52)
Work Limitation Questionnaire (WLQ) Index Score(Baseline, Week 4, 16, 28, 52)
Joint Pain Assessment (JPA) Score(Baseline, Week 4, 16, 28, 52)
Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score(Baseline, Week 16, 28, 40, 52)
Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS)(Baseline, Week 16, 28, 40, 52)
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional(Baseline, Week 16)
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work(Baseline, Week 16)
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status(Week 16)
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours(Baseline, Week 16)
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours(Baseline, Week 16)
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work(Baseline, Week 16)
Family Dermatology Life Quality Index (FDLQI) Score(Baseline, Week 16, 52)
Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16(Baseline, Week 16)
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16(Week 16)
Dermatology Life Quality Index (DLQI) Total Score(Baseline)
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16(Week 4, 16)
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 4(Week 4)
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4(Week 4)
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16(Baseline, Week 16)
Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 52(Week 52)
Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52(Week 52)
Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52(Week 52)
Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'(Baseline up to Week 16)
Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response(Baseline up to Week 16)
Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) Response(Baseline up to Week 16)
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'(Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score(Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response(Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Psoriasis Area and Severity Index (PASI) Score(Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52(Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Psoriasis Area and Severity Index (PASI) Component Scores(Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52(Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52(Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Total Body Surface Area (BSA) With Psoriasis(Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52(Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response(Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response(Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score(Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Nail Psoriasis Severity Index (NAPSI) Score(Baseline, Week 8, 16, 20, 28, 40, 52)
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52(Baseline, Week 8, 16, 20, 28, 40, 52)
Number of Affected Nails(Baseline, Week 8, 16, 20, 28, 40, 52)
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52(Baseline, Week 8, 16, 20, 28, 40, 52)
Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response(Week 8, 16, 20, 28, 40, 52)
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response(Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response(Week 16, 28, 52)
Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response(Week 8, 16, 20, 28, 40, 52)
Itch Severity Item (ISI) Score(Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52(Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Dermatology Life Quality Index (DLQI) Score(Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52)